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lamivudine

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Lamivudine, a nucleoside analog, is a potent antiviral drug used primarily to treat chronic hepatitis B infection and HIV infection. It is a synthetic analog of cytidine and acts by inhibiting the reverse transcriptase enzyme of HIV and the DNA polymerase of hepatitis B virus, preventing viral replication. It is well-tolerated with a favorable safety profile. It is studied for its antiviral properties and its potential to improve patient outcomes in treating HIV and hepatitis B.'

Cross-References

ID SourceID
PubMed CID60825
CHEMBL ID141
CHEBI ID63577
SCHEMBL ID109675
MeSH IDM0028682
PubMed CID73339
CHEMBL ID18314
SCHEMBL ID33979
MeSH IDM0028682

Synonyms (236)

Synonym
BIDD:GT0033
AC-1416
bch189
bch 189
4-amino-1-((2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)pyrimidin-2(1h)-one
AB00639995-08
3tc & sst
.beta.-l-(-)-2',3'-dideoxy-3'-thiacytidine & sho-saiko-to
3tc and nv-01
lamivir
(-)-sddc
zefix
bch-790
gg-714
3tc & gna
hha & lamivudine
2(1h)-pyrimidinone, 4-amino-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl], (-)(2r,5s) & galanthus nivalis agglutinin (gna)
hha & 3tc
2(1h)-pyrimidinone, 4-amino-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl], (-)(2r,5s) & hippeastrum hybrid agglutinin( hha)
lamivudine & gna
4-amino-1-[(2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]pyrimidin-2(1h)-one
hsdb 7155
gr109714x
heptovir
gr 109714x
bch 189, (-)-
hepitec
epivir
(-)-bch 189
2(1h)-pyrimidinone, 4-amino-1-(2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-, (2r-cis)-
4-amino-1-((2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-2(1h)-pyrimidinone
beta-l-3'-thia-2',3'-dideoxycytidine
2(1h)-pyrimidinone, 4-amino-1-((2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-
(-)-1-((2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)cytosine
3'-thia-2',3'-dideoxycytidine
beta-l-2',3'-dideoxy-3'-thiacytidine
(+/-)-3tc
136891-12-8
nsc620753
(+/-)-sddc
2(1h)-pyrimidinone, 4-amino-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl], (+/-) (cis)
(+/-)-bch-189
(+/-) (cis)-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine
bch-189
zeffix
(-)ngpb-21
epivir(tm)
drg-0126
(-)-(2'r,5's)-1-[2'-hydroxymethyl-5'-(1,3-oxathiolanyl)]cytosine
gr-109714x
(-)-2'-deoxy-3'-thiacytidine
(-)-bch-189
heptodin
epivir-hbv
4-amino-1-[(2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]pyrimidin-2-one
heptivir
dthc
MLS001424097
134678-17-4
lamivudine ,
2',3'-dideoxy-3'-thiacytidine
C07065
3tc ,
MLS000759424
smr000466319
cpd000466319
NCGC00159341-04
DB00709
epivir (tn)
D00353
lamivudine (jan/usp/inn)
HMS2051D21
(-)-1-[(2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine
L0217
nsc-760061
lamivudine teva
virolam
chebi:63577 ,
CHEMBL141 ,
lamivudinum
STK801940
AKOS005622556
NCGC00159341-05
HMS3259F08
2(1h)-pyrimidinone, 4-amino-1-[(2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-
2t8q726o95 ,
lamivudine [usan:usp:inn:ban]
nsc 760061
ccris 9274
unii-2t8q726o95
dtxsid7023194 ,
CCG-100984
bdbm50366817
lamivudine [usan:ban:inn]
kivexa component lamivudine
lamivudine [usp-rs]
temixys component lamivudine
lamivudine [ep impurity]
lamivudine component of triumeq
lamivudine [mi]
triumeq component lamivudine
lamivudine [mart.]
4-amino-1-((2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)pyrimidin-2(1h)-one [who-ip]
lamivudine [usp monograph]
telura component of lamivudine
lamivudine [usan]
lamivudine [vandf]
lamivudine component of epzicom
lamivudine [hsdb]
emtricitabine impurity c [who-ip]
trizivir component lamivudine
lamivudine teva pharma b.v.
combivir component lamivudine
lamivudine component of dutrebis
delstrigo component lamivudine
lamivudine [ema epar]
lamivudine [who-ip]
lamivudine [orange book]
lamivudine [inn]
epzicom component lamivudine
lamivudinum [who-ip latin]
lamivudine [jan]
lamivudine component of trizivir
lamivudine [ep monograph]
lamivudine component of delstrigo
lamivudine component of lamivudine/zidovudine teva
lamivudine component of temixys
lamivudine component of combivir
lamivudine [who-dd]
lamivudine/zidovudine teva component lamivudine
S1706
AKOS015854841
cis-lamivudine
BBL033871
HY-B0250
AB00639995-06
cis(+/-)-4-amino-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-2(1h)-pyrimidinone
(+/-)-(cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1h)-pyrimidin-2-one
4-amino-1-[(2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-(1h)-pyrimidin-2-one
JTEGQNOMFQHVDC-NKWVEPMBSA-N
(2r,5s)-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine
4-amino-1-[(2r,5s)-2-(hydroxymethyl)-[1,3]-oxathiolan-5-yl]-(1h)-pyrimidin-2-one
lamivudine & tnf-alpha & ifn-gamma
SCHEMBL109675
NC00705
NC00234
KS-1073
J-700183
MLS006011910
Q-201275
AB00639995_09
mfcd00869739
4-amino-1-[(2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-1,2-dihydropyrimidin-2-one
4-amino-1-[(2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-2(1h)-pyrimidinone
SR-01000759420-5
sr-01000759420
4-amino-1-(cis-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)pyrimidin-2(1h)-one
P17147
lamivudine, united states pharmacopeia (usp) reference standard
lamivudine, 1.0 mg/ml in methanol, certified reference material
lamivudine, >=98% (hplc), powder
lamivudine for system suitability 1, european pharmacopoeia (ep) reference standard
lamivudine for system suitability 2, european pharmacopoeia (ep) reference standard
lamivudine, european pharmacopoeia (ep) reference standard
lamivudine, pharmaceutical secondary standard; certified reference material
HMS3713C16
lamivudine, british pharmacopoeia (bp) reference standard
SW197614-3
(-)-l-2',3'-dideoxy-3'-thiacytidine; lamivudine; epivir
Q422631
gtpl12673
lamivudine (epivir)
mfcd00870542
1117764-41-6
(-)-bch189
AMY384
NCGC00159341-18
lamivudine 100 microg/ml in acetonitrile:water
NCGC00159341-20
rac-cis-lamivudine ((2rs,5sr)-lamivudine)
lamivudine- bio-x
BL164607
EN300-123034
Z1509637175
lamivudine, (+)-cis-
4-amino-1-((2s,5r)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)pyrimidin-2(1h)-one
nsc-620753
2'-deoxy-3'-thiacytidine
4-amino-1-[(2s,5r)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]pyrimidin-2(1h)-one
134680-32-3
(+)-bch-189
(+)-sddc
(+)-3tc
4-amino-1-[(2s,5r)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]pyrimidin-2-one
(+)-2',3'-dideoxy-3'-thiacytidine
2(1h)-pyrimidinone, 4-amino-1-[(2s,5r)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-
(+)-(2s,5r)-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine
NCGC00090679-01
smr000673568
MLS001055352
lamavudine
azt + 3tc combination
4-amino-1-[(2s,5r)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-2(1h)-pyrimidinone
ent-lamivudine
cis(+)-2-hydroxymethyl-5-(cytosin-1-yl)-1,3-oxathiolane
(2s-cis)-4-amino-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-2(1h)-pyrimidinone
HMS3039G03
dtxcid803194
tox21_303147
cas-134678-17-4
NCGC00257009-01
tox21_111585
tox21_111586
CHEMBL18314
4-amino-1-[(2s,5r)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-1,2-dihydropyrimidin-2-one
h6s9d88t3d ,
4-amino-1-(2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-2(1h)-pyrimidinone
unii-h6s9d88t3d
(+)-bch 189
2(1h)-pyrimidinone, 4-amino-1-((2s,5r)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-
(2s-cis)-4-amino-1-(2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-2(1h)-pyrimidinone
2(1h)-pyrimidinone, 4-amino-1-(2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-, (2s-cis)-
JTEGQNOMFQHVDC-RQJHMYQMSA-N
(2s*,5r*)-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine
SCHEMBL33979
bch-189, (+)-
lamivudine impurity d [usp impurity]
lamivudine impurity d [ep impurity]
F8881-8887
AKOS026729682
Q27279715
(+)-cis-lamivudine
AT23240
DTXSID301307509
4-amino-1-[(2s,5r)-2-(hydroxy-methyl)-1,3-oxathiolan-5-yl]pyrimidin-2(1h)-one
Z754931268

Research Excerpts

Overview

Lamivudine (3TC) is a nucleoside reverse transcriptase inhibitor (NRTI) licensed for as a first line drug in Human immunodeficiency virus (HIV) infection and also in the treatment of hepatitis B. It is a substrate of renal drug transporters OCT2, MATE1, and MATE2-K.

ExcerptReferenceRelevance
"Lamivudine is a first-line medication used for human immunodeficiency virus (HIV) treatment. "( Population pharmacokinetics and model-informed precision dosing of lamivudine in Chinese HIV-infected patients with mild and moderate impaired renal function.
Jiao, Z; Liu, L; Liu, X; Lu, H; Meng, X; Sun, T; Wang, J; Wen, H; Xing, Y; Xu, F; Yin, L; Zhang, L; Zhang, M; Zhang, R, 2022
)
2.4
"Lamivudine monotherapy is a common choice when holding regimens are used, on the premise that the lamivudine-associated M184V resistance mutation reduces viral replication and may maintain clinical and immunological stability compared with discontinuing treatment altogether."( Lamivudine monotherapy in children and adolescents: The devil is in the detail.
Bernheimer, J; Fairlie, L; Fick, C; Kuhn, L; Sipambo, N, 2017
)
2.62
"Lamivudine is a nucleoside reverse transcriptase inhibitor used to treat HIV and hepatitis B. "( Using PBPK Modeling to Predict Drug Exposure and Support Dosage Adjustments in Patients With Renal Impairment: An Example with Lamivudine.
Cha, A; Fischetti, B; Shah, K; Taft, DR, 2020
)
2.21
"Lamivudine (3TC) is a nucleoside reverse transcriptase inhibitor (NRTI) licensed for as a first line drug in Human immunodeficiency virus (HIV) infection and also in the treatment of hepatitis B. "( Severe skin rash with lamivudine in HIV infected patients: some unusual case reports.
Guha, SK; Modak, D,
)
1.89
"Lamivudine is a substrate of renal drug transporters OCT2, MATE1, and MATE2-K."( Role of organic cation transporter OCT2 and multidrug and toxin extrusion proteins MATE1 and MATE2-K for transport and drug interactions of the antiviral lamivudine.
Fromm, MF; Hoier, E; König, J; Mandery, K; Müller, F, 2013
)
1.31
"Lamivudine monotherapy is a relatively cheap and effective treatment to manage CHB."( Pretreatment and on-treatment indicators of virologic breakthrough of lamivudine therapy in chronic hepatitis B patients: an Egyptian study.
Abdelkader, NA; F, IM; Ismail, SA; Montasser, MF, 2014
)
1.36
"Lamivudine is an antiviral used for the treatment of chronic hepatitis B. "( Treatment of chronic hepatitis B patients with tyrosine-methionine-aspartate-aspartate mutations.
Calica Utku, A; Karabay, O, 2016
)
1.88
"Lamivudine resistance is a result of mutations in YMDD motif in which rt203-206th codons (Y: tyrosine; M: methionin; D: aspartic acid; D: aspartic acid) of reverse trancriptase; the catalytic part of hepatitis B polymerase enzyme, takes place. "( [YMDD motif variants detected by Inno-Lipa HBV DR assay in chronic hepatitis B patients during lamivudine therapy].
Arslan, U; Findik, D; Ural, O, 2008
)
2.01
"Lamivudine prophylaxis is an effective strategy in HbSAg-positive patients receiving cancer chemotherapy. "( Effect of prophylactic lamivudine for chemotherapy-associated hepatitis B reactivation in lymphoma: a meta-analysis of published clinical trials and a decision tree addressing prolonged prophylaxis and maintenance.
Karsaliakos, P; Mylonakis, E; Ziakas, PD, 2009
)
2.11
"Lamivudine is a nucleoside analogue approved for treating chronic hepatitis B, that decreases the amount of viral antigens by suppressing HBV replication."( Successful lamivudine monotherapy in an elderly patient suffering from HBV-related decompensated cirrhosis associated with widespread leukocytoclastic vasculitis.
Conca, P; Riccio, A; Tarantino, G,
)
1.24
"Lamivudine (LVD) is a nucleoside analogue and following long term LVD therapy, resistance emerges in a significant number of patients."( [Entecavir resistance in entecavir naive lamivudine treated chronic hepatitis B patients].
Akhan, SC; Cekmen, M; Hülagü, S; Meriç, M; Sayan, M; Sentürk, O, 2009
)
1.34
"Lamivudine is a nucleoside reverse transcriptase inhibitor that is widely used for the treatment of HIV-1 infection in combination with other antiretrovirals. "( Lamivudine for the treatment of HIV.
Kumar, PN; Patel, P, 2010
)
3.25
"Lamivudine is a nucleoside analogue that is used clinically for treating chronic hepatitis B infection. "( Hepatitis B virus genotyping among chronic hepatitis B patients with resistance to treatment with lamivudine in the City of Ribeirão Preto, State of São Paulo.
Haddad, R; Martinelli, Ade L; Uyemura, SA; Yokosawa, J,
)
1.79
"Lamivudine (3TC) is a nucleoside reverse transcriptase inhibitor."( Evaluation of steady-state pharmacokinetic interactions between ritonavir-boosted BILR 355, a non-nucleoside reverse transcriptase inhibitor, and lamivudine/zidovudine in healthy subjects.
Allen, L; Castles, MA; Huang, DB; Huang, F; MacGregor, TR; Moy, F; Nguyen, T; Robinson, P; Rowland, L; Vinisko, R, 2012
)
1.3
"Lamivudine is a potent oral anti-viral medicine for the treatment of hepatitis B virus (HBV) infection. "( Non-response to previous interferon therapy and cirrhosis are risk factors for predicting breakthrough during lamivudine therapy in patients with chronic hepatitis B.
Kojima, S; Mine, T; Motegi, S; Nishizaki, Y; Shiozawa, H; Watanabe, N, 2010
)
2.02
"Lamivudine is a nucleoside reverse transcriptase inhibitor widely used in infants and children in combination antiretroviral therapy to treat human immunodeficiency virus (HIV) infection. "( Developmental pharmacokinetic changes of Lamivudine in infants and children.
Capparelli, EV; Chokephaibulkit, K; Cressey, TR; McKinney, R; Mirochnick, M; Nikanjam, M; Tremoulet, AH, 2012
)
2.09
"Lamivudine (3TC) is an antiviral drug with a widely demonstrated clinical efficacy used to treat Acquired Immunodeficiency Syndrome (AIDS) in humans. "( Intestinal permeability of lamivudine (3TC) and two novel 3TC prodrugs. Experimental and theoretical analyses.
Briñón, MC; Gualdesi, MS; Quevedo, MA, 2012
)
2.12
"Lamivudine is a new alternative therapeutic agent for chronic hepatitis B, in which alpha interferon (IFN-alpha) monotherapy is not successful enough. "( Alpha interferon and lamivudine combination therapy for chronic hepatitis B in children.
Aydogdu, S; Selimoglu, MA; Unal, F; Yagci, RV; Yüce, G; Zeytinoglu, A, 2002
)
2.08
"Lamivudine (3TC) is a nucleoside analogue which inhibits replication of HIV and HBV and which is used in the treatment of chronic hepatitis B-infected patients with safety and efficacy. "( [Evaluation of a quantitative HBV-DNA PCR assay in lamivudine treated hepatitis B-infected patients].
Ajana, F; Bocket, L; Canva, V; Deal, C; Mouton, Y; Wattré, P; Yazdanpanah, Y,
)
1.83
"Lamivudine is an effective and well-tolerated therapeutic agent for treating chronic HBV in patients with and without cirrhosis."( Long-term lamivudine therapy for chronic hepatitis B in patients with and without cirrhosis.
Cho, SW; Kyun, J; Oh, JM, 2002
)
2.16
"Lamivudine is a nuleoside analog with potent inhibitory effects on hepatitis B virus (HBV) replication. "( Management of YMDD mutations during lamivudine therapy in patients with chronic hepatitis B.
Liaw, YF, 2002
)
2.03
"Lamivudine appears to be a safe and effective antiviral agent, which may improve or stabilize liver disease in selected patients with advanced cirrhosis and active HBV replication."( Management of patients with decompensated HBV cirrhosis.
Fontana, RJ, 2003
)
1.04
"Lamivudine is a potent inhibitor of hepatitis B virus (HBV) replication. "( Lamivudine treatment for chronic hepatitis B infection in children unresponsive to interferon.
Berkowitz, D; Daudi, N; Eshach-Adiv, O; Hartman, C; Hino, B; Kra-Oz, T; Rimon, N; Satinger, I; Shamir, R; Shouval, D, 2003
)
3.2
"Lamivudine is a nucleoside analogue and a potent inhibitor of HBV reverse transcription."( Prophylaxis against chemotherapy-induced reactivation of hepatitis B virus infection with Lamivudine.
Ahmed, A; Ahmed, AM; Garcia, G; Keeffe, EB; Nguyen, MH; Simpson, ND; Simpson, PW, 2003
)
1.26
"Lamivudine is a nucleoside analogue with potent antiviral activity against hepatitis B virus (HBV). "( Plasma pituitary adenylate cyclase activating polypeptide (PACAP) levels in chronic hepatitis B patients under lamivudine treatment.
Elefsiniotis, IS; Kafiri, G; Ketikoglou, I; Mavrogiannis, C; Moulakakis, A; Pantazis, KD, 2003
)
1.97
"Lamivudine is a promising agent in the treatment of chronic hepatitis B, but the success is hampered by a high relapse rate and the emergence of viral resistance."( [Therapy of viral hepatitis].
Burckhardt, B; Reichen, J, 2003
)
1.04
"Lamivudine is a nucleoside analogue which can directly suppress Hepatitis B virus (HBV) replication."( Lamivudine therapy in acute leukemia patients who are hepatitis B surface antigen carriers.
Aki, SZ; Aköz, AG; Ayli, M; Dagdas, S; Güler, N; Özet, G; Saritas, U; Yilmaz, M, 2003
)
2.48
"Lamivudine is a nucleoside analogue with potent inhibitory effects on hepatitis B virus (HBV) polymerase/reverse transcriptase activity. "( Short-term lamivudine therapy in patients with chronic hepatitis B.
Chien, RN; Liaw, YF, 2003
)
2.15
"Lamivudine is a treatment option for the therapy of chronic hepatitis B with an excellent safety profile. "( Severe exacerbation of chronic hepatitis B after emergence of lamivudine resistance in a cirrhotic patient: immediate switch to adefovir dipivoxil appears to be indicated.
Flemming, P; Klempnauer, J; Manns, MP; Nashan, B; Niemann, P; Rohde, P; Tillmann, HL; Tischendorf, JJ; Trautwein, C; Wiegand, J, 2004
)
2.01
"Lamivudine is a potent inhibitor of hepatitis B virus replication, but an increased incidence of YMDD mutation may be associated with its long term use. "( [Pretreatment ALT level and histologic activity as predictors of HBeAg loss in lamivudine treatment for chronic hepatitis B].
Kang, KH; Kweon, YO, 2004
)
1.99
"Lamivudine is an antiviral drug that is used to treat hepatitis B virus (HBV) infection. "( Quantitation of hepatitis B lamivudine resistant mutants by real-time amplification refractory mutation system PCR.
Cane, P; Punia, P; Saunders, N; Teo, CG, 2004
)
2.06
"Lamivudine is an effective first-line therapy for chronic hepatitis B virus (HBV) infection, accomplishing the goals of viral suppression, normalization of alanine aminotransferase (ALT) levels, histological improvement, and seroconversion. "( Clinical trial results and treatment resistance with lamivudine in hepatitis B.
Wright, TL, 2004
)
2.02
"Lamivudine is a safe drug with rare and generally mild side effects."( Current antiviral therapy for chronic hepatitis B.
Lim, YS; Suh, DJ, 2004
)
1.04
"Lamivudine is a relatively recent alternative to alpha interferon for the treatment of HBV infection, but unfortunately, resistance to lamivudine commonly develops during monotherapy."( Pyrosequencing for detection of lamivudine-resistant hepatitis B virus.
Albert, J; Lindström, A; Odeberg, J, 2004
)
1.33
"Lamivudine is a potent inhibitor of hepatitis B virus (HBV) replication. "( Long-term therapy with lamivudine in renal transplant recipients with chronic hepatitis B.
Benhamou, Y; Bernard-Chabert, B; Bitker, MO; Di Martino, V; Le Calvez, S; Mouquet, C; Opolon, P; Poynard, T; Thabut, D; Thibault, V, 2004
)
2.08
"Lamivudine is a safe and effective treatment of active hepatitis B in renal transplant patients. "( Long-term therapy with lamivudine in renal transplant recipients with chronic hepatitis B.
Benhamou, Y; Bernard-Chabert, B; Bitker, MO; Di Martino, V; Le Calvez, S; Mouquet, C; Opolon, P; Poynard, T; Thabut, D; Thibault, V, 2004
)
2.08
"Lamivudine is a potent antiviral agent with minimal immune modulator capacity."( In vivo immunization by vaccine therapy following virus suppression by lamivudine: a novel approach for treating patients with chronic hepatitis B.
Abe, M; Fazle Akbar, SM; Hiasa, Y; Horiike, N; Joukou, K; Kojima, N; Michitaka, K; Onji, M; Yamamoto, K, 2005
)
1.28
"Lamivudine is a safe, effective treatment for hepatitis B virus (HBV) reactivation after renal transplantation. "( Treatment with adefovir dipivoxil in a renal transplant patient with renal insufficiency and lamivudine-resistant hepatitis B infection.
Ceballos, M; Diaz, F; Garcia, A; Garcia, T; González, P; Mazuecos, A; Rivero, M, 2005
)
1.99
"Lamivudine is an antiretroviral agent, and skin eruption because of this agent has been rarely reported."( Ichthyosiform eruption associated with lamivudine in a patient with chronic hepatitis-B infection.
Kaptanoglu, AF; Kutluay, L, 2005
)
1.32
"Lamivudine is a nucleoside analogue with a potent antiviral activity used as prophylaxis against hepatitis B virus reactivation in patients with chronic HBV infection receiving chemotherapy. "( Fatal hepatic decompensation in a bone marrow transplant recipient with HBV-related cirrhosis following lamivudine withdrawal.
Boninsegna, S; Caroli, D; Fagiuoli, S; Floreani, A; Lobello, S, 2006
)
1.99
"Lamivudine is an effective therapy in chronic hepatitis B patients, but the emergence of resistant hepatitis B virus (HBV) mutants is a major concern. "( [Correlation of HBV DNA level and viral breakthrough during lamivudine therapy for chronic hepatitis B].
Cho, M; Heo, J; Kang, DH; Kim, GH; Lee, DH; Park, HS; Song, GA, 2006
)
2.02
"Lamivudine is a pyrimidine analogue that inhibits HBV-DNA reverse transcriptase."( Lamivudine treatment in patients with chronic hepatitis B and cirrhosis.
Haché, C; Villeneuve, JP, 2006
)
2.5
"Lamivudine is an oral nucleoside analogue with strong antiviral activity against hepatitis B virus. "( [Results of 48 weeks lamivudine treatment of patients with chronic hepatitis B and HBeAg (-)].
Berak, H; Cybula, A; Horban, A; Stańczak, JJ; Wasilewski, M, 2006
)
2.1
"Lamivudine is an oral nucleoside analogue with strong antiviral activity against hepatitis B virus."( [Results of 48 weeks lamivudine treatment of patients with chronic hepatitis B and HBeAg (+)].
Berak, H; Cybula, A; Horban, A; Stańczak, JJ; Wasilewski, M, 2006
)
1.37
"Lamivudine is a major drug approved for treatment of chronic hepatitis B virus (HBV) infection. "( Emergence of a novel lamivudine-resistant hepatitis B virus variant with a substitution outside the YMDD motif.
Abe, H; Chayama, K; Fujimoto, Y; Hiraga, N; Imamura, M; Iwao, E; Kumada, H; Maekawa, T; Mori, N; Noguchi, C; Ochi, H; Suzuki, F; Takahashi, S; Tateno, C; Tsuge, M; Yatsuji, H; Yoshizato, K, 2006
)
2.1
"Lamivudine is a nucleoside analogue used in chronic HBI treatment that works by suppressing replication of the hepatitis B virus (HBV)."( Successful treatment of hepatitis B-associated leukocytoclastic vasculitis with lamivudine treatment in a child patient.
Baskin, E; Bilezikçi, B; Canan, O; Melek, E; Ozçay, F; Surmali Onay, O, 2007
)
1.29
"Lamivudine (LAM) is a nucleoside analogue widely used for the treatment of chronic hepatitis B virus (HBV) infection. "( Serum HBV RNA is a predictor of early emergence of the YMDD mutant in patients treated with lamivudine.
Abe, H; Aimitsu, S; Aisaka, Y; Chayama, K; Fujimoto, Y; Hatakeyama, T; Hiraga, N; Imamura, M; Kawakami, H; Kawakami, Y; Kohno, H; Maekawa, T; Mori, N; Noguchi, C; Ochi, H; Takahashi, S; Tsuge, M; Yatsuji, H, 2007
)
2
"Lamivudine appeared to be a substrate of ABCG2 in vitro, but the disposition of lamivudine was not significantly influenced by known in vitro functional variants of ABCG2, Q141K, V12M and Q126X in healthy subjects."( The effect of ABCG2 V12M, Q141K and Q126X, known functional variants in vitro, on the disposition of lamivudine.
Jung, HE; Kang, HJ; Kim, EY; Kim, HS; Ryu, JY; Shim, JC; Shin, JG; Shon, JH; Song, IS; Sunwoo, YE, 2007
)
2
"Lamivudine is considered to be a drug of choice for these patients, however, its efficacy in patients with hepatitis B after renal transplantation (RT) has not been completely proven."( Treatment of chronic hepatitis B with lamivudine in renal transplant recipients.
Bakulin, I; Balakirev, E; Baranova, F; Chervinko, V; Kovalchuk, A; Novozhenov, V; Stahanova, V; Stanke, A; Stenina, I; Zolotarevsky, V; Zubkin, M, 2007
)
1.33
"Lamivudine is an effective therapy if used in early stages of both spontaneous exacerbation and reactivation after immunosuppressive therapy."( Lamivudine for treatment of spontaneous exacerbation and reactivation after immunosuppressive therapy in patients with hepatitis B virus infection.
Fuke, H; Inoue, T; Ito, K; Shiraki, K; Yamamoto, N; Yutaka, KY,
)
2.3
"Lamivudine is a suitable alternative to IFN alpha owing to its low cost, ease of administration and fewer side effects."( Hepatitis B viral infection with nephrotic syndrome treated with lamivudine.
Banu, NA; Khan, MA; Khatoon, S; Quadir, E; Rahman, MM, 2007
)
1.3
"Lamivudine is an effective, safe therapeutic agent for the treatment of chronic hepatitis B. "( [Change of HBV DNA level as a predictor of HBeAg loss after lamivudine treatment].
Cho, JY; Choi, JH; Han, JM; Jin, MI; Jung, JK; Jung, JT; Kim, BS; Kim, EY; Lee, CH; Shin, IH, 2007
)
2.02
"Lamivudine is an oral nucleoside analogue widely used for the treatment of chronic hepatitis B. "( Hepatitis B virus genotypes and resistance mutations in patients under long term lamivudine therapy: characterization of genotype G in Brazil.
Amendola, M; Bottecchia, M; Brandão, CE; Gomes, SA; Niel, C; O, KM; Souto, FJ, 2008
)
2.01
"Lamivudine is a novel cytosine nucleoside analog, reverse transcriptase inhibitor that has shown activity against human immunodeficiency virus (HIV) types 1 and 2 and hepatitis B virus in vitro. "( Pharmacokinetics, absolute bioavailability, and absorption characteristics of lamivudine.
Haidar, S; Hall, ST; Hussey, EK; Morris, DM; Mydlow, PK; Yuen, GJ, 1995
)
1.96
"Lamivudine is a new nucleoside analog with potent antiviral effects against hepatitis B."( Efficacy of lamivudine in chronic hepatitis B patients with active viral replication and decompensated cirrhosis undergoing liver transplantation.
Bain, VG; Fischer, K; Gutfreund, K; Jewell, LD; Kneteman, NM; Lee, H; Ma, MM; Shapiro, JA; Tipples, G; Tyrrell, DL, 1996
)
1.39
"Lamivudine is a novel 2',3'-dideoxy cytosine analogue that has potent inhibitory effects on hepatitis B virus replication in vitro and in vivo. "( Lamivudine is effective in suppressing hepatitis B virus DNA in Chinese hepatitis B surface antigen carriers: a placebo-controlled trial.
Ching, CK; Dent, J; Hill, A; Lai, CL; Li, E; Tung, AK; Wong, BC; Wu, PC; Young, J, 1997
)
3.18
"Lamivudine is a dideoxynucleoside analogue which undergoes intracellular phosphorylation to the putative active metabolite, lamivudine triphosphate. "( Lamivudine. A review of its antiviral activity, pharmacokinetic properties and therapeutic efficacy in the management of HIV infection.
Faulds, D; Perry, CM, 1997
)
3.18
"Lamivudine is an oral nucleoside analogue with strong antiviral activity against hepatitis B virus (HBV). "( Histological improvement in patients with chronic hepatitis B virus infection treated with lamivudine.
de Man, RA; Honkoop, P; Schalm, SW; Zondervan, PE, 1997
)
1.96
"Lamivudine is a non-toxic, potent inhibitor of hepatitis B virus replication. "( Lamivudine resistance in immunocompetent chronic hepatitis B. Incidence and patterns.
de Man, RA; Honkoop, P; Niesters, HG; Osterhaus, AD; Schalm, SW, 1997
)
3.18
"Lamivudine is a cytosine nucleoside analogue that inhibits hepatitis B virus replication. "( Transient emergence of hepatitis B variants in a patient with chronic hepatitis B resistant to lamivudine.
Buti, M; Cotrina, M; Esteban, R; Guardia, J; Jardi, R; Rodriguez-Frias, F, 1998
)
1.96
"Lamivudine is a nucleoside analogue with efficacy in the suppression of hepatitis B viral (HBV) replication. "( Postliver transplant allograft reinfection with a lamivudine-resistant strain of hepatitis B virus: long-term follow-up.
Bain, VG; Davis, JE; Erb, SR; Fischer, KP; Kneteman, NM; Ma, MM; Tyrrell, DL; Yoshida, EM, 1998
)
2
"Lamivudine is a potent inhibitor of hepatitis B virus replication. "( Treatment of chronic hepatitis B with lamivudine in renal transplant recipients.
Han, DJ; Jung, YO; Lee, YS; Park, JS; Park, SK; Yang, WS, 1998
)
2.01
"Lamivudine is a nucleoside analogue that is a potent inhibitor of HBV reverse transcriptase and HBV replication."( Lamivudine therapy for chemotherapy-induced reactivation of hepatitis B virus infection.
Ahmed, A; Keeffe, EB, 1999
)
2.47
"Lamivudine is a new antiviral agent effective against hepatitis B viral (HBV) infections but can result in virus-drug resistance associated with mutations in the conserved 'YM552DD' motif of the HBV DNA polymerase. "( Hepatitis B virus variants with lamivudine-related mutations in the DNA polymerase and the 'a' epitope of the surface antigen are sensitive to ganciclovir.
Chen, WN; Koh, S; Leong, AL; Lim, GK; Lim, N; Oon, CJ; Tan, GS, 1999
)
2.03
"Lamivudine is a novel nucleoside analogue."( Antiviral therapy for hepatitis B and C in Asians.
Lai, CL, 1999
)
1.02
"Lamivudine is a potent inhibitor of HBV-DNA replication, but does not improve disease activity or lower HDV-RNA levels in patients with chronic delta hepatitis."( Lamivudine for chronic delta hepatitis.
Doo, E; Hoofnagle, JH; Kleiner, DE; Kuhns, MC; Lau, DT; Park, Y; Schmid, P, 1999
)
2.47
"Lamivudine is a potent inhibitor of hepatitis B virus (HBV) replication, but its long-term use may be associated with HBV tyrosine-methionine-aspartate-aspartate (YMDD) motif mutation. "( Acute exacerbation and hepatitis B virus clearance after emergence of YMDD motif mutation during lamivudine therapy.
Chien, RN; Chu, CM; Liaw, YF; Tsai, SL; Yeh, CT, 1999
)
1.96
"Lamivudine is a deoxycytidine analogue that is active against hepatitis B virus (HBV). "( Lamivudine. A review of its therapeutic potential in chronic hepatitis B.
Faulds, D; Jarvis, B, 1999
)
3.19
"Lamivudine is a nucleoside analog with activity against human immunodeficiency virus (HIV) and hepatitis B virus (HBV). "( Chronic active hepatitis B exacerbations in human immunodeficiency virus-infected patients following development of resistance to or withdrawal of lamivudine.
Bessesen, M; Condreay, L; Ives, D; Lawrence, S; Sherman, KE, 1999
)
1.95
"Lamivudine is an effective antiviral agent for the treatment of chronic type B hepatitis. "( Emergence of YMDD motif mutants of hepatitis B virus during lamivudine treatment of immunocompetent type B hepatitis patients.
Imazeki, F; Saisho, H; Seta, T; Tagawa, M; Yokosuka, O, 2000
)
1.99
"Lamivudine is a new oral nucleoside analogue which potently inhibits hepatitis B virus (HBV) DNA replication."( Lamivudine and alpha interferon combination treatment of patients with chronic hepatitis B infection: a randomised trial.
Barber, J; Cianciara, J; Dhillon, A; Farrell, G; Gray, DF; Heathcote, J; Moorat, A; Schalm, SW; Sherman, M; Willems, B, 2000
)
2.47
"Lamivudine is a new antiviral agent whose use has been advocated to treat HBV-infected liver transplanted patients."( Lamivudine for treating active hepatitis B in renal transplant recipients: a case report.
Bordin, V; Catalano, C; Di Landro, D; Fabbian, F; Manani, SM; Vogel, W, 2000
)
2.47
"Lamivudine is a potent inhibitor of human immunodeficiency virus reverse transcriptase and hepatitis B virus (HBV) DNA polymerase. "( HBV genotypic resistance to lamivudine in kidney recipients and hemodialyzed patients.
Bréchot, C; Chrétien, Y; Fontaine, H; Kreis, H; Legendre, C; Pol, S; Poupon, RE; Thiers, V; Zylberberg, H, 2000
)
2.04
"Lamivudine is an oral nucleoside analogue that suppresses hepatitis B virus (HBV) replication, and so may achieve both these treatment objectives."( Profound suppression of hepatitis B virus replication with lamivudine.
Lai, CL; Yuen, MF, 2000
)
1.27
"Lamivudine is a potent, once-daily, oral antiviral therapy that is effective and well tolerated in most patient groups with chronic hepatitis B virus infection, including those with pre-core mutant infection. "( Lamivudine for hepatitis B in clinical practice.
Schiff, ER, 2000
)
3.19
"Lamivudine is an inhibitor of reverse transcriptase (RT) activity and is in clinical use in human immunodeficiency virus (HIV)-infected individuals."( Development of resistance and perspectives for future therapies against hepatitis B infections: lessons to be learned from HIV.
Deres, K; Rübsamen-Waigmann, H, 1999
)
1.02
"Lamivudine is a nucleoside analogue capable of inhibiting HBV replication."( Lamivudine after hepatitis B immune globulin is effective in preventing hepatitis B recurrence after liver transplantation.
Bonham, CA; de Vera, ME; Dodson, SF; Fung, JJ; Geller, DA; Rakela, J, 2000
)
2.47
"Lamivudine is a potent inhibitor of HBV and human immunodeficiency virus (HIV) reverse transcriptases, but substitutions of isoleucine or valine for methionine within the tyrosine-methionine-aspartate-aspartate (YMDD) motif are associated with virologic and clinical resistance to lamivudine therapy."( Molecular anatomy and pathophysiologic implications of drug resistance in hepatitis B virus infection.
Doo, E; Liang, TJ, 2001
)
1.03
"Lamivudine appears to be an attractive therapeutic option and may represent the best choice."( Lamivudine therapy for spontaneously occurring severe acute exacerbation in chronic hepatitis B virus infection: a preliminary study.
Arase, Y; Chayama, K; Ikeda, K; Kobayashi, M; Kumada, H; Murashima, N; Saitoh, S; Suzuki, F; Suzuki, Y; Tsubota, A, 2001
)
2.47
"Lamivudine is a nucleoside analogue with potent antiviral activity that has been used in the prophylaxis of HBV reactivation in at-risk BMT recipients."( Reactivation of hepatitis B e antigen-negative chronic hepatitis B in a bone marrow transplant recipient following lamivudine withdrawal.
Lee, SS; Myers, RP; Swain, MG; Urbanski, SJ, 2001
)
1.24
"Lamivudine is a nucleoside analogue with potent inhibitory effects on hepatitis B virus (HBV) replication. "( Impact of YMDD mutations during lamivudine therapy in patients with chronic hepatitis B.
Liaw, YF, 2001
)
2.04
"Lamivudine is a potent inhibitor of hepatitis B virus (HBV) replication."( Outcome of renal transplantation in hepatitis B surface antigen-positive patients after introduction of lamivudine.
Chang, JW; Choi, HJ; Han, DJ; Jung, HH; Lee, YS; Park, JS; Park, SK; Yang, WS, 2001
)
1.25
"Lamivudine is a potent inhibitor of hepatitis B virus (HBV) replication. "( Lamivudine is effective for the treatment of reactivation of hepatitis B virus and fulminant hepatic failure in renal transplant recipients.
Chen, CH; Cheng, CH; Lee, WC; Lian, JD; Shu, KH; Wu, MJ, 2001
)
3.2
"Lamivudine is a nucleoside analogue that can directly suppress HBV replication."( Primary prophylaxis with lamivudine of hepatitis B virus reactivation in chronic HbsAg carriers with lymphoid malignancies treated with chemotherapy.
Motta, M; Pelizzari, A; Puoti, M; Rossi, G, 2001
)
1.34
"Lamivudine is a potent anti-viral agent for treatment of chronic HBV infection. "( Detection of hepatitis B virus polymerase variations resistant to lamivudine therapy.
Cai, Y; Han, Y; Lu, Z; Zhang, D; Zhang, X, 2000
)
1.99
"Lamivudine is a nucleoside analogue with potent antiviral properties against HBV."( Efficacy of lamivudine in HBeAg-negative chronic hepatitis B.
Rizzetto, M, 2002
)
1.41

Effects

Lamivudine has an important role in patients with end-stage liver disease caused by HBV precore mutant strain. It has a high rate of antiviral resistance.

Lamivudine (LAM) has been shown to prevent de novo hepatitis B virus (HBV) infection in recipients of hepatitis B core antibody (HBcAb)-positive liver transplants (LT) but primarily in small studies with limited follow-up. Lamivudin resistance has been attributed mainly to a substitution of isoleucine or valine for methionine at residue 550 (M550I or M550V)

ExcerptReferenceRelevance
"Lamivudine has a high rate of antiviral resistance. "( Rapid re-emergence of YMDD mutation of hepatitis B virus with hepatic decompensation after lamivudine retreatment.
Byun, KS; Choe, WH; Kwon, SY; Lee, CH; Yeon, JE, 2008
)
2.01
"Lamivudine has an important role in patients with end-stage liver disease caused by HBV precore mutant strain. "( Efficacy of lamivudine therapy for advanced liver disease in patients with precore mutant hepatitis B virus infection awaiting liver transplantation.
Andreone, P; Bernardi, M; Biselli, M; Cursaro, C; Di Giammarino, L; Felline, F; Gramenzi, A; Lorenzini, S; Morelli, MC; Porzio, F; Sama, C; Spinucci, G, 2002
)
2.14
"Lamivudine has a unique resistance profile and has the ability to delay resistance to zidovudine and restore zidovudine sensitivity in zidovudine-experienced patients."( Lamivudine. A review of its antiviral activity, pharmacokinetic properties and therapeutic efficacy in the management of HIV infection.
Faulds, D; Perry, CM, 1997
)
2.46
"Lamivudine has a safety profile similar to that of placebo and it is better tolerated than IFN alpha."( Lamivudine for hepatitis B in clinical practice.
Schiff, ER, 2000
)
2.47
"Lamivudine has an excellent safety profile in RT recipients."( Management of hepatitis B after renal transplantation: an update.
Fabrizi, F; Lunghi, G; Martin, P; Poordad, FF,
)
0.85
"Lamivudine (LAM) has the advantages of low price, quick onset, good efficacy, and no drug resistance within 24 weeks."( Randomized Controlled Study of Tenofovir versus Lamivudine Followed by Tenofovir in Severe Exacerbation of Hepatitis B.
Chen, WC; Cheng, JS; Kao, SS; Li, YD; Li, YR; Lin, HS; Lu, CM; Sun, WC; Tsai, TJ; Tsai, WL; Tsay, FW; Wang, HM; Yin, CH, 2022
)
1.7
"Lamivudine (LAM) has been shown to prevent de novo hepatitis B virus (HBV) infection in recipients of hepatitis B core antibody (HBcAb)-positive liver transplants (LT) but primarily in small studies with limited follow-up."( Prevention of de novo hepatitis B in recipients of core antibody-positive livers with lamivudine and other nucleos(t)ides: a 12-year experience.
Brown, RS; Brubaker, WD; Chang, MS; Emond, JC; Guarrera, JV; Olsen, SK; Pichardo, EM; Rosenthal-Cogan, L; Stiles, JB, 2013
)
2.06
"Lamivudine has proven beneficial in short-term post-transplant follow-up."( Long-term effects of prophylactic and therapeutic lamivudine treatments in hepatitis B surface antigen-positive renal allograft recipients.
Hu, RH; Lee, CY; Lee, PH; Tsai, MK; Yang, YW, 2014
)
1.38
"Only lamivudine has been included for patients with chronic hepatitis B (CHB) in the National List of Essential Drugs (NLED), a pharmaceutical reimbursement list in Thailand. "( A cost-utility analysis of drug treatments in patients with HBeAg-positive chronic hepatitis B in Thailand.
Chaikledkaew, U; Tantai, N; Tanwandee, T; Teerawattananon, Y; Werayingyong, P, 2014
)
0.92
"Lamivudine has been recommended as prophylaxis for the reactivation of hepatitis B virus (HBV) infection in patients undergoing chemotherapy. "( The efficacy of lamivudine prophylaxis against hepatitis B reactivation in breast cancer patients undergoing chemotherapy: a meta-analysis.
Ding, XC; Hu, HD; Hu, P; Liao, Y; Liu, JY; Ren, H; Sheng, YJ; Tang, H; Tong, SW; Zhang, DZ; Zhou, Z, 2015
)
2.21
"Lamivudine has a high rate of antiviral resistance. "( Rapid re-emergence of YMDD mutation of hepatitis B virus with hepatic decompensation after lamivudine retreatment.
Byun, KS; Choe, WH; Kwon, SY; Lee, CH; Yeon, JE, 2008
)
2.01
"Lamivudine has been established as a safe and effective antiviral agent for the treatment of chronic HBV hepatitis."( Treatment of subacute hepatitis B with lamivudine: a pilot study in Serbia.
Boricić, I; Delić, D; Nesić, Z; Prostran, M; Svirtlih, N, 2009
)
1.34
"Lamivudine has been shown to be able to restore cytotoxic T-cell response in chronic hepatitis B."( Higher pretherapy and significant decrease during the first 12 months of therapy in serum laminin levels may associate with hepatitis B e antigen seroconversion in chronic hepatitis B patients treated with lamivudine.
Duan, S; Han, Q; Li, Z; Liu, Z; Lou, S; Lv, Y; Zhang, G; Zhang, N, 2010
)
1.27
"Lamivudine (LAM) has been successfully used to treat CHBV infections but prolonged use leads to the emergence of drug-resistant variants."( Application of PCR-LDR-nucleic acid detection strip in detection of YMDD mutation in hepatitis B patients treated with lamivudine.
Hu, L; Kong, H; Lu, F; Luo, Y; Pickerill, S; Shi, J; Wang, H; Xu, G; You, P; You, Q; Zhong, H, 2010
)
1.29
"Lamivudine (LAM) has been extensively used to treat hepatitis B, but high incidence of drug resistance has required rescue studies. "( Add-on adefovir is superior to a switch to entecavir as rescue therapy for Lamivudine-resistant chronic hepatitis B.
Chung, GE; Hwang, SY; Jeong, JB; Jung, YJ; Kim, BG; Kim, D; Kim, HY; Kim, W; Kim, YJ; Lee, HS; Lee, JH; Lee, KL; Yoon, JH, 2011
)
2.04
"Lamivudine therapy has been reported to prevent the replication of hepatitis B virus (HBV) in pregnant women with a high viral load that can lead to perinatal transmission."( Efficacy and safety of lamivudine treatment in late pregnancy with high HBV DNA: a perspective for mother and infants.
Devrim, I; Köse, S; Taner, C; Türken, M, 2011
)
1.4
"Lamivudine has been widely used in chronic hepatitis B patients with hepatic decompensation, but its use is limited by drug resistance. "( Entecavir versus lamivudine in the treatment of chronic hepatitis B patients with hepatic decompensation.
Chang, CY; Hsu, CC; Hsu, CY; Hsu, YC; Huang, SC; Lin, CW; Lin, JT; Lo, GH; Mo, LR; Perng, DS; Tai, CM; Tseng, CH, 2012
)
2.16
"Lamivudine has potential to inhibit hepatitis B virus (HBV) replication but long term lamivudine treatment results in mutations in YMDD region of HBV, making this therapy ineffective."( A PCR-RFLP based protocol for the detection of hepatitis B virus variants in some lamivudine-untreated chronic hepatitis B virus carriers in Pakistan.
Ali, M; Aslam, MA; Iqbal, F; Qureshi, JA; Rehman, W; Tauseef, I, 2012
)
1.33
"Lamivudine has previously been found to be effective not only in patients with compensated liver disease due to hepatitis B virus (HBV) but also in those with hepatic decompensation. "( Additional benefit of lamivudine treatment as a preventive therapy for hepatic encephalopathy in patients with decompensated liver cirrhosis associated with hepatitis B.
Hanada, S; Harada, M; Kaji, R; Kumashiro, R; Sata, M, 2002
)
2.07
"Lamivudine has an important role in patients with end-stage liver disease caused by HBV precore mutant strain. "( Efficacy of lamivudine therapy for advanced liver disease in patients with precore mutant hepatitis B virus infection awaiting liver transplantation.
Andreone, P; Bernardi, M; Biselli, M; Cursaro, C; Di Giammarino, L; Felline, F; Gramenzi, A; Lorenzini, S; Morelli, MC; Porzio, F; Sama, C; Spinucci, G, 2002
)
2.14
"Lamivudine has marked therapeutic effect for FCH."( [Clinical and histological features of fibrosing cholestatic hepatitis].
Luo, K; Yu, L; Zhu, Y, 2002
)
1.04
"Lamivudine has been widely used in the management of HBV transplant patients."( Prevention of and treatment for hepatitis B virus infection after liver transplantation in the nucleoside analogues era.
Burroughs, AK; Papatheodoridis, GV; Sevastianos, V, 2003
)
1.04
"Lamivudine has recently been registered for the treatment of chronic hepatitis B patients. "( Lamivudine plasma levels in chronic hepatitis B patients.
de Man, RA; Geerlings, CJ; Niesters, HG; van Dijk, L; Vulto, AG; Wolters, LM, 2003
)
3.2
"Lamivudine (3TC) has been shown to be a potent inhibitor of HBV replication."( Excellent outcome of Lamivudine treatment in patients with chronic renal failure and hepatitis B virus infection.
Ben-Ari, Z; Melzer, E; Schmilovitz-Weiss, H; Tur-Kaspa, R, 2003
)
1.36
"Lamivudine has been used in the reactivation of HBV in immunocompromised states."( Role of lamivudine in the reactivation of hepatitis B virus infection in immunodepressed patients.
De Diego, L; Martín, E; Martín, L; Martínez, MC; Rendón, P; Soria, MJ, 2003
)
1.47
"Lamivudine has been referred as a novel antiviral agent against HBV in HBV cirrhotic patients even in liver transplantation setting."( Lamivudine prophylaxis of liver allograft HBV reinfection in HBV related cirrhotic patients after liver transplantation.
Cheng, NS; Lei, BJ; Li, B; Li, XD; Liu, C; Liu, J; Lu, SC; Qin, S; Wang, XB; Wen, TF; Yan, LN; Zhang, XH; Zhao, JC; Zhao, LS, 2004
)
2.49
"Lamivudine has shown efficacy in HBeAg-negative patients and those with decompensated cirrhosis."( Therapeutic advances in chronic hepatitis B.
Lai, CL, 2004
)
1.04
"Lamivudine has demonstrated efficacy for the treatment of hepatitis B e antigen-negative chronic hepatitis B (e-CHB). "( Sustained response after a 2-year course of lamivudine treatment of hepatitis B e antigen-negative chronic hepatitis B.
Fung, SK; Hussain, M; Lok, AS; Wong, F, 2004
)
2.03
"Lamivudine has been known to be an effective antiviral agent for the treatment of HBV infection."( Oligonucleotide chip for detection of Lamivudine-resistant hepatitis B virus.
Cho, B; Cho, M; Heo, J; Jang, H; Jun, H; Kim, C; Kim, H; Park, H; Shin, W, 2004
)
1.32
"Lamivudine-resistant HBV has several types of mutations at the YMDD motif of its DNA polymerase."( Mutation detection in the drug-resistant hepatitis B virus polymerase gene using nanostructured reverse micelles.
Goto, M; Hamasaki, N; Kamiya, N; Kuma, H; Maruyama, T; Park, LC, 2004
)
1.04
"Lamivudine therapy has become the treatment of choice in HBV positive renal transplant recipients and improves prognosis and outcome of infected patients."( Lamivudine therapy for chronic hepatitis B in renal transplant recipients.
Durlik, M; Lewandowska, D, 2004
)
2.49
"Lamivudine has been shown to improve liver function and reduce the need for liver transplantation (LT) in patients with decompensated HBeAg-positive cirrhosis. "( Effect of lamivudine treatment in patients with decompensated cirrhosis due to anti-HBe positive/HBeAg-negative chronic hepatitis B.
Balaska, A; Eugenidis, N; Giouleme, O; Grammatikos, N; Nikolaidis, N; Orfanou-Koumerkeridou, E; Patsiaoura, K; Tziomalos, K; Vassiliadis, T, 2005
)
2.17
"Lamivudine has also dramatically reduced the recurrence of HBV in the patient undergoing liver transplantation."( Advances in prophylaxis and treatment of recurrent hepatitis B after liver transplantation.
Shen, ZY; Wang, ZF; Zhu, ZJ, 2005
)
1.05
"Lamivudine has demonstrated efficacy in the treatment and prevention of hepatitis B virus (HBV) reactivation after hematopoietic stem cell transplantation (HSCT). "( Extended lamivudine therapy against hepatitis B virus infection in hematopoietic stem cell transplant recipients.
Chao, TC; Chen, PM; Chiou, TJ; Chu, CJ; Hsiao, LT; Lin, YC; Liu, JH; Tzeng, CH; Wang, WS; Yang, MH; Yen, CC, 2006
)
2.19
"Lamivudine has been shown to be effective in the treatment of chronic hepatitis B, but resistance to this agent is common after prolonged administration."( Adefovir dipivoxil for the treatment of lamivudine-resistant hepatitis B mutants.
Lai, V; Mirza, D; Mutimer, D; Zhang, WX, 2006
)
1.32
"Lamivudine resistance has been described in subjects with chronic hepatitis B infections, associated with mutations in the viral polymerase gene. "( A prospective study of the evolution of lamivudine resistance mutations in patients with chronic hepatitis B treated with lamivudine.
Blin, P; Degos, F; Deny, P; El Hasnaoui, A; Landais, P; Mercier, F; Parvaz, P; Poynard, T; Slama, A; Trepo, C; Zoulim, F, 2006
)
2.04
"Lamivudine has been proven to be a potent inhibitor of hepatitis B virus replication in adults after kidney transplantation."( Antiviral treatment of chronic hepatitis B with lamivudine in pediatric renal transplantation.
Bonzel, KE; Gerken, G; Hoyer, PF; Kranz, B; Paul, A; Vester, U, 2006
)
1.31
"Lamivudine has remarkable inhibitory effects on HBV replication both in serum and in PBMCs. "( Dynamic changes of HBV DNA in serum and peripheral blood mononuclear cells of chronic hepatitis patients after lamivudine treatment.
Chen, Y; Gong, ZJ; Ke, CZ; Liu, L; Meng, ZJ; Ren, ZJ; Zhou, ZH, 2006
)
1.99
"Lamivudine has been shown to benefit patients with anti-HBe/HBV-DNA-positive chronic hepatitis B. "( Factors influencing outcome of lamivudine in anti-HBe-positive chronic hepatitis B.
Ascione, A; Ascione, T; Di Costanzo, GG; Lanza, AG; Macri, M; Utech, W,
)
1.86
"Lamivudine has been suggested to be useful as a prophylaxis for HBV reactivation; however, its impact on overall survival and HBV reactivation-related liver disease survival is unclear."( Lamivudine prophylaxis is effective in reducing hepatitis B reactivation and reactivation-related mortality in chemotherapy patients: a meta-analysis.
Martyak, LA; Saab, S; Taqavi, E, 2008
)
2.51
"Lamivudine has been shown to improve liver disease and survival of hepatitis B virus patients on the orthotopic liver transplantation (OLT) waiting list, but liver failure might worsen in patients with drug resistance. "( Outcomes of patients with hepatitis B who developed antiviral resistance while on the liver transplant waiting list.
Bzowej, NH; Han, SH; Ishitani, MB; Lok, AS; Osborn, MK; Regev, A; Tran, TT, 2007
)
1.78
"Lamivudine has been demonstrated safe and efficacious in the short term in a large cohort of children with chronic hepatitis B (CHB), but optimal duration of treatment has not been elucidated and limited data on the safety of long-term lamivudine administration have been reported. "( Long-term lamivudine treatment of children with chronic hepatitis B: durability of therapeutic responses and safety.
Gardner, SD; Jonas, MM; Little, NR, 2008
)
2.19
"Lamivudine monotherapy has not sufficed for the overwhelming majority of patients."( Potential and limitations of lamivudine monotherapy in chronic hepatitis B: evidence from genotyping.
Chandrasekhar, J; Dusheiko, G; Jacobs, M; Jacobs, R; Kennedy, PT; Phillips, N, 2008
)
1.36
"Lamivudine has entered initial clinical trials, and the present study was designed to describe the pharmacokinetic behavior of this compound in both plasma and cerebrospinal fluid (CSF) of primates."( Pharmacokinetics of lamivudine and BCH-189 in plasma and cerebrospinal fluid of nonhuman primates.
Balis, FM; Blaney, SM; Daniel, MJ; Godwin, K; Harker, AJ, 1995
)
1.34
"Lamivudine has a unique resistance profile and has the ability to delay resistance to zidovudine and restore zidovudine sensitivity in zidovudine-experienced patients."( Lamivudine. A review of its antiviral activity, pharmacokinetic properties and therapeutic efficacy in the management of HIV infection.
Faulds, D; Perry, CM, 1997
)
2.46
"Lamivudine has been shown to be a potent and nontoxic inhibitor of hepatitis B virus (HBV) replication in chronically infected patients. "( Identification of more than one mutation in the hepatitis B virus polymerase gene arising during prolonged lamivudine treatment.
de Man, RA; Haagsma, EB; Honkoop, P; Niesters, HG; Osterhaus, AD; Schalm, SW, 1998
)
1.96
"Lamivudine (3TC) has been studied in combination with zidovudine (ZDV) and is recommended for use specifically in combination therapy."( Modelling the cost effectiveness of lamivudine/zidovudine combination therapy in HIV infection.
Chancellor, JV; Hill, AM; Sabin, CA; Simpson, KN; Youle, M, 1997
)
1.29
"Lamivudine has also been assessed in anti-HBe positive, HBV DNA positive patients."( Lamivudine therapy for hepatitis B infection.
Dusheiko, G, 1999
)
2.47
"Lamivudine resistance has been attributed mainly to a substitution of isoleucine or valine for methionine at residue 550 (M550I or M550V) in the catalytic site of the virus polymerase."( Novel patterns of amino acid mutations in the hepatitis B virus polymerase in association with resistance to lamivudine therapy in japanese patients with chronic hepatitis B.
Asakura, H; Fujii, K; Ichida, T; Nomoto, M; Ogata, N; Takigawa, S, 1999
)
1.24
"Lamivudine has recently received approval for clinical use against chronic human HBV infection, and both PCV and PMEA have undergone clinical trials against HBV in their respective prodrug forms (famciclovir and adefovir dipivoxil [bis-(POM)-PMEA])."( In vitro antihepadnaviral activities of combinations of penciclovir, lamivudine, and adefovir.
Civitico, G; Colledge, D; Locarnini, S; Shaw, T, 2000
)
1.26
"Lamivudine has a safety profile similar to that of placebo and it is better tolerated than IFN alpha."( Lamivudine for hepatitis B in clinical practice.
Schiff, ER, 2000
)
2.47
"Lamivudine has been shown to be an effective therapy for chronic hepatitis B, but resistance to this nucleoside agent is common after prolonged use. "( Adefovir dipivoxil for the treatment of lamivudine-resistant hepatitis B mutants.
Gutfreund, K; Hirsch, K; Lamy, P; Murray, A; Perrillo, R; Schiff, E; Statler, A; Wright, T; Yoshida, E, 2000
)
2.02
"Lamivudine has potent activity against HIV-1 and hepatitis B virus (HBV). "( Evolution of lamivudine-resistant hepatitis B virus and HIV-1 in co-infected individuals: an analysis of the CAESAR study. CAESAR co-ordinating committee.
Atkins, M; Cane, PA; Cooper, D; Pillay, D; Ratcliffe, D, 2000
)
2.12
"Lamivudine has been demonstrated to have consistent efficacy and safety in large-scale, phase III clinical trials."( Nucleoside analogues in the treatment of chronic hepatitis B.
Leung, N, 2000
)
1.03
"Lamivudine has been shown to be an efficient drug for chronic hepatitis B (CHB) treatment."( Predictive factors for response to lamivudine in chronic hepatitis B.
Alves, VA; Carrilho, FJ; da Fonseca, LE; Da Silva, LC; Pinho, JR; Sitnik, R,
)
1.85
"Lamivudine has been shown to be effective in patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B, but its long-term efficacy and the rate of resistant mutations in patients with HBeAg-negative chronic hepatitis B is less clear. "( Evolution of hepatitis B virus polymerase gene mutations in hepatitis B e antigen-negative patients receiving lamivudine therapy.
Andreone, P; Benardi, M; Cursano, C; Gramenzi, A; Grazi, GL; Hussain, M; Jovine, E; Lok, AS; Margotti, M, 2000
)
1.96
"Lamivudine has good medium term efficacy in achieving each of these objectives."( Clinical potential of emerging new agents in hepatitis B.
Farrell, GC, 2000
)
1.03
"Lamivudine has shown promising results in patients with chronic hepatitis B, but experience with its use in RTR is limited."( Twelve months of lamivudine treatment for chronic hepatitis B virus infection in renal transplant recipients.
Demetriou, D; Ferenci, P; Kletzmayr, J; Kovarik, J; Müller, C; Puchhammer-Stöckl, E; Watschinger, B, 2000
)
1.37
"Lamivudine has been introduced as an alternative to IFN, showing at least similar efficacy, but with a wider spectrum of indications and without the adverse effects."( Drug therapy for hepatitis B.
Regev, A; Schiff, ER, 2001
)
1.03
"Lamivudine has been shown to be a potent inhibitor of HBV replication."( An open-label study of lamivudine for chronic hepatitis B in six patients with chronic renal failure before and after kidney transplantation.
Ben-Ari, Z; Broida, E; Chagnac, A; Kittai, Y; Tur-Kaspa, R, 2000
)
1.34
"Lamivudine has been reported to be able to stabilize liver enzyme and hepatitis B virus (HBV) replication with recurrent hepatitis that has been regarded as a frequent and major risk factor for hepatic dysfunction and chronic liver disease in renal transplant recipients. "( Results on preemptive or prophylactic treatment of lamivudine in HBsAg (+) renal allograft recipients: comparison with salvage treatment after hepatic dysfunction with HBV recurrence.
Han, DJ; Jung, JG; Kim, SB; Kim, SC; Kim, TH; Lee, SK; Park, JS; Park, SK; Yang, WS; Yu, ES, 2001
)
2.01
"Lamivudine has been found to suppress HBV replication manifested both by histology and serum HBV-DNA levels in chronic carriers of HBV who developed reactivation of hepatic disease following chemotherapy. "( Reactivation of chronic hepatitis B infection following intensive chemotherapy and successful treatment with lamivudine: a case report and review of the literature.
Allegra, CJ; Hamilton, JM; Little, RF; Saif, MW; Wilson, WH, 2001
)
1.97
"Lamivudine resistance has been found to confer cross-resistance to some of these compounds and it is likely that resistance to newer antivirals may also develop during prolonged use."( Resistance of hepatitis B virus to antiviral drugs: current aspects and directions for future investigation.
Delaney, WE; Locarnini, S; Shaw, T, 2001
)
1.03
"(8) Lamivudine has documented antiviral efficacy but its effect is only temporary in many patients."( Treatment of chronic hepatitis B: interferon alfa first.
, 2001
)
0.77
"Lamivudine has become a main therapeutic option for treating hepatitis B virus (HBV) infection. "( Selection of hepatitis B virus polymerase mutants with enhanced replication by lamivudine treatment after liver transplantation.
Bock, CT; Klempnauer, J; Locarnini, S; Manns, MP; Tillmann, HL; Torresi, J; Trautwein, C, 2002
)
1.98
"Lamivudine has benefits over IFN in its safety and efficacy profile in this patient group."( Efficacy of lamivudine in HBeAg-negative chronic hepatitis B.
Rizzetto, M, 2002
)
1.41
"Lamivudine has emerged as another effective first-line therapy for chronic hepatitis B as well as a beneficial treatment option for patients with decompensated hepatitis B cirrhosis."( Therapeutic advances in the management of hepatitis B and hepatitis C.
Nguyen, MH; Wright, TL, 2001
)
1.03
"Lamivudine has been most extensively studied."( Management of patients with chronic hepatitis B.
Liaw, YF, 2002
)
1.04
"Lamivudine has an excellent safety profile in RT recipients."( Management of hepatitis B after renal transplantation: an update.
Fabrizi, F; Lunghi, G; Martin, P; Poordad, FF,
)
0.85

Actions

Lamivudine therapy would increase the risk of mutations 5.23 times higher than the untreated patients. Lamivudin can inhibit HBV replication rapidly and normalize ALT in majority adolescent CHB patients.

ExcerptReferenceRelevance
"Lamivudine therapy would increase the risk of mutations 5.23 times higher than the untreated patients."( The naturally occurring YMDD mutation among patients chronically infected HBV and untreated with lamivudine: a systematic review and meta-analysis.
Chen, L; Chen, X; Cui, Q; Ding, K; Gong, Y; Lei, N; Peng, Z; Su, J; Tan, Y; Trinh, X; Yu, R, 2012
)
1.32
"Lamivudine can inhibit HBV replication rapidly and normalize ALT in majority adolescent CHB patients. "( [Efficacy and safety in chronic hepatitis B adolescent patients with lamivudine therapy].
Cui, ZY; Lu, WL; Wu, L; Xie, DY; Yao, GB; Yao, JL; Zhang, DF, 2004
)
2
"Lamivudine was added because of de nova hepatitis B infection during her follow-up."( Renal Fanconi syndrome and myopathy after liver transplantation: drug-related mitochondrial cytopathy?
Baskin, E; Bayrakci, US; Haberal, M; Karakayali, H; Ozcay, F; Ozdemir, BH, 2008
)
1.07

Treatment

Treatment with lamivudine of patients infected with hepatitis B virus (HBV) results in a high rate of drug resistance, which is primarily associated with the rtM204I/V substitution in the HBV reverse transcriptase domain. Re-treatment with lamvudine can control viral replication.

ExcerptReferenceRelevance
"The lamivudine antiviral treatment group was further analyzed according to different treatment withdrawal time points."( Meta-Analysis of the Risk for Abnormal Liver Function in Pregnancy with High HBV DNA After Antiviral Therapy Withdrawal.
Chen, Y; Duan, Z; Li, L; Liu, S; Xu, M; Zheng, S; Zhu, Y; Zou, H, 2023
)
1.39
"Lamivudine antiviral treatment, either on a prophylactic or therapeutic basis, provided long-term benefits for HBsAg-positive renal allograft recipients, in terms of reducing the occurrence of HCC and prolonging patient and graft survival. "( Long-term effects of prophylactic and therapeutic lamivudine treatments in hepatitis B surface antigen-positive renal allograft recipients.
Hu, RH; Lee, CY; Lee, PH; Tsai, MK; Yang, YW, 2014
)
2.1
"In lamivudine-treated patients with suboptimal virological response at week 24, promptly adding on ADV is necessary to prevent resistance development."( Randomized, three-arm study to optimize lamivudine efficacy in hepatitis B e antigen-positive chronic hepatitis B patients.
Chen, C; Chen, S; Chen, X; Cheng, J; Dou, X; Hou, J; Jia, J; Jiang, J; Li, T; Liang, X; Long, H; Ma, H; Ning, Q; Niu, J; Ren, H; Sheng, J; Shi, G; Shi, J; Sun, J; Sun, Y; Tan, D; Tang, H; Wan, M; Wang, H; Xie, Q; Yu, Y; Zhuang, H, 2015
)
1.2
"Lamivudine treatment had a high treatment modification rate in patients with low baseline viremia and early virological response over a long-term follow-up in a real-life setting. "( High treatment modification rates with lamivudine therapy in HBV-infected patients with low baseline viremia and early virological response: A multicenter study.
Ahishali, E; Doganay, L; Enc, FY; Erdem, E; Gonen, C; Gunduz, F; Ozdogan, O; Sokmen, M; Tuncer, I; Yegin, EG, 2015
)
2.13
""Lamivudine treatment for severe acute hepatitis B"."( Experience with lamivudine treatment for severe acute hepatitis B.
Verhaz, A,
)
1.1
"Lamivudine treatment was well tolerated by all patients."( Experience with lamivudine treatment for severe acute hepatitis B.
Verhaz, A,
)
1.2
"Lamivudine treatment appears to prevent hepatitis B virus reactivation and to decrease the mortality in at risk HSCT patients."( Hepatitis B reactivation in allogeneic hemopoietic stem cell transplantation setting: a pediatric experience.
Cappelli, B; Faraci, M; Fioredda, F; Giacchino, R; Giudice, CL; Lanino, E; Morreale, G, 2009
)
1.07
"Lamivudine treatment was started and HBV-DNA disappeared from the blood, and the joint swellings disappeared."( [Lamivudine treatment of a HBs antigen positive man with reactive arthritis].
Borup, C; Siboni, A, 2008
)
1.98
"In lamivudine-treated mothers, 56 infants received vaccine + HBIg (lamivudine + vaccine + HBIg) and 26 infants received vaccine (lamivudine + vaccine)."( Lamivudine in late pregnancy to prevent perinatal transmission of hepatitis B virus infection: a multicentre, randomized, double-blind, placebo-controlled study.
Atkins, M; Campbell, F; Chang, CN; Cui, YT; Gardner, S; Li, XM; Liang, ZQ; Qiao, FY; Wang, L; Xu, WM; Yang, H; Zhang, SL, 2009
)
2.31
"Lamivudine treatment resulted in a mean log hepatitis B virus (HBV)-DNA decline of 1.77 +/- 0.55 after 4 weeks and 3.79 +/- 1.70 log after 24 weeks."( Anti-hepatitis B virus treatment guided by long-term virus kinetics stepwise tracing.
Cai, T; Lou, GQ; Yang, J, 2009
)
1.07
"For lamivudine-treated HBeAg-positive CHB patients with pre-therapy ALT levels >5xULN, the PC stop codon mutation could predict a higher HBeAg seroclearance rate at the end of 12-18 months of therapy."( Association of baseline viral factors with response to lamivudine therapy in chronic hepatitis B patients with high serum alanine aminotransferase levels.
Chen, DS; Chen, PJ; Kao, JH; Lai, MY; Liu, CJ; Tseng, TC; Wang, CC, 2009
)
1.16
"In lamivudine-treated samples, wild-type strains (57.7%) were dominant and deletions in the preS region were observed."( Dynamic changes of HBV quasispecies and deletion patterns in a chronic hepatitis B patient.
Ding, H; Ji, F; Li, F; Ma, S; Zeng, C; Zhou, L, 2009
)
0.87
"In lamivudine-treated patients, the strongest predictor of emergence of YMDD mutations is baseline hepatitis B virus (HBV) DNA viral load."( Pretreatment with pegylated interferon prevents emergence of lamivudine mutants in lamivudine-naive patients: a pilot study.
Bianchini, M; Critelli, R; Ferretti, I; Gennari, W; Graziosi, A; Lei, B; Luongo, M; Taliani, G; Villa, E, 2009
)
1.11
"With lamivudine as initial treatment, 62% of patients developed drug resistance after 4 years. "( Long-term outcome of renal transplant recipients with chronic hepatitis B infection-impact of antiviral treatments.
Chan, TM; Choy, BY; Tang, CS; Yap, DY; Yuen, MF; Yung, S, 2010
)
0.87
"Lamivudine treatment reduced the mRNA levels of PPARγ and C/EBPα."( Adiponectin, a downstream target gene of peroxisome proliferator-activated receptor γ, controls hepatitis B virus replication.
Chwae, YJ; Jung, J; Kim, K; Kim, T; Park, S; Shin, HJ; Yoon, S, 2011
)
1.09
"Lamivudine (LAM)-treated patients demonstrated the highest frequency (4.9/100 person-years, 95% CI 3.2-7.4)."( Frequency and clinical outcomes of flares related to nucleos(t)ide analogue therapy in patients with chronic hepatitis B.
Hansen, BE; Janssen, HL; Perquin, M; Reijnders, JG; Zhang, NP, 2011
)
1.09
"Lamivudine treatment in HBV carrier-mothers from 28 wk of gestation may interrupt MTCT of HBV efficiently. "( A meta-analysis of lamivudine for interruption of mother-to-child transmission of hepatitis B virus.
Cao, GW; Han, L; Wang, HY; Xie, JX; Zhang, HW; Zhang, Q, 2011
)
2.14
"Lamivudine treatment resulted in the patient's recovery and allowed further chemotherapy."( [The efficacy of lamivudine in the treatment of reactivation of chronic hepatitis B virus infection in patients on immunosuppressive therapy].
Boričić, I; Delić, D; Mitrović, N; Popović, N; Simonović-Babić, J; Stojković-Švirtlih, N; Tomanović, N,
)
1.19
"Lamivudine treatment was effective in 35% of cases (15 of 43) and overall virological response (during or after treatment) was achieved in 51% of patients. "( Predictive factors of lamivudine treatment success in an hepatitis B virus-infected pediatric cohort: a 10-year study.
Alvarez, F; Beland, K; Bouron Dal Soglio, D; Lapierre, P; Mas, E; Yousef, Y, 2012
)
2.14
"Lamivudine treatment in a carefully selected cohort of HBV patients demonstrated a good rate of success and low incidence of mutation. "( Predictive factors of lamivudine treatment success in an hepatitis B virus-infected pediatric cohort: a 10-year study.
Alvarez, F; Beland, K; Bouron Dal Soglio, D; Lapierre, P; Mas, E; Yousef, Y, 2012
)
2.14
"Lamivudine pretreatment significantly reduced IFN-γ + TNF-α-mediated toxicity of HepG2.2.15 cells [85.82% ± 5.43% (sequential) vs 58.03% ± 8.03% (cytokine), P = 0.002]."( Effect of interferon-γ and tumor necrosis factor-α on hepatitis B virus following lamivudine treatment.
Lu, L; Shen, XZ; Shi, H; Zhang, NP; Zhang, SC, 2012
)
1.33
"Lamivudine-treated seroconverters had significant reduced HBV DNA concurrent with increased viral diversity after starting treatment (p = 0.001, compared to non-seroconverters, and resembled those of interferon-seroconverters published previously)."( Increased viral quasispecies evolution in HBeAg seroconverter patients treated with oral nucleoside therapy.
Cheng, Y; Guindon, S; Lim, SG; Rodrigo, A, 2013
)
1.11
"Lamivudine-treated HBeAg-seroconverters showed a higher viral diversity than non-seroconverters, and the pattern resembled that of interferon-treated seroconverters. "( Increased viral quasispecies evolution in HBeAg seroconverter patients treated with oral nucleoside therapy.
Cheng, Y; Guindon, S; Lim, SG; Rodrigo, A, 2013
)
1.83
"Lamivudine treatment is safe for chronic HBV-infected pregnant mothers and their fetuses with a gestational age of less than 12 wk or throughout the entire pregnancy."( Safety of lamivudine treatment for chronic hepatitis B in early pregnancy.
Cai, HD; Liu, M; Yi, W, 2012
)
2.22
"Lamivudine treatment improves renal outcome in patients with hepatitis B virus-associated MN (HBV-MN), but prolonged use leads to the emergence of lamivudine-resistant variants."( Experience of anti-viral therapy in hepatitis B-associated membranous nephropathy, including Lamivudine-resistant strains.
Choi, BS; Choi, SR; Chung, BH; Hong, YA; Kim, YS; Park, CW; Park, HS; Sun, IO; Yang, CW, 2012
)
1.32
"Lamivudine treatment can lead to significant improvements in liver disease severity in nontransplantation candidates with advanced disease."( A United States compassionate use study of lamivudine treatment in nontransplantation candidates with decompensated hepatitis B virus-related cirrhosis.
Anschuetz, G; Baker, A; Brown, N; Everson, G; Fontana, RJ; Gardner, SD; Griffiths, D; Hann, HW; Riely, C; Schiff, ER; Wright, T, 2003
)
1.3
"Lamivudine treatment in chronic hepatitis B leads to the reconstitution of virus-specific T cells in the circulation, but it is not clear whether this is the preferential result of T cell efflux from the liver or lymph nodes. "( Tracking the source of the hepatitis B virus-specific CD8 T cells during lamivudine treatment.
Behboudi, S; Bertoletti, A; Burroughs, AK; Dusheiko, GM; Gotto, J; Malacarne, F; Reignat, S; Webster, GJ; Williams, R, 2003
)
1.99
"Lamivudine retreatment for reappearance of hepatitis B markers can achieve resumption of viral suppression."( Durability of serologic response after lamivudine treatment of chronic hepatitis B.
Cianciara, J; Dienstag, JL; Gardner, S; Karayalcin, S; Kowdley, KV; Plisek, S; Schiff, E; Willems, B; Woessner, M, 2003
)
1.31
"Lamivudine is a treatment option for the therapy of chronic hepatitis B with an excellent safety profile. "( Severe exacerbation of chronic hepatitis B after emergence of lamivudine resistance in a cirrhotic patient: immediate switch to adefovir dipivoxil appears to be indicated.
Flemming, P; Klempnauer, J; Manns, MP; Nashan, B; Niemann, P; Rohde, P; Tillmann, HL; Tischendorf, JJ; Trautwein, C; Wiegand, J, 2004
)
2.01
"Lamivudine treatment can reduce the serum ferritin levels in chronic viral hepatitis B patients and decreases of ferritin levels can be more significant in patients exhibiting virological, serological and biochemical responses, indicating that dynamic observation of serum ferritin levels in patients with chronic viral hepatitis B during lamivudine treatment might be helpful for monitoring and predicting patients' responses to the therapy."( Sequential changes of serum ferritin levels and their clinical significance in lamivudine-treated patients with chronic viral hepatitis B.
Han, QY; Kang, W; Liu, ZW; Zhang, N, 2004
)
1.99
"Lamivudine treatment of individuals with chronic HBV infection leads to a rapid decline of hepatitis B virus (HBV) serum DNA. "( Patterns of circulating hepatitis B virus serum nucleic acids during lamivudine therapy.
Bock, T; Hacker, HJ; Schröder, CH; Tokus, M; Zhang, W, 2004
)
2
"Lamivudine treatment resulted in a significant decrease of TGF-beta1 and TIMP-1 during treatment with an increase after 24 wk of treatment."( Effect of lamivudine treatment on plasma levels of transforming growth factor beta1, tissue inhibitor of metalloproteinases-1 and metalloproteinase-1 in patients with chronic hepatitis B.
Al-Kadasi, H; Flisiak, I; Flisiak, R; Jaroszewicz, J; Prokopowicz, D, 2004
)
1.45
"Lamivudine treatment was associated with a decline in serum HBV DNA and serum transaminases in all patients."( The use of lamivudine for patients with acute hepatitis B (a series of cases).
Kondili, LA; Mutimer, D; Osman, H, 2004
)
1.43
"Lamivudine-treated patients (accounting for 73% of the study population) showed a significantly lower level of alanine aminotransferase over follow-up [-81.1 mU/ml mean difference; 95% confidence intervals (95% CI): -30.3; -131.7, P=0.003] and a significantly reduced risk of liver-related morbidity/mortality [Relative hazard (RH)=0.07; 95% CI: 0.01-0.38, P=0.002] than those starting a lamivudine sparing-regimen."( The management of hepatitis B virus/HIV-1 co-infected patients starting their first HAART regimen. Treating two infections for the price of one drug?
Ambu, S; Ancarani, F; Bonasso, M; Bruno, R; Cozzi-Lepri, A; d'Arminio Monforte, A; Ferraro, T; Puoti, M; Santantonio, T; Toti, M; Tundo, P, 2004
)
1.04
"Lamivudine treatment is well tolerated and safe in patients with renal insufficiency undergoing hemodialysis and kidney-transplantation."( Efficiency and safety of lamivudine therapy in patients with chronic HBV infection, dialysis or after kidney transplantation.
Flisiak, R; Jaroszewicz, J; Kowalczuk, O; Lapinski, TW; Michalewicz, M, 2005
)
1.35
"Lamivudine treatment (100 mg/day) was started and clearance of HBsAg was documented 1 year later."( Successful pregnancy in a liver transplant recipient treated with lamivudine for de novo hepatitis B in the graft.
Bo, P; Burra, P; Cillo, U; Loreno, M; Naoumov, N; Senzolo, M, 2005
)
1.29
"Six lamivudine-treated patients (24%)and seven controls (28%) rapidly developed hepatic failure. "( Lamivudine monotherapy for spontaneous severe acute exacerbation of chronic hepatitis B.
Akuta, N; Arase, Y; Hosaka, T; Ikeda, K; Kobayashi, M; Kumada, H; Saitoh, S; Sezaki, H; Someya, T; Suzuki, F; Suzuki, Y; Tsubota, A, 2005
)
2.33
"Lamivudine treatment was discontinued 10 months after transplantation."( Fatal fulminant hepatitis B after withdrawal of prophylactic lamivudine in hematopoietic stem cell transplantation patients.
Chen, PM; Chiou, TJ; Hsiao, LT; Lee, MY; Lin, PC; Poh, SB, 2005
)
1.29
"Lamivudine treatment in patients with chronic hepatitis B virus (HBV) infection may improve clinical state and suppress viral replication before liver transplantation. "( Liver transplantation for chronic hepatitis B with lamivudine-resistant YMDD mutant using add-on adefovir dipivoxil plus lamivudine.
Chan, SC; Fan, ST; Lau, GK; Liu, CL; Lo, CM; Ng, IO, 2005
)
2.02
"Lamivudine treatment in chronic carriers who acquired hepatitis B virus through maternal transmission were investigated."( Lamivudine treatment in maternally transmitted chronic hepatitis B virus infection patients.
Chang, MH; Chen, HL; Chen, PJ; Hsu, HY; Huang, FC; Jeng, YM; Kong, MS; Ni, YH; Tsuei, DJ; Wu, TC, 2005
)
3.21
"Lamivudine treatment is effective for maternally transmitted subjects with high ALT."( Lamivudine treatment in maternally transmitted chronic hepatitis B virus infection patients.
Chang, MH; Chen, HL; Chen, PJ; Hsu, HY; Huang, FC; Jeng, YM; Kong, MS; Ni, YH; Tsuei, DJ; Wu, TC, 2005
)
3.21
"Lamivudine treatment had a very significant impact overall."( Longitudinal assessment of histology surrogate markers (FibroTest-ActiTest) during lamivudine therapy in patients with chronic hepatitis B infection.
Blin, P; Degos, F; Deny, P; El Hasnaoui, A; Imbert-Bismut, F; Landais, P; Munteanu, M; Parvaz, P; Poynard, T; Ratziu, V; Slama, A; Thibault, V; Trepo, C; Zoulim, F, 2005
)
1.27
"Lamivudine treatment improves renal outcome in HBV carriers with MN and evidence of liver disease."( Lamivudine in hepatitis B-associated membranous nephropathy.
Chan, KW; Ho, YW; Kung, NN; Lai, FM; Lai, KN; Leung, JC; Lui, YH; Tang, CS; Tang, S, 2005
)
2.49
"Lamivudine plus rhIL-12 treatment was associated with a greater increase in virus-specific T-cell reactivity, IFN-gamma production, and an inverse correlation between the frequency of IFN-gamma-producing CD4+ T-cells and viremia."( Lamivudine plus interleukin-12 combination therapy in chronic hepatitis B: antiviral and immunological activity.
Chokshi, S; Mullerova, I; Naoumov, NV; Rice, S; Rigopoulou, EI; Suri, D; Tedder, RS; Williams, R, 2005
)
2.49
"The lamivudine-treated and untreated groups were compared with respect to changes in liver function, HCC recurrence, survival, and cause of death."( Lamivudine treatment in patients with HBV-related hepatocellular carcinoma--using an untreated, matched control cohort.
Araki, Y; Fujio, K; Fujioka, S; Hashimoto, K; Iwasaki, Y; Kaneyoshi, T; Kobashi, H; Nishida, T; Piao, CY; Sakaguchi, K; Senoh, T; Shiratori, Y; Terada, R, 2005
)
2.25
"Lamivudine treatment was initially effective in all patients; three patients during the second year of treatment developed lamivudine resistance-associated mutations (rt-L180M, rt-M204V) with severe disease reactivation, remitted after switch to adefovir treatment."( Heart transplantation in patients with chronic hepatitis B: clinical evolution, molecular analysis, and effect of treatment.
Cirillo, G; Costagliola, L; Karayiannis, P; Marrone, A; Ragone, E; Ruggiero, G; Utili, R; Zampino, R, 2005
)
1.05
"Lamivudine treatment may remit HBV-associated nephropathy."( Successful treatment of hepatitis B virus-associated membranous nephropathy with lamivudine.
Ikeda, H; Itoh, F; Kimura, K; Koike, J; Kondo, S; Okuse, C; Suzuki, M; Takahashi, H; Yamada, N; Yotsuyanagi, H, 2006
)
1.28
"Lamivudine treatment could suppress serum HBV DNA in most of the tested Japanese patients. "( Long-term lamivudine treatment for chronic hepatitis B in Japanese patients: a project of Kyushu University Liver Disease Study.
Azuma, K; Furusyo, N; Hayashi, J; Kajiwara, E; Maruyama, T; Masumoto, A; Murata, M; Nakamuta, M; Nomura, H; Sakai, H; Shimoda, S; Shimono, J; Takahashi, K; Takeoka, H; Tanabe, Y; Toyoda, K, 2006
)
2.18
"The lamivudine treated patients had significant higher frequency of survival without liver transplantation 82.4 vs 20% (4/20) in the historic control (P < 0.001)."( Safety and efficacy of lamivudine in patients with severe acute or fulminant hepatitis B, a multicenter experience.
Canbay, A; Dalekos, GN; Eisenbach, C; Encke, J; Gerken, G; Graziadei, I; Hadem, J; Leifeld, L; Manns, MP; Schmidt, H; Schneider, A; Spengler, U; Tillmann, HL; Vogel, W; Wedemeyer, H; Zachou, K, 2006
)
1.13
"Lamivudine treatment was resumed, with rapid normalization of the HBV-DNA."( Lamivudine prophylaxis for hepatitis B virus infection after lung transplantation.
Bakal, I; Ben Ari, Z; Kramer, MR; Morali, G; Shitrit, AB; Shitrit, D, 2006
)
2.5
"Lamivudine in the treatment of chronic HBV infection in pediatric renal recipients seems to be safe and effective in preventing acute liver deterioration."( Antiviral treatment of chronic hepatitis B with lamivudine in pediatric renal transplantation.
Bonzel, KE; Gerken, G; Hoyer, PF; Kranz, B; Paul, A; Vester, U, 2006
)
1.31
"Lamivudine treatment is associated with frequent development of resistant hepatitis B virus (HBV) and loss of treatment benefit. "( Entecavir for treatment of lamivudine-refractory, HBeAg-positive chronic hepatitis B.
Boron-Kaczmarska, A; Cianciara, J; Colonno, R; Cross, A; Denisky, G; Goodman, Z; Hindes, R; Kreter, B; Liaw, YF; Martin, P; Sherman, M; Silva, M; Sollano, J; Yurdaydin, C, 2006
)
2.07
"Lamivudine treatment was started in six recipients during the acute phase of HBV reactivation."( Beneficial effects of short-term lamivudine treatment for de novo hepatitis B virus reactivation after liver transplantation.
Chiba, T; Egawa, H; Marusawa, H; Takada, Y; Ueda, M; Uemoto, S; Umeda, M, 2006
)
1.34
"Lamivudine treatment was resumed in 3 patients on reappearance of HBV DNA, and a subsequent rapid decline in the serum HBV DNA was observed."( Discontinuation of lamivudine treatment for hepatitis flare after kidney or heart transplantation in hepatitis B surface antigen-positive patients: A retrospective case series.
Huang, YW; Kao, JH; Lai, MK; Lai, MY; Lee, PH; Liu, CJ; Tsai, MK; Wang, SS, 2006
)
1.38
"Lamivudine treatment in hepatitis B e antigen (HBeAg)-negative and hepatitis B virus (HBV) DNA-positive chronic hepatitis B (CHB) patients is associated with poor sustained response. "( Short-term lamivudine therapy in HBeAg-negative chronic active hepatitis B in Taiwan.
Chien, RN; Liaw, YF, 2006
)
2.17
"Lamivudine-treated patients had a significantly lower cumulative rate of development of cirrhosis and/or HCC compared with controls (P = 0.005). "( Long-term lamivudine therapy reduces the risk of long-term complications of chronic hepatitis B infection even in patients without advanced disease.
Chow, DH; Fung, J; Lai, CL; Ngai, VW; Seto, WK; Tsui, K; Wong, BC; Wong, DK; Yuen, JC; Yuen, MF, 2007
)
2.18
"Lamivudine treatment efficiently cleared the peripheral HBV DNA, HBsAg, and hepatitis B e antigen."( Hepatitis B caused by a hepatitis B surface antigen escape mutant.
Kajiwara, E; Kinjo, M; Mizokami, M; Ohashi, T; Sadoshima, S; Tanaka, Y; Uchimura, K, 2008
)
1.07
"Lamivudine treatment was continued until HBsAg was cleared."( Lamivudine treatment for acute severe hepatitis B: report of a case and review of the literature.
Apostolou, N; Grivas, E; Kalafatas, I; Kalantzis, C; Koilakou, S; Mantzaris, G; Raptis, N; Roussos, A,
)
2.3
"For lamivudine-treated HBeAg-positive patients with pretherapy ALT levels over five times ULN, an even higher ALT level could predict earlier HBeAg seroconversion; however, neither ALT levels nor viral factors correlate with higher response rates after 12-18 months of treatment."( A higher alanine aminotransferase level correlates with earlier hepatitis B e antigen seroconversion in lamivudine-treated chronic hepatitis B patients.
Chen, DS; Chen, PJ; Kao, JH; Lai, MY; Liu, CJ; Tseng, TC; Wang, CC, 2008
)
1.12
"For lamivudine-treated patients, combined mutation at the sites other than rtL180 and rtM204 in HBV P gene should also be detected for drug resistance evaluation."( [Mutations of HBV polymerase gene sequence in lamivudine-resistant chronic hepatitis B patients].
Chen, JJ; Hou, JL; Sun, J; Wang, C; Wang, ZH, 2008
)
1.16
"Lamivudine treatment may prove useful in preventing recurrence of hepatitis B after liver transplantation. "( Lamivudine prophylaxis against reinfection in liver transplantation for hepatitis B cirrhosis.
Ahmed, M; Beranek, P; Brown, D; Burroughs, AK; Dusheiko, G; Elias, E; Grellier, L; Kennedy, F; Kibbler, H; McMaster, P; McPhillips, P; Mutimer, D; Rolles, K, 1996
)
3.18
"Lamivudine treatment produced a slow but progressive decline in viral titers in serum, to about 0.3% or less of the initial level."( Lamivudine therapy of WHV-infected woodchucks.
Aldrich, CE; Averett, D; Condreay, LD; Cullen, J; Frick, L; Jilbert, AR; Mason, WS; Miller, DS; Moraleda, G; Saputelli, J; Tennant, B, 1998
)
2.46
"Lamivudine treatment effected a reduction in serum HBV levels, but six patients still had measurable viral DNA at the time of transplantation. "( High pre-treatment serum hepatitis B virus titre predicts failure of lamivudine prophylaxis and graft re-infection after liver transplantation.
Ahmed, M; Barmat, S; Boxall, E; Buchan, S; Burroughs, N; Cane, P; Dragon, E; Elias, E; Gutekunst, K; Martin, B; McMaster, P; Mutimer, D; O'Donnell, K; Pillay, D; Rand, D; Shaw, J; Tang, H, 1999
)
1.98
"Lamivudine treatment was well tolerated at all doses, with no significant adverse events or laboratory data changes."( A dose ranging study of the pharmacokinetics, safety, and preliminary efficacy of lamivudine in children and adolescents with chronic hepatitis B.
Barber, J; Boxall, E; Dallow, N; Johnson, M; Kelly, D; McPhillips, P; Mieli-Vergani, G; Roberts, EA; Sokal, EM, 2000
)
1.25
"Lamivudine treatment was not withdrawn since it has been suggested that the mutant form might be less pathogenic than the wild one."( Lamivudine for treating active hepatitis B in renal transplant recipients: a case report.
Bordin, V; Catalano, C; Di Landro, D; Fabbian, F; Manani, SM; Vogel, W, 2000
)
2.47
"With lamivudine treatment, serum HBV DNA decreased rapidly to very low concentrations and remained low throughout the 2 years of the study."( Management of hepatitis B in China.
Yao, GB, 2000
)
0.76
"Lamivudine treatment was associated with 1) normalization of serum ALT levels and rapid disappearance of serum HBV DNA (by hybridization) (five patients, one of whom died from sepsis); 2) seroconversion: disappearance of HBeAg (three patients) and HBsAg (two patients); 3) minor side effects: abdominal pain and nausea (one patient); 4) clinically asymptomatic lamivudine resistance 8 months after treatment (one patient); and 5) successful combined kidney and liver transplantation with no evidence of recurrent HBV infection at 6-8 months postoperatively (two patients with cirrhosis)."( An open-label study of lamivudine for chronic hepatitis B in six patients with chronic renal failure before and after kidney transplantation.
Ben-Ari, Z; Broida, E; Chagnac, A; Kittai, Y; Tur-Kaspa, R, 2000
)
2.06
"Lamivudine treatment of hepatitis B after orthotopic liver transplantation (OLT) is often accompanied by fast viral-resistance formation. "( Occurrence and clinical outcome of lamivudine-resistant hepatitis B infection after liver transplantation.
Berg, T; Hopf, U; Müller, AR; Neuhaus, P; Neuhaus, R; Radke, C; Rayes, N; Seehofer, D; Settmacher, U; Steinmüller, T, 2001
)
2.03
"Lamivudine treatment (100 mg daily) resulted in rapid loss of hepatitis B virus DNA, resolution of hepatitis, and clinical recovery."( Successful treatment with lamivudine for reactivated hepatitis B infection following chemotherapy for non-Hodgkin's lymphoma.
Andriani, A; Barlattani, A; Bibas, M; Stroffolini, T, 2002
)
1.34
"Lamivudine-treated patients were more likely to be men, hepatitis B e antigen positive, HBV DNA positive, and have lower serum albumin levels at listing (P <.05)."( Effect of lamivudine treatment on survival of 309 North American patients awaiting liver transplantation for chronic hepatitis B.
Carey, W; Fontana, RJ; Fried, M; Keeffe, EB; Kowdley, KV; Lok, AS; McClure, LA; Reddy, R; Soldevila-Pico, C, 2002
)
1.44
"Lamivudine treatment for 12 months leads to a control of viral replication during therapy in the majority of the patients and to sustained anti-hepatitis B e (anti-HBe) seroconversion in 16 to 22% of the patients, associated with a biochemical and histological response."( A preliminary benefit-risk assessment of lamivudine for the treatment of chronic hepatitis B virus infection.
Zoulim, F, 2002
)
1.3
"Treatment with lamivudine or telbivudine for active CHB in early pregnancy appears to be safe and effective for controlling maternal disease as well as interrupting MTCT."( Safety and efficacy of lamivudine or telbivudine started in early pregnancy for mothers with active chronic hepatitis B.
Bai, Y; Cai, H; He, T; Jia, J; Liu, M; Ou, X; Yi, W, 2018
)
1.14
"Treatment with lamivudine significantly decreases the mortality of fulminant hepatitis B patients without SIRS, and a rapid decline of HBV DNA load is one of the good predictors for the treatment outcome."( Lamivudine treatment is associated with improved survival in fulminant hepatitis B.
Kang, P; Sun, LJ; Yan, BZ; Yu, JW; Zhao, YH, 2011
)
2.16
"Mice treated with lamivudine served to compare the in vivo antiviral potency of l-Hyd4FC."( Strong antiviral activity of the new l-hydroxycytidine derivative, l-Hyd4FC, in HBV-infected human chimeric uPA/SCID mice.
Allweiss, L; Bierwolf, J; Dandri, M; Lütgehetmann, M; Matthes, E; Petersen, J; Pollok, JM; Volz, T; Warlich, M, 2012
)
0.7
"Treatment with lamivudine of patients infected with hepatitis B virus (HBV) results in a high rate of drug resistance, which is primarily associated with the rtM204I/V substitution in the HBV reverse transcriptase domain. "( Convergence and coevolution of hepatitis B virus drug resistance.
Campo, DS; Dimitrova, Z; Ganova-Raeva, L; Khudyakov, Y; Lara, J; Lok, A; Ramachandran, S; Teo, CG; Thai, H; Xia, G, 2012
)
0.73
"Treatment with lamivudine is safe and well tolerated and induces a virological and biochemical response in most patients within a short time."( Clinical experience with lamivudine.
Leung, N, 2002
)
0.96
"Oral treatment of lamivudine decreases the level of serum HBV DNA. "( The relationship between HBV lamivudine resistance and HBV genotypes or basic core promoter mutations.
Huang, JS; Lin, LY; Wang, H; Zhou, DY, 2003
)
0.94
"Re-treatment with lamivudine can control viral replication. "( Re-treatment of patients with anti-HBe-positive chronic hepatitis B who relapsed after an initial course of lamivudine.
Andriulli, A; Facciorusso, D; Fontana, R; Gioffreda, D; Guastadisegni, A; Insalata, M; Niro, GA; Palmieri, O; Pastore, G; Perri, F; Santantonio, T; Signorile, F, 2003
)
0.87
"Treatment with lamivudine did not result in significant improvement in the primary outcome measure of unstimulated whole salivary flow or other secondary measures, including minor salivary gland biopsy focus scores."( Lamivudine is not effective in primary Sjögren's syndrome.
Daniels, TE; Davis, JC; Fye, K; Gescuk, B; Lund, S; Whitcher, JP; Wu, AJ, 2005
)
2.12
"Treatment with lamivudine lasted through the first 6 weeks of pregnancy, which was complicated by a possibility of intrauterine hepatitis B virus infection, did not cause any fetus injury."( Pregnancy during lamivudine therapy in chronic hepatitis B--case report.
Borowicz, I; Fota-Markowska, H; Kiciak, S; Modrzewska, R, 2004
)
1
"Treatment with lamivudine is initially efficient in both infections but the incidence of lamivudine-resistant HBV emergence increases over time."( Study on the efficacy and safety of adefovir dipivoxil treatment in post-liver transplant patients with hepatitis B virus infection and lamivudine-resistant hepatitis B virus.
Avilés, JF; Bárcena, R; Barrios, C; Buti, M; Casanovas, T; Cuervas, V; De la Mata, M; Del Campo, S; Delgado, M; Dieguez, ML; Fraga, E; Gonzalez, A; Herrero, JI; Loinaz, C; Mas, A; Moraleda, G; Moreno, JM; Muñoz, R; Otero, A; Prieto, M; Rueda, M; Sousa, JM, 2005
)
0.87
"The treatment with lamivudine leads to drug resistant mutations in 19 to 70% cases after 1- and 5-year therapy, respectively, associated with the risk of severe rebound of liver disease with alaninaminotransferase flare. "( The prevention of an expected hepatic flare in HBe negative patients after lamivudine discontinuation.
Antonov, K; Jelev, DT; Krastev, Z, 2006
)
0.89
"Treatment with lamivudine for 1-year is highly cost-effective compared with no treatment of CHB but has limited effect on reducing the rate of disease progression."( The cost-effectiveness of long-term antiviral therapy in the management of HBeAg-positive and HBeAg-negative chronic hepatitis B in Singapore.
Gane, E; Lacey, LF, 2007
)
0.68
"Treatment with lamivudine and IFN has been compounded by, respectively, the emergence of drug-resistant virus strains and the appearance of serious side effects."( Antiviral treatment of chronic hepatitis B virus infections: the past, the present and the future.
De Clercq, E; Férir, G; Kaptein, S; Neyts, J,
)
0.47
"Treatment with lamivudine resulted in rapid loss of hepatitis B virus-DNA, resolution of hepatitis and clinical recovery."( Case report: lamivudine therapy for submassive hepatic necrosis due to reactivation of hepatitis B following chemotherapy.
Clouston, AD; Crawford, DH; Hourigan, LF; Maguire, CM; Powell, EE; Walpole, ET, 1999
)
1.01
"Treatment with lamivudine results in suppression of viral replication, and clinical improvement and stabilisation of some patients with end-stage liver disease, leading to increased pre-transplant survival as well as a reduced need for transplantation."( End-stage liver disease and liver transplantation: role of lamivudine therapy in patients with chronic hepatitis B.
Keeffe, EB, 2000
)
0.89
"Treatment with lamivudine (150 mg/day) was started because the HBV-DNA level increased gradually after allogeneic BMT."( [Prevention of hepatitis B flare-up using lamivudine in a patient with non-Hodgkin's lymphoma after allogeneic bone marrow transplantation].
Fujii, S; Fujiwara, T; Fukuda, S; Sezaki, T; Sunami, K; Yoshida, C, 2000
)
0.91
"Treatment with lamivudine, an antiviral nucleoside analog, was started at a dose of 100mg/day."( Lamivudine and glycyrrhizin for treatment of chemotherapy-induced hepatitis B virus (HBV) hepatitis in a chronic HBV carrier with non-Hodgkin lymphoma.
Fujii, N; Harada, M; Kiura, K; Matsuo, K; Shimomura, H; Shinagawa, K; Takenaka, K, 2001
)
2.09

Toxicity

The use of anti-TNF-alpha therapy (plus lamivudine in the presence of concurrent underlying hepatitis B viral infection) appeared to be safe. Incidence of drug-related adverse events was similar in the two groups, except for nausea and diarrhoea.

ExcerptReferenceRelevance
"The most commonly reported adverse event was headache, which was generally reported to be mild."( The safety and pharmacokinetics of a reverse transcriptase inhibitor, 3TC, in patients with HIV infection: a phase I study.
Danner, SA; Donn, KH; Hall, ST; Harker, AJ; Hussey, EK; Jonker, P; Lange, JM; van Leeuwen, R, 1992
)
0.28
" Twelve patients withdrew because of adverse events during the 24-week treatment period."( Safety and efficacy of lamivudine-zidovudine combination therapy in zidovudine-experienced patients. A randomized controlled comparison with zidovudine monotherapy. Lamivudine European HIV Working Group.
Danner, SA; Dellarnonica, P; Harrigan, PR; Hill, AM; Johnson, MA; Loveday, C; McDade, H; Picazo, JJ; Skinhøj, P; Staszewski, S; Verity, L, 1996
)
0.6
"Efficacy was measured by evaluating immunological and viral load changes, and safety was assessed by evaluating clinical manifestations and laboratory indexes of toxic effects."( Safety and efficacy of lamivudine-zidovudine combination therapy in zidovudine-experienced patients. A randomized controlled comparison with zidovudine monotherapy. Lamivudine European HIV Working Group.
Danner, SA; Dellarnonica, P; Harrigan, PR; Hill, AM; Johnson, MA; Loveday, C; McDade, H; Picazo, JJ; Skinhøj, P; Staszewski, S; Verity, L, 1996
)
0.6
" Safety was assessed by incidence of adverse clinical events and defined laboratory-measured toxic effects."( Safety and efficacy of lamivudine-zidovudine combination therapy in antiretroviral-naive patients. A randomized controlled comparison with zidovudine monotherapy. Lamivudine European HIV Working Group.
Clumeck, N; Hill, AM; Ingrand, D; Johnson, M; Katlama, C; Loveday, C; Mallolas, J; McDade, H; Pearce, G; Staszewski, S, 1996
)
0.6
" No statistically significant differences in incidence or severity of clinically manifested or laboratory-measured toxic effects were noted between treatment groups."( Safety and efficacy of lamivudine-zidovudine combination therapy in antiretroviral-naive patients. A randomized controlled comparison with zidovudine monotherapy. Lamivudine European HIV Working Group.
Clumeck, N; Hill, AM; Ingrand, D; Johnson, M; Katlama, C; Loveday, C; Mallolas, J; McDade, H; Pearce, G; Staszewski, S, 1996
)
0.6
" Finally, no adverse effects were noted."( Efficacy and safety of lamivudine on replication of recurrent hepatitis B after cadaveric renal transplantation.
Cisterne, JM; Duffaut, M; Durand, D; Henry, S; Icart, J; Rostaing, L, 1997
)
0.61
"We describe a human immunodeficiency virus-seronegative man who presented with a skin disorder that we diagnosed as acute generalized exanthematous pustulosis, which we believe was an adverse reaction to combination prophylactic therapy with zidovudine, lamivudine, and protease inhibitor for human immunodeficiency virus."( Acute generalized exanthematous pustulosis: a cutaneous adverse effect due to prophylactic antiviral therapy with protease inhibitor.
Aquilina, C; Roueire, A; Viraben, R, 1998
)
0.48
" Evaluation of safety and tolerance was based on clinical adverse events and laboratory analyses."( A dose-ranging study to evaluate the safety and efficacy of abacavir alone or in combination with zidovudine and lamivudine in antiretroviral treatment-naive subjects.
Cutrell, A; Harrer, T; Harrigan, RP; Katlama, C; Lanier, RE; Massip, P; Pearce, G; Staszewski, S; Steel, H; Tortell, SM; Yeni, P, 1998
)
0.51
" Abacavir was generally well tolerated with few clinically significant adverse events."( A dose-ranging study to evaluate the safety and efficacy of abacavir alone or in combination with zidovudine and lamivudine in antiretroviral treatment-naive subjects.
Cutrell, A; Harrer, T; Harrigan, RP; Katlama, C; Lanier, RE; Massip, P; Pearce, G; Staszewski, S; Steel, H; Tortell, SM; Yeni, P, 1998
)
0.51
" Mild to moderate headache, nausea, lymphadenopathy, hematuria, musculoskeletal chest pain, neck stiffness, and fever were the most common adverse events reported by those who received abacavir."( Single-dose pharmacokinetics and safety of abacavir (1592U89), zidovudine, and lamivudine administered alone and in combination in adults with human immunodeficiency virus infection.
Chittick, GE; McDowell, JA; Wang, LH, 1999
)
0.53
" The most common adverse events considered to be possibly drug related were nausea, rash, oral paresthesia, diarrhea, and fatigue."( A phase II safety and efficacy study of amprenavir in combination with zidovudine and lamivudine in HIV-infected patients with limited antiretroviral experience. Amprenavir PROAB2002 Study Team.
Antunes, F; Brown, DJ; Clumeck, N; Fetter, A; Haubrich, R; Kahl, L; Lang, W; Pagano, G; Richman, D; Schooley, R; Sereni, D; Stein, A; Thompson, M; van der Ende, ME, 1999
)
0.53
"Changes in HIV RNA from baseline, based on area under the curve and CD4+ cell levels, adverse events, and effect of baseline genotypic resistance on response to adefovir."( Efficacy and safety of adefovir dipivoxil with antiretroviral therapy: a randomized controlled trial.
Basgoz, N; Beall, G; Cherng, D; Cherrington, J; Coakley, D; Cooper, R; Deeks, S; Hardy, D; Kahn, J; Lagakos, S; Miller, M; Murphy, R; Ng, E; Toole, JJ; Winslow, D; Wulfsohn, M,
)
0.13
" Lamivudine treatment was well tolerated at all doses, with no significant adverse events or laboratory data changes."( A dose ranging study of the pharmacokinetics, safety, and preliminary efficacy of lamivudine in children and adolescents with chronic hepatitis B.
Barber, J; Boxall, E; Dallow, N; Johnson, M; Kelly, D; McPhillips, P; Mieli-Vergani, G; Roberts, EA; Sokal, EM, 2000
)
1.44
" The addition of IND to ZDV + 3TC did not result in any significant increase in adverse experiences."( AVANTI 2. Randomized, double-blind trial to evaluate the efficacy and safety of zidovudine plus lamivudine versus zidovudine plus lamivudine plus indinavir in HIV-infected antiretroviral-naive patients.
, 2000
)
0.53
"063), overall incidence of drug-related adverse events (21 versus 19%) (P=0."( Efficacy, safety, and adherence with a twice-daily combination lamivudine/zidovudine tablet formulation, plus a protease inhibitor, in HIV infection.
Becker, S; Eron, JJ; Fisher, RL; Ruane, PJ; Sawyer, GA; Shaefer, MS; Tolson, JM; Yetzer, ES, 2000
)
0.55
"7%) patients because of adverse events and three (3."( Efficacy and safety of twice daily first-line ritonavir/indinavir plus double nucleoside combination therapy in HIV-infected individuals. German Ritonavir/Indinavir Study Group.
Bergmann, F; Carls, H; Fätkenheuer, G; Fenske, S; Knechten, H; Nadler, M; Oette, M; Rieke, A; Rockstroh, JK; Thiesen, A; Wiesel, W, 2000
)
0.31
"Our preliminary data suggest that the protease inhibitor combination ritonavir/indinavir plus double nucleoside therapy appears to be effective and safe in short-term treatment (up to 24 weeks)."( Efficacy and safety of twice daily first-line ritonavir/indinavir plus double nucleoside combination therapy in HIV-infected individuals. German Ritonavir/Indinavir Study Group.
Bergmann, F; Carls, H; Fätkenheuer, G; Fenske, S; Knechten, H; Nadler, M; Oette, M; Rieke, A; Rockstroh, JK; Thiesen, A; Wiesel, W, 2000
)
0.31
" The association of adherence with demographic variables, hepatitis C virus infection, number of stopped antiretroviral regimens, HIV RNA level, CD4 cell count, and adverse effects to drugs was assessed."( Adherence, side effects and efficacy of stavudine plus lamivudine plus nelfinavir in treatment-experienced HIV-infected patients.
Arnedo, A; Gómez, CJ; Roca, B, 2000
)
0.55
" To characterize NVP-associated PEP toxicity, CDC and the Food and Drug Administration (FDA) reviewed MedWatch reports of serious adverse events in persons taking NVP for PEP received by FDA (Figure 1)."( Serious adverse events attributed to nevirapine regimens for postexposure prophylaxis after HIV exposures--worldwide, 1997-2000.
, 2001
)
0.31
" In cell culture (-)3TC is less toxic than its d(+) isomer, (+)3TC, containing the natural nucleoside configuration, and both are considerably less toxic than ddC."( Insights into the molecular mechanism of mitochondrial toxicity by AIDS drugs.
Anderson, KS; Feng, JY; Johnson, AA; Johnson, KA, 2001
)
0.31
" Incidence of drug-related adverse events was similar in the two groups, except for nausea (more common in zidovudine/lamivudine group; 40 versus 17%) and diarrhoea (more common in zidovudine/lamivudine/nelfinavir group; 45 versus 14%)."( AVANTI 3: a randomized, double-blind trial to compare the efficacy and safety of lamivudine plus zidovudine versus lamivudine plus zidovudine plus nelfinavir in HIV-1-infected antiretroviral-naive patients.
Gartland, M, 2001
)
0.75
"Four patients withdrew from the study (two because of adverse events), leaving 31 patients who received adefovir dipivoxil for a median of 48 weeks (range 44-48)."( Safety and efficacy of adefovir dipivoxil in patients co-infected with HIV-1 and lamivudine-resistant hepatitis B virus: an open-label pilot study.
Benhamou, Y; Bochet, M; Brosgart, C; Calvez, V; Fievet, MH; Fry, J; Gibbs, CS; Katlama, C; Namini, H; Poynard, T; Thibault, V; Vig, P, 2001
)
0.54
" Lamivudine therapy was well tolerated, with the rate of occurrence of adverse events similar to that observed in other clinical studies."( A multi-center open study to determine the effect of lamivudine on HBV DNA clearance and to assess the safety of the regimen in patients with chronic hepatitis B infection.
Adamek, J; Bolewska, B; Cianciara, J; Czajka, B; Gonciarz, Z; Gładysz, A; Juszczyk, J; Król, F; Kryczka, W; Mazur, W; Nazzal, K; Swietek, K, 2002
)
1.47
" No significant differences were detected between the treatment groups in virological or immunological response or cessation of study drugs due to adverse events, although it is possible that the study was underpowered to detect differences."( Randomized, open-label, comparative trial to evaluate the efficacy and safety of three antiretroviral drug combinations including two nucleoside analogues and nevirapine for previously untreated HIV-1 Infection: the OzCombo 2 study.
Amin, J; Carr, A; Cooper, D; Drummond, F; Emery, S; French, M; Law, M; Roth, N,
)
0.13
" We conclude that the judicious use of HBcAb-positive donors is reasonably safe and associated with low morbidity and mortality, with the appropriate follow-up protocols."( Safe use of livers from donors with positive hepatitis B core antibody.
Araya, VR; Manzarbeitia, C; Munoz, SJ; Ortiz, JA; Reich, DJ; Rothstein, KD, 2002
)
0.31
" In cell culture, (-)3TC is less toxic than its D (+) isomer, (+)3TC, containing the natural nucleoside configuration, and both are considerably less toxic than 2',3'-dideoxycytidine (ddC)."( Perspectives on the molecular mechanism of inhibition and toxicity of nucleoside analogs that target HIV-1 reverse transcriptase.
Anderson, KS, 2002
)
0.31
" There were no serious adverse events and no discontinuations due to adverse events."( Safety and efficacy of saquinavir soft-gelatin capsules + zidovudine + optional lamivudine in pregnancy and prevention of vertical HIV transmission.
Chantawuttinan, T; Dabtham, K; Hawkins, D; Hill, AM; Kanshana, S; Moyle, GJ; Sirichthaporn, P; Somburanasin, P; Supajatura, V; Vithayasai, V; Wattanatchariya, N, 2002
)
0.54
" Most patients experienced at least one drug-related adverse event that was not considered treatment-limiting by the investigator."( Efficacy and safety of a quadruple combination Combivir + abacavir + efavirenz regimen in antiretroviral treatment-naive HIV-1-infected adults: La Francilienne.
Chemlal, K; de Truchis, P; Devidas, A; Force, G; Mamet, JP; Mechali, D; Praindhui, D; Pulik, M; Rouveix, E; Welker, Y, 2002
)
0.31
"Safety and efficacy results from this study demonstrated that the quadruple regimen Combivir/abacavir/efavirenz is generally safe and displays potent and durable antiretroviral activity in antiretroviral treatment-naive HIV-1-infected patients, offering a promising therapeutic option in a PI-sparing strategy."( Efficacy and safety of a quadruple combination Combivir + abacavir + efavirenz regimen in antiretroviral treatment-naive HIV-1-infected adults: La Francilienne.
Chemlal, K; de Truchis, P; Devidas, A; Force, G; Mamet, JP; Mechali, D; Praindhui, D; Pulik, M; Rouveix, E; Welker, Y, 2002
)
0.31
" Combination prophylaxis with intravenous hepatitis B immune globulin and lamivudine substantially decreased rates of hepatitis B recurrence, but intravenous administration of hepatitis B immune globulin was expensive and associated with significant adverse effects."( Conversion from intravenous to intramuscular hepatitis B immune globulin in combination with lamivudine is safe and cost-effective in patients receiving long-term prophylaxis to prevent hepatitis B recurrence after liver transplantation.
Busuttil, RW; Durazo, F; Edelstein, M; Farmer, D; Ghobrial, RM; Goldstein, L; Han, SH; Holt, C; Hu, R; Kunder, G; Martin, P; Saab, S, 2003
)
0.77
" Assessments included plasma HIV-1 RNA, lymphocyte counts, clinical laboratory evaluations, adverse events, and adherence to treatment (obtained via subject self-report)."( TRIZAL study: switching from successful HAART to Trizivir (abacavir-lamivudine-zidovudine combination tablet): 48 weeks efficacy, safety and adherence results.
Beauvais, L; Clumeck, N; Fenske, S; Gazzard, B; Katlama, C; Lafeuillade, A; Lazzarin, A; Mallolas, J; Mamet, JP, 2003
)
0.55
" Incidence of adverse events was similar in both treatment groups."( TRIZAL study: switching from successful HAART to Trizivir (abacavir-lamivudine-zidovudine combination tablet): 48 weeks efficacy, safety and adherence results.
Beauvais, L; Clumeck, N; Fenske, S; Gazzard, B; Katlama, C; Lafeuillade, A; Lazzarin, A; Mallolas, J; Mamet, JP, 2003
)
0.55
" The advantage of lamivudine includes limited adverse effects and the fact that histological improvement has been documented in the majority of patients."( [Hepatotoxicity of chemotherapy].
Maeda, Y; Okamoto, R; Sasaki, T, 2003
)
0.65
" Severe adverse events due to HAART have been already reported for post exposure prophylaxis in HIV infected patients."( [Acute liver toxicity of antiretroviral therapy (HAART) after liver transplantation in a patient with HIV-HCV coinfection and associated hepatocarcinoma (HCC)].
Antonini, M; Boschetto, A; D'Offizzi, G; Del Nonno, F; Ettorre, GM; Lonardo, MT; Maritti, M; Moricca, P; Narciso, P; Palmieri, GP; Perracchio, L; Santoro, E; Vennarecci, G; Visco, G,
)
0.13
" Hyperbilirubinemia (experienced by 31% of subjects), nausea (17%), abdominal pain (14%), and nephrolithiasis (13%) were the most common drug-related adverse events during the extension."( Long-term efficacy, safety, and tolerability of indinavir-based therapy in protease inhibitor-naive adults with advanced HIV infection.
Chen, J; DiNubile, MJ; Fischl, MA; Harvey, CM; Hirsch, MS; Hirschel, B; Leavitt, RY; McMahon, D; Squires, K; Staszewski, S; Steigbigel, RT, 2003
)
0.32
"This data supports the strategy that in cases of symptomatic hyperlactatemia or lactic acidosis in which the toxicity is associated with stavudine, didanosine or both, it is safe and efficacious to reintroduce NRTI that are less potent inhibitors of mitochondria."( Safety and efficacy of switching to alternative nucleoside analogues following symptomatic hyperlactatemia and lactic acidosis.
Barber, RE; Lonergan, JT; Mathews, WC, 2003
)
0.32
" The aim of this analysis was to determine the incidence of hepatitis flares, hepatic decompensation, and liver-disease-related (LDR) serious adverse events (SAE) during long-term lamivudine treatment."( Long-term safety of lamivudine treatment in patients with chronic hepatitis B.
Castiglia, M; Cui, ZY; Dienstag, JL; Gardner, SD; Griffiths, DA; Heathcote, EJ; Lai, CL; Leung, N; Little, NR; Lok, AS; Schiff, ER; Yao, GB, 2003
)
0.83
" Ten patients discontinued the study treatment before W48: adverse events (eight), patient's will (one) and simplification of therapy (one)."( Efficacy and safety of ritonavir/indinavir 100/400 mg twice daily in combination with two nucleoside analogues in antiretroviral treatment-naive HIV-infected individuals.
Agher, R; Ait-Mohand, H; Bricaire, F; Calvez, V; Costagliola, D; Duvivier, C; Ghosn, J; Katlama, C; Marcelin, AG; Myrto, A; Peytavin, G; Schneider, L, 2003
)
0.32
"IDV/RTV 400/100 mg twice daily is an effective and safe first-line antiretroviral therapy."( Efficacy and safety of ritonavir/indinavir 100/400 mg twice daily in combination with two nucleoside analogues in antiretroviral treatment-naive HIV-infected individuals.
Agher, R; Ait-Mohand, H; Bricaire, F; Calvez, V; Costagliola, D; Duvivier, C; Ghosn, J; Katlama, C; Marcelin, AG; Myrto, A; Peytavin, G; Schneider, L, 2003
)
0.32
" Twenty-eight patients discontinued therapy prior to week 204 because of adverse events (n = 10), lost to follow-up (n = 9), or other reasons (n = 9)."( Long-term safety and durable antiretroviral activity of lopinavir/ritonavir in treatment-naive patients: 4 year follow-up study.
Benson, C; Brun, SC; Eron, JJ; Gulick, RM; Hicks, C; Kessler, HA; King, KR; King, MS; Murphy, RL; White, AC, 2004
)
0.32
" No new safety issues were identified, and the overall incidence of treatment-emergent adverse events during BMS AI424-044 was comparable across treatment groups."( Long-term efficacy and safety of atazanavir with stavudine and lamivudine in patients previously treated with nelfinavir or atazanavir.
Cahn, P; Giordano, M; Kelleher, T; Mancini, M; Murphy, R; Pantaleo, G; Phanuphak, P; Pokrovskiy, V; Rozenbaum, W; Sension, M; Wood, R, 2004
)
0.56
"5), severe adverse effects 17."( Effectiveness and safety of a generic fixed-dose combination of nevirapine, stavudine, and lamivudine in HIV-1-infected adults in Cameroon: open-label multicentre trial.
Andrieux-Meyer, I; Bourgeois, A; Calmy, A; Delaporte, E; Kazatchkine, M; Kouanfack, C; Koulla-Shiro, S; Lactuock, B; Laurent, C; Liégeois, F; Mougnutou, R; Mpoudi-Ngolé, E; Nerrienet, E; Nkoué, N; Nzeusseu, V; Peeters, M; Peytavin, G; Tardy, M; Zekeng, L,
)
0.35
" Adverse events were recorded and evaluated."( [Efficacy and safety in chronic hepatitis B adolescent patients with lamivudine therapy].
Cui, ZY; Lu, WL; Wu, L; Xie, DY; Yao, GB; Yao, JL; Zhang, DF, 2004
)
0.56
" During 52 weeks lamivudine treatment 26 mild adverse events were observed in 18 patients."( [Efficacy and safety in chronic hepatitis B adolescent patients with lamivudine therapy].
Cui, ZY; Lu, WL; Wu, L; Xie, DY; Yao, GB; Yao, JL; Zhang, DF, 2004
)
0.9
" Lamivudine treatment is well tolerated and safe in patients with renal insufficiency undergoing hemodialysis and kidney-transplantation."( Efficiency and safety of lamivudine therapy in patients with chronic HBV infection, dialysis or after kidney transplantation.
Flisiak, R; Jaroszewicz, J; Kowalczuk, O; Lapinski, TW; Michalewicz, M, 2005
)
1.54
" No adverse effects were observed in the maternal mice and the offsprings."( Preliminary study on the efficacy and safety of lamivudine and interferon alpha therapy in decreasing serum HBV DNA level in HBV positive transgenic mice during pregnancy.
Choi, BC; Lei, XY; Li, D; Men, K; Xu, DZ; Yan, YP; Zhang, JX, 2005
)
0.58
" It has no significant adverse effect on safety of pregnant mice and their offspring."( [Study on efficacy and safety of lamivudine and interferon-alpha in treatment of hepatitis B virus transgenic mice with pregnancy].
Lei, XY; Li, D; Men, K; Xu, DZ; Yan, YP; Zhang, JX, 2005
)
0.61
"These results suggest that adefovir dipivoxil would be an effective and safe treatment for patients with decompensated liver cirrhosis with lamivudine resistance, but its effect might be limited and slower for decompensated cirrhosis."( [Efficacy and safety of adefovir dipivoxil in patients with decompensated liver cirrhosis with Lamivudine resistance compared to patients with compensated liver disease].
Choi, MS; Koh, KC; Lee, JH; Moon, W; Moon, YM; Paik, SW; Rhee, JC; Shim, SG; Yoo, BC, 2005
)
0.75
" Therapy was discontinued in 18 patients due to virological failure in 11, adverse events in seven, loss to follow-up or withdrawal of consent in four and death in one."( Efficacy and safety of once-daily combination therapy with didanosine, lamivudine and nevirapine in antiretroviral-naive HIV-infected patients.
Blanco, JL; Crespo, M; Deig, E; Falcó, V; González, A; Miró, JM; Ocaña, I; Pahissa, A; Pedrol, E; Ribera, E; Rodríguez-Pardo, D; Rubio, M; Soler, A, 2005
)
0.56
"A once-daily combination of ddI, 3TC and NVP seems to be an effective, safe and easy-to-take regimen in antiretroviral-naive patients, at least in those who do not have severe immunodepression at baseline."( Efficacy and safety of once-daily combination therapy with didanosine, lamivudine and nevirapine in antiretroviral-naive HIV-infected patients.
Blanco, JL; Crespo, M; Deig, E; Falcó, V; González, A; Miró, JM; Ocaña, I; Pahissa, A; Pedrol, E; Ribera, E; Rodríguez-Pardo, D; Rubio, M; Soler, A, 2005
)
0.56
" No serious adverse events related to adefovir dipivoxil occurred during the study, and HIV-1 RNA and CD4+ cell counts were stable."( Safety and efficacy of adefovir dipivoxil in patients infected with lamivudine-resistant hepatitis B and HIV-1.
Benhamou, Y; Biao, L; Brosgart, C; Calvez, V; Chang, CG; Currie, G; Fievet, MH; Marcelin, AG; Poynard, T; Thibault, V; Vig, P; Xiong, S, 2006
)
0.57
" Our results confirm the efficacy and safety of adefovir treatment in post-liver transplantation patients with lamivudine-resistant HBV, neither were adefovir-resistant mutations identified in patients after 21 months of therapy, nor were there adverse events, especially renal toxicity."( Study on the efficacy and safety of adefovir dipivoxil treatment in post-liver transplant patients with hepatitis B virus infection and lamivudine-resistant hepatitis B virus.
Avilés, JF; Bárcena, R; Barrios, C; Buti, M; Casanovas, T; Cuervas, V; De la Mata, M; Del Campo, S; Delgado, M; Dieguez, ML; Fraga, E; Gonzalez, A; Herrero, JI; Loinaz, C; Mas, A; Moraleda, G; Moreno, JM; Muñoz, R; Otero, A; Prieto, M; Rueda, M; Sousa, JM, 2005
)
0.74
"25%) patients discontinued therapy because of adverse events and 36 (4."( Effectiveness and safety of abacavir, lamivudine, and zidovudine in antiretroviral therapy-naive HIV-infected patients: results from a large multicenter observational cohort.
Bellón, JM; Berenguer, J; Camba, M; Flores, J; Gatell, JM; Hernández-Quero, J; Knobel, H; Miguélez, M; Pérez-Elías, MJ; Podzamczer, D; Resino, S; Rivas-González, P; Sala, M; Santos, I; Soriano, V, 2006
)
0.6
" Treatment was stopped in 18 patients; two from intolerance, two switched therapy, four as a result of serious adverse event-related death, and ten were lost to follow-up."( Efficacy and safety of indinavir/ritonavir 400/100 mg twice daily plus two nucleoside analogues in treatment-naive HIV-1-infected patients with CD4+ T-cell counts <200 cells/mm3: 96-week outcomes.
Anunnatsiri, S; Boonyaprawit, P; Chetchotisakd, P; Mootsikapun, P, 2005
)
0.33
"Our study demonstrates that indinavir/ritonavir 400/100 mg plus stavudine and lamivudine twice daily, the least expensive boosted protease inhibitor, appears to be effective and safe up to 96 weeks despite high baseline viraemia and low CD4+ cell count in antiretroviral-naive patients."( Efficacy and safety of indinavir/ritonavir 400/100 mg twice daily plus two nucleoside analogues in treatment-naive HIV-1-infected patients with CD4+ T-cell counts <200 cells/mm3: 96-week outcomes.
Anunnatsiri, S; Boonyaprawit, P; Chetchotisakd, P; Mootsikapun, P, 2005
)
0.56
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects."( Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004
)
0.32
" Decrease in viral load of HIV (VC) has been assessed as primary endpoint and as secondary one, the increase of the numbers of CD4 lymphocytes, percentage of disease progression, adverse reactions and adherence."( [Clinical trial comparing efficacy and safety of four highly active antiretroviral therapy (HAART) in antiretroviral-naive treatment with advanced HIV infection].
Barberá Farré, JR; Beato Pérez, JL; Cuadra García-Tenorio, F; Geijo Martínez, MP; Maciá Martínez, MA; Marcos Sánchez, F; Martínez Alfaro, E; Moreno Mendaña, JM; Rodríguez Zapata, M; Sanz Moreno, J; Sanz Sanz, J; Solera Santos, J, 2006
)
0.33
" Treatment was discontinued due to adverse reactions: 24% in regimen 1, 48% in regimen 2, 26% in regimen 3 and 32% in regimen 4, without significant difference."( [Clinical trial comparing efficacy and safety of four highly active antiretroviral therapy (HAART) in antiretroviral-naive treatment with advanced HIV infection].
Barberá Farré, JR; Beato Pérez, JL; Cuadra García-Tenorio, F; Geijo Martínez, MP; Maciá Martínez, MA; Marcos Sánchez, F; Martínez Alfaro, E; Moreno Mendaña, JM; Rodríguez Zapata, M; Sanz Moreno, J; Sanz Sanz, J; Solera Santos, J, 2006
)
0.33
"In the HIV positive patients with advanced infection, efficacy between the four regimens of HAART is similar, but there is a tendency to require more withdrawal due to adverse effects in the RTV group than in those of IDV, the two used as single PI."( [Clinical trial comparing efficacy and safety of four highly active antiretroviral therapy (HAART) in antiretroviral-naive treatment with advanced HIV infection].
Barberá Farré, JR; Beato Pérez, JL; Cuadra García-Tenorio, F; Geijo Martínez, MP; Maciá Martínez, MA; Marcos Sánchez, F; Martínez Alfaro, E; Moreno Mendaña, JM; Rodríguez Zapata, M; Sanz Moreno, J; Sanz Sanz, J; Solera Santos, J, 2006
)
0.33
"The use of anti-TNF-alpha therapy (plus lamivudine in the presence of concurrent underlying hepatitis B viral infection) appeared to be safe in that it had no effect on serum aminotransferases and/or viral load."( Safety of anti-TNF-alpha therapy in rheumatoid arthritis and spondylarthropathies with concurrent B or C chronic hepatitis.
Albert, C; Breuil, V; Brocq, O; Euller-Ziegler, L; Roux, CH, 2006
)
0.6
" None of the patients showed an adverse event."( Safety and efficacy of lamivudine in patients with severe acute or fulminant hepatitis B, a multicenter experience.
Canbay, A; Dalekos, GN; Eisenbach, C; Encke, J; Gerken, G; Graziadei, I; Hadem, J; Leifeld, L; Manns, MP; Schmidt, H; Schneider, A; Spengler, U; Tillmann, HL; Vogel, W; Wedemeyer, H; Zachou, K, 2006
)
0.64
" All available safety data (including data beyond 48 weeks) were used in all analyses, which included calculation of treatment emergent laboratory values, adverse events (AEs), serious AEs, fatalities, drug discontinuations and any summaries by study week of safety data."( Long-term safety and tolerability of the lamivudine/abacavir combination as components of highly active antiretroviral therapy.
Brothers, CH; Castillo, SA; Hernandez, JE, 2006
)
0.6
"This analysis indicates that the combination of lamivudine/abacavir is generally safe for the majority of patients when used as part of combination therapy."( Long-term safety and tolerability of the lamivudine/abacavir combination as components of highly active antiretroviral therapy.
Brothers, CH; Castillo, SA; Hernandez, JE, 2006
)
0.86
" Study medication administration was stopped for 14 children, mostly because of nonadherence (4 cases) or virologic rebound (5 cases) and because of adverse events (unrelated death and grade 2 liver toxicity) in 2 cases."( Once-daily highly active antiretroviral therapy for HIV-infected children: safety and efficacy of an efavirenz-containing regimen.
Bekker, V; Jurriaans, S; Kuijpers, TW; Lange, JM; Pajkrt, D; Scherpbier, HJ, 2007
)
0.34
"These results suggest: (i) that suboptimal responses to adefovir 10 mg daily are due to underdosing; and (ii) that increasing the adefovir dose to 20 mg daily is beneficial and safe in patients with lamivudine-resistant HBV and a suboptimal response to adefovir 10 mg daily, especially when alanine aminotransferase levels are elevated and/or the liver disease is severe or rapidly progressive."( Efficacy and safety of adefovir dipivoxil 20 mg daily in HBeAg-positive patients with lamivudine-resistant hepatitis B virus and a suboptimal virological response to adefovir dipivoxil 10 mg daily.
Bouvier-Alias, M; Brillet, R; Chevaliez, S; Dhumeaux, D; Hézode, C; Pawlotsky, JM; Roudot-Thoraval, F; Zafrani, ES, 2007
)
0.75
"To assess adverse events associated with antiretroviral regimens for human immunodeficiency virus (HIV) postexposure prophylaxis (PEP), with a particular focus on the treatment combination of zidovudine, lamivudine, and tenofovir (ZDV-3TC-TDF)."( Assessment of adverse events associated with antiretroviral regimens for postexposure prophylaxis for occupational and nonoccupational exposures to prevent transmission of human immunodeficiency virus.
Antenozzi, S; Hulse, S; Luque, A; Shahzad, U; Smith, B; Tanzman, E; Wang, D, 2007
)
0.53
"Retrospective chart review for individuals who received HIV PEP for occupational and nonoccupational exposure, and multivariate analyses to identify risk factors for noncompletion of PEP and adverse events associated with PEP."( Assessment of adverse events associated with antiretroviral regimens for postexposure prophylaxis for occupational and nonoccupational exposures to prevent transmission of human immunodeficiency virus.
Antenozzi, S; Hulse, S; Luque, A; Shahzad, U; Smith, B; Tanzman, E; Wang, D, 2007
)
0.34
"Preventive treatment of adverse events may be necessary to ensure completion of HIV PEP."( Assessment of adverse events associated with antiretroviral regimens for postexposure prophylaxis for occupational and nonoccupational exposures to prevent transmission of human immunodeficiency virus.
Antenozzi, S; Hulse, S; Luque, A; Shahzad, U; Smith, B; Tanzman, E; Wang, D, 2007
)
0.34
" We start from the assumption that the concomitant use of cyclosporin with mycophenolate mofetil and lamivudine, despite normal concentrations of cyclosporin, might cause the accumulation of toxic metabolites and lead to neurotoxicity that mimics PML in a chronic viral environment."( Neurotoxicity that may mimic progressive multifocal leukoencephalopathy in patient with transplanted kidney.
Janković, S; Marović, A; Matijaca, M; Pintarić, I; Vlasić-Matas, J, 2007
)
0.56
" No patient discontinued due to renal adverse events."( The safety and efficacy of tenofovir DF in combination with lamivudine and efavirenz through 6 years in antiretroviral-naïve HIV-1-infected patients.
Cassetti, I; Cheng, AK; Enejosa, J; Etzel, A; Madruga, JV; Suleiman, JM; Zhong, L,
)
0.37
" TDF treatment was not associated with renal adverse events or limb fat loss in antiretroviral-naïve patients."( The safety and efficacy of tenofovir DF in combination with lamivudine and efavirenz through 6 years in antiretroviral-naïve HIV-1-infected patients.
Cassetti, I; Cheng, AK; Enejosa, J; Etzel, A; Madruga, JV; Suleiman, JM; Zhong, L,
)
0.37
" Overall, 142 participants (71%) discontinued the study after a median time of 112 weeks, including 4 (2%) due to unsuppressed viremia and 40 (20%) due to adverse events."( Efficacy, safety, and tolerability of long-term combination antiretroviral therapy in asymptomatic treatment-naïve adults with early HIV infection.
Dinubile, MJ; Marino, DR; McMahon, DK; Meibohm, AR; Robertson, MN,
)
0.13
"Simplification to a once-daily regimen containing TDF, 3TC, and EFV is virologically and immunologically effective, well-tolerated, and safe with benefits in the lipid profile in the majority of patients."( Effectiveness and safety of simplification therapy with once-daily tenofovir, lamivudine, and efavirenz in HIV-1-infected patients with undetectable plasma viral load on HAART.
Aguirrebengoa, K; Alvarez, ML; Arazo, P; Arrizabalaga, J; Chocarro, A; Echevarría, S; Fariñas, MC; Ferrer, P; García-Palomo, D; Iribarren, JA; Labarga, P; Letona, S; Muñoz-Sánchez, MJ; Oteo, JA; Peralta, G; Pinilla, J; Uriz, J,
)
0.36
" Overall, 29 adverse events were recorded in 23 patients, the majority associated with neuropsychiatric symptoms of EFV."( Efficacy and safety of a once daily regimen with efavirenz, lamivudine, and didanosine, with and without food, as initial therapy for HIV Infection: the ELADI study.
Asensi, V; Barreiro, P; de Mendoza, C; Estrada, V; González-Lahoz, J; Jiménez-Nacher, I; Palacios, R; Rivas, P; Rodríguez-Novoa, S; Sánchez-Conde, M; Santos, J; Sanz, J; Sola, J; Soriano, V, 2007
)
0.58
" Adverse event-related discontinuations were 8% among ATV300/RTV-treated patients and <1% among ATV400-treated patients."( Efficacy and safety of atazanavir, with or without ritonavir, as part of once-daily highly active antiretroviral therapy regimens in antiretroviral-naive patients.
David, N; Hammond, J; Krantz, E; Malan, DR; McGrath, D; Wirtz, V, 2008
)
0.35
"Lamivudine has been demonstrated safe and efficacious in the short term in a large cohort of children with chronic hepatitis B (CHB), but optimal duration of treatment has not been elucidated and limited data on the safety of long-term lamivudine administration have been reported."( Long-term lamivudine treatment of children with chronic hepatitis B: durability of therapeutic responses and safety.
Gardner, SD; Jonas, MM; Little, NR, 2008
)
2.19
" The primary endpoint was any serious adverse event (SAE) definitely/probably or uncertain whether related to blinded nevirapine/abacavir."( Twenty-four-week safety and tolerability of nevirapine vs. abacavir in combination with zidovudine/lamivudine as first-line antiretroviral therapy: a randomized double-blind trial (NORA).
, 2008
)
0.56
"There was a trend towards a lower rate of serious adverse reactions in Ugandan adults with low CD4 starting ARV regimens with abacavir than with nevirapine."( Twenty-four-week safety and tolerability of nevirapine vs. abacavir in combination with zidovudine/lamivudine as first-line antiretroviral therapy: a randomized double-blind trial (NORA).
, 2008
)
0.56
"The primary end point was occurrence of grades 2-4 adverse events and serious adverse events; abacavir hypersensitivity reactions were considered serious adverse events."( Short-term safety and tolerability of a once-daily fixed-dose abacavir-lamivudine combination versus twice-daily dosing of abacavir and lamivudine as separate components: findings from the ALOHA study.
Balu, RB; Brachman, PS; Cohen, CJ; Harley, WB; Kubota, M; Lim, ML; Schneider, S; Shaefer, MS; Sutherland-Phillips, DH; Williams, VC, 2008
)
0.58
"In the short-term, the rates of adverse events in the once-daily and twice-daily groups appeared to be similar."( Short-term safety and tolerability of a once-daily fixed-dose abacavir-lamivudine combination versus twice-daily dosing of abacavir and lamivudine as separate components: findings from the ALOHA study.
Balu, RB; Brachman, PS; Cohen, CJ; Harley, WB; Kubota, M; Lim, ML; Schneider, S; Shaefer, MS; Sutherland-Phillips, DH; Williams, VC, 2008
)
0.58
" Common clinical adverse events (AEs) were diarrhoea, nausea, fatigue and headache."( Antiviral activity and safety of aplaviroc with lamivudine/zidovudine in HIV-infected, therapy-naive patients: the ASCENT (CCR102881) study.
Bonny, T; Clumeck, N; Currier, J; Kleim, JP; Lazzarin, A; McCarty, D; Millard, J; Slims, J; Sloan, L; Steel, H, 2008
)
0.6
" Entecavir was well tolerated, with no patients discontinuing study drug due to adverse events."( Efficacy and safety of entecavir in lamivudine-refractory patients with chronic hepatitis B: randomized controlled trial in Japanese patients.
Imazeki, F; Kage, M; Katano, Y; Kumada, H; Moriyama, M; Omata, M; Sata, M; Seriu, T; Suzuki, F; Toyoda, J, 2008
)
0.62
" The frequency of adverse events with entecavir and placebo was comparable."( Efficacy and safety of entecavir for chronic HBV in HIV/HBV coinfected patients receiving lamivudine as part of antiretroviral therapy.
Brandão-Mello, CE; Brett-Smith, H; Cassetti, I; Gazzard, B; Hall, A; Huang, AK; Mendes-Corrêa, MC; Pessôa, MG; Phiri, P; Soriano, V, 2008
)
0.57
" One stopped IFN treatment because of adverse events and continued ADV only."( Efficacy and safety of adefovir dipivoxil plus pegylated interferon-alpha2a for the treatment of lamivudine-resistant hepatitis B virus infection in HIV-infected patients.
Benhamou, Y; Dominguez, S; Duvivier, C; Ingiliz, P; Katlama, C; Poynard, T; Thibault, V; Valantin, MA, 2008
)
0.56
"ADV and PEG-IFN is safe and effective for treating 3TC-R HBV in HIV patients."( Efficacy and safety of adefovir dipivoxil plus pegylated interferon-alpha2a for the treatment of lamivudine-resistant hepatitis B virus infection in HIV-infected patients.
Benhamou, Y; Dominguez, S; Duvivier, C; Ingiliz, P; Katlama, C; Poynard, T; Thibault, V; Valantin, MA, 2008
)
0.56
"We have demonstrated that low-dosage adefovir therapy in kidney-transplant patients is relatively safe as far as renal parameters are concerned, even though we observed a slight impairment of renal proximal-tubular function."( Renal side effects of adefovir in hepatitis B virus-(HBV) positive kidney allograft recipients.
Alric, L; Huart, A; Izopet, J; Kamar, N; Rostaing, L; Tack, I, 2009
)
0.35
"Primary endpoints were time to virologic failure (confirmed HIV-1 RNA > or = 1,000 copies/mL at 16-24 weeks or > or = 200 copies/mL at > or = 24 weeks) and time to first grade 3 or 4 adverse event or laboratory abnormality that was at least one grade higher than at baseline."( Virologic response and safety of the abacavir/lamivudine fixed-dose formulation as part of highly active antiretroviral therapy: analyses of six clinical studies.
Dix, LP; Ha, B; Liao, QM; Pappa, KA,
)
0.39
" Few subjects treated with ABC/3TC developed grade 3 or 4 adverse events, laboratory toxicities, or changes in lipid levels."( Virologic response and safety of the abacavir/lamivudine fixed-dose formulation as part of highly active antiretroviral therapy: analyses of six clinical studies.
Dix, LP; Ha, B; Liao, QM; Pappa, KA,
)
0.39
" Diarrhea was the most frequently reported adverse event."( Long-term efficacy and safety of fosamprenavir plus ritonavir versus lopinavir/ritonavir in combination with abacavir/lamivudine over 144 weeks.
Baril, JG; Duiculescu, D; Estrada, V; Lim, ML; Logue, K; Pharo, C; Plettenberg, A; Pulido, F; Schewe, K; Vavro, C; Yau, L,
)
0.34
"6% of patients experienced mild and self-limiting adverse events, none of which were attributed to the study drug."( Antiviral activity and safety of LB80380 in hepatitis B e antigen-positive chronic hepatitis B patients with lamivudine-resistant disease.
Han, KH; Kim, CR; Kim, HR; Kim, J; Lai, CL; Um, SH; Yoon, SK; Yuen, MF, 2010
)
0.57
"This review highlights the toxic and genotoxic effects of NRTIs, particularly lamivudine (3TC) and stavudine (d4T) analogues."( The genetic toxicity effects of lamivudine and stavudine antiretroviral agents.
Cunha, KS; de Andrade, HH; Dihl, RR; Guimarães, NN; Lehmann, M, 2010
)
0.87
"Considering that AIDS has become a chronic disease, more comprehensive toxic genetic studies are needed, with particular attention to the genetic alterations induced by NRTIs."( The genetic toxicity effects of lamivudine and stavudine antiretroviral agents.
Cunha, KS; de Andrade, HH; Dihl, RR; Guimarães, NN; Lehmann, M, 2010
)
0.64
" The adverse event rate was similar between arms (except drug hypersensitivity, reported more in the abacavir/lamivudine arm)."( Randomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lamivudine versus tenofovir/emtricitabine, administered with efavirenz, in antiretroviral-naive, HIV-1-infected adults: 48-week results from the ASSERT study.
Branco, T; Cavassini, M; Domingo, P; Fisher, M; Givens, N; Khuong-Josses, MA; Lim, ML; Moyle, GJ; Norden, AG; Pearce, HC; Podzamczer, D; Post, FA; Rieger, A; Stellbrink, HJ; Vavro, C, 2010
)
0.8
"The chewable FDC was safe and provided therapeutically adequate plasma drug exposures in human immunodeficiency virus-infected children."( A chewable pediatric fixed-dose combination tablet of stavudine, lamivudine, and nevirapine: pharmacokinetics and safety compared with the individual liquid formulations in human immunodeficiency virus-infected children in Thailand.
Capparelli, E; Chokephaibulkit, K; Chotpitayasunondh, T; Cressey, TR; Eksaengsri, A; Hongsiriwan, S; McIntosh, K; Muresan, P; Plipat, N; Prasitsuebsai, W; Sirisanthana, V; Smith, ME; Toye, M; Vanprapar, N; Yogev, R, 2010
)
0.6
"Anti-TNF agents represent a safe option for patients with chronic HBV infection when combined with antiviral therapy, as well as in patients previously exposed to HBV receiving no HBV prophylaxis."( Long-term safety of anti-TNF treatment in patients with rheumatic diseases and chronic or resolved hepatitis B virus infection.
Apostolopoulou, A; Archimandritis, AI; Hadziyannis, E; Koskinas, J; Manesis, EK; Manolakopoulos, S; Papatheodoridis, GV; Vassilopoulos, D, 2010
)
0.36
" Hyperbilirubinemia (13%), diarrhea (4%), nausea (2%), and rash (2%) were the most frequent drug-related Grade 2-4 adverse events."( Safety and efficacy of a 36-week induction regimen of abacavir/lamivudine and ritonavir-boosted atazanavir in HIV-infected patients.
Bellos, N; DeJesus, E; Murphy, D; Patel, LG; Ross, LL; Shaefer, MS; Squires, KE; Sutherland-Phillips, DH; Wannamaker, PG; Young, B; Zhao, HH,
)
0.37
" An understanding of structure-activity relationships (SARs) of chemicals can make a significant contribution to the identification of potential toxic effects early in the drug development process and aid in avoiding such problems."( Developing structure-activity relationships for the prediction of hepatotoxicity.
Fisk, L; Greene, N; Naven, RT; Note, RR; Patel, ML; Pelletier, DJ, 2010
)
0.36
" Combination therapy was safe for all pediatric CHB patients."( Combination therapy of lamivudine and interferon-alpha in pediatric patients with chronic hepatitis B in Bangladesh: a safe and effective therapeutic approach for pediatric CHB patients in developing countries.
Ahmed, F; Akbar, SM; Al-Mahtab, M; Karim, MF; Khan, SI; Rahman, S; Uddin, H,
)
0.44
" Maraviroc recipients had greater CD4 increases (+ 212 vs + 171 cells/mm(3)) and fewer adverse event discontinuations (6."( Efficacy and safety of maraviroc versus efavirenz, both with zidovudine/lamivudine: 96-week results from the MERIT study.
Burnside, R; Craig, C; Di Perri, G; Frank, I; Goodrich, J; Heera, J; Mayer, H; McCracken, J; Pontani, D; Saag, M; Sierra-Madero, J; Wood, R,
)
0.36
" Multivariate analyses were performed to compare, between the ddI and ZDV groups, the proportion of patients with a viral load <500 copies/ml during follow-up; the increase in the CD4 cell count; survival; treatment changes and severe adverse events."( Long-term effectiveness and safety of didanosine combined with lamivudine and efavirenz or nevirapine in antiretroviral-naive patients: a 9-year cohort study in Senegal.
Delaporte, E; Diouf, A; Etard, JF; Girard, PM; Landman, R; Laurent, C; Molinari, N; Ndoye, I; Ngom Guèye, NF; Sow, PS; Tchatchueng Mbougua, JB, 2011
)
0.61
" Adverse event rates were comparable between groups."( Efficacy and safety of entecavir versus adefovir in chronic hepatitis B patients with hepatic decompensation: a randomized, open-label study.
Beebe, S; Bialkowska, J; Brown, RS; Cheinquer, H; Cooney, E; Jeffers, L; Leung, N; Liaw, YF; Myers, RP; Peng, CY; Raptopoulou-Gigi, M; Sarin, SK; Tang, S; Tanwandee, T; Tsai, N, 2011
)
0.37
" The complications of CHB and the adverse effects of lamivudine treatment were also recorded."( Efficacy and safety of lamivudine treatment in late pregnancy with high HBV DNA: a perspective for mother and infants.
Devrim, I; Köse, S; Taner, C; Türken, M, 2011
)
0.93
" Neither adverse effects caused by lamivudine treatment nor complications due to CHB infection were experienced by mothers or infants."( Efficacy and safety of lamivudine treatment in late pregnancy with high HBV DNA: a perspective for mother and infants.
Devrim, I; Köse, S; Taner, C; Türken, M, 2011
)
0.96
" Three patients discontinued antiretroviral therapy due to mild adverse events."( Efficacy and safety of once-daily ritonavir-boosted darunavir and abacavir/lamivudine for treatment-naïve patients: a pilot study.
Gatanaga, H; Kikuchi, Y; Nishijima, T; Oka, S; Teruya, K; Tsukada, K, 2012
)
0.61
" Laboratory test results, clinical outcomes, and drug-related adverse events were compared among groups."( Long-term efficacy and safety of lamivudine, entecavir, and tenofovir for treatment of hepatitis B virus-related cirrhosis.
Akbal, E; Akin, E; Alkan, E; Ataseven, H; Aygün, C; Başar, O; Baykal, O; Coban, S; Demir, M; Gülşen, MT; Ibiş, M; Koçkar, MC; Köklü, S; Köksal, AŞ; Küçükazman, M; Nadir, I; Ozdil, K; Pürnak, T; Tuna, Y; Yildirim, B; Yüksel, I; Yüksel, O, 2013
)
0.67
"Tenofovir and entecavir are effective and safe for long-term use in patients with compensated or decompensated cirrhosis from HBV infection."( Long-term efficacy and safety of lamivudine, entecavir, and tenofovir for treatment of hepatitis B virus-related cirrhosis.
Akbal, E; Akin, E; Alkan, E; Ataseven, H; Aygün, C; Başar, O; Baykal, O; Coban, S; Demir, M; Gülşen, MT; Ibiş, M; Koçkar, MC; Köklü, S; Köksal, AŞ; Küçükazman, M; Nadir, I; Ozdil, K; Pürnak, T; Tuna, Y; Yildirim, B; Yüksel, I; Yüksel, O, 2013
)
0.67
" Lipodystrophy accounted for 87 of 96 toxic events."( Frequency of stavudine substitution due to toxicity in children receiving antiretroviral treatment in sub-Saharan Africa.
Chersich, M; Fairlie, L; Kuhn, L; Meyers, T; Moultrie, H; Palmer, M, 2013
)
0.39
" The drug combination appears to be generally safe and well tolerated."( Abacavir/lamivudine fixed-dose combination with ritonavir-boosted darunavir: a safe and efficacious regimen for HIV therapy.
Boissonnault, M; Dion, H; Gallant, S; Lavoie, S; Legault, D; Longpré, D; Machouf, N; Nguyen, VK; Thomas, R; Trottier, B; Vézina, S,
)
0.55
" Adverse events were observed throughout the entire pregnancy and perinatal period, and the effectiveness of lamivudine treatment for blocking mother-to-infant transmission of hepatitis B virus (HBV) was evaluated."( Safety of lamivudine treatment for chronic hepatitis B in early pregnancy.
Cai, HD; Liu, M; Yi, W, 2012
)
0.99
" During pregnancy, the main maternal adverse events were vaginitis (12/72, 16."( Safety of lamivudine treatment for chronic hepatitis B in early pregnancy.
Cai, HD; Liu, M; Yi, W, 2012
)
0.78
"Lamivudine treatment is safe for chronic HBV-infected pregnant mothers and their fetuses with a gestational age of less than 12 wk or throughout the entire pregnancy."( Safety of lamivudine treatment for chronic hepatitis B in early pregnancy.
Cai, HD; Liu, M; Yi, W, 2012
)
2.22
" Seven moderate to severe adverse events were recorded (including four renal colics, possibly treatment-related) in six patients."( Safety and feasibility of treatment simplification to atazanavir/ritonavir + lamivudine in HIV-infected patients on stable treatment with two nucleos(t)ide reverse transcriptase inhibitors + atazanavir/ritonavir with virological suppression (Atazanavir an
Cauda, R; Ciccarelli, N; Cingolani, A; Colafigli, M; D'Avino, A; De Luca, A; Di Giambenedetto, S; Fabbiani, M; Farina, S; Mondi, A; Murri, R; Navarra, P; Sidella, L; Tamburrini, E, 2013
)
0.62
"Simplification to atazanavir/ritonavir + lamivudine was apparently safe and associated with rare virological failure, without resistance selection."( Safety and feasibility of treatment simplification to atazanavir/ritonavir + lamivudine in HIV-infected patients on stable treatment with two nucleos(t)ide reverse transcriptase inhibitors + atazanavir/ritonavir with virological suppression (Atazanavir an
Cauda, R; Ciccarelli, N; Cingolani, A; Colafigli, M; D'Avino, A; De Luca, A; Di Giambenedetto, S; Fabbiani, M; Farina, S; Mondi, A; Murri, R; Navarra, P; Sidella, L; Tamburrini, E, 2013
)
0.88
" In conclusion, a combination of LAM and ADV initiated at the time of wait listing provides safe and effective protection against recurrent HBV infection without the high costs and inconvenience associated with long-term HBIG therapy."( Combination of lamivudine and adefovir without hepatitis B immune globulin is safe and effective prophylaxis against hepatitis B virus recurrence in hepatitis B surface antigen-positive liver transplant candidates.
Angus, PW; Gane, EJ; McCaughan, GW; Patterson, S; Strasser, SI, 2013
)
0.74
" Pressure of work and insufficient perceived benefit of side-effect recording are suspected causes."( Underreporting of side effects of standard first-line ART in the routine setting in Blantyre, Malawi.
Lungu, M; Mathews, T; Tapsfield, J; van Oosterhout, JJ, 2011
)
0.37
" Most adverse events were mild or moderate in severity and transient."( Efficacy and safety of continuous 4-year telbivudine treatment in patients with chronic hepatitis B.
Bao, W; Chan, HL; Gane, EJ; Hou, J; Jia, J; Liaw, YF; Naoumov, NV; Niu, J; Papatheodoridis, G; Thongsawat, S; Trylesinski, A; Wan, M; Wang, Y, 2013
)
0.39
" All NAs were relatively safe and well tolerated."( The efficacy and safety of Nucleos(t)ide analogues in patients with spontaneous acute exacerbation of chronic hepatitis B: a systematic review and meta-analysis.
Fan, J; Lu, H; Shen, C; Wang, Y; Yu, W; Zhao, C, 2013
)
0.39
" The most common adverse events were those known to occur with pegylated interferon-α2a therapy, and safety profiles were similar between both patient populations."( Efficacy and safety of pegylated interferon-α2a in patients with lamivudine-resistant HBeAg-positive chronic hepatitis B.
Byun, KS; Cho, M; Chon, CY; Koh, KC; Kweon, YO; Lee, HC; Lee, YS; Suh, DJ; Tak, WY, 2013
)
0.63
"TDF-based rescue treatment is effective in reducing HBV DNA levels and is safe for patients with CHB who failed prior antiviral treatments."( Efficacy and safety of tenofovir-based rescue therapy for chronic hepatitis B patients with previous nucleo(s/t)ide treatment failure.
Byun, KS; Choe, WH; Kim, JH; Kim, YS; Kwon, SY; Lee, CH; Lee, CI; Yeon, JE; Yoon, EL, 2014
)
0.4
" Adverse drug reactions (ADRs) were defined as adverse events (AE) of which association with Epzicom could not be 'ruled out'."( Safety analysis of Epzicom® (lamivudine/abacavir sulfate) in post-marketing surveillance in Japan.
Kitaichi, T; Kitazono, Y; Kurita, T; Miura, T; Nagao, T, 2014
)
0.69
" Therefore it is a safe way to expand the donor pool when no suitable donor is available."( Safe use of liver grafts from hepatitis B surface antigen positive donors in liver transplantation.
Cheng, L; Geng, L; Wang, W; Wu, L; Yan, S; Ye, Y; Yu, J; Yu, S; Yu, Z; Zhang, W; Zheng, S, 2014
)
0.4
"The most frequent clinical side effect was fatigue (in 23 cases, 88."( Side effects and tolerability of post-exposure prophylaxis with zidovudine, lamivudine, and lopinavir/ritonavir: a comparative study with HIV/AIDS patients.
Cai, J; Xiao, J; Zhang, Q, 2014
)
0.63
" Bayesian fixed-effect network meta-analysis models adjusting for the type of nucleoside reverse transcriptase inhibitor backbone (tenofovir disoproxil fumarate/emtricitabine [TDF/FTC] or abacavir/lamivudine [ABC/3TC]) were used to evaluate week 48 efficacy (HIV-RNA suppression to <50 copies/mL and change in CD4+ cells/µL) and safety (lipid changes, adverse events, and discontinuations due to adverse events) of DTG relative to all other treatments."( 48-week efficacy and safety of dolutegravir relative to commonly used third agents in treatment-naive HIV-1-infected patients: a systematic review and network meta-analysis.
Camejo, RR; Cuffe, R; Gilchrist, KA; Lim, JW; Nichols, G; Patel, DA; Pulgar, S; Snedecor, SJ; Stephens, J; Sudharshan, L; Tang, WY, 2014
)
0.59
" Dolutegravir had better or equivalent changes in total cholesterol, LDL, triglycerides, and lower odds of adverse events and discontinuation due to adverse events compared to all treatments."( 48-week efficacy and safety of dolutegravir relative to commonly used third agents in treatment-naive HIV-1-infected patients: a systematic review and network meta-analysis.
Camejo, RR; Cuffe, R; Gilchrist, KA; Lim, JW; Nichols, G; Patel, DA; Pulgar, S; Snedecor, SJ; Stephens, J; Sudharshan, L; Tang, WY, 2014
)
0.4
"This retrospective investigation carried out in Guangdong Province indicated that not only are anti-HBV drugs efficacious for blocking vertical transmission of HBV but also are safe for both mothers and infants when taken by fathers or mothers during the reproduction phases of insemination and pregnancy."( [Retrospective analysis of the efficacy and safety of anti-hepatitis B virus drugs taken during pregnancy in women from the Guangdong Province].
Chen, X; Gao, W; Li, D; Peng, J; Wen, F; Xia, J; Xu, C; Xu, M; Yao, Z, 2014
)
0.4
" Eleven patients (92%) reported ≥1 adverse event (AE), considered in 2 patients to be at least possibly related to darunavir (gastrointestinal-related events and dizziness)."( Efficacy and safety of darunavir/ritonavir at 48 weeks in treatment-naïve, HIV-1-infected adolescents: results from a phase 2 open-label trial (DIONE).
Blanche, S; Flynn, P; Giaquinto, C; Kakuda, TN; Komar, S; Lathouwers, E; Noguera-Julian, A; Opsomer, M; Van de Casteele, T; Welch, S, 2014
)
0.4
" The concomitant use of ATT including rifabutin and an ART (RAL + ABC/3TC) regimen was safe since one patient was noted to have a RAL-related adverse event (AE) (an allergic reaction) and caused the patient to discontinue therapy."( [The efficacy and safety of a therapy regimen including raltegravir and a fixed dose combination of lamivudine and abacavir in previously rifabutin-treated patients with tuberculosis and HIV infection].
Deulina, MO; Ivanova, ES; Kanestri, VG; Kravchenko, AV; Pokrovsky, VV; Popova, AA; Yakovlev, AA; Zimina, VN, 2014
)
0.62
" No serious adverse event related to tenofovir."( Efficacy, safety and pharmacokinetics of tenofovir disoproxil fumarate in virologic-suppressed HIV-infected children using weight-band dosing.
Aurpibul, L; Chokephaibulkit, K; Cressey, TR; Phongsamart, W; Sirisanthana, V; Sricharoenchai, S; Sudjaritruk, T; Wittawatmongkol, O, 2015
)
0.42
"TDF substitution in children and adolescents who were otherwise stable while receiving a first-line nonnucleoside reverse transcriptase inhibitor-based regimen achieved adequate exposure without clinically significant renal or bone adverse events over 96 weeks."( Efficacy, safety and pharmacokinetics of tenofovir disoproxil fumarate in virologic-suppressed HIV-infected children using weight-band dosing.
Aurpibul, L; Chokephaibulkit, K; Cressey, TR; Phongsamart, W; Sirisanthana, V; Sricharoenchai, S; Sudjaritruk, T; Wittawatmongkol, O, 2015
)
0.42
" Discontinuation rates due to adverse effects were 2% and 3%, respectively."( [Safety profile of dolutegravir].
Domingo, P; Rivero, A, 2015
)
0.42
" Concerning safety, 10 moderate to severe adverse events were recorded in eight patients; overall seven cases of renal colic (possibly treatment related) were observed, leading to a discontinuation of treatment in two patients."( Efficacy and safety of treatment simplification to atazanavir/ritonavir + lamivudine in HIV-infected patients with virological suppression: 144 week follow-up of the AtLaS pilot study.
Borghetti, A; Cauda, R; Ciccarelli, N; Colafigli, M; D'Avino, A; De Luca, A; Di Giambenedetto, S; Fabbiani, M; Gagliardini, R; Mondi, A, 2015
)
0.65
"Intramuscular hepatitis B immunoglobulin in combination with lamivudine or tenofovir and discontinuation of hepatitis B immunoglobulin after 1 year posttransplant may provide safe and cost-effective protection against posttransplant hepatitis B reinfection."( Efficacy and safety of lamivudine or tenofovir plus intramuscular hepatitis B immunoglobulin in prevention of hepatitis B virus reinfection after liver transplant.
Ahmadinejad, Z; Dashti, H; Jafarian, A; Kasraianfard, A; Moini, M; Najafi, A; Nassiri-Toosi, M; Salimi, J, 2015
)
0.97
" Viral load, CD4 count, and adverse events were assessed at baseline, 24, and 48 weeks."( Removing inactive NRTIs in a salvage regimen is safe, maintains virological suppression and reduces treatment costs: results from the VERITAS study (TMC114HIV4054).
Boissonnault, M; Costiniuk, C; Dion, H; Galanakis, C; Jenabian, MA; Lavoie, S; Longpré, D; Machouf, N; Thomas, R; Trottier, B; Vézina, S,
)
0.13
" No serious adverse events were observed."( Removing inactive NRTIs in a salvage regimen is safe, maintains virological suppression and reduces treatment costs: results from the VERITAS study (TMC114HIV4054).
Boissonnault, M; Costiniuk, C; Dion, H; Galanakis, C; Jenabian, MA; Lavoie, S; Longpré, D; Machouf, N; Thomas, R; Trottier, B; Vézina, S,
)
0.13
" We investigated the frequency and severity of adverse events (AE) in infants receiving multiple drug prophylaxis compared to ZDV alone."( Serious adverse events are uncommon with combination neonatal antiretroviral prophylaxis: a retrospective case review.
Barr, E; Davies, J; Forster, JE; Kinzie, K; Levin, MJ; McFarland, EJ; Pappas, J; Paul, S; Smith, C; Weinberg, A, 2015
)
0.42
" Antiretroviral drugs have well documented toxicities and produce adverse events in patients living with HIV/AIDS."( Adverse events and adherence to HIV post-exposure prophylaxis: a cohort study at the Korle-Bu Teaching Hospital in Accra, Ghana.
Dodoo, AN; Lartey, M; Leufkens, HG; Mantel-Teeuwisse, AK; Nartey, ET; Nortey, PA; Tetteh, RA, 2015
)
0.42
"Following the introduction of a HIV post-exposure prophylaxis program in the Korle-Bu Teaching Hospital in January 2005, the incidence of adverse events and adherence were documented in occupationally-exposed healthcare workers (HCWs) and healthcare students (HCSs)."( Adverse events and adherence to HIV post-exposure prophylaxis: a cohort study at the Korle-Bu Teaching Hospital in Accra, Ghana.
Dodoo, AN; Lartey, M; Leufkens, HG; Mantel-Teeuwisse, AK; Nartey, ET; Nortey, PA; Tetteh, RA, 2015
)
0.42
" The frequency of adverse events was 28% (n = 28) in exposed HCWs/HCSs administered 3TC/AZT for 3 days, 91% (n = 68) in exposed HCWs/HCSs administered 3TC/AZT for 28 days and 96% (n = 50) in exposed HCWs/HCSs administered 3TC/AZT/LPV-RTV for 28 days."( Adverse events and adherence to HIV post-exposure prophylaxis: a cohort study at the Korle-Bu Teaching Hospital in Accra, Ghana.
Dodoo, AN; Lartey, M; Leufkens, HG; Mantel-Teeuwisse, AK; Nartey, ET; Nortey, PA; Tetteh, RA, 2015
)
0.42
"The intolerance to adverse events was cited as the sole reason for truncating PEP, thereby indicating the need for adequate, appropriate and effective counselling, education, active follow-up (possibly through mobile /phone contact) and management of adverse events."( Adverse events and adherence to HIV post-exposure prophylaxis: a cohort study at the Korle-Bu Teaching Hospital in Accra, Ghana.
Dodoo, AN; Lartey, M; Leufkens, HG; Mantel-Teeuwisse, AK; Nartey, ET; Nortey, PA; Tetteh, RA, 2015
)
0.42
"This combination ART regimen is safe and effective for patients with HIV/HBV co-infection."( Efficacy and Safety of Tenofovir and Lamivudine in Combination with Efavirenz in Patients Co-infected with Human Immunodeficiency Virus and Hepatitis B Virus in China.
Cai, WP; He, HL; Huang, SB; Ling, XM; Liu, YF; Wang, H; Wang, M; Wang, XC; Wei, FL; Wu, H; Wu, YS; Wu, ZY; Yang, L; Zhang, FJ; Zhang, WW, 2016
)
0.71
" Two patients were lost to follow-up and five ceased the new regimen (4 due to adverse effects and 1 virologic failure)."( Efficacy and safety of switching to abacavir/lamivudine (ABC/3TC) plus rilpivirine (RPV) in virologically suppressed HIV-infected patients on HAART.
González-Domenech, CM; Hernández-Quero, J; Martínez, MA; Mayorga, ML; Olalla, J; Omar, M; Palacios, R; Pérez-Camacho, I; Pérez-Hernández, IA; Romero, A; Romero, JM; Santos, J, 2016
)
0.69
" There was no statistically significant differences in the risk difference for serious adverse events (5."( An Indirect Comparison of Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate and Abacavir/Lamivudine + Dolutegravir in Initial Therapy.
Behrens, G; Borg, P; Bouee, S; M Llibre, J; Moyle, G; Piontkowsky, D; Raffi, F; Reilly, G; Rogatto, F, 2016
)
0.64
"Many adverse drug reactions are caused by the cytochrome P450 (CYP)-dependent activation of drugs into reactive metabolites."( Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
Jones, LH; Nadanaciva, S; Rana, P; Will, Y, 2016
)
0.43
" We recorded the ORs for dual-therapy versus control groups for serious adverse events (1·16 [0·92-1·48]), adverse events (0·82 [0·52-1·28]), and mutations (2·11 [1·32-3·36])."( Efficacy and safety of contemporary dual-drug antiretroviral regimens as first-line treatment or as a simplification strategy: a systematic review and meta-analysis.
Achhra, AC; Amin, J; Boyd, MA; Mwasakifwa, G, 2016
)
0.43
"Dual therapy, especially with regimens excluding maraviroc, could be safe and efficacious, particularly in patients with baseline viral loads of less than 100 000 copies per mL."( Efficacy and safety of contemporary dual-drug antiretroviral regimens as first-line treatment or as a simplification strategy: a systematic review and meta-analysis.
Achhra, AC; Amin, J; Boyd, MA; Mwasakifwa, G, 2016
)
0.43
" The aim of this study was to compare the rate of any discontinuation of antiretroviral (ARV) regimen because of virologic failure (VF), and/or adverse drug reaction (ADR) among patients receiving stable ARV regimens for at least 6 months."( Long-term efficacy and toxicity of abacavir/lamivudine/nevirapine compared to the most prescribed ARV regimens before 2013 in a French Nationwide Cohort Study.
Bani-Sadr, F; Cabie, A; Cotte, L; de Boissieu, P; Delobel, P; Dramé, M; Garraffo, R; Huleux, T; Poizot-Martin, I; Raffi, F; Rey, D, 2016
)
0.7
"Short episodes of corticosteroids seem to be safe in HBV carriers, even in the presence of DMARDs, but lamivudine prophylaxis should be considered for patients exposed to biologicals or cyclophosphamide."( Safety of Corticosteroid Treatment in Rheumatologic Patients With Markers of Hepatitis B Viral Infection: Pilot Evaluation Study.
Balbir-Gurman, A; Braun, M; Braun-Moscovici, Y; Markovits, D; Nahir, MA; Saadi, T, 2016
)
0.65
" Of the nine patients excluded from the study, only one was withdrawn due to adverse events."( Effectiveness and safety of generic version of abacavir/lamivudine and efavirenz in treatment naïve HIV-infected patients: a nonrandomized, open-label, phase IV study in Cali-Colombia, 2011-2012.
Amariles, P; Galindo, J; Galindo-Orrego, X; González-Avendaño, S; Hincapié, JA; Mueses-Marín, HF, 2016
)
0.68
" The secondary objectives analyzed were adverse effects changes in renal, hepatic or lipid profiles, changes in CD4+ cell count and treatment discontinuations."( Abacavir/Lamivudine plus Rilpivirine Is an Effective and Safe Strategy for HIV-1 Suppressed Patients: 48 Week Results of the SIMRIKI Retrospective Study.
Barrufet, P; Berenguer, J; Boix, V; Carrero, A; Castaño, M; Esteban, H; Galindo, MJ; González-García, J; Hontañón, V; Imaz, A; Knobel, H; Moreno, S; Podzamczer, D; Raffo, M; Ribera, E; Ryan, P; Solís, J; Suárez-Lozano, I; Terrón, JA; Troya, J; Yllescas, M, 2016
)
0.85
" Thirty-eight adverse events (AE) were detected in 32 patients."( Abacavir/Lamivudine plus Rilpivirine Is an Effective and Safe Strategy for HIV-1 Suppressed Patients: 48 Week Results of the SIMRIKI Retrospective Study.
Barrufet, P; Berenguer, J; Boix, V; Carrero, A; Castaño, M; Esteban, H; Galindo, MJ; González-García, J; Hontañón, V; Imaz, A; Knobel, H; Moreno, S; Podzamczer, D; Raffo, M; Ribera, E; Ryan, P; Solís, J; Suárez-Lozano, I; Terrón, JA; Troya, J; Yllescas, M, 2016
)
0.85
"There is no known reason to suspect an adverse drug interaction between dolutegravir-based antiretroviral therapy and sofosbuvir, simeprevir, or ledipasvir."( Clinical experience with dolutegravir/abacavir/lamivudine in HIV-HCV co-infected patients treated with a sofosbuvir-based regimen-safety and efficacy.
Bhattarai, S; Fallon, JP; Galang, H; Habeeb, R; Johnson, TM; Shukla, PP; Sison, R; Slim, J, 2016
)
0.69
" No patients ended therapy secondary to adverse events."( Clinical experience with dolutegravir/abacavir/lamivudine in HIV-HCV co-infected patients treated with a sofosbuvir-based regimen-safety and efficacy.
Bhattarai, S; Fallon, JP; Galang, H; Habeeb, R; Johnson, TM; Shukla, PP; Sison, R; Slim, J, 2016
)
0.69
"Long-term TDF treatment appears to be safe and effective in patients with prior failure of LAM and a suboptimal response to ADV therapy."( Five-year efficacy and safety of tenofovir-based salvage therapy for patients with chronic hepatitis B who previously failed LAM/ADV therapy.
Angus, P; Bowden, S; Desmond, P; George, J; Lee, A; Lim, L; Locarnini, S; Marion, K; Nicoll, A; Patterson, S; Roberts, S; Sievert, W; Strasser, S; Thompson, A, 2017
)
0.46
" Rates of Division of AIDS (DAIDS) grade ≥3 laboratory adverse events (AEs) for hepatobiliary and haematological disorders were estimated by duration on drug (<12, 12-24, >24 months)."( Safety of zidovudine/lamivudine scored tablets in children with HIV infection in Europe and Thailand.
, 2017
)
0.77
"Our results demonstrate the efficacy of switching to TDF monotherapy in virologically suppressed CHB patients receiving long-term LAM+ADV therapy, with a low rate of adverse events."( Long-term efficacy and safety of switching from lamivudine+adefovir to tenofovir disoproxil fumarate in virologically suppressed patients.
Angarano, G; Fasano, M; Fiore, JR; Leone, A; Maggi, P; Santantonio, TA; Volpe, A, 2017
)
0.71
"5% of those treated with EVG discontinued due to adverse events (AE)."( Clinical Experience with the Integrase Inhibitors Dolutegravir and Elvitegravir in HIV-infected Patients: Efficacy, Safety and Tolerance.
Balboa-Barreiro, V; Castro-Iglesias, Á; Cid-Silva, P; Fernández-Bargiela, N; Llibre, JM; Margusino-Framiñán, L; Martín-Herranz, I; Pernas-Souto, B; Poveda, E, 2017
)
0.46
" The incidence of serious adverse events was low and unrelated to the study medications."( Efficacy and safety of entecavir versus lamivudine over 5 years of treatment: A randomized controlled trial in Korean patients with hepatitis B e antigen-negative chronic hepatitis B.
Byun, KS; Heo, J; Kim, BH; Kim, D; Kim, DJ; Kim, TH; Kweon, YO; Lee, HJ; Lee, KS; Lee, MS; Lee, YS; Lim, YS; Paik, SW; Suh, DJ; Um, SH; Yu, K, 2017
)
0.72
"Treatment with lamivudine or telbivudine for active CHB in early pregnancy appears to be safe and effective for controlling maternal disease as well as interrupting MTCT."( Safety and efficacy of lamivudine or telbivudine started in early pregnancy for mothers with active chronic hepatitis B.
Bai, Y; Cai, H; He, T; Jia, J; Liu, M; Ou, X; Yi, W, 2018
)
1.14
" The form is designed to obtain information on the demographics of the patients, WHO clinical stage of their HIV infection, HAART regimen for the patients, and suspected adverse events associated with the antiretroviral drugs used by the patients."( A prospective study of adverse events to antiretroviral therapy in HIV- infected adults in Ekiti State, Nigeria.
Awodele, O; Oshikoya, KA; Popoola, TD, 2016
)
0.43
" About half (57%) of the participants reported clinical adverse events; 92% of which were reported within two weeks of HAART initiation."( A prospective study of adverse events to antiretroviral therapy in HIV- infected adults in Ekiti State, Nigeria.
Awodele, O; Oshikoya, KA; Popoola, TD, 2016
)
0.43
"Antiretroviral drugs exposure often presents with adverse events, an observation similar to other studies."( A prospective study of adverse events to antiretroviral therapy in HIV- infected adults in Ekiti State, Nigeria.
Awodele, O; Oshikoya, KA; Popoola, TD, 2016
)
0.43
"Our findings suggest that ART drugs are not associated with an increased risk of CMs, yet some may increase adverse birth events."( Comparative safety and effectiveness of perinatal antiretroviral therapies for HIV-infected women and their children: Systematic review and network meta-analysis including different study designs.
Antony, J; Ashoor, HM; Blondal, E; Finkelstein, Y; Ghassemi, M; Gough, K; Hemmelgarn, BR; Hutton, B; Ivory, JD; Khan, PA; Lillie, E; Straus, SE; Tricco, AC; Vafaei, A; Veroniki, AA, 2018
)
0.48
"The change from a regimen of abacavir + lamivudine + dolutegravir seems to be safe and effective at 24 weeks."( Efficacy and safety of the switch of Triumeq® to generic (abacavir + lamivudine) + Tivicay®: data at 24 weeks.
De la Torre, J; Del Arco, A; García de Lomas, JM; García-Alegría, J; Márquez, E; Nieto, M; Olalla, J; Pérez-Stachowski, J; Prada, JL; Tortajada, B, 2018
)
0.98
" And for women with the HBV viral loads lower than 106 copies/mL, we suggest clinicians to examine the use of lamivudine on a case-to-case basis, noting that lamivudine seems to be a safe drug for the mother and the fetus."( Lamivudine's efficacy and safety in preventing mother-to-child transmission of hepatitis B: A meta-analysis.
Alavian, SM; Fesharaki, MG; Jalilianhasanpour, R; Khalighinejad, P, 2019
)
2.17
" This study investigated the toxic and genotoxic potential of ABC when administered alone or in combination with AZT and/or 3TC using the somatic mutation and recombination test in Drosophila melanogaster."( Toxicity and genotoxicity induced by abacavir antiretroviral medication alone or in combination with zidovudine and/or lamivudine in Drosophila melanogaster.
Bailão, E; Cardoso, CG; Chen-Chen, L; Cunha, KS; de Jesus Silva Carvalho, C; de Moraes Filho, AV; Spanó, MA; Véras, JH, 2019
)
0.72
" What is known of the differences in adverse effects between zidovudine, tenofovir and abacavir? How should their respective adverse effect profiles influence the choice between available combinations? We sought answers to these questions by reviewing the literature using the standard Prescrire methodology."( Zidovudine, tenofovir or abacavir? Different adverse effect profiles.
, 2016
)
0.43
"In this small group of patients, the generic scheme 3TC/TDF/EFV is effective and safe in the treatment of patients with HIV/AIDS naïve, and its effectiveness and safety profile is similar to show by innovator scheme 3TC/TDF/EFV in patients with similar clinical conditions."( [Effectiveness and safety of generic version of lamivudine/tenofovir and efavirenz in treatment naïve HIV-infected patients: a nonrandomized, open-label, phase IV study in Cali-Colombia, 2012-2014].
Amariles, P; Castañeda, C; Galindo, J; Mueses-Marín, HF, 2019
)
0.77
" Secondary outcomes included CD4 cell count change from baseline and safety (adverse events, serious adverse events, and drug-related adverse events) at Week 48."( Comparative efficacy and safety and dolutegravir and lamivudine in treatment naive HIV patients.
Ferrante, S; Parks, DC; Punekar, Y; Radford, M, 2019
)
0.76
" With regard to other outcomes (CD4, adverse event, serious adverse event, drug-related adverse events) at 48 weeks, DTG+3TC was broadly similar to all regimens analysed."( Comparative efficacy and safety and dolutegravir and lamivudine in treatment naive HIV patients.
Ferrante, S; Parks, DC; Punekar, Y; Radford, M, 2019
)
0.76
" However, less attention has been put on their adverse events."( Bayesian Network Meta-Analysis for Assessing Adverse Effects of Anti-hepatitis B Drugs.
Ji, J; Jia, Y; Shen, Y; Xun, P; Zhou, J, 2019
)
0.51
" Poisson-prior-based Bayesian NMA was performed to synthesize both direct and indirect evidence with reporting hazard ratios (HRs) and 95% credible intervals (CrIs) for serious adverse events (SAEs) and hepatic/renal impairments."( Bayesian Network Meta-Analysis for Assessing Adverse Effects of Anti-hepatitis B Drugs.
Ji, J; Jia, Y; Shen, Y; Xun, P; Zhou, J, 2019
)
0.51
" We evaluated the adverse events associated with the use of zidovudine (ZDV)/lamivudine (3TC)/nevirapine (NVP) for neonatal PEP during the first 6 weeks of life."( Safety of 6-week Neonatal Triple-combination Antiretroviral Postexposure Prophylaxis in High-risk HIV-exposed Infants.
Anugulruengkitt, S; Chokephaibulkit, K; Cressey, TR; Jantarabenjakul, W; Ounchanum, P; Pancharoen, C; Punnahitanon, S; Puthanakit, T; Sophonphan, J; Srirompotong, U; Suntarattiwong, P, 2019
)
0.74
" Proportions of women engaged in care, incidence of DAIDS grade ≥ 2 laboratory toxicity, grade ≥ 3 adverse events (AEs), viral suppression (<1000 copies/mL), birth outcomes and infant HIV infections are reported."( Safety and efficacy of Option B+ ART in Malawi: few severe maternal toxicity events or infant HIV infections among pregnant women initiating tenofovir/lamivudine/efavirenz.
Chagomerana, MB; DiPrete, BL; Harrington, BJ; Hosseinipour, MC; Jumbe, AN; Limarzi, L; Ngongondo, M; Wallie, SD, 2019
)
0.71
" While some women experienced adverse laboratory events, clinical symptom monitoring is likely reasonable."( Safety and efficacy of Option B+ ART in Malawi: few severe maternal toxicity events or infant HIV infections among pregnant women initiating tenofovir/lamivudine/efavirenz.
Chagomerana, MB; DiPrete, BL; Harrington, BJ; Hosseinipour, MC; Jumbe, AN; Limarzi, L; Ngongondo, M; Wallie, SD, 2019
)
0.71
" We gathered data on viral loads (VLs) during exposure to the DT, calculating the rate with VL < 50 copies/mL at week 48, and on associated adverse effects."( DOLAMA study: Effectiveness, safety and pharmacoeconomic analysis of dual therapy with dolutegravir and lamivudine in virologically suppressed HIV-1 patients.
Cortés, LL; Fernández, E; Gálvez, C; García, C; Gutiérrez, A; Hidalgo-Tenorio, C; Jesús, SE; Omar, M; Pasquau, J; Santos, J; Sequera, S; Téllez, F, 2019
)
0.73
" The Grade 3-4 adverse events (AEs) and serious AEs (for hematological, hepatic and gastrointestinal events), maximal toxicities for liver enzymes, serum creatinine and bilirubin and maximum treatment-emergent hematology toxicities were comparable for groups with baseline CLcr 30-49 versus CLcr≥50 mL/min."( Changes over time in creatinine clearance and comparison of emergent adverse events for HIV-positive adults receiving standard doses (300 mg/day) of lamivudine-containing antiretroviral therapy with baseline creatinine clearance of 30-49 vs ≥50 mL/min.
Cutrell, A; Double, J; Gibb, DM; Gilks, C; Grosskurth, H; Hakim, J; Kityo, CM; Lou, Y; McCoig, CC; Mugyenyi, PN; Munderi, P; Musoro, G; Perger, T; Ross, LL; Shaefer, MS; Tenorio, AR; Walker, AS, 2019
)
0.71
" However, there are several reasons as to why patients may discontinue their antiretroviral therapy, with adverse events being one of the main reasons reported in the literature."( Factors associated to modification of first-line antiretroviral therapy due to adverse events in people living with HIV/AIDS.
Azevedo, LN; Miranda-Filho, DB; Montarroyos, UR; Monteiro, P; Ximenes, RAA,
)
0.13
" Drug-related grade ≥2 adverse events and withdrawals due to adverse events occurred in 17 (4."( Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phas
Aboud, M; Ait-Khaled, M; Ajana, F; Bisshop, F; De Wit, S; Gartland, MJ; Nascimento, MC; Osiyemi, O; Pappa, KA; Portilla Sogorb, J; Routy, JP; Smith, KY; Tenorio, AR; van Wyk, J; Wang, R; Wright, J; Wyen, C; Wynne, B, 2020
)
0.81
"NVP/ZDV/3TC started in the first week of life was safe and effective, even when trough NVP levels were below target."( Safety and Efficacy of Starting Antiretroviral Therapy in the First Week of Life.
Ajibola, G; Batlang, O; Bennett, K; Capparelli, EV; Hughes, MD; Jean-Philippe, P; Kuritzkes, DR; Lichterfeld, M; Lockman, S; Makhema, J; Maswabi, K; Mohammed, T; Moyo, S; Sakoi, M; Shapiro, RL, 2021
)
0.62
" Secondary outcomes included CD4-count change, treatment discontinuation and treatment-related adverse events."( Efficacy and safety of abacavir/lamivudine plus rilpivirine as a first-line regimen in treatment-naïve HIV-1 infected adults.
Ho, S; Lee, CC; Leo, YS; Lye, DCB; Ng, OT; Wong, CS; Wong, JG, 2020
)
0.84
" Of these, 23 discontinuations were due to drug adverse effects, and only 1 attributed to RPV (p < 0."( Efficacy and safety of abacavir/lamivudine plus rilpivirine as a first-line regimen in treatment-naïve HIV-1 infected adults.
Ho, S; Lee, CC; Leo, YS; Lye, DCB; Ng, OT; Wong, CS; Wong, JG, 2020
)
0.84
"RPV is effective, safe and considerably more tolerable than compared to NNRTI or boosted PI in ABC/3TC-containing regimens for treatment-naïve patients."( Efficacy and safety of abacavir/lamivudine plus rilpivirine as a first-line regimen in treatment-naïve HIV-1 infected adults.
Ho, S; Lee, CC; Leo, YS; Lye, DCB; Ng, OT; Wong, CS; Wong, JG, 2020
)
0.84
" Grade 3/4 adverse events (especially efavirenz-related neuropsychiatric adverse events) leading to regimen discontinuation were also noted."( Efficacy and safety of a single-tablet regimen containing tenofovir disoproxil fumarate 300 mg, lamivudine 300 mg and efavirenz 400 mg as a switch strategy in virologically suppressed HIV-1-infected subjects on nonnucleoside reverse transcriptase inhibito
Betha, TP; Dravid, A; Dravid, M; Gawali, R; Kore, S; Kulkarni, M; Mahajan, U; Rathod, N; Saraf, C; Sharma, AK, 2020
)
0.78
" Grade 3/4 adverse events leading to TLE400 STR discontinuation were seen in 11 (2."( Efficacy and safety of a single-tablet regimen containing tenofovir disoproxil fumarate 300 mg, lamivudine 300 mg and efavirenz 400 mg as a switch strategy in virologically suppressed HIV-1-infected subjects on nonnucleoside reverse transcriptase inhibito
Betha, TP; Dravid, A; Dravid, M; Gawali, R; Kore, S; Kulkarni, M; Mahajan, U; Rathod, N; Saraf, C; Sharma, AK, 2020
)
0.78
" Grade ≥3 adverse events were compared between cohorts."( Pharmacokinetics and Safety of Zidovudine, Lamivudine, and Lopinavir/Ritonavir in HIV-infected Children With Severe Acute Malnutrition in Sub-Saharan Africa: IMPAACT Protocol P1092.
Aweeka, F; Bradford, S; Browning, R; Coletti, A; Costello, D; Graham, B; Hughes, E; Kamthunzi, P; Kawalazira, R; Mmbaga, BT; Moye, J; Musoke, P; Nathoo, K; Norman, J; Owor, M; Purdue, L; Reding, C; Tierney, C; Whalen, ME; Wiesner, L; Ziemba, L, 2021
)
0.88
" 73 (56%) of 131 participants allocated to dual therapy had 150 adverse effects, compared with 78 (58%) of 134 participants allocated to triple therapy who also had 150 adverse events (p=0·68)."( Efficacy and safety of switching to dolutegravir plus lamivudine versus continuing triple antiretroviral therapy in virologically suppressed adults with HIV at 48 weeks (DOLAM): a randomised non-inferiority trial.
Abdulghani, N; Blanco, JL; Clotet, B; de Lazzari, E; Domingo, P; Gatell, JM; Gutierrez, MM; Martínez, E; Mateo, MG; Negredo, E; Paredes, R; Podzamczer, D; Puig, J; Ribera, E; Rojas, J; Tiraboschi, J, 2021
)
0.87
" Outcomes were incidence rate and rate ratios for discontinuation due to all causes (DAC), to adverse events (DAE) and to virological failure (VF) after 4 years of follow-up."( Comparison of the efficacy, safety and durability of a switch to co-formulated RPV/TDF-TAF/FTC or DTG/ABC/3TC in virologically-suppressed HIV-1-infected patients in a single Italian centre: a cohort data analysis.
Bartoloni, A; Borchi, B; Botta, A; Cavallo, A; Kiros, ST; Lagi, F; Meli, M; Pozzi, M; Sterrantino, G, 2022
)
0.72
" A total of 49 adverse events were observed in 31 out of 222 individuals (14."( Safety and effectiveness of switching to Abacavir/Lamivudine plus rilpivirine for maintenance therapy in virologically suppressed HIV-1 individuals in Singapore (SEALS).
Ang, JH; Ang, LW; Hoo, GS; Law, HL; Lee, CC; Leo, YS; Lim, ZC; Ng, OT; Teng, CB; Wong, CS, 2021
)
0.87
"ABC/3TC + RPV is a safe and effective switch option for maintenance therapy in virologically suppressed HIV-1 individuals with in Singapore."( Safety and effectiveness of switching to Abacavir/Lamivudine plus rilpivirine for maintenance therapy in virologically suppressed HIV-1 individuals in Singapore (SEALS).
Ang, JH; Ang, LW; Hoo, GS; Law, HL; Lee, CC; Leo, YS; Lim, ZC; Ng, OT; Teng, CB; Wong, CS, 2021
)
0.87
" No adverse events were related to study drugs."( Pharmacokinetics and Safety of the Abacavir/Lamivudine/Lopinavir/Ritonavir Fixed-Dose Granule Formulation (4-in-1) in Neonates: PETITE Study.
Andrieux-Meyer, I; Bekker, A; Capparelli, E; Cotton, MF; Cressey, R; Cressey, TR; du Toit, S; Groenewald, M; Kumar, M; Lallemant, M; Nielsen, J; Rabie, H; Salvadori, N; Than-In-At, K, 2022
)
0.98
" Drug-related adverse events were more frequent with DTG/3TC (15%; leading to discontinuation in 4%) than TAF-based regimens (5%; leading to discontinuation in 1%) through week 144, but rates were comparable after week 48 (4%; leading to discontinuation in 1% in both groups)."( Efficacy and Safety of Switching to Dolutegravir/Lamivudine Versus Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Results Through Week 144 F
Aboud, M; Ait-Khaled, M; Ajana, F; Bisshop, F; De Wit, S; George, N; Leone, P; Osiyemi, O; Pappa, KA; Portilla, J; Routy, JP; Smith, KY; van Wyk, J; Wang, R; Wright, J; Wyen, C; Wynne, B, 2022
)
0.98
" Drug-related adverse events were more frequent with DTG/3TC (20%) than CAR (6%) through week 48 but comparable post-week 24 (5% vs 2%, respectively)."( Efficacy and Safety of Switching to the 2-Drug Regimen Dolutegravir/Lamivudine Versus Continuing a 3- or 4-Drug Regimen for Maintaining Virologic Suppression in Adults Living With Human Immunodeficiency Virus 1 (HIV-1): Week 48 Results From the Phase 3, N
Blair, E; Bontempo, G; Brites, C; Cheng, CY; Curtis, L; Degen, O; Galera, C; Hocqueloux, L; Llibre, JM; Maggiolo, F; Man, C; Osiyemi, O; Oyee, J; Taylor, S; Underwood, M; van Wyk, J; Wynne, B, 2023
)
1.15
" The proportions of participants with any grade 3-4 adverse event were similar between the dolutegravir (26 [11%]) and darunavir (28 [12%]) groups and between the tenofovir (22 [9%]) and zidovudine (32 [14%]) groups."( Efficacy and safety of dolutegravir or darunavir in combination with lamivudine plus either zidovudine or tenofovir for second-line treatment of HIV infection (NADIA): week 96 results from a prospective, multicentre, open-label, factorial, randomised, non
Asienzo, J; Ategeka, G; Balyegisawa, A; Borok, M; Castelnuovo, B; Hoppe, A; Kaimal, A; Kambugu, A; Kiragga, A; Kityo, C; Lugemwa, A; Mirembe, G; Mugerwa, H; Musaazi, J; Odongpiny, ELA; Paton, NI; Siika, A; Walimbwa, S, 2022
)
0.96
" Safety was assessed by adverse event (AE) reporting."( Brief Report: Efficacy and Safety of Oral Islatravir Once Daily in Combination With Doravirine Through 96 Weeks for Treatment-Naive Adults With HIV-1 Infection Receiving Initial Treatment With Islatravir, Doravirine, and Lamivudine.
Afani Saud, A; Bettacchi, C; Chahin Anania, C; Correll, T; Eves, K; Grandhi, A; Hanna, GJ; Hepler, D; Hwang, C; Klopfer, SO; Molina, JM; Robertson, MN; Yazdanpanah, Y, 2022
)
0.91
"In this multicenter, retrospective, observational study that included HIV-1-infected patients in China, baseline and follow-up data were collected to analyze the virological suppression rate, immune restoration, and adverse events during follow-up in HIV-1-infected patients who switched to the 3TC + DTG dual therapy."( Efficacy and Safety of a Simplified Lamivudine Plus Dolutegravir Dual Therapy in HIV-1-Infected Patients: A Multicenter Cohort Study in China.
Chen, C; Hu, Y; Huang, J; Lv, R; Ma, P; Pei, X; Qi, M; Su, Y; Wei, H; Yan, L; Ye, Z; Zhong, M; Zou, M, 2022
)
1
"Thus, the 3TC + DTG dual therapy displayed an excellent virological efficacy against HIV-1 infections and had an acceptable safety profile, with predominantly mild adverse events in HIV-1-infected patients in China."( Efficacy and Safety of a Simplified Lamivudine Plus Dolutegravir Dual Therapy in HIV-1-Infected Patients: A Multicenter Cohort Study in China.
Chen, C; Hu, Y; Huang, J; Lv, R; Ma, P; Pei, X; Qi, M; Su, Y; Wei, H; Yan, L; Ye, Z; Zhong, M; Zou, M, 2022
)
1
"Previous clinical data have shown that raltegravir-based antiretroviral therapy (ART) with fewer drug-drug interactions (DDIs) and adverse events (AEs) is a good regimen in patients with HIV infection who need cancer chemotherapy."( Safety and efficacy of pharmacotherapy containing INSTIs and chemotherapy drugs in people living with HIV and concomitant colorectal cancer.
Chen, T; Gui, F; Tan, J; Wei, G; Yang, J; Zhao, Y, 2022
)
0.72
" No drug-related serious or grade 3 or 4 adverse events occurred."( Pharmacokinetics, Tolerability, and Safety of Doravirine and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate Fixed-Dose Combination Tablets in Adolescents Living With HIV: Week 24 Results From IMPAACT 2014.
Aurpibul, L; Best, BM; Campbell, H; Cassim, H; Cooper, E; Flynn, P; Gray, KP; Krotje, C; McCarthy, K; McFarland, E; Melvin, AJ; Moye, J; Ounchanum, P; Rungmaitree, S; Scheckter, R; Teppler, H; Tobin, NH; Townley, E; Wan, H; Yedla, M; Yee, KL, 2023
)
1.14
" DTG + 3TC achieved virological suppression more rapidly and stably versus TDF + 3TC + EFV in ART-naïve HIV-1-infected adults, with better immunological response and less adverse drug effect, and reduced total HIV-1 DNA effectively."( Real-world efficacy and safety of dolutegravir plus lamivudine versus tenofovir plus lamivudine and efavirenz in ART-naïve HIV-1-infected adults.
Chen, D; Du, Y; Huang, Z; Li, J; Wang, Y; Wen, Z; Yin, S; Zhong, H, 2022
)
0.97
" Significantly lower study drug-related adverse events were observed in TLE 400 group compared to TLE 600 group (52."( Efficacy and safety of 400 mg efavirenz versus standard 600 mg dose when taken with tenofovir and lamivudine combination in Indian adult patients with HIV-1 infection: An open-label, interventional, randomized, non-inferiority trial.
Bhrusundi, M; Dravid, A; K R, R; Kulkarni, V; Madhukarrao, KM; Morkar, DN; Nageswaramma, S; Naik, KS; Pilawan, AS; Ramapuram, JT; S, A, 2022
)
0.94
" The safety was evaluated by incidence of adverse drug reactions (ADRs)."( Safety and Effectiveness Analyses of Dolutegravir/Lamivudine in Patients with HIV: 2-Year Report of Post-Marketing Surveillance in Japan.
Fukuda, A; Hongo, H; Kurosaki, E; Maeno, Y; Nagao, T; Sebata, A; Suzuki, M; Tofukuji, A; Watanabe, T, 2023
)
1.16
"These results suggest that the 2-drug regimen DTG + 3TC offers comparable and durable efficacy with fewer serious adverse events vs BIC/FTC/TAF and DTG/ABC/3TC through 144 weeks of treatment in ART-naive PWH."( An indirect comparison of 144-week efficacy, safety, and tolerability of dolutegravir plus lamivudine and second-generation integrase inhibitor-based, 3-drug, single-tablet regimens in therapy-naive people with HIV-1.
Evitt, LA; Grove, RA; Nanji, S; Okoli, C; Snedecor, SJ; van Wyk, J, 2023
)
1.13
" Adverse drug reactions were uncommon."( Efficacy and Safety of Two-Drug Regimens with Dolutegravir plus Rilpivirine or Lamivudine in HIV-1 Virologically Suppressed People Living with HIV.
Buzón, L; De la Fuente, S; De Los Santos, I; Dueñas-Gutiérrez, C; Ferreira, E; Gómez, J; Iribarren, JA; Moran, MA; Moreno, E; Pedrero-Tomé, R; Pousada, G; Troya, J, 2023
)
1.14
"We conclude that DTG-based 2DRs (combined with 3TC or RPV) in clinical practice were effective and safe as a switching strategy, with a low VF and high viral suppression rates."( Efficacy and Safety of Two-Drug Regimens with Dolutegravir plus Rilpivirine or Lamivudine in HIV-1 Virologically Suppressed People Living with HIV.
Buzón, L; De la Fuente, S; De Los Santos, I; Dueñas-Gutiérrez, C; Ferreira, E; Gómez, J; Iribarren, JA; Moran, MA; Moreno, E; Pedrero-Tomé, R; Pousada, G; Troya, J, 2023
)
1.14
" We also measured changes from baseline in CD4 + cell counts, CD4/CD8 ratio, lipid parameters, weight, creatinine (Cr), estimated glomerular filtration rate (eGFR), and drug-related adverse effects (DRAEs)."( Efficacy and safety profiles of dolutegravir plus lamivudine vs . bictegravir/emtricitabine/tenofovir alafenamide in therapy-naïve adults with HIV-1.
Deng, Y; He, L; Li, J; Wang, Y; Wei, Y; Wen, L; Xu, R; Zhong, H, 2023
)
1.16
" Safety endpoints assessed included all the adverse events (AEs) related to the study treatment (TLE400 and TLE600)."( Safety of low dose efavirenz regimen in Indian adults with HIV-1 infection: Insights from a phase 4 interventional randomised trial.
Anuradha, S; Bhrusundi, M; Dravid, AN; Kulkarni, V; Madhukarrao, KM; Morkar, DN; Nageswaramma, S; Naik, KS; Pilawan, AS; Ramapuram, JT; Raveendra, KR, 2023
)
0.91

Pharmacokinetics

Lamivudine pharmacokinetic parameters (mean +/- SD) after administration of 150mg twice daily were: peak plasma concentration (Cmax) 2077+/-816 microg/L; trough plasma concentration. (Cmin) 332+/-219 microg-L; elimination half-life (t 1/2beta) 6.

ExcerptReferenceRelevance
" 3TC concentrations in humans were predicted before the initiation of clinical trials by interspecies scaling of pharmacokinetic parameters observed in animal species."( Interspecies scaling and pharmacokinetic parameters of 3TC in humans.
Daniel, MJ; Donn, KH; Evans, GL; Hall, ST; Harker, AJ; Hussey, EK, 1994
)
0.29
" The published pharmacokinetic data for the nucleoside antiretroviral agents zidovudine, didanosine, zalcitabine, stavudine, and lamivudine show that administration of fixed doses of certain agents results in a considerable degree of between-patient variability in in vivo drug exposure."( Clinical pharmacokinetics of nucleoside antiretroviral agents.
Dudley, MN, 1995
)
0.5
" Lamivudine has entered initial clinical trials, and the present study was designed to describe the pharmacokinetic behavior of this compound in both plasma and cerebrospinal fluid (CSF) of primates."( Pharmacokinetics of lamivudine and BCH-189 in plasma and cerebrospinal fluid of nonhuman primates.
Balis, FM; Blaney, SM; Daniel, MJ; Godwin, K; Harker, AJ, 1995
)
1.52
" Pharmacokinetic parameters were calculated by using standard noncompartmental techniques."( Pharmacokinetics of lamivudine in human immunodeficiency virus-infected patients with renal dysfunction.
Bartlett, JA; Heald, AE; Hsyu, PH; Mydlow, P; Robinson, P; Yuen, GJ, 1996
)
0.62
" Serum concentration data were analyzed to determine pharmacokinetic parameter estimates including area under the curve (AUC), terminal half-life (t1/2), mean residence time (MRT) for each formulation, systemic clearance, oral clearance, and apparent volume of distribution (Vd)."( Pharmacokinetics, absolute bioavailability, and absorption characteristics of lamivudine.
Haidar, S; Hall, ST; Hussey, EK; Morris, DM; Mydlow, PK; Yuen, GJ, 1995
)
0.52
" Pharmacokinetic parameters were calculated by using standard non compartmental techniques."( Single dose pharmacokinetics of lamivudine in subjects with impaired renal function and the effect of haemodialysis.
Daniel, MJ; De Broe, ME; Johnson, MA; Moss, J; Plumb, R; Van Caesbroeck, D; Verpooten, GA, 1998
)
0.58
"Hepatic impairment does not warrant dose modification of lamivudine based on this single-dose pharmacokinetic study."( The pharmacokinetics of lamivudine in patients with impaired hepatic function.
Breuel, P; Horak, J; Johnson, MA, 1998
)
0.85
" The average half-life value in humans, normalized to fraction of area under the serum virus load-time curve, was similar to the average half-life value observed in woodchucks given the highest 3TC dose (2."( Pharmacodynamics of (-)-beta-2',3'-dideoxy-3'-thiacytidine in chronically virus-infected woodchucks compared to its pharmacodynamics in humans.
Gerin, JL; Hurwitz, SJ; Korba, BE; Schinazi, RF; Tennant, BC, 1998
)
0.3
" To evaluate the potential pharmacokinetic interactions between these agents, 15 HIV-1-infected adults with a median CD4(+) cell count of 347 cells/mm3 (range, 238 to 570 cells/mm3) were enrolled in a randomized, seven-period crossover study."( Single-dose pharmacokinetics and safety of abacavir (1592U89), zidovudine, and lamivudine administered alone and in combination in adults with human immunodeficiency virus infection.
Chittick, GE; McDowell, JA; Wang, LH, 1999
)
0.53
" On the last day another full pharmacokinetic profile was obtained to 24 h postdose."( The pharmacokinetics of lamivudine in healthy Chinese subjects.
Chen, H; Fan, F; Harker, A; Hu, P; Jiang, J; Johnson, MA; Xie, H, 1999
)
0.61
" On day 1 and day 7 the overall geometric mean Cmax was 1304 and 1385 ng ml-1, and AUC(0,24h) was 4357 and 4353 ng ml-1 h, respectively."( The pharmacokinetics of lamivudine in healthy Chinese subjects.
Chen, H; Fan, F; Harker, A; Hu, P; Jiang, J; Johnson, MA; Xie, H, 1999
)
0.61
" Pharmacokinetic parameters were calculated based on lamivudine and lamivudine anabolite concentration-time data."( The pharmacokinetics of lamivudine phosphorylation in peripheral blood mononuclear cells from patients infected with HIV-1.
Back, D; Barrett, JE; Barry, MG; Churchus, R; Kapoor, A; Lloyd, J; Moore, KH; Pakes, GE; Shaw, S, 1999
)
0.86
"Intracellular pharmacokinetic parameters were highly variable between patients (coefficient of variations approximately 50%)."( The pharmacokinetics of lamivudine phosphorylation in peripheral blood mononuclear cells from patients infected with HIV-1.
Back, D; Barrett, JE; Barry, MG; Churchus, R; Kapoor, A; Lloyd, J; Moore, KH; Pakes, GE; Shaw, S, 1999
)
0.61
"1 liters/h) and volume of distribution (V/F; 128 liters) were similar to values previously reported for HIV-infected patients in phase I pharmacokinetic studies."( Population pharmacokinetics of lamivudine in adult human immunodeficiency virus-infected patients enrolled in two phase III clinical trials.
Bartlett, JA; Eron, JJ; Hussey, EK; Moore, KH; Pakes, GE; Yuen, GJ, 1999
)
0.59
" Blood samples for pharmacokinetic assay were taken on days 1 and 28."( A dose ranging study of the pharmacokinetics, safety, and preliminary efficacy of lamivudine in children and adolescents with chronic hepatitis B.
Barber, J; Boxall, E; Dallow, N; Johnson, M; Kelly, D; McPhillips, P; Mieli-Vergani, G; Roberts, EA; Sokal, EM, 2000
)
0.53
"The indinavir dosage regimen currently used for human immunodeficiency virus (HIV)-infected children is not based on pharmacokinetic data obtained in the target patient population."( Indinavir pharmacokinetics and parmacodynamics in children with human immunodeficiency virus infection.
Bassetti, D; Bassetti, M; Gatti, G; Principi, N; Sala, N; Vella, S; Vigano', A, 2000
)
0.31
" However, pharmacokinetic values of lamivudine will differ among individual patients."( Pharmacokinetic consideration on administration regimen of lamivudine in japanese patients infected with HIV-1.
Fukutake, K; Ito, A; Kawata, K; Kuwabara, R; Tatsunami, S; Yamada, K, 2000
)
0.83
" It suggests that individual pharmacokinetic values of lamivudine should be determined before deciding the optimal administration dose for specific patients."( Pharmacokinetic consideration on administration regimen of lamivudine in japanese patients infected with HIV-1.
Fukutake, K; Ito, A; Kawata, K; Kuwabara, R; Tatsunami, S; Yamada, K, 2000
)
0.8
"This study was designed to investigate any possible pharmacokinetic interaction between lamivudine and alpha interferon as potential candidates for combination therapy for the treatment of hepatitis B virus (HBV)."( A study of the pharmacokinetic interaction between lamivudine and alpha interferon.
Bye, C; Jenkins, JM; Johnson, MA, 2000
)
0.78
" Statistical analysis of pharmacokinetic parameters indicated no significant effect of lamivudine on alpha-interferon pharmacokinetics."( A study of the pharmacokinetic interaction between lamivudine and alpha interferon.
Bye, C; Jenkins, JM; Johnson, MA, 2000
)
0.78
"Plasma population pharmacokinetic analysis was performed on 805 IDV plasma values from 171 patients, using a non-linear mixed-effects modeling approach."( Plasma population pharmacokinetics and penetration into cerebrospinal fluid of indinavir in combination with zidovudine and lamivudine in HIV-1-infected patients.
Acosta, EP; Collier, AC; Havlir, DV; Hirsch, M; Richman, DD; Sommadossi, JP; Tebas, P; Zhou, XJ, 2000
)
0.51
"Population estimates of pharmacokinetic parameters of IDV and its CSF penetration were in excellent agreement with previously reported data from individual analyses."( Plasma population pharmacokinetics and penetration into cerebrospinal fluid of indinavir in combination with zidovudine and lamivudine in HIV-1-infected patients.
Acosta, EP; Collier, AC; Havlir, DV; Hirsch, M; Richman, DD; Sommadossi, JP; Tebas, P; Zhou, XJ, 2000
)
0.51
"To establish whether a feline model can predict nucleoside analogue behavior in human semen, zidovudine (ZDV) and lamivudine (3TC) pharmacokinetic parameters (PKs) were determined in the blood and seminal plasma of healthy cats."( Domestic cat model for predicting human nucleoside analogue pharmacokinetics in blood and seminal plasma.
Cohen, MS; Jordan, HL; Kashuba, AD; Pereira, AS, 2001
)
0.52
"Nonblind, sequential, pharmacokinetic study."( Comparison of the plasma pharmacokinetics of lamivudine during twice and once daily administration in patients with HIV.
Bruno, R; Ciappina, V; Filice, G; Montagna, M; Panebianco, R; Regazzi, MB; Sacchi, P; Villani, P, 2001
)
0.57
" Blood samples for pharmacokinetic analysis were taken over a 12-hour period after > or =7 days of twice daily administration, and again over a 24-hour period after 7 days of once daily administration,."( Comparison of the plasma pharmacokinetics of lamivudine during twice and once daily administration in patients with HIV.
Bruno, R; Ciappina, V; Filice, G; Montagna, M; Panebianco, R; Regazzi, MB; Sacchi, P; Villani, P, 2001
)
0.57
" Since once daily administration may result in improved compliance, these results provide the pharmacokinetic basis for using lamivudine in a once daily regimen."( Comparison of the plasma pharmacokinetics of lamivudine during twice and once daily administration in patients with HIV.
Bruno, R; Ciappina, V; Filice, G; Montagna, M; Panebianco, R; Regazzi, MB; Sacchi, P; Villani, P, 2001
)
0.78
" This pharmacokinetic interaction study was nested within a larger Phase III clinical trial conducted to characterize the safety and efficacy of coadministered nevirapine and lamivudine."( Pharmacokinetics of nevirapine and lamivudine in patients with HIV-1 infection.
Lamson, MJ; Leitz, G; MacGregor, TR; Sabo, JP; Yong, CL, 2000
)
0.78
"Four women completed the SQV pharmacokinetic assessments."( Pharmacokinetics of saquinavir-SGC in HIV-infected pregnant women.
Acosta, EP; Bardeguez, A; Huang, S; Hughes, M; Mofenson, L; Pitt, J; Smith, E; Van Dyke, R; Watts, H; Zorrilla, C,
)
0.13
" 5,510 +/- 237 microg/L), or terminal elimination half-life (t 1/2; 55."( The pharmacokinetics of methadone following co-administration with a lamivudine/zidovudine combination tablet in opiate-dependent subjects.
Andrews, L; Friedland, GH; Jatlow, P; Lane, B; McCance-Katz, EF; Mitchell, SM; Rainey, PM; Snidow, JW, 2002
)
0.55
" In the absence of hemodialysis, the geometric mean lamivudine terminal elimination half-life was 17."( Steady-state pharmacokinetics of lamivudine in human immunodeficiency virus-infected patients with end-stage renal disease receiving chronic dialysis.
Bohjanen, PR; Hicks, CB; Johnson, MD; Miller, CR; Petros, WP; Szczech, LA; Wray, DW, 2002
)
0.85
" Median values of the primary pharmacokinetic parameters of nelfinavir 30 mg/kg every-8-hours (n = 8) and 45 mg/kg every 12 hours (n = 10) were, respectively, for the area under the plasma concentration-time curve over 24 hours, 90."( The pharmacokinetics of nelfinavir in HIV-1-infected children.
Beijnen, JH; de Koning, LA; Heymans, HS; Hoetelmans, RM; Lange, JM; Scherpbier, HJ; van Heeswijk, RP, 2002
)
0.31
" A pharmacodynamic model that superimposes the pharmacokinetics of anti-HIV nucleoside reverse transcription (RT) and protease inhibitors over a previously published predator-prey model of HIV and CD4 dynamics was developed to address this need."( Development of a pharmacodynamic model for HIV treatment with nucleoside reverse transcriptase and protease inhibitors.
Hurwitz, SJ; Schinazi, RF, 2002
)
0.31
" Pharmacokinetic parameters were calculated based on lamivudine and lamivudine-TP concentration-time data."( Equivalent steady-state pharmacokinetics of lamivudine in plasma and lamivudine triphosphate within cells following administration of lamivudine at 300 milligrams once daily and 150 milligrams twice daily.
Bishop, JP; Bumgarner, NF; Hoelscher, DD; Lou, Y; Otto, VR; Smith, GA; Yuen, GJ, 2004
)
0.83
" Concentrations of the agents were quantitated at steady state after observed doses, and the pharmacokinetic parameters were determined."( Pharmacokinetic characteristics of ritonavir, zidovudine, lamivudine, and stavudine in children with human immunodeficiency virus infection.
Fletcher, CV; McIntosh, K; Nachman, SA; Pelton, S; Stanley, K; Wiznia, A; Yogev, R, 2004
)
0.57
"Therapy for HIV is complex, and pharmacodynamic data indicate that relationships exist between systemic concentrations of antiretroviral drugs and virologic response."( Pharmacokinetic characteristics of ritonavir, zidovudine, lamivudine, and stavudine in children with human immunodeficiency virus infection.
Fletcher, CV; McIntosh, K; Nachman, SA; Pelton, S; Stanley, K; Wiznia, A; Yogev, R, 2004
)
0.57
"To study the effect of mycophenolate mofetil therapy on the pharmacokinetic parameters of a number of antiretroviral drugs, on intracellular pools of deoxycytidine triphosphate (dCTP) and deoxyguanosine triphosphate (dGTP), and on intracellular concentrations of the triphosphate of lamivudine (3TCTP)."( Effect of mycophenolate mofetil on the pharmacokinetics of antiretroviral drugs and on intracellular nucleoside triphosphate pools.
Back, DJ; Beijnen, JH; Crommentuyn, KM; Hoggard, PG; Huitema, AD; Kewn, S; Lange, JM; Prins, JM; Sankatsing, SU; Sparidans, RW, 2004
)
0.5
"Randomised pharmacokinetic study."( Effect of mycophenolate mofetil on the pharmacokinetics of antiretroviral drugs and on intracellular nucleoside triphosphate pools.
Back, DJ; Beijnen, JH; Crommentuyn, KM; Hoggard, PG; Huitema, AD; Kewn, S; Lange, JM; Prins, JM; Sankatsing, SU; Sparidans, RW, 2004
)
0.32
" After 8 weeks of therapy, the plasma pharmacokinetic profiles of mycophenolic acid (the active metabolite of mycophenolate mofetil), abacavir, indinavir and nevirapine, and triphosphate concentrations (dCTP, dGTP and 3TCTP) in peripheral blood mononuclear cells, were determined."( Effect of mycophenolate mofetil on the pharmacokinetics of antiretroviral drugs and on intracellular nucleoside triphosphate pools.
Back, DJ; Beijnen, JH; Crommentuyn, KM; Hoggard, PG; Huitema, AD; Kewn, S; Lange, JM; Prins, JM; Sankatsing, SU; Sparidans, RW, 2004
)
0.32
" Mean maternal antenatal d4T pharmacokinetics (terminal plasma half-life [T1/2], 83."( Pharmacokinetics and safety of stavudine in HIV-infected pregnant women and their infants: Pediatric AIDS Clinical Trials Group protocol 332.
Burchett, SK; Ciupak, G; Delke, I; Frenkel, L; Hitti, J; Huang, S; Mathias, A; Mofenson, L; Rathore, M; Samelson, R; Shapiro, DE; Smith, ME; Unadkat, JD; Wade, NA; Watts, DH; Yasin, S, 2004
)
0.32
"The aim of this 2NN pharmacokinetic substudy was to investigate the population pharmacokinetics of nevirapine and efavirenz."( Nevirapine and efavirenz pharmacokinetics and covariate analysis in the 2NN study.
Beijnen, JH; Huitema, AD; Kappelhoff, BS; Lange, J; MacGregor, TR; van Leth, F, 2005
)
0.33
"The present study compared pharmacokinetic (PK) profile and single-dose tolerability of 2 marketed brands of lamivudine (3TC) 150-mg tablets, Lamivir (Cipla, Mumbai, India) and Epivir (GSK, Basingstoke, UK)."( Pharmacokinetic profiling and bioequivalence evaluation of 2 lamivudine tablet formulations after single oral administration in healthy human Indian volunteers.
Lulla, A; Malhotra, G; Narang, VS; Purandare, S, 2005
)
0.78
"AUC0-24 and Cmax of both 3TC and ABC q24h were not inferior to q12h dosing in children."( Plasma pharmacokinetics of once- versus twice-daily lamivudine and abacavir: simplification of combination treatment in HIV-1-infected children (PENTA-13).
Bergshoeff, A; Burger, D; Farrelly, L; Flynn, J; Gibb, D; Khoo, S; Le Prevost, M; Lyall, H; Novelli, V; Verweij, C; Walker, S, 2005
)
0.58
"This was a steady-state, open-label pharmacokinetic study of 19 patients."( Pharmacokinetics of reduced-dose indinavir/ritonavir 400/100 mg twice daily in HIV-1-infected Thai patients.
Boyd, M; Bunyaprawit, P; Burger, D; Chuenyam, T; Cooper, D; Horsakulchai, M; Lange, J; Mahanontharit, A; Mootsikapun, P; Phanuphak, P; Ruxrungtham, K; Sangkote, J; Ubolyam, S, 2005
)
0.33
" The median (interquartile ranges) for indinavir AUC, Cmax and Cmin were 18."( Pharmacokinetics of reduced-dose indinavir/ritonavir 400/100 mg twice daily in HIV-1-infected Thai patients.
Boyd, M; Bunyaprawit, P; Burger, D; Chuenyam, T; Cooper, D; Horsakulchai, M; Lange, J; Mahanontharit, A; Mootsikapun, P; Phanuphak, P; Ruxrungtham, K; Sangkote, J; Ubolyam, S, 2005
)
0.33
" Therapeutic Cmin levels of indinavir were achieved in >80% of the subjects and short-term virological response was satisfactory in this cohort of patients starting highly active antiretroviral therapy at an advanced disease stage with high baseline viral loads."( Pharmacokinetics of reduced-dose indinavir/ritonavir 400/100 mg twice daily in HIV-1-infected Thai patients.
Boyd, M; Bunyaprawit, P; Burger, D; Chuenyam, T; Cooper, D; Horsakulchai, M; Lange, J; Mahanontharit, A; Mootsikapun, P; Phanuphak, P; Ruxrungtham, K; Sangkote, J; Ubolyam, S, 2005
)
0.33
"Human pharmacokinetic parameters are often predicted prior to clinical study from in vivo preclinical pharmacokinetic data."( Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
Jolivette, LJ; Ward, KW, 2005
)
0.33
"We have investigated the pharmacokinetics of nevirapine and paclitaxel in a patient who used both drugs concomitantly, as there are strong theoretical indications for a potential pharmacokinetic drug-drug interaction."( No pharmacokinetic drug-drug interaction between nevirapine and paclitaxel.
Beijnen, JH; Huitema, AD; Kappelhoff, BS; Mairuhu, AT; Schellens, JH, 2005
)
0.33
" TFV-DP also had persistent intracellular levels on TDF discontinuation (median half-life of 150 hours, range: 60 to >175 hours)."( Intracellular pharmacokinetics of tenofovir diphosphate, carbovir triphosphate, and lamivudine triphosphate in patients receiving triple-nucleoside regimens.
Clark, N; Guyer, B; Hawkins, T; Kearney, BP; St Claire, RL; Veikley, W, 2005
)
0.55
"The intracellular triphosphorylation and plasma pharmacokinetics of lamivudine (3TC), stavudine (d4T), and zidovudine (ZDV) were assessed in a pharmacokinetic substudy, in 56 human immunodeficiency virus-hepatitis C virus (HIV-HCV) coinfected patients receiving peginterferon alfa-2a (40KD) 180 microg/week plus either placebo or ribavirin (RBV) 800 mg/day in the AIDS PEGASYS Ribavirin International Coinfection Trial."( Effect of ribavirin on intracellular and plasma pharmacokinetics of nucleoside reverse transcriptase inhibitors in patients with human immunodeficiency virus-hepatitis C virus coinfection: results of a randomized clinical study.
Back, D; Borucki, MJ; Dieterich, D; Gries, JM; Hoggard, PG; Lissen, E; Rodriguez-Torres, M; Soriano, V; Sulkowski, M; Torriani, FJ; Wang, K, 2005
)
0.56
" Dosage and dosing frequency did not influence clearance or volume of distribution of nevirapine, indicating linear pharmacokinetic behavior of nevirapine whether given as a single daily dose or as divided doses over 24 hours."( Pharmacokinetics of nevirapine: once-daily versus twice-daily dosing in the 2NN study.
Beijnen, JH; Huitema, AD; Kappelhoff, BS; Lange, JM; MacGregor, TR; Robinson, PA; van Leth, F,
)
0.13
" The Cmin of nevirapine is lower and the Cmax of nevirapine is higher for the once-daily regimen as compared to the twice-daily regimen."( Pharmacokinetics of nevirapine: once-daily versus twice-daily dosing in the 2NN study.
Beijnen, JH; Huitema, AD; Kappelhoff, BS; Lange, JM; MacGregor, TR; Robinson, PA; van Leth, F,
)
0.13
" The objective was to find cutoff values of the Cmin and AUC24 below which the risk of virologic failure increased."( Pharmacokinetic parameters of nevirapine and efavirenz in relation to antiretroviral efficacy.
Beijnen, JH; Boron-Kaczmarska, A; Hall, DB; Huitema, AD; Johnson, D; Kappelhoff, BS; Lange, JM; Leith, J; Leth, FV; Livrozet, JM; Losso, MH; Saag, MS; Wit, FW, 2006
)
0.33
" The mean (standard deviation) AUC0-24, Cmax and Cmin of lopinavir were 149."( Pharmacokinetics of a once-daily regimen of lopinavir/ritonavir in HIV-1-infected children.
Burger, D; de Groot, R; van der Lee, M; Verweel, G, 2006
)
0.33
"Our findings indicate that 460/115 mg/m2 lopinavir/ritonavir once daily leads to mean pharmacokinetic parameters comparable to data of 800/200 mg lopinavir/ritonavir once daily in adults, although the variability observed in the trough levels is much higher in children."( Pharmacokinetics of a once-daily regimen of lopinavir/ritonavir in HIV-1-infected children.
Burger, D; de Groot, R; van der Lee, M; Verweel, G, 2006
)
0.33
" We determined the pharmacokinetic profiles of stavudine, lamivudine and nevirapine in Pedimune and compared these with the branded products."( Pharmacokinetics of two generic fixed-dose combinations for HIV-infected children (Pedimune Baby & Pedimune Junior) are similar to the branded products in healthy adults.
Burger, DM; Dijkema, T; Gibb, DM; L'homme, RF; van der Ven, AJ; Warris, A, 2007
)
0.58
" An 8 h pharmacokinetic curve was recorded at day 1 of every cycle after medication intake."( Pharmacokinetics of two generic fixed-dose combinations for HIV-infected children (Pedimune Baby & Pedimune Junior) are similar to the branded products in healthy adults.
Burger, DM; Dijkema, T; Gibb, DM; L'homme, RF; van der Ven, AJ; Warris, A, 2007
)
0.34
"Non-parametric statistical tests revealed no statistically significant differences in Cmax (0."( Pharmacokinetics of two generic fixed-dose combinations for HIV-infected children (Pedimune Baby & Pedimune Junior) are similar to the branded products in healthy adults.
Burger, DM; Dijkema, T; Gibb, DM; L'homme, RF; van der Ven, AJ; Warris, A, 2007
)
0.34
"The pharmacokinetic profiles of stavudine, lamivudine and nevirapine in Pedimune Baby and Junior are comparable to the branded products."( Pharmacokinetics of two generic fixed-dose combinations for HIV-infected children (Pedimune Baby & Pedimune Junior) are similar to the branded products in healthy adults.
Burger, DM; Dijkema, T; Gibb, DM; L'homme, RF; van der Ven, AJ; Warris, A, 2007
)
0.6
" Patients taking Triomune had notably higher stavudine Cmax values."( Pharmacokinetic comparison of generic and trade formulations of lamivudine, stavudine and nevirapine in HIV-infected Malawian adults.
Corbett, AH; Hosseinipour, MC; Kanyama, C; Kashuba, AD; Mshali, I; Phakati, S; Rezk, NL; van der Horst, C, 2007
)
0.58
" Data were selected from children who were using lamivudine for at least 2 weeks before a full pharmacokinetic (PK) study was conducted."( Age-dependent pharmacokinetics of lamivudine in HIV-infected children.
Bergshoeff, AS; Burger, DM; de Groot, R; Gibb, DM; Green, H; Hartwig, NG; La Porte, CJ; Lyall, H; Rakhmanina, N; Soldin, S; Verweel, G; Verwey-Van Wissen, CP, 2007
)
0.87
"Twelve HIV-infected patients were assigned into a one-sequence, two-period pharmacokinetic interaction study."( Effect of efavirenz on the pharmacokinetics of ketoconazole in HIV-infected patients.
Jaruratanasirikul, S; Mahatthanatrakul, W; Ridtitid, W; Sriwiriyajan, S, 2007
)
0.34
" A total of 12 subjects undergoing PD, six continuous ambulatory peritoneal dialysis (CAPD) and six automated peritoneal dialysis (APD), for at least 3 months received lamivudine 10 mg (5 mg ml (-1) x 2 ml) daily for 8 consecutive days, followed by an intensive pharmacokinetic assessment."( Pharmacokinetics of lamivudine in subjects receiving peritoneal dialysis in end-stage renal failure.
Asari, A; Chen, YC; Dunn, JA; Gokal, R; Iles-Smith, H; Johnson, MA; Naderer, OJ; Otto, V; Yuen, GJ, 2007
)
0.86
"This work aimed at building a population pharmacokinetic (PK) model for lamivudine (LMV), stavudine (STV) and zidovudine (ZDV), estimating their inter and intraindividual PK variability and investigating the influence of different covariates."( Population pharmacokinetic analysis of lamivudine, stavudine and zidovudine in controlled HIV-infected patients on HAART.
Diquet, B; Goujard, C; Legrand, M; Mentré, F; Panhard, X; Taburet, AM, 2007
)
0.84
" The clinical consequences of these substantial pharmacokinetic changes should be investigated."( Lopinavir-ritonavir dramatically affects the pharmacokinetics of irinotecan in HIV patients with Kaposi's sarcoma.
Corona, G; Innocenti, F; Sandron, S; Sartor, I; Tirelli, U; Toffoli, G; Vaccher, E, 2008
)
0.35
" This population pharmacokinetic analysis affirms that adjusting the dose of lamivudine from 2 mg/kg to 4 mg/kg q12 h at the age of 4 weeks for infants with normal maturation of renal function will provide optimal lamivudine exposure, potentially contributing to more successful therapy."( Population pharmacokinetics of lamivudine in human immunodeficiency virus-exposed and -infected infants.
Acosta, EP; Bryson, Y; Capparelli, EV; Holland, D; Luzuriaga, K; Mirochnick, M; Patel, P; Tremoulet, AH; Wara, D; Zorrilla, C, 2007
)
0.85
" Here we present 24 h serum pharmacokinetic parameters after a single oral exposure to the combination of AZT (40 mg) and 3TC (24 mg), doses equivalent to a human daily dose of Combivir."( Metabolism and pharmacokinetics of the combination Zidovudine plus Lamivudine in the adult Erythrocebus patas monkey determined by liquid chromatography-tandem mass spectrometric analysis.
Divi, RL; Doerge, DR; Harbaugh, JW; Harbaugh, SW; Poirier, MC; Shockley, ME; St Claire, MC; Twaddle, NC, 2008
)
0.58
" Pharmacokinetic parameters were calculated using noncompartmental methods, and bioequivalence was assessed using an analysis of variance model."( Pharmacokinetics of lamivudine, zidovudine, and nevirapine administered as a fixed-dose combination formulation versus coadministration of the individual products.
Dimarco, M; Dodard, C; Guilbaud, R; Marier, JF; Monif, T; Morelli, G; Singla, AK; Thudi, NR; Tippabhotla, SK, 2007
)
0.66
" After 4 weeks or more, a 12-h pharmacokinetic curve was recorded."( Nevirapine, stavudine and lamivudine pharmacokinetics in African children on paediatric fixed-dose combination tablets.
Burger, DM; Chintu, C; Ewings, FM; Gibb, DM; Kabamba, D; Kankasa, C; L'homme, RF; Mulenga, V; Thomason, MJ; Walker, AS, 2008
)
0.65
"Nevirapine concentrations were higher but more variable than in adults; the pharmacokinetic parameters of stavudine and lamivudine were comparable to adults."( Nevirapine, stavudine and lamivudine pharmacokinetics in African children on paediatric fixed-dose combination tablets.
Burger, DM; Chintu, C; Ewings, FM; Gibb, DM; Kabamba, D; Kankasa, C; L'homme, RF; Mulenga, V; Thomason, MJ; Walker, AS, 2008
)
0.85
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
" The pharmacokinetic (PK) target was an extrapolated NFV AUC0-24 > 30 mug ."( Pharmacokinetics and safety of nelfinavir when used in combination with zidovudine and lamivudine in HIV-infected pregnant women: Pediatric AIDS Clinical Trials Group (PACTG) Protocol 353.
Asfaw, Y; Bryson, YJ; Capparelli, E; Connor, J; Huang, S; Hughes, MD; Kaiser, K; Keller, M; Mirochnick, M; Mofenson, LM; Purdue, L; Smith, E; Stek, A; Watts, DH,
)
0.35
" When Cohort 2 NFV PK parameters AP and PP were compared, median Cmax (3."( Pharmacokinetics and safety of nelfinavir when used in combination with zidovudine and lamivudine in HIV-infected pregnant women: Pediatric AIDS Clinical Trials Group (PACTG) Protocol 353.
Asfaw, Y; Bryson, YJ; Capparelli, E; Connor, J; Huang, S; Hughes, MD; Kaiser, K; Keller, M; Mirochnick, M; Mofenson, LM; Purdue, L; Smith, E; Stek, A; Watts, DH,
)
0.35
"We aimed to compare the steady-state pharmacokinetic parameters and tolerability of Triomune 40 (stavudine 40 mg, lamivudine 150 mg and nevirapine 200 mg) and branded formulations of these drugs in HIV-infected Ugandans."( Steady-state pharmacokinetic comparison of generic and branded formulations of stavudine, lamivudine and nevirapine in HIV-infected Ugandan adults.
Back, D; Boffito, M; Byakika-Kibwika, P; D'Avolio, A; Di Perri, G; Kalemeera, F; Khoo, S; Lamorde, M; Mauro, S; Mayanja-Kizza, H; Merry, C; Ryan, M, 2008
)
0.78
" Similarity between steady-state pharmacokinetic parameters was assessed using the US Food and Drug Administration standards for bioequivalency testing."( Steady-state pharmacokinetic comparison of generic and branded formulations of stavudine, lamivudine and nevirapine in HIV-infected Ugandan adults.
Back, D; Boffito, M; Byakika-Kibwika, P; D'Avolio, A; Di Perri, G; Kalemeera, F; Khoo, S; Lamorde, M; Mauro, S; Mayanja-Kizza, H; Merry, C; Ryan, M, 2008
)
0.57
" Pharmacokinetic parameter inter-individual variability ranged from 29% to 99%."( Steady-state pharmacokinetic comparison of generic and branded formulations of stavudine, lamivudine and nevirapine in HIV-infected Ugandan adults.
Back, D; Boffito, M; Byakika-Kibwika, P; D'Avolio, A; Di Perri, G; Kalemeera, F; Khoo, S; Lamorde, M; Mauro, S; Mayanja-Kizza, H; Merry, C; Ryan, M, 2008
)
0.57
" Capacity building for pharmacokinetic research in resource-limited settings is a priority."( Steady-state pharmacokinetic comparison of generic and branded formulations of stavudine, lamivudine and nevirapine in HIV-infected Ugandan adults.
Back, D; Boffito, M; Byakika-Kibwika, P; D'Avolio, A; Di Perri, G; Kalemeera, F; Khoo, S; Lamorde, M; Mauro, S; Mayanja-Kizza, H; Merry, C; Ryan, M, 2008
)
0.57
"New phosphonate depot forms of AZT and 3TC were synthesized and their anti-HIV properties in cell systems, cellular uptake, intracellular transformations and some pharmacokinetic and toxicological data were studied."( New depot forms of AZT and 3TC based on their phosphonate derivatives: anti-HIV activity and pharmacokinetic parameters.
Jasco, MV; Khandazhynskaya, AL; Kukhanova, MK; Shipitzyn, AV; Yanvarev, DV, 2008
)
0.35
" The effect of three routinely prescribed antiretroviral (ARV) drugs on the pharmacokinetic profile of an antidiabetic drug, chlorpropamide, was investigated in 18 human subjects, who had recently been diagnosed positive for human immunodeficiency virus (HIV) infection."( The influence of lamivudine, stavudine and nevirapine on the pharmacokinetics of chlorpropamide in human subjects.
Bakare-Odunola, MT; Enemali, I; Garba, M; Mustapha, KB; Obodozie, OO,
)
0.47
" Statistical analyses were performed on pharmacokinetic parameters: the area under the concentration-time curve from 0 to 4 h (AUC(0-4)), the maximum concentration of the drug (C(max)), and the residual concentration of the drug at the end of the dosing interval (C(trough)) for plasma and the AUC(0-4) and C(trough) for intracellular data."( Pilot pharmacokinetic study of human immunodeficiency virus-infected patients receiving tenofovir disoproxil fumarate (TDF): investigation of systemic and intracellular interactions between TDF and abacavir, lamivudine, or lopinavir-ritonavir.
Ayen, R; Clotet, B; Grassi, J; Levi, M; Negredo, E; Pruvost, A; Puig, J; Théodoro, F, 2009
)
0.54
" A 12 h pharmacokinetic study was done at 4-6 weeks after starting treatment."( Pharmacokinetics and 48 week efficacy of low-dose lopinavir/ritonavir in HIV-infected children.
Ananworanich, J; Boonrak, P; Bunupuradah, T; Burger, D; Gorowara, M; Jupimai, T; Pancharoen, C; Phasomsap, C; Puthanakit, T; Ruxrungtham, K; van der Lugt, J, 2009
)
0.35
"Low-dose lopinavir displayed adequate pharmacokinetic parameters and good efficacy as compared with standard-dose lopinavir in Thai children."( Pharmacokinetics and 48 week efficacy of low-dose lopinavir/ritonavir in HIV-infected children.
Ananworanich, J; Boonrak, P; Bunupuradah, T; Burger, D; Gorowara, M; Jupimai, T; Pancharoen, C; Phasomsap, C; Puthanakit, T; Ruxrungtham, K; van der Lugt, J, 2009
)
0.35
" Finally, the validated UPLC-MS/MS method was successfully applied to the pharmacokinetic study after either didanosine or valdidanosine orally administrated to the Sprague-Dawley rats."( Simultaneous determination of didanosine and its amino acid prodrug, valdidanosine by hydrophilic interaction chromatography coupled with electrospray ionization tandem mass spectrometry: application to a pharmacokinetic study in rats.
Chang, Y; Fu, Q; He, Z; Meng, P; Sun, J; Sun, Y; Wang, J; Xu, Y; Yan, Z; Zhu, M, 2010
)
0.36
" The method has been successfully applied to the pharmacokinetic study of a combination treatment of 300 mg lamivudine, 30 mg stavudine and 200 mg nevirapine in 22 healthy male volunteers under fasting conditions."( Simultaneous determination of lamivudine, stavudine and nevirapine in human plasma by LC-MS/MS and its application to pharmacokinetic study in clinic.
Ding, C; Ge, Q; Li, Z; Liu, X; Zhi, X; Zhou, Z, 2010
)
0.86
" After 10 days of one formulation, 6-h pharmacokinetic sampling was performed, and patients were crossed over to subsequent formulations."( Pharmacokinetics of generic and trade formulations of lamivudine, stavudine and nevirapine in HIV-infected Malawian children.
Corbett, AH; Hosseinipour, MC; Kanyama, C; Kashuba, AD; Kazembe, P; Mkupani, P; Mwansambo, C; Nyirenda, J; Rezk, NL; Sichali, D; Tien, H; Weigel, R, 2010
)
0.61
"Full 12-hour pharmacokinetic profiles of nevirapine, stavudine, and lamivudine in HIV-infected children taking fixed-dose combination antiretroviral tablets have been reported previously by us."( Limited sampling models to predict the pharmacokinetics of nevirapine, stavudine, and lamivudine in HIV-infected children treated with pediatric fixed-dose combination tablets.
Burger, D; Chintu, C; Ewings, F; Gibb, DM; Kabamba, D; Kankasa, C; L'homme, R; Mulenga, V; Thomason, M; Walker, AS, 2010
)
0.82
"The International Maternal Pediatric Adolescent AIDS Clinical Trials group (IMPAACT) P1056 study was a phase I/II, 2-arm, randomized, open-label, multidose pharmacokinetic cross-over study."( A chewable pediatric fixed-dose combination tablet of stavudine, lamivudine, and nevirapine: pharmacokinetics and safety compared with the individual liquid formulations in human immunodeficiency virus-infected children in Thailand.
Capparelli, E; Chokephaibulkit, K; Chotpitayasunondh, T; Cressey, TR; Eksaengsri, A; Hongsiriwan, S; McIntosh, K; Muresan, P; Plipat, N; Prasitsuebsai, W; Sirisanthana, V; Smith, ME; Toye, M; Vanprapar, N; Yogev, R, 2010
)
0.6
" We conducted a pharmacokinetic study of once-daily and twice-daily abacavir and lamivudine in children aged 3-<36 months."( Pharmacokinetic study of once-daily versus twice-daily abacavir and lamivudine in HIV type-1-infected children aged 3-<36 months.
, 2010
)
0.82
"Children with stable HIV type-1 (HIV-1) RNA levels after 12 weeks treatment with twice-daily abacavir (8 mg/kg) with or without lamivudine (4 mg/kg) underwent plasma pharmacokinetic sampling."( Pharmacokinetic study of once-daily versus twice-daily abacavir and lamivudine in HIV type-1-infected children aged 3-<36 months.
, 2010
)
0.8
"A total of 18 children (4, 6 and 8 in the 3-<12, 12-<24 and 24-<36 month age ranges, respectively) provided pharmacokinetic data for abacavir (17 for lamivudine)."( Pharmacokinetic study of once-daily versus twice-daily abacavir and lamivudine in HIV type-1-infected children aged 3-<36 months.
, 2010
)
0.8
"The shorter half-life was observed first in Chinese HIV patients with once- and twice-daily regimens."( Steady-state pharmacokinetics of lamivudine once-daily versus twice-daily dosing in Chinese HIV-infected patients.
Fu, Q; Li, P; Li, T; Wang, L; Ye, M; Zhu, Z,
)
0.41
" It has shown promising in vitro anti-HIV-1 activities and favourable human pharmacokinetic properties after co-administration with ritonavir (RTV)."( Evaluation of steady-state pharmacokinetic interactions between ritonavir-boosted BILR 355, a non-nucleoside reverse transcriptase inhibitor, and lamivudine/zidovudine in healthy subjects.
Allen, L; Castles, MA; Huang, DB; Huang, F; MacGregor, TR; Moy, F; Nguyen, T; Robinson, P; Rowland, L; Vinisko, R, 2012
)
0.58
" Intensive blood samples were taken on days 7 and 14 for pharmacokinetic assessments."( Evaluation of steady-state pharmacokinetic interactions between ritonavir-boosted BILR 355, a non-nucleoside reverse transcriptase inhibitor, and lamivudine/zidovudine in healthy subjects.
Allen, L; Castles, MA; Huang, DB; Huang, F; MacGregor, TR; Moy, F; Nguyen, T; Robinson, P; Rowland, L; Vinisko, R, 2012
)
0.58
"After co-administration with BILR 355/r, the AUC(12,ss) and C(max,ss) of 3TC increased by 45% and 24%, respectively; the elimination half-life (t(1/2) ,ss) of 3TC was significantly increased."( Evaluation of steady-state pharmacokinetic interactions between ritonavir-boosted BILR 355, a non-nucleoside reverse transcriptase inhibitor, and lamivudine/zidovudine in healthy subjects.
Allen, L; Castles, MA; Huang, DB; Huang, F; MacGregor, TR; Moy, F; Nguyen, T; Robinson, P; Rowland, L; Vinisko, R, 2012
)
0.58
" Mean HBIg half-life was 21."( Pharmacokinetics and efficacy of intravenous or intramuscular hepatitis B immunoglobulins in prophylaxis of hepatitis B after liver transplantation.
Andreone, P; Bacci, M; Burra, P; Canova, D; Cursaro, C; Fiorentino, B; Guazzini, S; Marengo, A; Marzano, A; Riili, A; Volpes, R, 2010
)
0.36
" Anti-HBs titers three times higher than aimed and four weeks mean half-life could suggest the reduction of doses and the elongation of the interval of administration of im-HBIg."( Pharmacokinetics and efficacy of intravenous or intramuscular hepatitis B immunoglobulins in prophylaxis of hepatitis B after liver transplantation.
Andreone, P; Bacci, M; Burra, P; Canova, D; Cursaro, C; Fiorentino, B; Guazzini, S; Marengo, A; Marzano, A; Riili, A; Volpes, R, 2010
)
0.36
"The population pharmacokinetic parameters of zidovudine (AZT), lamivudine (3TC), and their active intracellular metabolites in 75 naïve HIV-infected patients receiving an oral combination of AZT and 3TC twice daily as part of their multitherapy treatment in the COPHAR2-ANRS 111 trial are described."( Joint population pharmacokinetic analysis of zidovudine, lamivudine, and their active intracellular metabolites in HIV patients.
Bazzoli, C; Bénech, H; Duval, X; Mentré, F; Retout, S; Rey, E; Salmon, D; Tréluyer, JM, 2011
)
0.85
"Intensive 12-hour pharmacokinetic profiles were performed between either days 4-7 or days 10-14 of life in 26 Brazilian infants."( Nelfinavir and Lamivudine pharmacokinetics during the first two weeks of life.
Bryson, Y; Camarca, M; Mirochnick, M; Mofenson, L; Moye, J; Nielsen-Saines, K; Pilotto, JH; Pinto, J; Rossi, S; Veloso, VG; Watts, DH, 2011
)
0.72
": Lamivudine pharmacokinetic parameters observed in this study were consistent with those seen in other studies of neonates."( Nelfinavir and Lamivudine pharmacokinetics during the first two weeks of life.
Bryson, Y; Camarca, M; Mirochnick, M; Mofenson, L; Moye, J; Nielsen-Saines, K; Pilotto, JH; Pinto, J; Rossi, S; Veloso, VG; Watts, DH, 2011
)
1.44
"To evaluate international pediatric efavirenz dosing recommendations using full pharmacokinetic (PK) information."( Pediatric underdosing of efavirenz: a pharmacokinetic study in Uganda.
Balungi, J; Burger, DM; Bwakura-Dangarembizi, M; Ferrier, A; Fillekes, Q; Gibb, DM; Keishanyu, R; Kendall, L; Lutakome, J; Natukunda, E; Walker, AS, 2011
)
0.37
" More comprehensive in vivo pharmacokinetic data are required to justify the potential use of these agents as safe and effective options during pregnancy."( Pharmacokinetics of antiretroviral drugs in anatomical sanctuary sites: the fetal compartment (placenta and amniotic fluid).
Back, DJ; Else, LJ; Khoo, SH; Taylor, S, 2011
)
0.37
"In this Phase I/II open-label pharmacokinetic study, 42 children weighing 6-30 kg treated with NVP-based HAART for ≥4 weeks were randomized to receive the FDC tablets (GPO-VIR Z30) or the liquid formulations."( Pharmacokinetics and safety of a new paediatric fixed-dose combination of zidovudine/lamivudine/nevirapine in HIV-infected children.
Aurpibul, L; Capparelli, E; Chokephaibulkit, K; Cressey, TR; Eksaengsri, A; Hongsiriwon, S; Kabat, B; Limwongse, C; McIntosh, K; Muresan, P; Ngampiyaskul, C; Sirisanthana, V; Smith, ME; Toye, M; Wittawatmongkol, O; Yogev, R, 2011
)
0.59
" Developmental changes in lamivudine pharmacokinetic disposition were assessed by combining data from 7 studies of lamivudine (Pediatric AIDS Clinical Trials Group 300, 353, 356, 358, 386, 1056, and 1069) representing subjects across the pediatric age continuum."( Developmental pharmacokinetic changes of Lamivudine in infants and children.
Capparelli, EV; Chokephaibulkit, K; Cressey, TR; McKinney, R; Mirochnick, M; Nikanjam, M; Tremoulet, AH, 2012
)
0.94
" Pharmacokinetic (PK) profiles (0 to 24 h) were assessed on days 10 and 30."( Pharmacokinetics of lamivudine and lamivudine-triphosphate after administration of 300 milligrams and 150 milligrams once daily to healthy volunteers: results of the ENCORE 2 study.
Amara, A; Back, DJ; Boffito, M; Else, LJ; Emery, S; Fahey, P; Hill, A; Jackson, A; Khoo, S; Lin, E; Puls, R; Siccardi, M; Tjia, J; Watson, V, 2012
)
0.7
" Dose-normalized area under curve (AUC)(0-12) and peak concentration (C(max)) for the tablet formulation were bioequivalent with those of the oral solution with respect to zidovudine and abacavir (e."( Pharmacokinetics of antiretroviral drug varies with formulation in the target population of children with HIV-1.
Adkison, KK; Bakeera-Kitaka, S; Burger, DM; Gibb, DM; Kasirye, P; Kekitiinwa, A; Kendall, L; Mhute, T; Nahirya-Ntege, P; Snowden, W; Ssenyonga, M; Tumusiime, C; Walker, AS, 2012
)
0.38
" The proposed assay method was found to be applicable to a pharmacokinetic study in human male volunteers."( A novel LC-MS/MS method for simultaneous quantification of tenofovir and lamivudine in human plasma and its application to a pharmacokinetic study.
Burugula, L; Inamadugu, JK; J V L N, SR; Matta, MK; Pilli, NR, 2012
)
0.61
" The method was successfully applied to quantify them in a rat pharmacokinetic study in whole blood, plasma and DBS cards after a single oral co-administration at the dose of 10, 2 and 13 mg/kg for lamivudine, stavudine and nevirapine, respectively, to male Wistar rats."( Exploring dried blood spot sampling technique for simultaneous quantification of antiretrovirals: lamivudine, stavudine and nevirapine in a rodent pharmacokinetic study.
Aleti, R; Bhyrapuneni, G; Kalaikadhiban, I; Kandikere, V; Komarneni, P; Muddana, N; Nirogi, R; Padala, N, 2012
)
0.78
" The developed and validated method was successfully applied to quantitative determination of the three analytes in plasma for pharmacokinetic study in 12 healthy human volunteers."( Development and validation of an HPLC-UV method for simultaneous determination of zidovudine, lamivudine, and nevirapine in human plasma and its application to pharmacokinetic study in human volunteers.
Choudhury, H; Das, A; Gorain, B; Nandi, U; Pal, TK; Roy, B, 2013
)
0.61
"Twenty-two children received antituberculosis and antiretroviral therapy (ART) concurrently for 4 weeks before pharmacokinetic sampling."( Pharmacokinetics of nevirapine in HIV-infected children under 3 years on rifampicin-based antituberculosis treatment.
Burger, DM; Chintu, C; Cook, A; Gibb, DM; McIlleron, H; Merry, C; Mulenga, V; Oudijk, JM; Walker, AS, 2012
)
0.38
" We developed a population pharmacokinetic model of lamivudine in young children to propose reference lamivudine concentrations for evaluation of adherence to recent treatment doses."( Population pharmacokinetic model for adherence evaluation using lamivudine concentration monitoring.
Denti, P; Karlsson, MO; McIlleron, H; Ren, Y; Smith, P; van der Walt, JS; Zhang, C, 2012
)
0.87
"This is the first pharmacokinetic modelling of antiretroviral disposition in BP and CVF."( Pharmacokinetic modelling of efavirenz, atazanavir, lamivudine and tenofovir in the female genital tract of HIV-infected pre-menopausal women.
Cohen, MS; Dumond, JB; Forrest, A; Garonzik, SM; Kashuba, AD; Kendrick, RN; Nicol, MR; Patterson, KB, 2012
)
0.63
"This study compared the pharmacokinetic profiles of an FDC capsule containing lamivudine/adefovir dipivoxil 100/10 mg and conventional lamivudine 100-mg + adefovir dipivoxil 10-mg tablets to determine bioequivalence."( Pharmacokinetic properties of single-dose lamivudine/adefovir dipivoxil fixed-dose combination in healthy Chinese male volunteers.
Chan, JC; Chen, S; Chu, TT; Fok, BS; Gardner, S; Piscitelli, S; Tomlinson, B, 2013
)
0.88
" The pharmacokinetic profiles of lamivudine and adefovir were similar between the FDC and reference formulations."( Pharmacokinetic properties of single-dose lamivudine/adefovir dipivoxil fixed-dose combination in healthy Chinese male volunteers.
Chan, JC; Chen, S; Chu, TT; Fok, BS; Gardner, S; Piscitelli, S; Tomlinson, B, 2013
)
0.94
"The evidence to date does not support major pharmacokinetic changes in adults between ∼ 20 and 60 years of age."( Clinical pharmacokinetics of antiretroviral drugs in older persons.
Anderson, PL; Erlandson, KM; Schoen, JC, 2013
)
0.39
"To investigate pharmacokinetic interactions associated with coadministration of lersivirine with zidovudine, tenofovir disoproxil fumarate (DF)/emtricitabine (Truvada(®)) or abacavir/lamivudine (Epzicom(®)/Kivexa(®))."( Pharmacokinetic interactions between lersivirine and zidovudine, tenofovir disoproxil fumarate/emtricitabine and abacavir/lamivudine.
Choo, HW; Davis, J; Fang, J; Hansson, AG; Langdon, G; Layton, G; Tawadrous, M; Vourvahis, M, 2013
)
0.79
" Pharmacokinetic parameters were calculated by standard non-compartmental methods."( Pharmacokinetic interactions between lersivirine and zidovudine, tenofovir disoproxil fumarate/emtricitabine and abacavir/lamivudine.
Choo, HW; Davis, J; Fang, J; Hansson, AG; Langdon, G; Layton, G; Tawadrous, M; Vourvahis, M, 2013
)
0.6
" Pharmacokinetic and bioavailability parameters were calculated."( Single-dose pharmacokinetic properties, bioavailability, and tolerability of two lamivudine 100-mg tablet formulations: a randomized crossover study in healthy Chinese male subjects.
Chen, H; Ding, Y; Li, X; Liu, B; Sun, Y; Zhang, H; Zhang, Q, 2013
)
0.62
"There were no significant differences in mean (SD) pharmacokinetic parameters between the test and reference drugs, including Cmax (1239 [328."( Single-dose pharmacokinetic properties, bioavailability, and tolerability of two lamivudine 100-mg tablet formulations: a randomized crossover study in healthy Chinese male subjects.
Chen, H; Ding, Y; Li, X; Liu, B; Sun, Y; Zhang, H; Zhang, Q, 2013
)
0.62
" Here we use lamivudine to show how a comprehensive population pharmacokinetic model can account for the influence of demographic covariates on exposure (i."( Covariate effects and population pharmacokinetics of lamivudine in HIV-infected children.
Adkison, K; Burger, D; Danhof, M; Della Pasqua, O; Jacqz-Aigrain, E; Piana, C; Zhao, W, 2014
)
1.02
"A total of 244 patients, ranging in age from 18 to 79 years (median 40 years) and in bodyweight from 38 to 117 kg (median 71 kg), with 344 lamivudine plasma concentrations, were analysed using a population pharmacokinetic analysis."( Evaluation of effect of impaired renal function on lamivudine pharmacokinetics.
Benaboud, S; Bouazza, N; Foissac, F; Ghosn, J; Hirt, D; Tréluyer, JM; Urien, S; Viard, JP, 2014
)
0.86
" The pharmacokinetic data demonstrated that the area under the concentration-time curve (AUC) of the lamivudine alone and the LDXGT pretreated group were 532±37."( Development of a microdialysis system to monitor lamivudine in blood and liver for the pharmacokinetic application in herbal drug interaction and the gene expression in rats.
Hou, ML; Lin, LC; Lu, CM; Tsai, TH, 2014
)
0.87
" The authors studied ATV pharmacokinetic (PK) parameters among children who received atazanavir/ritonavir co-administered with TDF."( Pharmacokinetics of atazanavir/ritonavir among HIV-infected Thai children concomitantly taking tenofovir disoproxil fumarate.
Ananworanich, J; Bunupuradah, T; Keadpudsa, S; Prasitsuebsai, W; Puthanakit, T; Sahakijpicharn, T; Srimuan, A; Techasaensiri, C; Thammajaruk, N, 2014
)
0.4
" The present study was undertaken to evaluate the absolute oral bioavailability of FNC in rats and the pharmacokinetic properties of FNC after intragastric administration of single and multiple doses in rats and dogs."( Quantification of 2'-deoxy-2'-β-fluoro-4'-azidocytidine in rat and dog plasma using liquid chromatography-quadrupole time-of-flight and liquid chromatography-triple quadrupole mass spectrometry: Application to bioavailability and pharmacokinetic studies.
Chang, J; Chen, X; Cheng, T; Dong, L; Guo, M; Guo, X; Jiang, J; Peng, Y; Wang, Q; Zhang, J; Zhang, Y, 2014
)
0.4
"5 h for 20 mg group; the mean Cmax of last dose was 498 ± 54 ng/mL for 10 mg group and 897 ± 136 ng/mL for 20 mg group."( Pharmacokinetics of sifuvirtide in treatment-naive and treatment-experienced HIV-infected patients.
Che, J; Chen, X; Cheng, Y; Dong, T; Meng, Q; Qian, X; Tong, B, 2014
)
0.4
" But there are limited pharmacokinetic data evaluating the higher dose of rifabutin in combination with LPV/r."( Randomized pharmacokinetic evaluation of different rifabutin doses in African HIV- infected tuberculosis patients on lopinavir/ritonavir-based antiretroviral therapy.
Connolly, C; Harries, A; Kellerman, T; Lienhardt, C; McIlleron, H; Naiker, S; Pym, A; Reddy, T; Wiesner, L, 2014
)
0.4
" The median AUC0-48 and Cmax of rifabutin in patients taking 150 mg rifabutin tiw was significantly reduced compared to the other treatment arms."( Randomized pharmacokinetic evaluation of different rifabutin doses in African HIV- infected tuberculosis patients on lopinavir/ritonavir-based antiretroviral therapy.
Connolly, C; Harries, A; Kellerman, T; Lienhardt, C; McIlleron, H; Naiker, S; Pym, A; Reddy, T; Wiesner, L, 2014
)
0.4
" Pharmacokinetic sampling was performed over 12-hour periods, 4 weeks after initiation of RAL together with RIF (period 1), 4 weeks after RIF discontinuation (period 2), and after the RAL dose reduction in arm 2 (period 3)."( Pharmacokinetics of Raltegravir in HIV-Infected Patients on Rifampicin-Based Antitubercular Therapy.
Assuied, A; De Castro, N; Fagard, C; Grinsztejn, B; Grondin, C; Molina, JM; Pilotto, JH; Sauvageon, H; Taburet, AM; Veloso, V, 2015
)
0.42
" Here, we use population pharmacokinetic (PK) modeling-based methods to simultaneously describe parent and intracellular metabolite PK in blood, semen, and PBMCs and SMCs."( Pharmacokinetic Modeling of Lamivudine and Zidovudine Triphosphates Predicts Differential Pharmacokinetics in Seminal Mononuclear Cells and Peripheral Blood Mononuclear Cells.
Bridges, AS; Cohen, MS; Dumond, JB; Fiscus, SA; Forrest, A; Kashuba, AD; Kendrick, R; Reddy, YS; Troiani, L; Yang, KH, 2015
)
0.71
"The in vitro-in vivo pharmacokinetic correlation models (IVIVC) are a fundamental part of the drug discovery and development process."( In vitro-in vivo Pharmacokinetic correlation model for quality assurance of antiretroviral drugs.
Restrepo Valencia, P; Rojas Gómez, R, 2015
)
0.42
"To develop a comprehensive model to predict the in vivo absorption of antiretroviral drugs based on permeability studies, in vitro and in vivo solubility and demonstrate its correlation with the pharmacokinetic profile in humans."( In vitro-in vivo Pharmacokinetic correlation model for quality assurance of antiretroviral drugs.
Restrepo Valencia, P; Rojas Gómez, R, 2015
)
0.42
"To our knowledge, there is no published data on the pharmacokinetic (PK) profile of antiretroviral (ART) drugs on patients undergoing extracorporeal membrane oxygenation (ECMO) therapy."( The effect of veno-venous ECMO on the pharmacokinetics of Ritonavir, Darunavir, Tenofovir and Lamivudine.
Ashworth, A; Barker, J; Davies, A; Feddy, L; Fedor, I; Ghazi Suliman, MA; Hayes, T; Kosmidis, C; Malagon, I; Ogungbenro, K; Stirling, S; Szabo-Barnes, A, 2017
)
0.67
" Indinavir significantly increased the pharmacokinetic exposure of lamivudine in mice; however, the effect by indinavir was significantly less pronounced in Mate1 (-/-) mice as compared to Mate1(+/+) mice."( Indinavir Alters the Pharmacokinetics of Lamivudine Partially via Inhibition of Multidrug and Toxin Extrusion Protein 1 (MATE1).
Guo, D; Huang, J; Li, Q; Polli, JE; Shu, Y; Yang, H; Ye, Z; Zhang, W; Zhu, P, 2018
)
0.98
"Intensive pharmacokinetic sampling of maternal dried blood spots (DBS), dried breast milk spots (DBMS) and infant DBS from 30 Ugandan and 29 Nigerian mothers receiving first-line ART and their infants was conducted."( Plasma and breast milk pharmacokinetics of emtricitabine, tenofovir and lamivudine using dried blood and breast milk spots in nursing African mother-infant pairs.
Khoo, S; Kyohaire, I; Lamorde, M; Nakalema, S; Olagunju, A; Owen, A; Waitt, C, 2018
)
0.71
"Full pharmacokinetic profiling nested in a multicenter, observational, prospective cohort study."( Pharmacokinetic profiles of boosted darunavir, dolutegravir and lamivudine in aging people living with HIV.
Alves Saldanha, S; Battegay, M; Buclin, T; Cavassini, M; Courlet, P; Decosterd, LA; Guidi, M; Marzolini, C; Stader, F; Stoeckle, M, 2020
)
0.8
"Nineteen PLWH with a median age of 64 years participated in the full pharmacokinetic investigations."( Pharmacokinetic profiles of boosted darunavir, dolutegravir and lamivudine in aging people living with HIV.
Alves Saldanha, S; Battegay, M; Buclin, T; Cavassini, M; Courlet, P; Decosterd, LA; Guidi, M; Marzolini, C; Stader, F; Stoeckle, M, 2020
)
0.8
" Plasma concentration of each antiretroviral drug was tested for calculation of pharmacokinetic parameters."( Influence of a herbal preparation on the pharmacokinetics of highly active antiretroviral therapy drugs in rats.
Jiang, F; Lu, Z; Su, Q; Tang, Y; Wei, S; Zhou, Z, 2020
)
0.56
"3) ADVAN 13, based on a previously established pharmacokinetic model."( Pharmacokinetic-pharmacodynamic modelling of atazanavir in hair among adolescents on antiretroviral treatment in Zimbabwe.
Chawana, TD; Ngara, B; Nhachi, CFB; Rusakaniko, S; Zvada, S, 2021
)
0.62
"This is an open-label, randomized, fixed sequence single intravenous dosing study to assess pharmacokinetic interactions between remdesivir and TDF/3TC (Study A, crossover design) or TDF/3TC plus ATV/r (Study B)."( An open-label, randomized, single intravenous dosing study to investigate the effect of fixed-dose combinations of tenofovir/lamivudine or atazanavir/ritonavir on the pharmacokinetics of remdesivir in Ugandan healthy volunteers (RemTLAR).
Byakika-Kibwika, P; D'Avolio, A; Kaboggoza, JP; Lamorde, M; Waitt, C; Walimbwa, SI, 2021
)
0.83
" Furthermore, this study will deliver pharmacokinetic datasets for remdesivir drug concentrations and demographic characteristics which could support pharmacometric approaches for simulation of remdesivir treatment regimens in patients concurrently using tenofovir/lamivudine and/or atazanavir/ritonavir."( An open-label, randomized, single intravenous dosing study to investigate the effect of fixed-dose combinations of tenofovir/lamivudine or atazanavir/ritonavir on the pharmacokinetics of remdesivir in Ugandan healthy volunteers (RemTLAR).
Byakika-Kibwika, P; D'Avolio, A; Kaboggoza, JP; Lamorde, M; Waitt, C; Walimbwa, SI, 2021
)
1.01
" In stage 1, term neonates exposed to HIV on standard antiretroviral prophylaxis (nevirapine ± zidovudine) received single dose(s) of the 4-in-1 formulation, followed by intensive pharmacokinetic sampling and safety assessments."( Pharmacokinetics and Safety of the Abacavir/Lamivudine/Lopinavir/Ritonavir Fixed-Dose Granule Formulation (4-in-1) in Neonates: PETITE Study.
Andrieux-Meyer, I; Bekker, A; Capparelli, E; Cotton, MF; Cressey, R; Cressey, TR; du Toit, S; Groenewald, M; Kumar, M; Lallemant, M; Nielsen, J; Rabie, H; Salvadori, N; Than-In-At, K, 2022
)
0.98
"Sixteen neonates, with a median (range) birth weight of 3130 g (2790-3590 g), completed 24 pharmacokinetic visits."( Pharmacokinetics and Safety of the Abacavir/Lamivudine/Lopinavir/Ritonavir Fixed-Dose Granule Formulation (4-in-1) in Neonates: PETITE Study.
Andrieux-Meyer, I; Bekker, A; Capparelli, E; Cotton, MF; Cressey, R; Cressey, TR; du Toit, S; Groenewald, M; Kumar, M; Lallemant, M; Nielsen, J; Rabie, H; Salvadori, N; Than-In-At, K, 2022
)
0.98
"Our objective was to predict maternal and fetal drug disposition using a physiologically based pharmacokinetic (PBPK) modeling approach."( Prediction of Maternal and Fetal Acyclovir, Emtricitabine, Lamivudine, and Metformin Concentrations during Pregnancy Using a Physiologically Based Pharmacokinetic Modeling Approach.
Abduljalil, K; Jamei, M; Ning, J; Pansari, A, 2022
)
0.96
" Predicted pharmacokinetic parameters were within twofold of the observed values."( Prediction of Maternal and Fetal Acyclovir, Emtricitabine, Lamivudine, and Metformin Concentrations during Pregnancy Using a Physiologically Based Pharmacokinetic Modeling Approach.
Abduljalil, K; Jamei, M; Ning, J; Pansari, A, 2022
)
0.96
" This study aimed to develop a population pharmacokinetic model for oral lamivudine in Chinese HIV-infected adults and to determine the optimal lamivudine dosage regimens."( Population pharmacokinetics and model-informed precision dosing of lamivudine in Chinese HIV-infected patients with mild and moderate impaired renal function.
Jiao, Z; Liu, L; Liu, X; Lu, H; Meng, X; Sun, T; Wang, J; Wen, H; Xing, Y; Xu, F; Yin, L; Zhang, L; Zhang, M; Zhang, R, 2022
)
1.19

Compound-Compound Interactions

In therapy-naive patients, DTG combined with abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC) resulted in a significantly better virological outcome.

ExcerptReferenceRelevance
" When 3TC was combined with TSAO-m3T, UC10, UC42, BHAP, or MKC-442, breakthrough of virus was markedly delayed or even suppressed."( Marked inhibitory activity of non-nucleoside reverse transcriptase inhibitors against human immunodeficiency virus type 1 when combined with (-)2',3'-dideoxy-3'-thiacytidine.
Balzarini, J; Camarasa, MJ; De Clercq, E; Karlsson, A; Pelemans, H; Pérez-Pérez, MJ; San-Félix, A, 1996
)
0.29
"When MKC-442 was combined with 3TC and ZDV, they synergistically suppressed HIV-1 replication in MT-4 cells over a wide range of doses irrespective of the endpoints for synergy calculations."( Three-drug combination of MKC-442, lamivudine and zidovudine in vitro: potential approach towards effective chemotherapy against HIV-1.
Baba, M; Nakade, K; Piras, G; Yuasa, S, 1997
)
0.57
"Our results demonstrate a potential efficacy of MKC-442 in combination with 3TC and ZDV, and the three-drug combination should be considered for treatment of AIDS patients."( Three-drug combination of MKC-442, lamivudine and zidovudine in vitro: potential approach towards effective chemotherapy against HIV-1.
Baba, M; Nakade, K; Piras, G; Yuasa, S, 1997
)
0.57
" 3TC and PCV are deoxycytidine and deoxyguanosine analogs, respectively, and their modes of action and how they interact are matters of both theoretical and practical interest."( Synergistic inhibition of hepadnaviral replication by lamivudine in combination with penciclovir in vitro.
Colledge, D; Locarnini, S; Shaw, T, 1997
)
0.55
"The safety, pharmacokinetics, and antiretroviral activity of lamivudine alone and in combination with zidovudine was studied in pregnant women infected with human immunodeficiency virus type 1 (HIV-1) and their neonates."( Pharmacokinetics and antiretroviral activity of lamivudine alone or when coadministered with zidovudine in human immunodeficiency virus type 1-infected pregnant women and their offspring.
Coovadia, H; Goodwin, C; Harrigan, PR; Johnson, MA; Moodley, D; Moodley, J; Moore, KH; Pillay, K; Plumb, R; Saba, J; Stone, C; van Leeuwen, R, 1998
)
0.8
"To compare antiretroviral efficacy, safety and tolerance of three dosing regimens of the novel nucleoside reverse transcriptase inhibitor, abacavir (1592U89) over 24 weeks and its efficacy in open-label combination with zidovudine and lamivudine."( A dose-ranging study to evaluate the safety and efficacy of abacavir alone or in combination with zidovudine and lamivudine in antiretroviral treatment-naive subjects.
Cutrell, A; Harrer, T; Harrigan, RP; Katlama, C; Lanier, RE; Massip, P; Pearce, G; Staszewski, S; Steel, H; Tortell, SM; Yeni, P, 1998
)
0.69
"To determine the safety and efficacy of amprenavir (APV) in combination with lamivudine (3TC) and zidovudine (ZDV)."( A phase II safety and efficacy study of amprenavir in combination with zidovudine and lamivudine in HIV-infected patients with limited antiretroviral experience. Amprenavir PROAB2002 Study Team.
Antunes, F; Brown, DJ; Clumeck, N; Fetter, A; Haubrich, R; Kahl, L; Lang, W; Pagano, G; Richman, D; Schooley, R; Sereni, D; Stein, A; Thompson, M; van der Ende, ME, 1999
)
0.76
"Treatment with APV, dosed at 1200 mg twice daily in combination with 3TC/ZDV, resulted in sustained viral suppression."( A phase II safety and efficacy study of amprenavir in combination with zidovudine and lamivudine in HIV-infected patients with limited antiretroviral experience. Amprenavir PROAB2002 Study Team.
Antunes, F; Brown, DJ; Clumeck, N; Fetter, A; Haubrich, R; Kahl, L; Lang, W; Pagano, G; Richman, D; Schooley, R; Sereni, D; Stein, A; Thompson, M; van der Ende, ME, 1999
)
0.53
" To date, combination with IFN and lamivudine has not been shown to confer additional benefit compared with lamivudine monotherapy."( Hepatitis B e antigen seroconversion: effects of lamivudine alone or in combination with interferon alpha.
Farrell, G, 2000
)
0.84
"To compare the safety and efficacy of stavudine (d4T) + lamivudine (3TC) with zidovudine (ZDV) + 3TC, each in combination with indinavir (IDV)."( A comparison of stavudine plus lamivudine versus zidovudine plus lamivudine in combination with indinavir in antiretroviral naive individuals with HIV infection: selection of thymidine analog regimen therapy (START I).
Clark, R; Cohen, C; Cooley, T; Grosso, R; Gulick, R; Marlowe, SI; Mauney, J; Mulanovich, V; Santana, J; Schoellkopf, N; Squires, KE; Stevens, M; Tebas, P; Uffelman, K; Wright, D; Yangco, B, 2000
)
0.84
"These results support the choice of d4T + 3TC as a nucleoside analog pair in combination with a protease inhibitor in an initial HIV treatment regimen."( A comparison of stavudine plus lamivudine versus zidovudine plus lamivudine in combination with indinavir in antiretroviral naive individuals with HIV infection: selection of thymidine analog regimen therapy (START I).
Clark, R; Cohen, C; Cooley, T; Grosso, R; Gulick, R; Marlowe, SI; Mauney, J; Mulanovich, V; Santana, J; Schoellkopf, N; Squires, KE; Stevens, M; Tebas, P; Uffelman, K; Wright, D; Yangco, B, 2000
)
0.59
"To compare the efficacy and safety of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine."( Comparative studies of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine.
Arathoon, E; Benetucci, L; Cahn, P; Chodakewitz, J; Chung, MO; Collier, AC; Currier, J; de Jesus Pedro, R; Gallant, JE; Haas, DW; Harvey, C; Lewi, DS; Mehrotra, D; Nguyen, BY; Noriega, LM; Paar, D; Ramirez-Ronda, CH; Thompson, MA; Uip, DE; Uribe, P; White, AC, 2000
)
0.73
"Three-times-daily indinavir appears more efficacious than two-times-daily dosing when administered with zidovudine and lamivudine."( Comparative studies of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine.
Arathoon, E; Benetucci, L; Cahn, P; Chodakewitz, J; Chung, MO; Collier, AC; Currier, J; de Jesus Pedro, R; Gallant, JE; Haas, DW; Harvey, C; Lewi, DS; Mehrotra, D; Nguyen, BY; Noriega, LM; Paar, D; Ramirez-Ronda, CH; Thompson, MA; Uip, DE; Uribe, P; White, AC, 2000
)
0.73
"To compare the antiviral activity and safety of a new protease inhibitor, amprenavir (141W94) in combination with lamivudine and zidovudine, versus lamivudine and zidovudine alone in HIV-1 infected, antiretroviral-naive subjects."( Amprenavir in combination with lamivudine and zidovudine versus lamivudine and zidovudine alone in HIV-1-infected antiretroviral-naive adults. Amprenavir PROAB3001 International Study Team.
Brothers, CH; Feinberg, J; Fischl, M; Goodgame, JC; Hardy, WD; Jablonowski, H; Morrow, P; Nacci, P; Pedneault, L; Pottage, JC; Stein, A; Vafidis, I; Yeo, J, 2000
)
0.8
" Subjects received double-blind treatment with either 1200 mg amprenavir twice daily in combination with lamivudine (150 mg twice daily) and zidovudine (300 mg twice daily) (amprenavir/lamivudine/zidovudine) or matched placebo, lamivudine and zidovudine for 16 weeks."( Amprenavir in combination with lamivudine and zidovudine versus lamivudine and zidovudine alone in HIV-1-infected antiretroviral-naive adults. Amprenavir PROAB3001 International Study Team.
Brothers, CH; Feinberg, J; Fischl, M; Goodgame, JC; Hardy, WD; Jablonowski, H; Morrow, P; Nacci, P; Pedneault, L; Pottage, JC; Stein, A; Vafidis, I; Yeo, J, 2000
)
0.81
"Amprenavir, in combination with lamivudine and zidovudine, has potent and durable antiviral activity in antiretroviral-naive subjects over 48 weeks."( Amprenavir in combination with lamivudine and zidovudine versus lamivudine and zidovudine alone in HIV-1-infected antiretroviral-naive adults. Amprenavir PROAB3001 International Study Team.
Brothers, CH; Feinberg, J; Fischl, M; Goodgame, JC; Hardy, WD; Jablonowski, H; Morrow, P; Nacci, P; Pedneault, L; Pottage, JC; Stein, A; Vafidis, I; Yeo, J, 2000
)
0.88
" In addition, the effects on viral load, CD4 counts, and opportunistic infections were examined with the use of combination chemotherapy combined with HAART."( Chemotherapy for human immunodeficiency virus-associated non-Hodgkin's lymphoma in combination with highly active antiretroviral therapy.
Ambinder, R; Flexner, C; Grochow, L; Hamzeh, F; Harrington, W; Herndier, B; Kaplan, L; Lee, J; Levine, A; Ratner, L; Redden, D; Scadden, D; Straus, D; Tan, B; Tang, S, 2001
)
0.31
" The first 40 patients entered onto the study received reduced doses of cyclophosphamide and doxorubicin, combined with vincristine and prednisone (modified CHOP [mCHOP]), whereas the subsequent 25 patients entered onto the study received full doses of CHOP combined with granulocyte colony-stimulating factor (G-CSF)."( Chemotherapy for human immunodeficiency virus-associated non-Hodgkin's lymphoma in combination with highly active antiretroviral therapy.
Ambinder, R; Flexner, C; Grochow, L; Hamzeh, F; Harrington, W; Herndier, B; Kaplan, L; Lee, J; Levine, A; Ratner, L; Redden, D; Scadden, D; Straus, D; Tan, B; Tang, S, 2001
)
0.31
"The complete response rates were 30% and 48% among patients who received mCHOP and full-dose CHOP combined with HAART, respectively."( Chemotherapy for human immunodeficiency virus-associated non-Hodgkin's lymphoma in combination with highly active antiretroviral therapy.
Ambinder, R; Flexner, C; Grochow, L; Hamzeh, F; Harrington, W; Herndier, B; Kaplan, L; Lee, J; Levine, A; Ratner, L; Redden, D; Scadden, D; Straus, D; Tan, B; Tang, S, 2001
)
0.31
"GW420867X was well tolerated and has potent antiretroviral activity alone and in combination with 3TC plus ZDV."( GW420867X administered to HIV-1-infected patients alone and in combination with lamivudine and zidovudine.
Arasteh, K; Burt, V; Cass, L; Dallow, N; Jones, A; Kleim, JP; Klein, A; Moore, KH; Müller, M; Prince, W; Wood, R,
)
0.36
"Triple drug combination regimen the most often was composed of: either AZT + 3TC + NFV, ddi + d4T + NFV, or ddI + d4T + NVP."( [Drug combination therapy for children infected with HIV/AIDS--own experience].
Klinowska-Skupniewska, J; Prandota-Schoepp, A, 2001
)
0.31
"We compared the efficacy and the toxicity of zidovudine (AZT) versus stavudine (d4T), in combination with lamivudine (3TC) and indinavir, in AZT-, dideoxyinosine (ddI)-, and/or dideoxycytosine (ddC)-experienced patients in a randomized comparative multicenter trial."( Efficacy of zidovudine compared to stavudine, both in combination with lamivudine and indinavir, in human immunodeficiency virus-infected nucleoside-experienced patients with no prior exposure to lamivudine, stavudine, or protease inhibitors (novavir tria
Aboulker, JP; Brun-Vezinet, F; Certain, A; Descamps, D; Flandre, P; Gastaut, JA; Goujard, C; Joly, V; Meiffredy, V; Remy, G; Ruffault, A; Yeni, P, 2002
)
0.76
"The authors studied the effect of zidovudine (ZDV) resistance mutation on virologic response to treatment with ZDV or stavudine (d4T) each in combination with lamivudine and indinavir."( Effect of zidovudine resistance mutations on virologic response to treatment with zidovudine or stavudine, each in combination with lamivudine and indinavir.
Aboulker, JP; Brun-Vézinet, F; Descamps, D; Flandre, P; Harel, M; Izopet, J; Joly, V; Lastère, S; Meiffrédy, V; Peytavin, G; Tamalet, C; Yéni, P; Zeng, AF, 2002
)
0.72
" In the current study, 59 patients receiving primary liver transplantation for chronic hepatitis B infection were prospectively followed up after converting from intravenous to intramuscular hepatitis B immune globulin in combination with lamivudine."( Conversion from intravenous to intramuscular hepatitis B immune globulin in combination with lamivudine is safe and cost-effective in patients receiving long-term prophylaxis to prevent hepatitis B recurrence after liver transplantation.
Busuttil, RW; Durazo, F; Edelstein, M; Farmer, D; Ghobrial, RM; Goldstein, L; Han, SH; Holt, C; Hu, R; Kunder, G; Martin, P; Saab, S, 2003
)
0.72
"Lamivudine in combination with thymopentin can exert great and lasting effects on HBV and is effective in normalization of ALT."( [Therapeutic effects of Lamivudine in combination with Thymopentin on chronic hepatitis B].
Shi, W; Tang, S; Zhang, W, 2002
)
2.06
" In this study, the anti-HIV-1 activity of EMV in combination with two nucleoside reverse transcriptase inhibitors was examined in cell cultures."( Three-drug combinations of emivirine and nucleoside reverse transcriptase inhibitors in vitro: long-term culture of HIV-1-infected cells and breakthrough viruses.
Baba, M; Nitanda, T; Somekawa, K; Wang, X; Yuasa, S, 2001
)
0.31
"The purpose of this study was to evaluate the effect of telomerase inhibitors combined with X-irradiation on bone marrow hematopoiesis in tumor-carrying mice."( [Inhibitory effect of telomerase inhibitors combined with X-irradiation on bone marrow hematopoiesis in mice].
Ruan, XF; Xue, MH; Zhou, YF, 2003
)
0.32
" This study assessed the safety and efficacy of adefovir dipivoxil alone and in combination with lamivudine compared with ongoing lamivudine therapy in patients with chronic hepatitis B with compensated liver disease and lamivudine-resistant hepatitis B virus (HBV)."( Adefovir dipivoxil alone or in combination with lamivudine in patients with lamivudine-resistant chronic hepatitis B.
Bourliere, M; Brosgart, CL; Buggisch, P; Ebrahimi, R; Gray Df, Df; Hann Hw, Hw; Heathcote, EJ; Kleber, K; Kowdley, K; Martin, P; Peters, MG; Rubin, R; Sullivan, M; Trepo, C; Xiong, S, 2004
)
0.8
"These data, limited to patients with compensated liver disease, indicate that adefovir dipivoxil alone or in combination with ongoing lamivudine therapy provides effective antiviral therapy in patients with lamivudine-resistant HBV."( Adefovir dipivoxil alone or in combination with lamivudine in patients with lamivudine-resistant chronic hepatitis B.
Bourliere, M; Brosgart, CL; Buggisch, P; Ebrahimi, R; Gray Df, Df; Hann Hw, Hw; Heathcote, EJ; Kleber, K; Kowdley, K; Martin, P; Peters, MG; Rubin, R; Sullivan, M; Trepo, C; Xiong, S, 2004
)
0.78
"To evaluate the efficacy and tolerability of indinavir/ritonavir (IDV/RTV) 400/100 mg twice daily in combination with two nucleoside reverse transcriptase inhibitors in antiretroviral-naive patients."( Efficacy and safety of ritonavir/indinavir 100/400 mg twice daily in combination with two nucleoside analogues in antiretroviral treatment-naive HIV-infected individuals.
Agher, R; Ait-Mohand, H; Bricaire, F; Calvez, V; Costagliola, D; Duvivier, C; Ghosn, J; Katlama, C; Marcelin, AG; Myrto, A; Peytavin, G; Schneider, L, 2003
)
0.32
"Mutations selected or deselected during passage of human immunodeficiency virus strain HXB2 or resistant variants with tenofovir (TFV), abacavir (ABC), and lamivudine (3TC) differed depending on the drug combination and virus genotype."( Human immunodeficiency virus type 1 reverse transcriptase mutation selection during in vitro exposure to tenofovir alone or combined with abacavir or lamivudine.
Ait-Khaled, M; Craig, C; Griffin, P; Stone, C; Tisdale, M, 2004
)
0.72
" The combined results of the three trials support the conclusion that d4T can be used effectively in combination with either ddI or 3TC to reduce viral loads and increase CD4 cell counts in patients with HIV-1 infection."( Nucleoside combinations for antiretroviral therapy: efficacy of stavudine in combination with either didanosine or lamivudine.
Fisher, M, 1998
)
0.51
"A randomized, double-blind, double-dummy, active-controlled, 2-arm study comparing the antiviral efficacy and safety of atazanavir 400 mg administered once daily with efavirenz 600 mg administered once daily in combination with open-label fixed-dose zidovudine plus lamivudine twice daily."( Comparison of once-daily atazanavir with efavirenz, each in combination with fixed-dose zidovudine and lamivudine, as initial therapy for patients infected with HIV.
Delfraissy, JF; Gatell, JM; Giordano, M; Jemsek, J; Lazzarin, A; Pokrovskiy, V; Powderly, WG; Rivero, A; Rozenbaum, W; Schrader, S; Sension, M; Squires, K; Thiry, A; Vibhagool, A, 2004
)
0.72
"73% patients treated with combination with IFN, and in 13."( [IFN or oxymatrine in combination with lamivudine in patients with lamivudine-resistant chronic hepatitis B].
Cheng, YQ; Fu, JL; Lan, Y; Li, HW; Lou, M; Zhao, P, 2004
)
0.59
"These data indicated that IFN or oxymatrine in combination with ongoing lamivudine therapy provided effective antiviral therapy in patients with lamivudine-resistant HBV."( [IFN or oxymatrine in combination with lamivudine in patients with lamivudine-resistant chronic hepatitis B].
Cheng, YQ; Fu, JL; Lan, Y; Li, HW; Lou, M; Zhao, P, 2004
)
0.83
"Abacavir provided an effective and durable antiretroviral response that was noninferior to zidovudine, when combined with lamivudine and efavirenz."( Abacavir versus zidovudine combined with lamivudine and efavirenz, for the treatment of antiretroviral-naive HIV-infected adults.
Bonny, T; Brand, JD; Brothers, CH; Buendia, CB; Castillo, SA; DeJesus, E; Gerstoft, J; Hernandez, J; Herrera, G; Lanier, ER; Scott, TR; Teofilo, E, 2004
)
0.8
" Combination with lamivudine in the regimen used is not superior to monotherapy."( Pegylated interferon alfa-2b alone or in combination with lamivudine for HBeAg-positive chronic hepatitis B: a randomised trial.
Akarca, US; Cakaloglu, Y; de Man, RA; Gerken, G; Hansen, B; Janssen, HL; Niesters, HG; Schalm, SW; Senturk, H; Simon, C; So, TM; van Zonneveld, M; Zeuzem, S; Zondervan, P,
)
0.71
"The combination of abacavir + lamivudine (ABC+3TC) versus didanosine + stavudine (ddI+d4T), each combined with other classes of antiretrovirals (ARVs) in ARV-naive patients, was compared for the combined endpoint of time to plasma HIV RNA >50 copies/mL (at or after the 8-month visit) or death (primary endpoint) in a nested substudy of an ongoing multicenter randomized trial."( Efficacy and safety of abacavir plus lamivudine versus didanosine plus stavudine when combined with a protease inhibitor, a nonnucleoside reverse transcriptase inhibitor, or both in HIV-1 positive antiretroviral-naive persons.
Besch, L; Chen, L; Dehlinger, M; Henley, C; Kozal, M; MacArthur, RD; Novak, RM; Peng, G; Schmetter, B; van den Berg-Wolf, M; Yurik, T,
)
0.69
" A randomized double-blind clinical trial compared the efficacy and safety of 600 mg of ABC administered once daily (n = 384) versus 300 mg of ABC administered twice daily (n = 386) in combination with 300 mg of lamivudine (3TC) and 600 mg of efavirenz (EFV) administered once daily in antiretroviral-naive patients over 48 weeks."( Abacavir once or twice daily combined with once-daily lamivudine and efavirenz for the treatment of antiretroviral-naive HIV-infected adults: results of the Ziagen Once Daily in Antiretroviral Combination Study.
Cahn, P; Castillo, SA; Craig, C; DeJesus, E; Gordon, DN; Moyle, GJ; Scott, TR; Zhao, H, 2005
)
0.76
"We have investigated the pharmacokinetics of nevirapine and paclitaxel in a patient who used both drugs concomitantly, as there are strong theoretical indications for a potential pharmacokinetic drug-drug interaction."( No pharmacokinetic drug-drug interaction between nevirapine and paclitaxel.
Beijnen, JH; Huitema, AD; Kappelhoff, BS; Mairuhu, AT; Schellens, JH, 2005
)
0.33
" Combination with lamivudine showed no additional benefit over monotherapy during 24 weeks of treatment in these patients."( Adefovir dipivoxil alone or in combination with ongoing lamivudine in patients with decompensated liver disease and lamivudine-resistant hepatitis B virus.
Choi, WB; Chung, YH; Kim, KM; Lee, HC; Lee, YS; Lim, YS; Suh, DJ, 2005
)
0.91
"HIV-positive patients with CD4 cell counts > or = 100 cells/mm3 were randomized to 1 of 2 treatment arms: (1) atazanavir, 400 mg given once daily, plus efavirenz placebo; or (2) efavirenz, 600 mg given once daily, plus atazanavir placebo; each drug was administered with fixed-dose zidovudine (300 mg) and lamivudine (150 mg) given twice daily, and patients were treated for at least 48 weeks."( Body fat and other metabolic effects of atazanavir and efavirenz, each administered in combination with zidovudine plus lamivudine, in antiretroviral-naive HIV-infected patients.
Arathoon, E; Arlotti, M; Giordano, M; Jemsek, JG; Noor, MA; Perez, C; Pokrovskiy, V; Soccodato, M; Sosa, N; Thiry, A, 2006
)
0.72
"Lamivudine combined with Hepatitis B immune globulin (HBIg) prevents post liver transplant (LT) HBV recurrence."( Protective antibody levels and dose requirements for IV 5% Nabi Hepatitis B immune globulin combined with lamivudine in liver transplantation for hepatitis B-induced end stage liver disease.
Brown, RS; Brundage, R; Dickson, RC; Fried, M; Horwith, G; Ishitani, M; Jensen, D; Lok, A; Luketic, V; Reddy, KR; Sheiner, P; Soldevila-Pico, C; Terrault, NA, 2006
)
1.99
"The aim of our study was to determine the outcomes of liver transplant recipients receiving either lamivudine (LAM) monotherapy or LAM combined with low-dose intramuscular (IM) hepatitis B Immunoglobulin (HBIG) therapy."( Prevention of hepatitis B recurrence after liver transplantation using lamivudine or lamivudine combined with hepatitis B Immunoglobulin prophylaxis.
Chen, Y; Liang, T; Lu, A; Shen, Y; Wang, W; Zhang, M; Zheng, S, 2006
)
0.78
"The effect of pegylated interferon or its combination with lamivudine on liver histology of patients with chronic hepatitis B (CHB) is unknown."( Peg-interferon improves liver histology in patients with HBeAg-positive chronic hepatitis B: no additional benefit of combination with lamivudine.
Akarca, US; Cakaloglu, Y; de Man, RA; Flink, HJ; Janssen, HL; Schalm, SW; Simon, C; So, TM; van Zonneveld, M; Zondervan, PE, 2006
)
0.78
" It is possible that lamivudine combined with chemotherapy may have had a therapeutic effect on ATL in this case."( [Development of acute type, CD 8 positive adult T-cell leukemia in a carrier of hepatitis B virus--possible therapeutic effect of lamivudine combined with chemotherapy].
Hasegawa, H; Miyagi, T; Nagasaki, A; Nakachi, S; Shinzato, O; Taira, N; Takasu, N; Tomoyose, T, 2006
)
0.86
"Two phase I studies were conducted to assess the plasma pharmacokinetics of telbivudine and potential drug-drug interactions between telbivudine (200 or 600 mg/day) and lamivudine (100 mg/day) or adefovir dipivoxil (10 mg/day) in healthy subjects."( Pharmacokinetics of telbivudine in healthy subjects and absence of drug interaction with lamivudine or adefovir dipivoxil.
Brown, NA; Chao, GC; Fielman, BA; Lloyd, DM; Zhou, XJ, 2006
)
0.75
"Prophylaxis against recurrent hepatitis B virus (HBV) infection with hepatitis B immune globulin (HBIG), in combination with antiviral agents such as lamivudine, has allowed transplantation for this condition to become feasible and accepted."( Subcutaneous administration of hepatitis B immune globulin in combination with lamivudine following orthotopic liver transplantation: effective prophylaxis against recurrence.
Apiratpracha, W; Buczkowski, AK; Chung, SW; Erb, SR; Partovi, N; Powell, JJ; Scudamore, CH; Steinbrecher, UP; Yoshida, EM,
)
0.56
" Fosamprenavir-ritonavir has shown similar efficacy and safety to lopinavir-ritonavir when each is combined with two nucleoside reverse transcriptase inhibitors."( The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial.
DeJesus, E; Eron, J; Estrada, V; Gathe, J; Katlama, C; Lackey, P; Patel, L; Shaefer, M; Staszewski, S; Sutherland-Phillips, D; Vavro, C; Wannamaker, P; Yau, L; Yeni, P; Yeo, J; Young, B, 2006
)
0.55
"Fosamprenavir-ritonavir twice daily in treatment-naive patients provides similar antiviral efficacy, safety, tolerability, and emergence of resistance as lopinavir-ritonavir, each in combination with abacavir-lamivudine."( The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial.
DeJesus, E; Eron, J; Estrada, V; Gathe, J; Katlama, C; Lackey, P; Patel, L; Shaefer, M; Staszewski, S; Sutherland-Phillips, D; Vavro, C; Wannamaker, P; Yau, L; Yeni, P; Yeo, J; Young, B, 2006
)
0.73
"Lamivudine combined with intramuscular HBIg can effectively prevent allograft from the recurrence of HBV after liver transplantation."( Intramuscular hepatitis B immune globulin combined with lamivudine in prevention of hepatitis B recurrence after liver transplantation.
Chen, YB; Li, B; Li, ZH; Wang, WT; Wen, TF; Xu, MQ; Yan, LN; Yan, ML; Yang, JY; Zeng, Y, 2006
)
2.02
" The results of our observations are encouraging and we suggest that HBIg in combination with lamivudine may be used in such cases especially in post-transplant early period to prevent HBV reactivation."( Hepatitis B immunoglobulin in combination with lamivudine for prevention of hepatitis B virus reactivation in children undergoing bone marrow transplantation.
Cetin, M; Demir, H; Kasem, M; Kuşkonmaz, B; Tavil, B; Uçkan, D, 2006
)
0.81
" This work investigates the use of an IM separator in combination with high-pressure liquid chromatography (HPLC) and MS, to improve the separation of drug-related materials from excipients, thus aiding the identification of trace-level impurities in an anti-HIV medication, Combivir."( Evaluating the utility of ion mobility separation in combination with high-pressure liquid chromatography/mass spectrometry to facilitate detection of trace impurities in formulated drug products.
Eckers, C; Giles, K; Laures, AM; Major, H; Pringle, S, 2007
)
0.34
" Mutagenicity experiments with ABC alone, or in combination with AZT-3TC, were complicated by the extreme cytotoxicity of ABC."( Mutagenicity of zidovudine, lamivudine, and abacavir following in vitro exposure of human lymphoblastoid cells or in utero exposure of CD-1 mice to single agents or drug combinations.
Carter, MM; Cook, DL; Cordova, EM; McCash, CL; Olivero, OA; Poirier, MC; Torres, SM; Walker, DM; Walker, VE,
)
0.43
"We sought to determine the outcomes of long-term use of lamivudine combined with hepatitis B immune globulin according to the titer of antibody to hepatitis B surface antigen in preventing recurrent hepatitis B in Chinese patients after liver transplantation."( Prophylaxis of recurrent hepatitis B in Chinese patients after liver transplantation using lamivudine combined with hepatitis B immune globulin according to the titer of antibody to hepatitis B surface antigen.
Jiao, Z; Jiao, ZY, 2007
)
0.81
" Fifty-seven patients used lamivudine combined with hepatitis B immune globulin therapy according to the titer of antibody to hepatitis B surface antigen."( Prophylaxis of recurrent hepatitis B in Chinese patients after liver transplantation using lamivudine combined with hepatitis B immune globulin according to the titer of antibody to hepatitis B surface antigen.
Jiao, Z; Jiao, ZY, 2007
)
0.86
"Long-term use of lamivudine combined with hepatitis B immune globulin, according to the titer of antibody to hepatitis B surface antigen was efficacious and cost effective to prevent recurrent hepatitis B in Chinese patients after liver transplantation."( Prophylaxis of recurrent hepatitis B in Chinese patients after liver transplantation using lamivudine combined with hepatitis B immune globulin according to the titer of antibody to hepatitis B surface antigen.
Jiao, Z; Jiao, ZY, 2007
)
0.9
"Study 903 is a phase 3 trial with a completed 144-week, double-blind phase comparing tenofovir DF (TDF) to stavudine (d4T) in combination with lamivudine (3TC) and efavirenz (EFV) and an ongoing additional 336-week open-label extension phase."( The safety and efficacy of tenofovir DF in combination with lamivudine and efavirenz through 6 years in antiretroviral-naïve HIV-1-infected patients.
Cassetti, I; Cheng, AK; Enejosa, J; Etzel, A; Madruga, JV; Suleiman, JM; Zhong, L,
)
0.57
"Study 903 is a phase 3 trial with a completed 144-week, double-blind phase comparing tenofovir DF (TDF) with stavudine (d4T), in combination with lamivudine (3TC) and efavirenz (EFV), and an ongoing 336-week open-label extension phase."( The safety and efficacy of switching stavudine to tenofovir df in combination with lamivudine and efavirenz in hiv-1-infected patients: three-year follow-up after switching therapy.
Cassetti, I; Cheng, AK; Enejosa, J; Etzel, A; Holmes, CB; Madruga, JR; Suleiman, JM; Zhong, L,
)
0.56
"The aim of this study was designed to evaluate the outcomes of liver transplant recipients with chronic hepatitis B (CHB) receiving either lamivudine monotherapy or lamivudine combined with individualized low-dose hepatitis B immunoglobulin (HBIG) therapy."( [Liver transplantation for chronic hepatitis B patients with lamivudine monotherapy or lamivudine combined with individualized low-dose hepatitis B immunoglobulin treatment].
Chen, ZY; Jiao, ZY; Li, B; Li, ZH; Lu, SC; Ma, YK; Wang, WT; Wen, TF; Xu, MQ; Yan, LN; Yang, JY; Zeng, Y; Zhang, ZW; Zhao, JC, 2007
)
0.78
" Thirty-two patients received lamivudine monotherapy (100 mg/d) and 79 patients received lamivudine (100 mg/d) combined with individualized low-dose HBIG (intramuscular administration) to maintain the titer of antibody to hepatitis B virus (HBV) surface antigen (anti-HBs) not less than 100 U/L."( [Liver transplantation for chronic hepatitis B patients with lamivudine monotherapy or lamivudine combined with individualized low-dose hepatitis B immunoglobulin treatment].
Chen, ZY; Jiao, ZY; Li, B; Li, ZH; Lu, SC; Ma, YK; Wang, WT; Wen, TF; Xu, MQ; Yan, LN; Yang, JY; Zeng, Y; Zhang, ZW; Zhao, JC, 2007
)
0.87
"Compared with lamivudine monotherapy, lamivudine combined with individualized low-dose HBIG can further reduce the recurrence risk of hepatitis B in liver transplant recipients."( [Liver transplantation for chronic hepatitis B patients with lamivudine monotherapy or lamivudine combined with individualized low-dose hepatitis B immunoglobulin treatment].
Chen, ZY; Jiao, ZY; Li, B; Li, ZH; Lu, SC; Ma, YK; Wang, WT; Wen, TF; Xu, MQ; Yan, LN; Yang, JY; Zeng, Y; Zhang, ZW; Zhao, JC, 2007
)
0.94
"A prospective cohort study on therapy with adefovir alone (29 patients) or combined with ongoing lamivudine (23 patients) was performed."( Lamivudine-resistant chronic hepatitis B: an observational study on adefovir in monotherapy or in combination with lamivudine.
Alessandria, C; Barbon, V; Carenzi, S; Gaia, S; Lagget, M; Marzano, A; Olivero, A; Rizzetto, M; Smedile, A, 2008
)
2.01
"We assessed the 18-month effectiveness of short-course (sc) antiretroviral peripartum regimens combined with alternatives to prolonged breastfeeding to prevent mother-to-child transmission (MTCT) of HIV-1 in Abidjan, Côte d'Ivoire."( 18-month effectiveness of short-course antiretroviral regimens combined with alternatives to breastfeeding to prevent HIV mother-to-child transmission.
Becquet, R; Dabis, F; Dequae-Merchadou, L; Ekouevi, DK; Horo, A; Leroy, V; Rouet, F; Rouzioux, C; Sakarovitch, C; Timité-Konan, M; Tonwe-Gold, B; Viho, I, 2008
)
0.35
"HIV-1-infected men enrolled in the Monark randomized trial were eligible for the present study after 48 weeks of a first-line lopinavir/ritonavir alone or in combination with zidovudine and lamivudine."( Absence of HIV-1 shedding in male genital tract after 1 year of first-line lopinavir/ritonavir alone or in combination with zidovudine/lamivudine.
Bresson, JL; Chaix, ML; Cohen-Codar, I; Delfraissy, JF; Galimand, J; Ghosn, J; Girard, PM; Peytavin, G; Raffi, F; Rouzioux, C, 2008
)
0.74
" We studied the safety, antiviral effect, and pharmacokinetics of NFV and its M8 metabolite with two dosing regimens in combination with zidovudine (ZDV) and lamivudine (3TC) in HIV-infected pregnant women."( Pharmacokinetics and safety of nelfinavir when used in combination with zidovudine and lamivudine in HIV-infected pregnant women: Pediatric AIDS Clinical Trials Group (PACTG) Protocol 353.
Asfaw, Y; Bryson, YJ; Capparelli, E; Connor, J; Huang, S; Hughes, MD; Kaiser, K; Keller, M; Mirochnick, M; Mofenson, LM; Purdue, L; Smith, E; Stek, A; Watts, DH,
)
0.55
"Overall, NFV in combination with ZDV and 3TC was well tolerated."( Pharmacokinetics and safety of nelfinavir when used in combination with zidovudine and lamivudine in HIV-infected pregnant women: Pediatric AIDS Clinical Trials Group (PACTG) Protocol 353.
Asfaw, Y; Bryson, YJ; Capparelli, E; Connor, J; Huang, S; Hughes, MD; Kaiser, K; Keller, M; Mirochnick, M; Mofenson, LM; Purdue, L; Smith, E; Stek, A; Watts, DH,
)
0.35
"NFV used in combination with ZDV and 3TC was well tolerated in pregnant HIV-infected women and produced a significant improvement in HIV disease parameters."( Pharmacokinetics and safety of nelfinavir when used in combination with zidovudine and lamivudine in HIV-infected pregnant women: Pediatric AIDS Clinical Trials Group (PACTG) Protocol 353.
Asfaw, Y; Bryson, YJ; Capparelli, E; Connor, J; Huang, S; Hughes, MD; Kaiser, K; Keller, M; Mirochnick, M; Mofenson, LM; Purdue, L; Smith, E; Stek, A; Watts, DH,
)
0.35
" Pharmacokinetic profiles were also determined in HIV-1-infected patients dosed with raltegravir monotherapy versus raltegravir in combination with TDF and lamivudine."( Lack of a significant drug interaction between raltegravir and tenofovir.
Breidinger, SA; Chen, J; Friedman, EJ; Gottesdiener, KM; Iwamoto, M; Kost, JT; Lasseter, KC; Stek, JE; Stone, JA; Teppler, H; Wagner, JA; Wenning, LA, 2008
)
0.54
" We aimed to test the efficacy of short-term use of a nucleoside analog in combination with a pre-S2-containing vaccine in patients with CHB."( Efficacy of pre-S-containing HBV vaccine combined with lamivudine in the treatment of chronic HBV infection.
Canbakan, B; Erdem, L; Mert, A; Ozaras, R; Senturk, H; Tabak, F; Yurdakul, I, 2009
)
0.6
" These mt-QSARs offer also a good opportunity to construct drug-drug Complex Networks (CNs) that can be used to explore large and complex drug-viral species databases."( Unified QSAR approach to antimicrobials. 4. Multi-target QSAR modeling and comparative multi-distance study of the giant components of antiviral drug-drug complex networks.
Chou, KC; González-Díaz, H; Martinez de la Vega, O; Prado-Prado, FJ; Ubeira, FM; Uriarte, E, 2009
)
0.35
"The efficacy of pegylated interferon alfa-2b alone or in combination with lamivudine for the treatment of patients with hepatitis B e antigen (HBeAg) negative (-) chronic hepatitis B (CHB) is understudied."( Peginterferon alfa-2b as monotherapy or in combination with lamivudine in patients with HBeAg-negative chronic hepatitis B: a randomised study.
Chrysagis, DN; Dimitriadis, GT; Goulis, IG; Mimidis, KP; Papadopoulos, VP; Protopapas, AN, 2009
)
0.83
"This 96-week, open-label, randomized study assessed changes in body composition in treatment-naive patients infected with human immunodeficiency virus type 1 who were treated with either atazanavir or ritonavir-boosted atazanavir, in combination with stavudine and lamivudine."( Changes in body composition with ritonavir-boosted and unboosted atazanavir treatment in combination with Lamivudine and Stavudine: a 96-week randomized, controlled study.
Mathew, M; McComsey, G; McGrath, D; Rightmire, A; Wirtz, V; Yang, R, 2009
)
0.75
"The KLEAN study extension assessed the long-term efficacy and safety of fosamprenavir-ritonavir (FPV/r) and lopinavir-ritonavir (LPV/r), both administered with abacavir/lamivudine (ABC/3TC) fixed dose combination, over 144 weeks."( Long-term efficacy and safety of fosamprenavir plus ritonavir versus lopinavir/ritonavir in combination with abacavir/lamivudine over 144 weeks.
Baril, JG; Duiculescu, D; Estrada, V; Lim, ML; Logue, K; Pharo, C; Plettenberg, A; Pulido, F; Schewe, K; Vavro, C; Yau, L,
)
0.53
"The findings of the KLEAN study extension (48 to 144 weeks) support durable viral suppression with both FPV/r and LPV/r treatment regimens when used in combination with ABC/3TC irrespective of viral load at baseline."( Long-term efficacy and safety of fosamprenavir plus ritonavir versus lopinavir/ritonavir in combination with abacavir/lamivudine over 144 weeks.
Baril, JG; Duiculescu, D; Estrada, V; Lim, ML; Logue, K; Pharo, C; Plettenberg, A; Pulido, F; Schewe, K; Vavro, C; Yau, L,
)
0.34
"Similar virological efficacy was observed for efavirenz and lopinavir/r, when administered with Kivexa in antiretroviral-naïve patients, while immunological improvement was slightly superior for efavirenz."( Similar antiviral efficacy and tolerability between efavirenz and lopinavir/ritonavir, administered with abacavir/lamivudine (Kivexa), in antiretroviral-naïve patients: a 48-week, multicentre, randomized study (Lake Study).
Bravo, I; Carosi, G; Clotet, B; del Arco, A; Echeverría, P; Gálvez, J; Gómez, JL; López, JC; López-Blazquez, R; Mariño, A; Moreno, A; Negredo, E; Ocampo, A; Pedrol, E; Pérez-Alvarez, N; Portilla, J; Prieto, A; Rubio, R; Viladés, C, 2010
)
0.57
"Forty-eight-week data are presented from this multicenter, randomized, open-label study comparing the safety profiles of abacavir/lamivudine and tenofovir/emtricitabine, both administered with efavirenz, in HLA-B*5701-negative HIV-1-infected adults."( Randomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lamivudine versus tenofovir/emtricitabine, administered with efavirenz, in antiretroviral-naive, HIV-1-infected adults: 48-week results from the ASSERT study.
Branco, T; Cavassini, M; Domingo, P; Fisher, M; Givens, N; Khuong-Josses, MA; Lim, ML; Moyle, GJ; Norden, AG; Pearce, HC; Podzamczer, D; Post, FA; Rieger, A; Stellbrink, HJ; Vavro, C, 2010
)
0.79
" We report the results of an open-label pilot trial with unboosted atazanavir in combination with lamivudine and didanosine as first-line therapy conducted in Senegal."( Efficacy and safety of unboosted atazanavir in combination with lamivudine and didanosine in naive HIV type 1 patients in Senegal.
Benalycherif, A; Bennai, Y; Diallo, MB; Fall, MB; Girard, PM; Gueye, NF; Kane, CT; Landman, R; Mboup, S; Ndiaye, B; Peytavin, G; Sow, PS, 2010
)
0.82
" We investigated the activity of clevudine (CLV) in combination with other nucleoside/nucleotide analogues to determine if these combinations were compatible in vitro."( Evaluation of the in vitro anti-HBV activity of clevudine in combination with other nucleoside/nucleotide inhibitors.
Bao, H; Furman, PA; Korba, B; Micolochick Steuer, HM; Murakami, E; Niu, C; Tolstykh, T, 2010
)
0.36
"Using the HepAD38 cell line, which expresses wild-type HBV, and a real-time PCR assay, we tested the anti-HBV activity of CLV in combination with entecavir, lamivudine, adefovir, tenofovir and telbivudine (TBV)."( Evaluation of the in vitro anti-HBV activity of clevudine in combination with other nucleoside/nucleotide inhibitors.
Bao, H; Furman, PA; Korba, B; Micolochick Steuer, HM; Murakami, E; Niu, C; Tolstykh, T, 2010
)
0.56
"When CLV was combined with entecavir, lamivudine, adefovir or tenofovir, a synergistic antiviral effect was observed; however, the combination of CLV and TBV gave an antagonistic antiviral response."( Evaluation of the in vitro anti-HBV activity of clevudine in combination with other nucleoside/nucleotide inhibitors.
Bao, H; Furman, PA; Korba, B; Micolochick Steuer, HM; Murakami, E; Niu, C; Tolstykh, T, 2010
)
0.63
"Randomised clinical trials addressing benefits and harms of lamivudine or adefovir dipivoxil alone or in combination with hepatitis B immunoglobulins (HBIg) for preventing recurrent HBV infection in patients who are liver transplanted due to HBV infection with or without hepatocellular carcinoma."( Lamivudine or adefovir dipivoxil alone or combined with immunoglobulin for preventing hepatitis B recurrence after liver transplantation.
Guy, DG; Katz, LH; Paul, M; Tur-Kaspa, R, 2010
)
2.05
"We retrospectively evaluated the durability and reasons for discontinuation of nevirapine (NVP) in combination with a tenofovir (TDF) and emtricitabine (FTC) or lamivudine (3TC)-containing antiretroviral therapy (ART) regimen in an Australian outpatient setting."( Clinical experience with nevirapine combined with tenofovir plus emtricitabine or lamivudine-containing regimens in HIV-infected subjects.
Chan, DJ; Jeganathan, S; Maruszak, H; Smith, DE, 2011
)
0.79
"Limited data are available on the use of unboosted atazanavir in combination with nucleoside reverse transcriptase inhibitors (NRTIs) in treatment-experienced HIV-infected patients."( Efficacy and safety of a switch to unboosted atazanavir in combination with nucleoside analogues in HIV-1-infected patients with virological suppression under antiretroviral therapy.
Ammassari, A; Castagna, A; Delaugerre, C; Ghosn, J; Medrano, J; Molina, JM; Pavie, J; Porcher, R; Rusconi, S; Torti, C; Valin, N, 2011
)
0.37
" NRTIs used in combination with atazanavir were tenofovir, abacavir and emtricitabine/lamivudine in 36."( Efficacy and safety of a switch to unboosted atazanavir in combination with nucleoside analogues in HIV-1-infected patients with virological suppression under antiretroviral therapy.
Ammassari, A; Castagna, A; Delaugerre, C; Ghosn, J; Medrano, J; Molina, JM; Pavie, J; Porcher, R; Rusconi, S; Torti, C; Valin, N, 2011
)
0.59
"In patients with virological suppression and no prior history of virological failure, a switch to unboosted atazanavir in combination with NRTIs is associated with a low probability of virological failure and a good safety profile."( Efficacy and safety of a switch to unboosted atazanavir in combination with nucleoside analogues in HIV-1-infected patients with virological suppression under antiretroviral therapy.
Ammassari, A; Castagna, A; Delaugerre, C; Ghosn, J; Medrano, J; Molina, JM; Pavie, J; Porcher, R; Rusconi, S; Torti, C; Valin, N, 2011
)
0.37
"We evaluated the safety and efficacy of the coformulation of ABC/3TC administered with DRV/r in treatment-naïve and treatment-experienced patients."( Abacavir/lamivudine fixed-dose combination with ritonavir-boosted darunavir: a safe and efficacious regimen for HIV therapy.
Boissonnault, M; Dion, H; Gallant, S; Lavoie, S; Legault, D; Longpré, D; Machouf, N; Nguyen, VK; Thomas, R; Trottier, B; Vézina, S,
)
0.55
" The drug combination appears to be generally safe and well tolerated."( Abacavir/lamivudine fixed-dose combination with ritonavir-boosted darunavir: a safe and efficacious regimen for HIV therapy.
Boissonnault, M; Dion, H; Gallant, S; Lavoie, S; Legault, D; Longpré, D; Machouf, N; Nguyen, VK; Thomas, R; Trottier, B; Vézina, S,
)
0.55
"Comprehensive information on the effects of cytochrome P450 2B6 (CYP2B6) polymorphisms, clinical factors, and drug-drug interactions on efavirenz concentrations in HIV/tuberculosis-coinfected (HIV/TB) patients is unavailable."( Impact of pharmacogenetic markers of CYP2B6, clinical factors, and drug-drug interaction on efavirenz concentrations in HIV/tuberculosis-coinfected patients.
Lueangniyomkul, A; Mankatitham, W; Manosuthi, S; Manosuthi, W; Nilkamhang, S; Sukasem, C; Sungkanuparph, S; Thongyen, S, 2013
)
0.39
"The study aimed to investigate the efficacy and safety of peginterferon α-2a (PEG IFNα-2a) in combination with lamivudine or adefovir in the treatment of hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB)."( Extended treatment with peginterferon α-2a in combination with lamivudine or adefovir for 96 weeks yields high rates of HBeAg and HBsAg seroconversion.
Cao, ZH; Chen, XY; Liu, YL; Ma, LN; Zhang, HW, 2013
)
0.84
" Moreover, the frequency of comorbidity with human immunodeficiency virus (HIV) and with diabetes is on the rise, increasing the risk of these patients for experiencing drug-drug interactions (DDIs) due to polypharmacy."( Interaction of Ethambutol with human organic cation transporters of the SLC22 family indicates potential for drug-drug interactions during antituberculosis therapy.
Gründemann, D; Pan, X; Sweet, DH; Wang, L, 2013
)
0.39
" The herb-drug pharmacokinetic interaction showed that with either lamivudine alone or in combination with pretreated with LDXGT, the pharmacokinetic parameters were not significantly changed except the apparent volume of distribution (Vd) at a high dose of lamivudine (30mg/kg)."( Development of a microdialysis system to monitor lamivudine in blood and liver for the pharmacokinetic application in herbal drug interaction and the gene expression in rats.
Hou, ML; Lin, LC; Lu, CM; Tsai, TH, 2014
)
0.89
" Here we reported the in vitro activity of azvudine against HIV-1 and HIV-2 when used alone or in combination with other antiretroviral drugs and its drug resistance features."( Azvudine, a novel nucleoside reverse transcriptase inhibitor showed good drug combination features and better inhibition on drug-resistant strains than lamivudine in vitro.
Chang, JB; Chen, H; Cui, XQ; Dai, SX; Huang, JF; Liu, YJ; Luo, RH; Peng, YM; Wang, RR; Yang, QH; Zhang, XJ; Zheng, YT, 2014
)
0.6
" The aim of this study was to evaluate whether LAM combined with IFN-α offer advantage over lamivudine monotherapy for the occurrence of YMDD mutations in CHB using a meta-analysis."( Interferon-α combined with lamivudine versus lamivudine monotherapy for the emergence of YMDD mutations in chronic hepatitis B infection: a meta-analysis of randomized controlled trials.
Cui, LY; Zhang, J; Zhang, YL,
)
0.65
"Our present meta-analysis suggests that different types of IFN-a in combination with LAM can significantly reduce the rate of YMDD mutation compared to LAM monotherapy."( Interferon-α combined with lamivudine versus lamivudine monotherapy for the emergence of YMDD mutations in chronic hepatitis B infection: a meta-analysis of randomized controlled trials.
Cui, LY; Zhang, J; Zhang, YL,
)
0.43
" We compared the treatment responses to 3TC and FTC combined with TDF in boosted protease inhibitor (PI)-based cART for HIV-1-infected patients."( Virological responses to lamivudine or emtricitabine when combined with tenofovir and a protease inhibitor in treatment-naïve HIV-1-infected patients in the Dutch AIDS Therapy Evaluation in the Netherlands (ATHENA) cohort.
Gras, L; Rijnders, B; Rokx, C; van de Vijver, D; Verbon, A, 2016
)
0.74
" These data indicate that the 3-direct-acting-antiviral regimen can be administered with dolutegravir or abacavir plus lamivudine without dose adjustment."( Drug-Drug Interaction between the Direct-Acting Antiviral Regimen of Ombitasvir-Paritaprevir-Ritonavir plus Dasabuvir and the HIV Antiretroviral Agent Dolutegravir or Abacavir plus Lamivudine.
Khatri, A; Menon, R; Podsadecki, T; Trinh, R; Zhao, W, 2016
)
0.83
"In general, DTG 50 mg given once daily combined with an active background drug is a better choice in terms of both efficacy and safety."( Dolutegravir(DTG, S/GSK1349572) combined with other ARTs is superior to RAL- or EFV-based regimens for treatment of HIV-1 infection: a meta-analysis of randomized controlled trials.
Chen, H; Guo, W; Huang, J; Jiang, J; Liang, B; Liang, H; Liao, Y; Su, J; Xu, X; Ye, L; Zang, N, 2016
)
0.43
"Dolutegravir plasma trough concentrations were measured in 78 HIV-infected patients given the drug in combination with a protease inhibitor, a non-nucleoside reverse transcriptase inhibitor or abacavir/lamivudine."( Dolutegravir plasma concentrations according to companion antiretroviral drug: unwanted drug interaction or desirable boosting effect?
Cattaneo, D; Clementi, E; Cozzi, V; Galli, M; Gervasoni, C; Meraviglia, P; Minisci, D; Riva, A, 2017
)
0.64
" The 4200 patients who have been treated for hepatitis B combined with pulmonary TB in 8 different hospitals from Feb 2014 to Feb 2016 were selected as research objects."( Clinical effect of lamivudine in treating liver function lesion caused by hepatitis B combined with Anti-TB drugs.
Han, Y; Xia, S; Zhou, J, 2018
)
0.81
" This study investigated the toxic and genotoxic potential of ABC when administered alone or in combination with AZT and/or 3TC using the somatic mutation and recombination test in Drosophila melanogaster."( Toxicity and genotoxicity induced by abacavir antiretroviral medication alone or in combination with zidovudine and/or lamivudine in Drosophila melanogaster.
Bailão, E; Cardoso, CG; Chen-Chen, L; Cunha, KS; de Jesus Silva Carvalho, C; de Moraes Filho, AV; Spanó, MA; Véras, JH, 2019
)
0.72
" Accordingly, it is important that physicians be aware and confident about the drug-drug interactions (DDIs) involving dolutegravir, lamivudine, and other medications."( Drug-drug interactions of a two-drug regimen of dolutegravir and lamivudine for HIV treatment.
Capetti, A; Cattaneo, D; Rizzardini, G, 2019
)
0.96
" The combination with ACC007 significantly increases the dose reduction index value of lamivudine and tenofovir disoproxil fumarate, compared with two-drug combination."( The New NNRTI ACC007 Combined with Lamivudine and Tenofovir Disoproxil Fumarate Show Synergy Anti-HIV Activity In Vitro.
Chen, H; Hu, XL; Huang, XS; Luo, RH; Shen, XN; Tang, CR; Xiang, SY; Zhang, CT; Zheng, YT, 2020
)
1.06
" Doravirine in combination with islatravir has the potential to be a potent two-drug regimen that warrants further clinical development."( Islatravir in combination with doravirine for treatment-naive adults with HIV-1 infection receiving initial treatment with islatravir, doravirine, and lamivudine: a phase 2b, randomised, double-blind, dose-ranging trial.
Afani Saud, A; Bettacchi, C; Chahin Anania, C; Correll, T; DeJesus, E; Eves, K; Grandhi, A; Hanna, GJ; Hwang, C; Molina, JM; Olsen Klopfer, S; Robertson, MN; Sklar, P; Yazdanpanah, Y, 2021
)
0.82
" We did not find an elevated risk of AMI when abacavir-lamivudine was combined with efavirenz or raltegravir."( Acute myocardial infarction associated with abacavir and tenofovir based antiretroviral drug combinations in the United States.
Baxi, SM; Choden, T; Desai, M; Dorjee, K; Hubbard, AE; Reingold, AL, 2021
)
0.87
"We assessed virological failure (VF) and resistance-associated mutations (RAMs) on dolutegravir maintenance regimens in combination with rilpivirine or with lamivudine or emtricitabine (xTC) and analysed the factors associated with VF."( Dolutegravir-based dual maintenance regimens combined with lamivudine/emtricitabine or rilpivirine: risk of virological failure in a real-life setting.
Allavena, C; Bani-Sadr, F; Cabie, A; Cuzin, L; Deschanvres, C; Duvivier, C; Hocqueloux, L; Joly, V; Lamaury, I; Palich, R; Raffi, F; Rey, D; Reynes, J; Robineau, O, 2021
)
1.06
" Following a 2 × 2 factorial design and stratified by site and screening HIV-1 RNA concentration, participants were randomly assigned (1:1:1:1) to receive a 96-week regimen containing either dolutegravir (50 mg once daily) or ritonavir-boosted darunavir (800 mg of darunavir plus 100 mg of ritonavir once daily) in combination with either tenofovir (300 mg once daily) plus lamivudine (300 mg once daily) or zidovudine (300 mg twice daily) plus lamivudine (150 mg twice daily)."( Efficacy and safety of dolutegravir or darunavir in combination with lamivudine plus either zidovudine or tenofovir for second-line treatment of HIV infection (NADIA): week 96 results from a prospective, multicentre, open-label, factorial, randomised, non
Asienzo, J; Ategeka, G; Balyegisawa, A; Borok, M; Castelnuovo, B; Hoppe, A; Kaimal, A; Kambugu, A; Kiragga, A; Kityo, C; Lugemwa, A; Mirembe, G; Mugerwa, H; Musaazi, J; Odongpiny, ELA; Paton, NI; Siika, A; Walimbwa, S, 2022
)
1.12
" NNRTIs are typically administered in combination with two nucleoside reverse transcriptase inhibitors as first-line recommended regimens in several guidelines."( No Meaningful Drug-Drug Interactions Are Associated with the Coadministration of ACC007, Lamivudine, and Tenofovir Disoproxil Fumarate.
Hao, X; Li, B; Li, L; Ni, J; Tian, Z; Wu, L; Xiao, Y; Zhang, W; Zhao, D; Zhao, X, 2023
)
1.13
"In this study, the clinical effect of lamivudine combined with leflunomide and methylprednisolone in the treatment of hepatitis B virus-associated glomerulonephritis (HBV-GN) and their influence on renal function indexes was explored."( Clinical Effect of Lamivudine Combined with Leflunomide and Methylprednisolone Tablets in the Treatment of Hepatitis B Virus-Associated Glomerulonephritis and Its Influence on Renal Function Indicators.
Jiang, F; Liu, H; Xing, X; Zhang, M; Zheng, K; Zhou, C, 2023
)
1.51
"Lamivudine combined with methylprednisolone and leflunomide treatment is conducive to clearing Hepatitis B virus (HBV) and improving renal function."( Clinical Effect of Lamivudine Combined with Leflunomide and Methylprednisolone Tablets in the Treatment of Hepatitis B Virus-Associated Glomerulonephritis and Its Influence on Renal Function Indicators.
Jiang, F; Liu, H; Xing, X; Zhang, M; Zheng, K; Zhou, C, 2023
)
2.68
" Albuvirtide (ABT), a new peptide drug, is a long-acting HIV fusion inhibitor with limited drug-drug interactions and fast onset time."( Tolerability and effectiveness of albuvirtide combined with dolutegravir for hospitalized people living with HIV/AIDS.
Cheng, J; He, S; He, Y; Liu, H; Lu, C; Yang, T; Yao, Y; Yin, K; Zhou, R, 2023
)
0.91

Bioavailability

In children aged ≤4 years, the relative bioavailability of lamivudine oral solution was 37% lower than that of a tablet formulation. In several Phase I pharmacokinetic studies, one Dutrebis fixed-dose combination tablet showed a higher bioavailability but comparable lamvudine and 400 mg raltegravir exposures.

ExcerptReferenceRelevance
" The mean bioavailability of 3TC was 82% following oral administration."( The safety and pharmacokinetics of a reverse transcriptase inhibitor, 3TC, in patients with HIV infection: a phase I study.
Danner, SA; Donn, KH; Hall, ST; Harker, AJ; Hussey, EK; Jonker, P; Lange, JM; van Leeuwen, R, 1992
)
0.28
" Absolute bioavailability and in vivo mean absorption time (MAT) and mean dissolution time (MDT) were calculated for the oral formulations."( Pharmacokinetics, absolute bioavailability, and absorption characteristics of lamivudine.
Haidar, S; Hall, ST; Hussey, EK; Morris, DM; Mydlow, PK; Yuen, GJ, 1995
)
0.52
" The oral bioavailability of 3TC ranged from 18 to 54%."( Pharmacokinetics of (-)-2'-3'-dideoxy-3'-thiacytidine in woodchucks.
Baldwin, BH; Boudinot, FD; Chu, CK; Rajagopalan, P; Schinazi, RF; Tennant, BC, 1996
)
0.29
" Ritonavir has good oral bioavailability, and may increase the bioavailability of other protease inhibitors including saquinavir, nelfinavir, indinavir and VX-478."( Ritonavir.
Faulds, D; Lea, AP, 1996
)
0.29
" The absolute bioavailability is approximately 82 and 68% in adults and children, respectively."( Clinical pharmacokinetics of lamivudine.
Bye, A; Johnson, MA; Moore, KH; Pakes, GE; Yuen, GJ, 1999
)
0.59
"A single-center, open-label, three-way crossover study was conducted in 24 healthy subjects to assess (1) the bioequivalence of a combined lamivudine 150 mg/zidovudine 300 mg tablet relative to the separate brand-name components administered concurrently and (2) the effect of food on the bioavailability of the drugs from the combination tablet."( Lamivudine/zidovudine as a combined formulation tablet: bioequivalence compared with lamivudine and zidovudine administered concurrently and the effect of food on absorption.
Duncan, B; Laurent, AL; Lloyd, P; Moore, KH; Morris, DM; O'Mara, MJ; Pakes, GE; Shaw, S, 1999
)
1.95
"Lamivudine was well absorbed in all subjects (tmax 1 h)."( The pharmacokinetics of lamivudine in healthy Chinese subjects.
Chen, H; Fan, F; Harker, A; Hu, P; Jiang, J; Johnson, MA; Xie, H, 1999
)
2.05
"A single-center, open-label, three-way crossover study was conducted in 24 healthy subjects to assess (1) the bioequivalence of a combined abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg (A/L/Z) combination tablet relative to the separate brand-name components administered simultaneously and (2) the effect of food on the bioavailability of the drugs from the combination tablet."( Abacavir/lamivudine/zidovudine as a combined formulation tablet: bioequivalence compared with each component administered concurrently and the effect of food on absorption.
Allsup, TL; Hutman, HW; Lou, Y; Mahony, WB; Otto, VR; Thompson, NF; Yuen, GJ, 2001
)
0.93
" ACTG 333 tested the consequences of long-term use of hard capsule saquinavir, and found that it is poorly absorbed and there is only a very modest effect on HIV."( Spring cleaning in trial land.
Gilden, D, 1997
)
0.3
"The present study describes the determination of the bioavailability of a new commercial tablet formulation of lamivudine (CAS 134678-17-4) compared with a reference formulation."( Bioequivalence of two lamivudine tablet formulations.
Alves, AJ; Cavalcante, RM; Costa, RM; de Carvalho, JN; de Oliveira, HM; de Souza, SD; Esteves, IL; Guimarães, MI; Pontes, A; Ramalho, MS; Rangel, FA; Santos-Magalhães, NS; Vieira, SL, 2001
)
0.84
"Emergence of human immunodeficiency virus type-1 (HIV-1) genotypic drug resistance is generally attributed to noncompliance, poorly absorbed drugs, or drug-to-drug interaction."( In vivo emergence of drug-resistant mutations at less than 50 HIV-1 RNA copies/mL that are maintained at viral rebound in longitudinal plasma samples from human immunodeficiency virus type-1-infected patients on highly active antiretroviral therapy.
Benetti, MS; Bortolozzi, RL; Campodonico, ME; Chernoff, D; Dileanis, J; Elbeik, T; Fay, FF; Fay, OH; Hoo, BS; Marlowe, N; Ng, VL; Petrauskene, O; Smith, L,
)
0.13
" Volume of distribution and absorption rate constant were 77."( Nevirapine and efavirenz pharmacokinetics and covariate analysis in the 2NN study.
Beijnen, JH; Huitema, AD; Kappelhoff, BS; Lange, J; MacGregor, TR; van Leth, F, 2005
)
0.33
"25 for log-transformed data, the 2 formulations were considered bioequivalent in the extent (AUCinfinity) and rate of absorption (Cmax and time to Cmax [tmax])."( Pharmacokinetic profiling and bioequivalence evaluation of 2 lamivudine tablet formulations after single oral administration in healthy human Indian volunteers.
Lulla, A; Malhotra, G; Narang, VS; Purandare, S, 2005
)
0.57
" It is well absorbed by the intestinal mucosa, its bio-availability is approx."( [Adefovir dipivoxil-a new effective treatment for chronic infection with hepatitits B virus.].
Husa, P, 2005
)
0.33
"An open-label, balanced, randomized, 2-treatment, 2-period, 2-sequence, single-dose, crossover bioavailability study was conducted in 40 subjects with 21-day washout period between each treatment."( Nevirapine/lamivudine/stavudine as a combined-formulation tablet: bioequivalence study compared with each component administered concurrently under fasting condition.
Garg, M; Monif, T; Singla, AK; Tippabhotla, SK; Vijan, T, 2006
)
0.72
" Human oral bioavailability is an important pharmacokinetic property, which is directly related to the amount of drug available in the systemic circulation to exert pharmacological and therapeutic effects."( Hologram QSAR model for the prediction of human oral bioavailability.
Andricopulo, AD; Moda, TL; Montanari, CA, 2007
)
0.34
" Inclusion of interoccasion variability for bioavailability improved the individual subject clearance prediction over the age range studies."( Population pharmacokinetics of lamivudine in human immunodeficiency virus-exposed and -infected infants.
Acosta, EP; Bryson, Y; Capparelli, EV; Holland, D; Luzuriaga, K; Mirochnick, M; Patel, P; Tremoulet, AH; Wara, D; Zorrilla, C, 2007
)
0.63
" In vitro quality control of the FDC tablets was determined and a crossover bioavailability study using 18 adult volunteers was performed after oral administration of the novel FDC tablet and a Duovir tablet."( Development of fixed dose combination tablets containing zidovudine and lamivudine for paediatric applications.
Bortel, V; Kayitare, E; Ntawukulilyayo, JD; Remon, JP; Seminega, B; Vervaet, C, 2009
)
0.59
" HDP-(S)-HPMPA is orally bioavailable and provides excellent liver exposure to the drug."( Alkoxyalkyl esters of 9-(s)-(3-hydroxy-2-phosphonomethoxypropyl) adenine are potent and selective inhibitors of hepatitis B virus (HBV) replication in vitro and in HBV transgenic mice in vivo.
Beadle, JR; Hostetler, KY; Korba, BE; Morrey, JD; Wyles, DL, 2009
)
0.35
"63 h and oral bioavailability (F) of 40."( Anti-HBV agents. Part 3: preliminary structure-activity relationships of tetra-acylalisol A derivatives as potent hepatitis B virus inhibitors.
Chen, JJ; Du, FF; Guo, RH; Jiang, ZY; Li, C; Li, L; Liu, JF; Luo, J; Ma, YB; Niu, W; Zhang, Q; Zhang, XM; Zhou, J, 2009
)
0.35
"Oral bioavailability (F) is a product of fraction absorbed (Fa), fraction escaping gut-wall elimination (Fg), and fraction escaping hepatic elimination (Fh)."( Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
Chang, G; El-Kattan, A; Miller, HR; Obach, RS; Rotter, C; Steyn, SJ; Troutman, MD; Varma, MV, 2010
)
0.36
"The acyloxyalkyl derivatives of a model anti-HBV dinucleotide were synthesized and evaluated as orally bioavailable prodrugs."( Orally bioavailable anti-HBV dinucleotide acyloxyalkyl prodrugs.
Coughlin, JE; Govardhan, CP; Green, CE; Iyer, RP; Kirk, CJ; Korba, BE; Mirsalis, J; Morrey, JD; O'Loughlin, K; Padmanabhan, S; Zhang, G, 2010
)
0.36
" A two-compartment model in which the slope of distribution is assumed to be equal to the absorption rate constant adequately described the data."( Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
Bardin, C; Blanche, S; Bouazza, N; Diagbouga, S; Hien, H; Hirt, D; Msellati, P; Nacro, B; Ouiminga, A; Rouet, F; Tréluyer, JM; Urien, S; Van De Perre, P; Zoure, E, 2010
)
0.63
" The method was successfully applied to a bioavailability study of a combined tablet formulation containing 30 mg of stavudine and 150 mg of lamivudine compared with each reference formulation concurrently administered in 26 healthy Thai male volunteers."( Simultaneous determination of stavudine and lamivudine in human plasma by high performance liquid chromatography and its application to a bioavailability study.
Akarawut, W; Prasanchaimontri, IO; Wattananat, T, 2010
)
0.82
" Typical population estimates (percent interindividual variability) standardized for 70 kg of the apparent clearance, including central and peripheral volumes of distribution, intercompartmental clearance, and absorption rate constant, were 31 liters · h(-1) (32%), 76."( Developmental pharmacokinetics of lamivudine in 580 pediatric patients ranging from neonates to adolescents.
Blanche, S; Bouazza, N; Frange, P; Hirt, D; Rey, E; Tréluyer, JM; Urien, S, 2011
)
0.65
" We found particularly a gender effect on the apparent bioavailability of AZT, as well as on the mean plasma and intracellular concentrations of AZT, which were significantly higher in females than in males."( Joint population pharmacokinetic analysis of zidovudine, lamivudine, and their active intracellular metabolites in HIV patients.
Bazzoli, C; Bénech, H; Duval, X; Mentré, F; Retout, S; Rey, E; Salmon, D; Tréluyer, JM, 2011
)
0.61
" The lead candidates, both 1a (PBHBV-001) and 3c (PBHBV-2-15), were well-tolerated in both normal and HBV-transgenic mice and exhibited acceptable pharmacokinetics and bioavailability in Sprague-Dawley rats."( Design, synthesis, and biological evaluation of triazolo-pyrimidine derivatives as novel inhibitors of hepatitis B virus surface antigen (HBsAg) secretion.
Block, TM; Clearfield, E; Cuconati, A; Goddard, C; Guo, H; Mills, C; Morrey, JD; Motter, NE; Xiao, T; Xu, X; Yu, W; Zhao, K, 2011
)
0.37
" We report the bioavailability and short-term safety of a novel paediatric FDC tablet of zidovudine (ZDV)/lamivudine (3TC)/nevirapine (NVP; 30/15/28 mg) in HIV-infected children."( Pharmacokinetics and safety of a new paediatric fixed-dose combination of zidovudine/lamivudine/nevirapine in HIV-infected children.
Aurpibul, L; Capparelli, E; Chokephaibulkit, K; Cressey, TR; Eksaengsri, A; Hongsiriwon, S; Kabat, B; Limwongse, C; McIntosh, K; Muresan, P; Ngampiyaskul, C; Sirisanthana, V; Smith, ME; Toye, M; Wittawatmongkol, O; Yogev, R, 2011
)
0.81
"Besides unravelling the polymer synergism, the study helped in developing an optimal once-a-day gastroretentive drug delivery system with improved bioavailability potential exhibiting excellent swelling, floating and bioadhesive characteristics."( Formulation development of gastroretentive tablets of lamivudine using the floating-bioadhesive potential of optimized polymer blends.
Arora, S; Chaturvedi, SC; Garg, B; Kapil, R; Mandsaurwale, R; Singh, B, 2012
)
0.63
" The relative bioavailability of LMX-loaded liposomes was 1074."( Preparation and evaluation of liposome-encapsulated codrug LMX.
Wang, J; Wang, Y; Wu, B; Zhong, Y, 2012
)
0.38
" Based on these characteristics, the Biopharmaceutical Classification System (BCS) was proposed as a tool to assist in biowaiver and bioavailability prediction of drugs."( Determination of lamivudine and zidovudine permeability using a different ex vivo method in Franz cells.
Caffaro, AM; Dezani, AB; Pereira, TM; Reis, JM; Serra, CH,
)
0.47
" Pharmacokinetic and bioavailability parameters were calculated."( Single-dose pharmacokinetic properties, bioavailability, and tolerability of two lamivudine 100-mg tablet formulations: a randomized crossover study in healthy Chinese male subjects.
Chen, H; Ding, Y; Li, X; Liu, B; Sun, Y; Zhang, H; Zhang, Q, 2013
)
0.62
" Typical population estimates (percentage interindividual variability) of the apparent clearance (CL/F), central (Vc /F) and peripheral volumes of distribution (Vp /F), intercompartmental clearance (Q/F) and absorption rate constant (Ka ) were 29."( Evaluation of effect of impaired renal function on lamivudine pharmacokinetics.
Benaboud, S; Bouazza, N; Foissac, F; Ghosn, J; Hirt, D; Tréluyer, JM; Urien, S; Viard, JP, 2014
)
0.65
" The present study was undertaken to evaluate the absolute oral bioavailability of FNC in rats and the pharmacokinetic properties of FNC after intragastric administration of single and multiple doses in rats and dogs."( Quantification of 2'-deoxy-2'-β-fluoro-4'-azidocytidine in rat and dog plasma using liquid chromatography-quadrupole time-of-flight and liquid chromatography-triple quadrupole mass spectrometry: Application to bioavailability and pharmacokinetic studies.
Chang, J; Chen, X; Cheng, T; Dong, L; Guo, M; Guo, X; Jiang, J; Peng, Y; Wang, Q; Zhang, J; Zhang, Y, 2014
)
0.4
" In several Phase I pharmacokinetic studies, one Dutrebis (150 mg lamivudine/300 mg raltegravir) fixed-dose combination tablet showed a higher bioavailability but comparable lamivudine and 400 mg raltegravir poloxamer exposures."( Dutrebis (lamivudine and raltegravir) for use in combination with other antiretroviral products for the treatment of HIV-1 infection.
Bañón, S; Casado, JL, 2015
)
1.06
" These IVIVC models are proposed as alternative and cost/effective methods to evaluate the biopharmaceutical properties that determine the bioavailability of a drug and their application includes the development process, quality assurance, bioequivalence studies and pharmacosurveillance."( In vitro-in vivo Pharmacokinetic correlation model for quality assurance of antiretroviral drugs.
Restrepo Valencia, P; Rojas Gómez, R, 2015
)
0.42
" Co-administration with some antiretroviral therapies (ART) changes the bioavailability of the etonogestrel (ENG)-releasing contraceptive implant, possibly affecting the bleeding pattern."( Bleeding patterns of HIV-infected women using an etonogestrel-releasing contraceptive implant and efavirenz-based or lopinavir/ritonavir-based antiretroviral therapy.
Amaral, E; Bahamondes, L; Bahamondes, MV; Brito, MB; Duarte, G; Ferriani, RA; Prandini, TR; Quintana, SM; Ragazini, CS; Vieira, CS, 2016
)
0.43
" This study investigated the differences in bioavailability between WHO-prequalified first-line antiretroviral generics by means of adjusted indirect comparisons to ensure interchangeability between these generics."( Interchangeability between first-line generic antiretroviral products prequalified by WHO using adjusted indirect comparisons.
García-Arieta, A; Gordon, J; Gwaza, L; Leufkens, H; Potthast, H; Stahl, M; Welink, J, 2017
)
0.46
"To enhance efficacy, bioavailability and reduce toxicity of first-line highly active anti-retroviral regimen, zidovudine + efavirenz + lamivudine loaded lactoferrin nanoparticles were prepared (FLART-NP) and characterized for physicochemical properties, bioactivity and pharmacokinetic profile."( Triple Drug Combination of Zidovudine, Efavirenz and Lamivudine Loaded Lactoferrin Nanoparticles: an Effective Nano First-Line Regimen for HIV Therapy.
Kondapi, AK; Kumar, P; Lakshmi, YS, 2017
)
0.91
"In children aged ≤4 years, the relative bioavailability of lamivudine oral solution was 37% lower than that of a tablet formulation."( Effect of Sorbitol on the Pharmacokinetic Profile of Lamivudine Oral Solution in Adults: An Open-Label, Randomized Study.
Adkison, K; Eld, A; Hayward, K; Lou, Y; McCoig, C; Perger, T; Shaefer, M; Vangerow, H; Wolstenholme, A; Zhang, Z, 2018
)
0.97
"Mannosylated polymeric nanoparticles (NPs) enable improvement of brain bioavailability and reduction of dosing due to efficient drug delivery at the target site."( Targeted delivery of mannosylated-PLGA nanoparticles of antiretroviral drug to brain.
Parikh, RH; Patel, BK; Patel, N, 2018
)
0.48
"A phase 1, open-label, randomized study was conducted in healthy adults to evaluate the relative bioavailability of a novel dispersible FDC tablet of abacavir 150 mg/dolutegravir 10 mg/lamivudine 75 mg administered under 4 different dosing conditions compared with dolutegravir plus abacavir/lamivudine nondispersible, film-coated tablets."( Effects of Low- and High-Mineral Content Water on the Relative Bioavailability of a Coformulated Abacavir/Dolutegravir/Lamivudine Dispersible Tablet in Healthy Adults.
Buchanan, AM; Casillas, L; Joshi, S; Shaik, JSB; Shreeves, T; Singh, RP; Skoura, N, 2018
)
0.88
"Following administration of dispersible abacavir/dolutegravir/lamivudine, the relative bioavailability of dolutegravir was approximately 50% higher."( Effects of Low- and High-Mineral Content Water on the Relative Bioavailability of a Coformulated Abacavir/Dolutegravir/Lamivudine Dispersible Tablet in Healthy Adults.
Buchanan, AM; Casillas, L; Joshi, S; Shaik, JSB; Shreeves, T; Singh, RP; Skoura, N, 2018
)
0.93
" RG7834, a compound from the dihydroquinolizinone (DHQ) chemical series, is a first-in-class highly selective and orally bioavailable HBV inhibitor which can reduce both viral antigens and viral DNA with a novel mechanism of action."( Discovery of RG7834: The First-in-Class Selective and Orally Available Small Molecule Hepatitis B Virus Expression Inhibitor with Novel Mechanism of Action.
Cheng, Z; Han, X; Javanbakht, H; Jiang, M; Liang, C; Liu, Y; Luangsay, S; Lv, W; Mayweg, AV; Shen, HC; Wang, J; Wang, M; Wang, Y; Wang, Z; Weikert, R; Xie, J; Yang, S; Yu, X; Zhou, C; Zhou, X, 2018
)
0.48
" Abacavir PK was described by a 2-compartment model, patients randomized to early ART showed increased bioavailability of 31%."( Population pharmacokinetics of abacavir and lamivudine in severely malnourished human immunodeficiency virus-infected children in relation to treatment outcomes.
Archary, M; Bobat, R; Hennig, S; LaRussa, P; Mcllleron, H; Sibaya, T; Wiesner, L, 2019
)
0.78
"Increases in Abacavir's CL/F between day 1 to day 14, bioavailability and PK variability with early start of ART was found in this cohort of severely malnourished children; however, these changes did not influence virological outcomes."( Population pharmacokinetics of abacavir and lamivudine in severely malnourished human immunodeficiency virus-infected children in relation to treatment outcomes.
Archary, M; Bobat, R; Hennig, S; LaRussa, P; Mcllleron, H; Sibaya, T; Wiesner, L, 2019
)
0.78
" This article outlines the chronology of dolutegravir pediatric formulation development as granules and conventional and dispersible tablets in a total of 5 pharmacokinetic studies evaluating the relative bioavailability of dolutegravir SE and FDC formulations in healthy adults."( Development of Dolutegravir Single-entity and Fixed-dose Combination Formulations for Children.
Adkison, KK; Baker, M; Brothers, C; Buchanan, AM; Davies, M; Parasrampuria, R; Sewell, N; Singh, RP; Wolstenholme, A, 2022
)
0.72
"The relative bioavailability studies were 2-part, Phase I, open-label, randomized studies in healthy adults."( Development of Dolutegravir Single-entity and Fixed-dose Combination Formulations for Children.
Adkison, KK; Baker, M; Brothers, C; Buchanan, AM; Davies, M; Parasrampuria, R; Sewell, N; Singh, RP; Wolstenholme, A, 2022
)
0.72
"As observed in previous studies, dolutegravir administered as dispersion (granules/dispersible tablets) showed relatively higher bioavailability compared with conventional tablets."( Development of Dolutegravir Single-entity and Fixed-dose Combination Formulations for Children.
Adkison, KK; Baker, M; Brothers, C; Buchanan, AM; Davies, M; Parasrampuria, R; Sewell, N; Singh, RP; Wolstenholme, A, 2022
)
0.72
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51

Dosage Studied

The entecavir dose-response curve of lamivudine-resistant HBV RT mutants rtM204 for the replication of HBV decreased less than expected with increasing drug dose. Stavudine and lamivUDine are administered as fixed combination while nevirapine as separate dosage form which often results in poor compliance and adherence to therapy.

ExcerptRelevanceReference
" Four patients were dosed at each of five dose levels (0."( The safety and pharmacokinetics of a reverse transcriptase inhibitor, 3TC, in patients with HIV infection: a phase I study.
Danner, SA; Donn, KH; Hall, ST; Harker, AJ; Hussey, EK; Jonker, P; Lange, JM; van Leeuwen, R, 1992
)
0.28
" The concentration-time profile and the average serum concentration at steady state after various dosage regimens were estimated as a basis for initial dose selection for clinical trials."( Interspecies scaling and pharmacokinetic parameters of 3TC in humans.
Daniel, MJ; Donn, KH; Evans, GL; Hall, ST; Harker, AJ; Hussey, EK, 1994
)
0.29
" There was no consistent dose-response correlation for any surrogate marker."( Evaluation of safety and efficacy of 3TC (lamivudine) in patients with asymptomatic or mildly symptomatic human immunodeficiency virus infection: a phase I/II study.
Boucher, CA; Hill, A; Ingrand, D; Katlama, C; Kitchen, V; McBride, M; McDade, H; Tubiana, R; van Leeuwen, R; Weber, J, 1995
)
0.56
"To determine the effect of multiple dosing of combined sulfamethoxazole and trimethoprim on the single-dose pharmacokinetics of lamivudine."( Pharmacokinetics of lamivudine administered alone and with trimethoprim-sulfamethoxazole.
Eron, JJ; Hussey, EK; Martin, D; Moore, KH; Mydlow, PK; Raasch, RH; Yuen, GJ, 1996
)
0.82
"Coadministration of a single dose of lamivudine and trimethoprim-sulfamethoxazole after daily dosing for 5 days altered the pharmacokinetics of lamivudine."( Pharmacokinetics of lamivudine administered alone and with trimethoprim-sulfamethoxazole.
Eron, JJ; Hussey, EK; Martin, D; Moore, KH; Mydlow, PK; Raasch, RH; Yuen, GJ, 1996
)
0.89
" Dosage adjustment, by either dose reduction or lengthening of the dosing interval, is warranted."( Pharmacokinetics of lamivudine in human immunodeficiency virus-infected patients with renal dysfunction.
Bartlett, JA; Heald, AE; Hsyu, PH; Mydlow, P; Robinson, P; Yuen, GJ, 1996
)
0.62
"To compare antiretroviral efficacy, safety and tolerance of three dosing regimens of the novel nucleoside reverse transcriptase inhibitor, abacavir (1592U89) over 24 weeks and its efficacy in open-label combination with zidovudine and lamivudine."( A dose-ranging study to evaluate the safety and efficacy of abacavir alone or in combination with zidovudine and lamivudine in antiretroviral treatment-naive subjects.
Cutrell, A; Harrer, T; Harrigan, RP; Katlama, C; Lanier, RE; Massip, P; Pearce, G; Staszewski, S; Steel, H; Tortell, SM; Yeni, P, 1998
)
0.69
" Serum lamivudine concentrations were maintained above 1 microM for >/=8 h of 24 h on the twice daily oral dosing schedule with doses of >/=2 mg/kg."( Serum and cerebrospinal fluid pharmacokinetics of intravenous and oral lamivudine in human immunodeficiency virus-infected children.
Balis, FM; Church, JA; Farley, M; Goldsmith, JC; Keller, A; Lewis, LL; Mueller, BU; Pizzo, PA; Rubin, M; Venzon, DJ; Yuen, GJ, 1998
)
0.99
" HAART was started at an initial dosage of 600 mg zidovudine (AZT), 300 mg lamivudine (3TC), and 2400 mg indinavir (IDV) daily."( Highly active antiretroviral therapy used to treat concurrent hepatitis B and human immunodeficiency virus infections.
Hosaka, H; Kubo, S; Nagai, K; Nakamura, N; Nonaka, H; Shinohara, M, 1999
)
0.53
" The variations in intracellular lamivudine-TP concentrations following these two lamivudine dosage regimens are unlikely to result in differences in clinical effect."( The pharmacokinetics of lamivudine phosphorylation in peripheral blood mononuclear cells from patients infected with HIV-1.
Back, D; Barrett, JE; Barry, MG; Churchus, R; Kapoor, A; Lloyd, J; Moore, KH; Pakes, GE; Shaw, S, 1999
)
0.89
" However, as only three patients had an estimated creatinine clearance of <60 ml/min, dosage adjustments for patients with impaired renal function should not be determined based on the population parameters derived in this analysis."( Population pharmacokinetics of lamivudine in adult human immunodeficiency virus-infected patients enrolled in two phase III clinical trials.
Bartlett, JA; Eron, JJ; Hussey, EK; Moore, KH; Pakes, GE; Yuen, GJ, 1999
)
0.59
" All medications were dosed twice daily."( A phase II safety and efficacy study of amprenavir in combination with zidovudine and lamivudine in HIV-infected patients with limited antiretroviral experience. Amprenavir PROAB2002 Study Team.
Antunes, F; Brown, DJ; Clumeck, N; Fetter, A; Haubrich, R; Kahl, L; Lang, W; Pagano, G; Richman, D; Schooley, R; Sereni, D; Stein, A; Thompson, M; van der Ende, ME, 1999
)
0.53
"Treatment with APV, dosed at 1200 mg twice daily in combination with 3TC/ZDV, resulted in sustained viral suppression."( A phase II safety and efficacy study of amprenavir in combination with zidovudine and lamivudine in HIV-infected patients with limited antiretroviral experience. Amprenavir PROAB2002 Study Team.
Antunes, F; Brown, DJ; Clumeck, N; Fetter, A; Haubrich, R; Kahl, L; Lang, W; Pagano, G; Richman, D; Schooley, R; Sereni, D; Stein, A; Thompson, M; van der Ende, ME, 1999
)
0.53
" Although protease inhibitor (PI) containing therapies are very potent, many problems have now been identified that reduce quality of life such as a high pill burden, multiple daily dosing and dietary constraints."( Review of NNRTIs: 'today and tomorrow'.
Katlama, C, 1999
)
0.3
"The indinavir dosage regimen currently used for human immunodeficiency virus (HIV)-infected children is not based on pharmacokinetic data obtained in the target patient population."( Indinavir pharmacokinetics and parmacodynamics in children with human immunodeficiency virus infection.
Bassetti, D; Bassetti, M; Gatti, G; Principi, N; Sala, N; Vella, S; Vigano', A, 2000
)
0.31
" The other combination treatment regimen used a staggered dosing schedule of 12 weeks of administration of lamivudine alone, followed by 12 weeks of simultaneous dosing with both drugs, followed by 12 weeks of therapy with rHu alpha B/D IFN alone."( Enhanced antiviral benefit of combination therapy with lamivudine and alpha interferon against WHV replication in chronic carrier woodchucks.
Cote, P; Gangemi, JD; Gerin, JL; Hornbuckle, W; Korba, BE; Schinazi, R; Tennant, BC, 2000
)
0.77
"Three-times-daily indinavir appears more efficacious than two-times-daily dosing when administered with zidovudine and lamivudine."( Comparative studies of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine.
Arathoon, E; Benetucci, L; Cahn, P; Chodakewitz, J; Chung, MO; Collier, AC; Currier, J; de Jesus Pedro, R; Gallant, JE; Haas, DW; Harvey, C; Lewi, DS; Mehrotra, D; Nguyen, BY; Noriega, LM; Paar, D; Ramirez-Ronda, CH; Thompson, MA; Uip, DE; Uribe, P; White, AC, 2000
)
0.73
"NVP reaches concentrations in the semen approximately 60% of those in the blood plasma throughout the 12 h dosing period."( Concentrations of nevirapine, lamivudine and stavudine in semen of HIV-1-infected men.
Drake, SM; Hoetelmans, RM; Pillay, D; Taylor, S; van Heeswijk, RP; White, DJ; Workman, J, 2000
)
0.6
" PEP included zidovudine (150 HCW, group B), zidovudine plus lamivudine (48 HCW, group C), or zidovudine, lamivudine, and indinavir (85 HCW, group D), at standard dosage for a mean of 30, 27, and 27 days of treatment, respectively."( Brief report: effect of antiretroviral agents on T-lymphocyte subset counts in healthy HIV-negative individuals. The Italian Registry on Antiretroviral Postexposure Prophylaxis.
Ippolito, G; Puro, V, 2000
)
0.55
" At 4-week intervals, plasma levels were measured and dosage of IND/RIT switched to 1000/100 mg daily and then 800/200 mg daily."( Dose-finding study of once-daily indinavir/ritonavir plus zidovudine and lamivudine in HIV-infected patients.
Arnaiz, JA; Blanco, JL; Carné, X; Codina, C; Cruceta, A; García-Viejo, MA; Gatell, JM; Giner, V; Mallolas, J; Martínez, E; Pumarola, T; Sarasa, M; Soriano, A; Soy, D; Tuset, M, 2000
)
0.54
" Prospective studies of lamivudine pharmacokinetics and dosing in renal failure are needed to be able to treat patients appropriately."( An open-label study of lamivudine for chronic hepatitis B in six patients with chronic renal failure before and after kidney transplantation.
Ben-Ari, Z; Broida, E; Chagnac, A; Kittai, Y; Tur-Kaspa, R, 2000
)
0.92
" Clinicians should use recommended PEP guidelines and dosing instructions to reduce the risk for serious adverse events."( Serious adverse events attributed to nevirapine regimens for postexposure prophylaxis after HIV exposures--worldwide, 1997-2000.
, 2001
)
0.31
"Mycophenolate mofetil at the dosage used is not effective in suppressing HBV replication after liver transplantation."( The addition of mycophenolate mofetil for suppressing hepatitis B virus replication in liver recipients who developed lamivudine resistance--no beneficial effect.
Ben-Ari, Z; Tur-Kaspa, R; Zemel, R, 2001
)
0.52
" These results indicate that beta-L-Fd4C exhibits a more potent antiviral effect than lamivudine in the WHV model but was not able to eradicate CCC DNA and infected cells from the liver at the dosage and with the protocol used."( Antiviral activity of beta-L-2',3'-dideoxy-2',3'-didehydro-5-fluorocytidine in woodchucks chronically infected with woodchuck hepatitis virus.
Cheng, YC; Chevallier, M; Guerret, S; Hantz, O; Jamard, C; King, I; Le Guerhier, F; Peyrol, S; Pichoud, C; Trépo, C; Zoulim, F, 2001
)
0.53
"Steady-state pharmacokinetics of ABC, 3TC, and ZDV were assessed after dosing with ABC-COM and the triple combination tablet."( A comparison of the steady-state pharmacokinetics and safety of abacavir, lamivudine, and zidovudine taken as a triple combination tablet and as abacavir plus a lamivudine-zidovudine double combination tablet by HIV-1-infected adults.
Crémieux, AC; Demarles, D; Gillotin, C; Katlama, C; Raffi, F; Yuen, GJ, 2001
)
0.54
" Findings from studies for each drug in such areas as the drug's purpose, dosage level, effectiveness, and side effects are examined."( What we know about anti-HIV drugs.
, 1995
)
0.29
" Each drug trial demonstrates the relationship between dosing and resistance; patients are advised to adhere completely to dosing instructions."( Protease inhibitors and prevention of cross resistance.
Levin, J, 1995
)
0.29
" Invirase is also expensive, particularly at the higher dosage levels."( FDA approves 3TC and saquinavir. Food and Drug Administration.
Baker, R, 1995
)
0.29
" A recommended dosage schedule for ddI and d4T combined with indinavir is provided."( ddI and d4T plus protease inhibitors.
, 1996
)
0.29
" Combining d4T/ddI with protease inhibitors presents problems, such as a complicated dosing schedule and harsh gastrointestinal side effects."( Dethroning AZT.
Falkenberg, J; Gilden, D; Torres, G, 1997
)
0.3
" Food restrictions, drug interactions, dosing requirements, and side effects may make a particular regimen less desirable."( Reevaluating initial therapy.
Cadman, J, 1998
)
0.3
"Two studies examined the effectiveness of reducing the dosage of anti-HIV medications for patients who have achieved a viral load under 200 copies of HIV RNA."( Lower dose maintenance therapy?
, 1998
)
0.3
" This case involves a 38-year-old, HIV-positive male who, in response to numbness in his left foot, reduced his dosage of d4T by half, without consulting his physician."( Too little of a good thing.
Friedland, GH; Gulick, RM, 1998
)
0.3
"Efavirenz (Sustiva) is the first once-daily dosing anti-HIV drug approved by the Food and Drug Administration."( First once-daily drug simplifies dosing, offers new options in HIV-1 treatment.
, 1998
)
0.3
" Information on each drug, such as the name of the drug, the dosage normally prescribed, and cost of treatment is listed."( What they say about: nucleoside drugs.
,
)
0.13
" Indinavir and ritonavir plasma concentrations remained above respective inhibitory and effective concentrations (IC95 and EC50) (uncorrected for protein binding) throughout the 24-hour dosing interval for 6 of 10 and 8 of 10 subjects, respectively."( A pilot trial of indinavir, ritonavir, didanosine, and lamivudine in a once-daily four-drug regimen for HIV infection.
Holodniy, M; Mole, L; Schmidgall, D, 2001
)
0.56
"Our pilot study demonstrates excellent virologic suppression despite low minimum protease inhibitor concentrations during a dosing interval in some patients and is supportive of further study."( A pilot trial of indinavir, ritonavir, didanosine, and lamivudine in a once-daily four-drug regimen for HIV infection.
Holodniy, M; Mole, L; Schmidgall, D, 2001
)
0.56
" The area under the curve over the dosing interval (AUCtau)on day 14 increased less than proportionally to dose, suggesting there was increased clearance and/or decreased absorption."( GW420867X administered to HIV-1-infected patients alone and in combination with lamivudine and zidovudine.
Arasteh, K; Burt, V; Cass, L; Dallow, N; Jones, A; Kleim, JP; Klein, A; Moore, KH; Müller, M; Prince, W; Wood, R,
)
0.36
"7h; average concentration over the dosage interval (Cav) 711+/-269 microg/L; and area under the concentration-time curve (AUC) over 2 dosage intervals (24h) 17085+/-6464 microg x h/L."( Comparison of the plasma pharmacokinetics of lamivudine during twice and once daily administration in patients with HIV.
Bruno, R; Ciappina, V; Filice, G; Montagna, M; Panebianco, R; Regazzi, MB; Sacchi, P; Villani, P, 2001
)
0.57
"When the combination of large dosage interferon-alpha 2b and lamivudine therapy in children was compared at the end of therapy and 6 months after therapy, normalization of alanine aminotransferase and the clearances of hepatitis B e antigen and hepatitis B surface antigen in both groups were directly proportional to the duration of treatment."( Lamivudine and interferon-alpha combination treatment of childhood patients with chronic hepatitis B infection.
Bosnak, M; Dagli, A; Dikici, B; Dogru, O; Gürkan, F; Haspolat, K; Kara, IH, 2001
)
1.99
" According to principles of anti-viral therapy today, simultaneously dosing of both drugs is to be preferred, since rapid maximal virus suppression is thought to be essential to prevent drug resistance and enhance seroconversion."( Is combination therapy with lamivudine and interferon-alpha superior to monotherapy with either drug?
de Man, RA; Janssen, HL; Niesters, HG; Schalm, SW; van Nunen, AB; Wolters, LM, 2001
)
0.6
" Despite ongoing progress, challenges remain for the next millennium, including the determination of cost-effective dosing strategies, treatment of HBV infection in liver transplant recipients, and ramifications of the use of new antiviral agents, specifically, the appearance of resistant strains."( A concise update on the status of liver transplantation for hepatitis B virus: the challenges in 2002.
Dodson, FS; Rakela, J; Vargas, HE, 2002
)
0.31
" More conveniently dosed and patient-friendly regimens are needed."( Virological and immunological responses to a once-a-day antiretroviral regimen with didanosine, lamivudine and efavirenz.
Maggiolo, F; Maserati, R; Migliorino, M; Pan, A; Provettoni, G; Rizzi, L; Rizzi, M; Suter, F, 2001
)
0.53
" Pregnant monkeys were dosed with either no drug (n = 2), 40."( Transplacental genotoxicity of combined antiretroviral nucleoside analogue therapy in Erythrocebus patas monkeys.
Antiochos, BB; Fernandez, JJ; Olivero, OA; Poirier, MC; St Claire, ME; Wagner, JL, 2002
)
0.31
"The complexity of highly active antiretroviral therapy (HAART), with multiple medications, formulations, and dosing intervals, makes adherence challenging."( Reported adherence as a determinant of response to highly active antiretroviral therapy in children who have human immunodeficiency virus infection.
Johnson, GM; Krogstad, PA; Lee, S; Mohan, K; Morse, EV; Nachman, S; Stanley, K; Van Dyke, RB; Wiznia, A, 2002
)
0.31
" Between June, 1996, and January, 2000, HIV-1-infected mothers were randomised to one of four regimens: A, zidovudine plus lamivudine starting at 36 weeks' gestation, followed by oral intrapartum dosing and by 7 days' postpartum dosing of mothers and infants; B, as regimen A, but without the prepartum component; C, intrapartum zidovudine and lamivudine only; or placebo."( Efficacy of three short-course regimens of zidovudine and lamivudine in preventing early and late transmission of HIV-1 from mother to child in Tanzania, South Africa, and Uganda (Petra study): a randomised, double-blind, placebo-controlled trial.
, 2002
)
0.77
" This formulation allows a dosing schedule of one pill twice-daily."( Trizivir.
Keiser, P; Nassar, N, 2002
)
0.31
" Lamivudine dose-ranging studies showed a higher clearance in children, and the optimal dosage was established to be 3 mg/kg once daily in children up to 12 years of age."( Drug treatment of pediatric chronic hepatitis B.
Sokal, E, 2002
)
1.22
" APV SP concentrations were consistently lower than BP concentrations, ZDV SP concentrations approximated BP concentrations early but became greater later in the dosing interval, and 3TC SP concentrations were substantially greater than BP concentrations throughout."( The pharmacokinetics of amprenavir, zidovudine, and lamivudine in the genital tracts of men infected with human immunodeficiency virus type 1 (AIDS clinical trials group study 850).
Acosta, EP; Eron, JJ; Fiscus, SA; Gerber, JG; Gulick, RM; Murphy, RL; Pereira, AS; Smeaton, LM; Snyder, S; Tidwell, RR, 2002
)
0.57
" In group 2, there were 13 patients who only received the same dosage of alpha-interferon and no lamivudine over the same period of time."( Comparison of treatments of chronic hepatitis B in children with lamivudine and alpha-interferon combination and alpha-interferon alone.
Bosnak, M; Bosnak, V; Dagli, A; Davutoglu, M; Dikici, B; Haspolat, K; Yagci, RV, 2002
)
0.77
" Oral lamivudine is generally well tolerated by children and adolescents with chronic hepatitis B, with a similar tolerability profile to placebo at the recommended once daily dosage of 3 mg/kg up to a maximum of 100 mg/day."( Lamivudine: in children and adolescents with chronic hepatitis B virus infection.
Keam, SJ; Scott, LJ, 2002
)
2.24
" Ganciclovir was administered at a dosage of 3 g daily for 6 months."( Oral ganciclovir for treatment of lamivudine-resistant hepatitis B virus infection: a pilot study.
Bozdayi, AM; Bozkaya, H; Erkan, O; Karayalcin, S; Uzunalimoglu, O; Yurdaydin, C, 2002
)
0.59
" Based on these findings this pharmacodynamic model can be applied to predict starting doses for a new agent based on simulated biological responses as a function of time for dosage regimens comprising one or two agents."( Development of a pharmacodynamic model for HIV treatment with nucleoside reverse transcriptase and protease inhibitors.
Hurwitz, SJ; Schinazi, RF, 2002
)
0.31
" The second episode ended when lamivudine dosage was reduced."( Rheumatoid arthritis after 9 years of human immunodeficiency virus infection: possible contribution of tritherapy.
Livrozet, JM; Miossec, P; Touraine, JL; Wegrzyn, J, 2002
)
0.6
" A clear dose-response relationship was observed for entecavir with the higher doses showing significantly greater viral suppression."( Entecavir is superior to lamivudine in reducing hepatitis B virus DNA in patients with chronic hepatitis B infection.
Anderson, FH; Dehertogh, D; Lai, CL; Lao, J; Rosmawati, M; Thomas, N; Van Vlierberghe, H, 2002
)
0.62
" Hepatitis B immune globulin (HBIG) and lamivudine, either alone or in combination, are effective in preventing reinfection, but the most cost-effective dosing regimen with optimum efficacy without the prohibitive cost remains to be determined, an issue that is particularly relevant to liver transplant centers with serious financial constraints in Asia."( Prophylaxis and treatment of recurrent hepatitis B after liver transplantation.
Fan, ST; Lai, CL; Liu, CL; Lo, CM; Wong, J, 2003
)
0.59
" Preemptive post-transplant lamivudine monotherapy is associated with progressively increasing HBV recurrence rates, but combined therapy with lamivudine and HBIG at relatively low dosage is currently the most effective approach in this setting, even in HBV-DNA-positive patients, who also receive lamivudine in the pretransplant period."( Prevention of and treatment for hepatitis B virus infection after liver transplantation in the nucleoside analogues era.
Burroughs, AK; Papatheodoridis, GV; Sevastianos, V, 2003
)
0.61
" HBIG monotherapy given at a high dosage and indefinitely can prevent recurrence in 65% to 80% of patients."( Hepatitis B immune globulin preparations and use in liver transplantation.
Terrault, NA; Vyas, G, 2003
)
0.32
" The treatment for recurrent hepatitis B after liver transplantation includes increased dosage of lamivudine, application of famciclovir, and other liver protection measures."( Prophylaxis and treatment of hepatitis B virus reinfection following liver transplantation.
Huang, DS; Liang, TB; Wang, WL; Wu, J; Xu, X; Zheng, SS, 2002
)
0.53
") and oral dosing with either 400 mg/kg AZT or 200 mg/kg 3TC, pharmacokinetics were determined for AZT, AZT-5'-glucuronide, 3'-amino-3'-deoxythymidine (AMT), AZT-5'-phosphate, 3TC, and 3TC-5'-phosphate in serum of adult female mice."( Liquid chromatographic-mass spectrometric determination of the metabolism and disposition of the anti-retroviral nucleoside analogs zidovudine and lamivudine in C57BL/6N and B6C3F1 mice.
Beland, FA; Doerge, DR; Von Tungeln, LS; Williams, LD, 2003
)
0.52
" Our data suggest that the frequency of chemotherapy-related HBV reactivation may be significantly decreased by lamivudine prophylaxis with maintenance of the dosage of adriamycin."( The prophylactic use of lamivudine can maintain dose-intensity of adriamycin in hepatitis-B surface antigen (HBs Ag)-positive patients with Non-Hodgkin's lymphoma who receive cytotoxic chemotherapy.
Kang, YK; Kim, E; Kim, SB; Kim, SW; Kim, WK; Lee, GW; Lee, JH; Lee, JL; Lee, JS; Lee, KH; Oh, S; Ryu, MH; Suh, C, 2003
)
0.84
" Compared with amprenavir 1,200 mg BID, both GW433908 1,395 mg BID and GW433908 1,860 mg BID delivered equivalent steady-state (ss) values for area under the plasma amprenavir concentration-time curve (AUC) at the end of a dosing interval (tau), lower maximum plasma amprenavir concentrations (30% lower), and higher plasma amprenavir concentrations at the end of a dosing interval (28% higher for GW433908 1,395 mg BID and 46% higher for GW433908 1,860 mg BID)."( Six-week randomized controlled trial to compare the tolerabilities, pharmacokinetics, and antiviral activities of GW433908 and amprenavir in human immunodeficiency virus type 1-infected patients.
Arasteh, K; Eron, J; Millard, J; Naderer, OJ; Pollard, RB; Raffi, F; Stellbrink, HJ; Teofilo, E; Wire, MB; Wood, R; Yeo, J, 2004
)
0.32
" GW433908 was generally well tolerated and provides a convenient dosing option without food or fluid restrictions."( The NEAT study: a 48-week open-label study to compare the antiviral efficacy and safety of GW433908 versus nelfinavir in antiretroviral therapy-naive HIV-1-infected patients.
Boghossian, J; Gray, GE; Millard, JM; Nadler, JP; Quinones, AR; Rodriguez-French, A; Sepulveda, GE; Wannamaker, PG, 2004
)
0.32
"Our study shows that ADV dosed at 10 mg/day for the treatment of LAM-resistant chronic hepatitis B in patients co-infected with HIV is not associated with renal tubular dysfunction or a significant change in renal function."( The renal tolerance of low-dose adefovir dipivoxil by lamivudine-resistant individuals co-infected with hepatitis B and HIV.
Bagnis, CI; Beaufils, H; Benhamou, Y; Brosgart, C; Deray, G; Hannon, H; Izzedine, H; Poynard, T; Sullivan, M, 2004
)
0.57
" Overall, the data indicate that significant mitochondrial damage was observed at birth in monkey fetuses exposed in utero to AZT plus 3TC in a human-equivalent dosing protocol."( Mitochondrial toxicity in fetal Erythrocebus patas monkeys exposed transplacentally to zidovudine plus lamivudine.
Albert, PS; Ceresa, A; Divi, RL; Ewings, EL; Gerschenson, M; Harbaugh, JW; Harbaugh, SW; Nagashima, K; Nguyen, V; Olivero, OA; Poirier, MC; Shaw, JA; St Claire, MC, 2004
)
0.54
" After 48 weeks, LPV/r was dosed open-label at 400/100 mg every 12 hours with stavudine and lamivudine."( Long-term safety and durable antiretroviral activity of lopinavir/ritonavir in treatment-naive patients: 4 year follow-up study.
Benson, C; Brun, SC; Eron, JJ; Gulick, RM; Hicks, C; Kessler, HA; King, KR; King, MS; Murphy, RL; White, AC, 2004
)
0.54
" Dosing schedule comprised (co-formulated) zidovudine, lamivudine, and abacavir bid."( Simplified therapy with zidovudine, lamivudine, and abacavir for very nonadherent, treatment-failing patients.
Carmona, A; Colomés, JL; Gimeno, JL; Gonzalez, A; Guelar, A; Knobel, H; Pedrol, E; Saballs, P; Soler, A; Vallecillo, G,
)
0.65
"To compare dosing convenience and adherence with abacavir (ABC) 300 mg plus a fixed-dose lamivudine 150 mg/zidovudine 300 mg combination tablet (COM) twice daily versus indinavir (IDV) plus COM twice daily in treatment-naïve, HIV-1-infected adults; and to evaluate the association among difficulty taking antiretroviral regimens, adherence, and virologic efficacy."( Predictors of adherence and virologic outcome in HIV-infected patients treated with abacavir- or indinavir-based triple combination HAART also containing lamivudine/zidovudine.
Cahn, P; Carosi, G; Jordan, JC; Pharo, CE; Schechter, M; Smaill, F; Soto-Ramirez, L; Steel, HM; Thomas, NE; Vibhagool, A, 2004
)
0.74
" a maximum of 40% of cases with long-lasting therapeutic response to interferon), while the second is the presence of various side effects, which can force the reducing of dosage or even the discontinuation of treatment."( The treatment of chronic hepatitis B.
Voiosu, R,
)
0.13
"Once daily (QD) dosing facilitates regimen simplification and adherence to antiretroviral therapy."( A randomized study of emtricitabine and lamivudine in stably suppressed patients with HIV.
Benson, CA; Haas, DW; Lamarca, A; McDonald, CK; Mondou, E; Quinn, JB; Rousseau, F; Rublein, J; Steinhart, CR; van der Horst, C, 2004
)
0.59
" ABC administered once daily in combination with 3TC and EFV administered once daily was non-inferior to the ABC twice-daily dosing schedule when combined with 3TC and EFV over 48 weeks."( Abacavir once or twice daily combined with once-daily lamivudine and efavirenz for the treatment of antiretroviral-naive HIV-infected adults: results of the Ziagen Once Daily in Antiretroviral Combination Study.
Cahn, P; Castillo, SA; Craig, C; DeJesus, E; Gordon, DN; Moyle, GJ; Scott, TR; Zhao, H, 2005
)
0.58
" Before studying HAART in infected SCID mice, nonmanipulated SCID mice were treated with a single injection of the HAART cocktail (consisting of zidovudine, lamivudine, and indinavir) to determine optimum dosage and sampling time and to measure antiretroviral levels in the brain."( Highly active antiretroviral therapy and human immunodeficiency virus encephalitis.
Cook, JE; Dasgupta, S; Gorry, PR; Middaugh, LD; Terry, EC; Tyor, WR; Wesselingh, SL, 2005
)
0.53
" Intensive plasma PK sampling was performed at steady state, after which children switched to q24h dosing and PK sampling was repeated 4 weeks later."( Plasma pharmacokinetics of once- versus twice-daily lamivudine and abacavir: simplification of combination treatment in HIV-1-infected children (PENTA-13).
Bergshoeff, A; Burger, D; Farrelly, L; Flynn, J; Gibb, D; Khoo, S; Le Prevost, M; Lyall, H; Novelli, V; Verweij, C; Walker, S, 2005
)
0.58
"AUC0-24 and Cmax of both 3TC and ABC q24h were not inferior to q12h dosing in children."( Plasma pharmacokinetics of once- versus twice-daily lamivudine and abacavir: simplification of combination treatment in HIV-1-infected children (PENTA-13).
Bergshoeff, A; Burger, D; Farrelly, L; Flynn, J; Gibb, D; Khoo, S; Le Prevost, M; Lyall, H; Novelli, V; Verweij, C; Walker, S, 2005
)
0.58
" The Phase I clinical study demonstrated that end-of-treatment virological response rates were better for telbivudine recipients at multiple dosing levels as compared with placebo patients."( Telbivudine: a new nucleoside analogue for the treatment of chronic hepatitis B.
Han, SH, 2005
)
0.33
" At the same time, eighteen C57BL/6J female mice (clean level) were randomly allocated into control groups 1, 2 and 3 (each group of six), which were given lamivudine, IFN-alpha and saline respectively (the dosage was the same as that of experimental groups)."( [Study on efficacy and safety of lamivudine and interferon-alpha in treatment of hepatitis B virus transgenic mice with pregnancy].
Lei, XY; Li, D; Men, K; Xu, DZ; Yan, YP; Zhang, JX, 2005
)
0.81
" Recovery of both the drugs in tablet dosage form and spiked drugs in plasma were > or =99."( Simultaneous determination of HIV-protease inhibitors lamivudine and zidovudine in pharmaceutical formulations by micellar electrokinetic chromatography.
Azhaguvel, S; Sekar, R, 2005
)
0.58
"Both the animal and cell model showed that the large and the small dosage Lamivudine have no significant inhibitory effect on the LRDHBV."( Mutations outside the YMDD motif in the P protein can also cause DHBV resistant to Lamivudine.
Chen, HS; Feng, LL; Guo, XB; He, JY; Yang, RY; Zhang, FX; Zhu, YT, 2005
)
0.78
"Few data are available regarding clinical outcomes or dosing requirements for the protease inhibitor ritonavir in human immunodeficiency virus (HIV)-infected children younger than under 24 months of age."( Ritonavir-based highly active antiretroviral therapy in human immunodeficiency virus type 1-infected infants younger than 24 months of age.
Abrams, EJ; Borkowsky, W; Britto, P; Chadwick, EG; Flynn, PM; Hughes, M; Luzuriaga, K; Palumbo, P; Powell, C; Rodman, JH; Yogev, R, 2005
)
0.33
" Two sequential dosing cohorts were treated with 350 or 450 mg/m(2) ritonavir every 12 hours; this report includes results of pharmacokinetics, safety, tolerability and efficacy through 104 weeks of follow-up of all subjects."( Ritonavir-based highly active antiretroviral therapy in human immunodeficiency virus type 1-infected infants younger than 24 months of age.
Abrams, EJ; Borkowsky, W; Britto, P; Chadwick, EG; Flynn, PM; Hughes, M; Luzuriaga, K; Palumbo, P; Powell, C; Rodman, JH; Yogev, R, 2005
)
0.33
" Daily drug dosage was 250 or 400 mg didanosine, 300mg lamivudine and 400 mg nevirapine."( Efficacy and safety of once-daily combination therapy with didanosine, lamivudine and nevirapine in antiretroviral-naive HIV-infected patients.
Blanco, JL; Crespo, M; Deig, E; Falcó, V; González, A; Miró, JM; Ocaña, I; Pahissa, A; Pedrol, E; Ribera, E; Rodríguez-Pardo, D; Rubio, M; Soler, A, 2005
)
0.81
"Adherence to a fixed dose combination of dual nucleoside antiretroviral therapy was compared between human immunodeficiency virus (HIV)-infected patients newly started on a fixed dosed combination of lamivudine (3TC) 150 mg/zidovudine (ZDV) 300 mg versus its components taken as separate pills."( Adherence to combined Lamivudine + Zidovudine versus individual components: a community-based retrospective medicaid claims analysis.
Chernicoff, H; Gilmore, A; Jordan, J; Legorreta, A; Rosenzweig, JC; Yu, A, 2005
)
0.83
"To study the efficacy of the protocol of combination of lamivudine with low dosage hepatitis B immuno-globulin (HBIG) to prevent HBV reinfection and of the treatment for HBV reinfection after liver transplantation."( [Prevention and treatment of hepatitis B virus reinfection after liver transplantation].
Gao, DC; Jia, JD; Liu, J; Sun, MC; Wang, BE; Wang, Y; Wu, GC; Wu, P; Zhang, D; Zhang, ZT, 2005
)
0.57
" All patients received the protocol of combination of lamivudine with low dosage HBIG to prevent HBV reinfection after liver transplantation."( [Prevention and treatment of hepatitis B virus reinfection after liver transplantation].
Gao, DC; Jia, JD; Liu, J; Sun, MC; Wang, BE; Wang, Y; Wu, GC; Wu, P; Zhang, D; Zhang, ZT, 2005
)
0.58
" Through using adefovir and adding the dosage of HBIG, the hepatitis B is in control."( [Prevention and treatment of hepatitis B virus reinfection after liver transplantation].
Gao, DC; Jia, JD; Liu, J; Sun, MC; Wang, BE; Wang, Y; Wu, GC; Wu, P; Zhang, D; Zhang, ZT, 2005
)
0.33
"The protocol of combination of lamivudine with low dosage HBIG proved to be highly effective and safe in preventing the recurrence of HBV after liver transplantation."( [Prevention and treatment of hepatitis B virus reinfection after liver transplantation].
Gao, DC; Jia, JD; Liu, J; Sun, MC; Wang, BE; Wang, Y; Wu, GC; Wu, P; Zhang, D; Zhang, ZT, 2005
)
0.61
"Antiretroviral combinations that reduce the number of pills and dosing frequency have the potential to simplify therapy."( Early virologic nonresponse to tenofovir, abacavir, and lamivudine in HIV-infected antiretroviral-naive subjects.
Berger, DS; Gallant, JE; Johnson, J; Liao, Q; Lim, ML; Rodriguez, AE; Ross, L; Shaefer, MS; Weinberg, WG; Young, B, 2005
)
0.57
"To improve the dosing frequency and pill burden of antiretroviral therapy, we compared two once-daily dosed regimens to a twice-daily dosed regimen."( Comparison of two once-daily regimens with a regimen consisting of nelfinavir, didanosine, and stavudine in antiretroviral therapy-naïve adults: 48-week results from the Antiretroviral Regimen Evaluation Study (ARES).
Borleffs, JC; Hassink, EA; Juttmann, JR; Koopmans, PP; Lange, JM; Lowe, SH; Richter, C; Schreij, G; ten Kate, RW; van der Tweel, I; Wensing, AM,
)
0.13
"HIV-1-infected, antiretroviral drug-naïve adults were randomized to either twice-daily nelfinavir and stavudine and once-daily didanosine (regimen A) or simplified once-daily dosed antiretroviral regimens consisting of nevirapine, didanosine, and lamivudine (regimen B) or saquinavir, ritonavir, didanosine, and lamivudine (regimen C)."( Comparison of two once-daily regimens with a regimen consisting of nelfinavir, didanosine, and stavudine in antiretroviral therapy-naïve adults: 48-week results from the Antiretroviral Regimen Evaluation Study (ARES).
Borleffs, JC; Hassink, EA; Juttmann, JR; Koopmans, PP; Lange, JM; Lowe, SH; Richter, C; Schreij, G; ten Kate, RW; van der Tweel, I; Wensing, AM,
)
0.31
"No statistically significant difference in efficacy was found between the two investigated once-daily dosed treatment regimens (B and C) and the reference (A)."( Comparison of two once-daily regimens with a regimen consisting of nelfinavir, didanosine, and stavudine in antiretroviral therapy-naïve adults: 48-week results from the Antiretroviral Regimen Evaluation Study (ARES).
Borleffs, JC; Hassink, EA; Juttmann, JR; Koopmans, PP; Lange, JM; Lowe, SH; Richter, C; Schreij, G; ten Kate, RW; van der Tweel, I; Wensing, AM,
)
0.13
"As part of the large international, randomized 2NN trial, the pharmacokinetics of nevirapine in once-daily 400 mg and twice-daily 200 mg dosing regimens were investigated."( Pharmacokinetics of nevirapine: once-daily versus twice-daily dosing in the 2NN study.
Beijnen, JH; Huitema, AD; Kappelhoff, BS; Lange, JM; MacGregor, TR; Robinson, PA; van Leth, F,
)
0.13
" Differences in pharmacokinetics between once- versus twice-daily dosing were investigated with nonlinear mixed effects modelling (NONMEM)."( Pharmacokinetics of nevirapine: once-daily versus twice-daily dosing in the 2NN study.
Beijnen, JH; Huitema, AD; Kappelhoff, BS; Lange, JM; MacGregor, TR; Robinson, PA; van Leth, F,
)
0.13
" Dosage and dosing frequency did not influence clearance or volume of distribution of nevirapine, indicating linear pharmacokinetic behavior of nevirapine whether given as a single daily dose or as divided doses over 24 hours."( Pharmacokinetics of nevirapine: once-daily versus twice-daily dosing in the 2NN study.
Beijnen, JH; Huitema, AD; Kappelhoff, BS; Lange, JM; MacGregor, TR; Robinson, PA; van Leth, F,
)
0.13
"The daily exposure to nevirapine (AUC24h) was similar for the 400 mg once-daily and the 200 mg twice-daily dosing regimens."( Pharmacokinetics of nevirapine: once-daily versus twice-daily dosing in the 2NN study.
Beijnen, JH; Huitema, AD; Kappelhoff, BS; Lange, JM; MacGregor, TR; Robinson, PA; van Leth, F,
)
0.13
" It achieves comparable suppression of plasma HIV RNA with the pill's individual components dosed twice daily and with thymidine analogs combined with lamivudine."( Fixed dose combination abacavir/lamivudine in the treatment of HIV-1 infection.
Anderson, AM; Bartlett, JA, 2005
)
0.81
" The study was designed to assess the impact of lamivudine on hepatitis B antibody (anti-HBs) and dosage requirements of intravenous 5% HBIg (Nabi-HB) in the first 36 weeks post LT."( Protective antibody levels and dose requirements for IV 5% Nabi Hepatitis B immune globulin combined with lamivudine in liver transplantation for hepatitis B-induced end stage liver disease.
Brown, RS; Brundage, R; Dickson, RC; Fried, M; Horwith, G; Ishitani, M; Jensen, D; Lok, A; Luketic, V; Reddy, KR; Sheiner, P; Soldevila-Pico, C; Terrault, NA, 2006
)
0.8
" A historical control group of 36 CHBe- patients, matched for age and sex and treated with the same dosage of interferon-alpha2b was used."( A partially overlapping treatment course with lamivudine and interferon in hepatitis B e antigen-negative chronic hepatitis B.
Hadziyannis, SJ; Manesis, EK; Papatheodoridis, GV, 2006
)
0.59
"BSA is a significant predictor for the normalizing the effect of lamivudine therapy on ALT for an initial 2-year period, suggesting that lamivudine dosage should be based on the individual BSA."( Relationship between body surface area and ALT normalization after long-term lamivudine treatment.
Azuma, K; Enjoji, M; Furusyo, N; Hayashi, J; Kajiwara, E; Kotoh, K; Maruyama, T; Masumoto, A; Morizono, S; Nakamuta, M; Nomura, H; Sakai, H; Shimoda, S; Shimono, J; Takahashi, K; Tanabe, Y, 2005
)
0.8
" NRTI-exposed Erythrocebus patas monkey dams (n = 3 per treatment group) were given human-equivalent dosing regimens containing 3TC, AZT/3TC, AZT/ddI, or Stavudine (d4T)/3TC during gestation."( Transplacentally exposed human and monkey newborn infants show similar evidence of nucleoside reverse transcriptase inhibitor-induced mitochondrial toxicity.
Divi, RL; Kuo, MM; Leonard, SL; Nagashima, K; Poirier, MC; St Claire, MC; Thamire, C; Wade, NA; Walker, VE,
)
0.13
" Acceptability of once daily drugs was best when the whole regimen was dosed once daily."( Adherence and acceptability of once daily Lamivudine and abacavir in human immunodeficiency virus type-1 infected children.
Burger, DM; Clapson, M; Farrelly, L; Flynn, J; Gibb, DM; Green, H; Head, S; LePrevost, M; Lyall, H; Novelli, V; Walker, AS, 2006
)
0.6
"Tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) are nucleoside reverse transcriptase inhibitors (NRTIs) with once-daily dosing approved for use in HIV-1 infection."( In vitro evaluation of the anti-HIV activity and metabolic interactions of tenofovir and emtricitabine.
Borroto-Esoda, K; Miller, MD; Myrick, F; Ray, AS; Vela, JE, 2006
)
0.33
"Sixty-eight treatment-naove patients with HBeAg-positive CHB were randomized to receive either 9 MU of IFN-a2a three times a week and lamivudine 100 mg daily (Group 1), or IFN-a2a alone in the same dosage (Group 2), for 12 months."( Comparison of lamivudine and alpha-interferon combination with alpha-interferon alone in the treatment of HBeAg-positive chronic hepatitis B.
Ayaz, C; Celen, MK; Colak, H; Geyik, MF; Hosoglu, S,
)
0.7
" Steady state was reached after daily dosing for 5 to 7 days."( Pharmacokinetics of telbivudine in healthy subjects and absence of drug interaction with lamivudine or adefovir dipivoxil.
Brown, NA; Chao, GC; Fielman, BA; Lloyd, DM; Zhou, XJ, 2006
)
0.56
" Our experience suggests that subcutaneous delivery of HBIG may be a feasible consideration when intramuscular/intravenous dosing is not possible."( Subcutaneous administration of hepatitis B immune globulin in combination with lamivudine following orthotopic liver transplantation: effective prophylaxis against recurrence.
Apiratpracha, W; Buczkowski, AK; Chung, SW; Erb, SR; Partovi, N; Powell, JJ; Scudamore, CH; Steinbrecher, UP; Yoshida, EM,
)
0.36
" Once-daily dosing may offer an advantage to adherence."( Pharmacokinetics of a once-daily regimen of lopinavir/ritonavir in HIV-1-infected children.
Burger, D; de Groot, R; van der Lee, M; Verweel, G, 2006
)
0.33
" Further research, especially in young children, is necessary to determine whether a higher dosage of lopinavir/ritonavir once daily must be given to reach the target level for Cmin."( Pharmacokinetics of a once-daily regimen of lopinavir/ritonavir in HIV-1-infected children.
Burger, D; de Groot, R; van der Lee, M; Verweel, G, 2006
)
0.33
" However, early HAART often consisted of drugs with complex dosing schedules, strict food requirements, treatment-limiting adverse effects, and the need to take 16-20 pills/day."( An update and review of antiretroviral therapy.
Piacenti, FJ, 2006
)
0.33
" Based on these results, it is acceptable to test the pharmacokinetics and dosing requirements of Pedimune in HIV-infected children."( Pharmacokinetics of two generic fixed-dose combinations for HIV-infected children (Pedimune Baby & Pedimune Junior) are similar to the branded products in healthy adults.
Burger, DM; Dijkema, T; Gibb, DM; L'homme, RF; van der Ven, AJ; Warris, A, 2007
)
0.34
" Genotyping all additional ETV patients with PCR-detectable HBV DNA at Weeks 48, 96, or end of dosing identified seven additional patients with LVDr substitutions, including one with simultaneous emergence of LVDr/ETVr."( Entecavir resistance is rare in nucleoside naïve patients with hepatitis B.
Baldick, CJ; Colonno, RJ; Eggers, B; Fang, J; Hsu, M; Klesczewski, K; Levine, S; Mazzucco, C; Plym, M; Pokornowski, K; Rose, R; Tenney, DJ; Walsh, A; Yu, CF; Zhang, S, 2006
)
0.33
" As adherence is crucial for treatment success, regimens with fewer pills, simpler dosing schedules and fewer adverse events have become the first choice for antiretroviral therapy."( Abacavir/lamividune combination in the treatment of HIV-1 infection: a review.
Moyle, G; Waters, L, 2006
)
0.33
" HBIg at a dosage of 200 IU/kg per day was administered for one week postoperatively."( Short-term high-dose followed by long-term low-dose hepatitis B immunoglobulin and lamivudine therapy prevented recurrent hepatitis B after liver transplantation.
Iwasaki, Y; Kobashi, H; Matsuda, H; Matsukawa, H; Miyake, Y; Sadamori, H; Sakaguchi, K; Shinoura, S; Shiratori, Y; Takaki, A; Tanaka, N; Terada, R; Umeda, Y; Yagi, T, 2007
)
0.56
" A formulation of abacavir sulfate/lamivudine/zidovudine allows a dosing schedule of one pill twice daily."( Abacavir sulfate/lamivudine/zidovudine fixed combination in the treatment of HIV infection.
Keiser, P; Nassar, N, 2007
)
0.96
"To evaluate the efficacy and safety of hepatitis B immunoglobulin (HBIG) by different medicating ways in patients with liver transplantation and to explore the methods for calculating the intravenous loading dosage of HBIG."( [The study of the different medicating ways and the formula for intravenous loading dosage of hepatitis B immunoglobulin in liver transplantation].
Chen, XG; Li, W; Liu, Y; Niu, YJ; Shen, ZY; Wang, Y; Wei, ZY; Zang, YJ; Zhang, ZT; Zhu, XD, 2006
)
0.33
" The preoperative body weight, serum HBsAg and HBeAg titer were analyzed with the intravenous loading dosage of HBIG by multiple-factor linear regression (Stepwise)."( [The study of the different medicating ways and the formula for intravenous loading dosage of hepatitis B immunoglobulin in liver transplantation].
Chen, XG; Li, W; Liu, Y; Niu, YJ; Shen, ZY; Wang, Y; Wei, ZY; Zang, YJ; Zhang, ZT; Zhu, XD, 2006
)
0.33
" Tenofovir is largely prescribed at the standard dosage of 300 mg once daily: therefore, the per kilogram dose is higher in Thailand than in the USA."( No change in calculated creatinine clearance after tenofovir initiation among Thai patients.
Ananworanich, J; Chetchotisakd, P; Gayet-Ageron, A; Hirschel, B; Jupimai, T; Le Braz, M; Prasithsirikul, W; Rooney, JF; Ruxrungtham, K; Ubolyam, S, 2007
)
0.34
" Tenofovir could be safely prescribed at a standard dosage of 300 mg once daily in the Thai population."( No change in calculated creatinine clearance after tenofovir initiation among Thai patients.
Ananworanich, J; Chetchotisakd, P; Gayet-Ageron, A; Hirschel, B; Jupimai, T; Le Braz, M; Prasithsirikul, W; Rooney, JF; Ruxrungtham, K; Ubolyam, S, 2007
)
0.34
" Spot urine samples were collected before dosing and at 4, 8, 12, 24, 28, 32, 48, 72, and 96 hours post dosing from 10 healthy subjects, and lamivudine was estimated by high-pressure liquid chromatography (HPLC)."( Can urine lamivudine be used to monitor antiretroviral treatment adherence?
Kumar, AK; Kumar, P; Kumaraswami, V; Ramachandran, G; Swaminathan, S, 2006
)
0.94
" To manage the growing populations of hard-to-treat patients with chronic viral hepatitis, there is a need for more effective treatment modalities, including optimized, individualized dosing and novel antivirals."( [Experiences in antiviral treatment of chronic viral hepatitis B and C in Hungary (1998-2004)].
Pár, A; Szalay, F; Tornai, I, 2007
)
0.34
"We retrospectively analyzed the impact of sirolimus addition (SRL) with a 25% dosing reduction in calcineurin inhibitors on liver function among patients with or without hepatitis B virus (HBV) or hepatitis C virus (HCV) infection."( Lack of hepatotoxicity upon sirolimus addition to a calcineurin inhibitor-based regimen in hepatitis virus-positive renal transplant recipients.
Chang, HR; Lian, JD; Lin, CC, 2007
)
0.34
"To establish whether peritoneal dialysis (PD) requires dosing modification from the CL(CR)-corrected lamivudine dose in end-stage renal failure subjects."( Pharmacokinetics of lamivudine in subjects receiving peritoneal dialysis in end-stage renal failure.
Asari, A; Chen, YC; Dunn, JA; Gokal, R; Iles-Smith, H; Johnson, MA; Naderer, OJ; Otto, V; Yuen, GJ, 2007
)
0.88
" These patients should follow the standard dosing reduction for patients infected with HIV or HBV with renal dysfunction."( Pharmacokinetics of lamivudine in subjects receiving peritoneal dialysis in end-stage renal failure.
Asari, A; Chen, YC; Dunn, JA; Gokal, R; Iles-Smith, H; Johnson, MA; Naderer, OJ; Otto, V; Yuen, GJ, 2007
)
0.66
" All infants received combination antiretroviral therapy including lamivudine dosed at 2 mg/kg of body weight every 12 h (q12h) for the first 4 to 6 weeks of life and at 4 mg/kg q12h thereafter."( Population pharmacokinetics of lamivudine in human immunodeficiency virus-exposed and -infected infants.
Acosta, EP; Bryson, Y; Capparelli, EV; Holland, D; Luzuriaga, K; Mirochnick, M; Patel, P; Tremoulet, AH; Wara, D; Zorrilla, C, 2007
)
0.86
" In inactive HBV replicative patients with strictly combined prophylaxis and availability of other medications and using 3 years after liver transplantation as a point of time, we think that tapering down the dosage of HBIG and tailoring individualized treatment methods based on virological and immunological situations of each recipient are worth trying."( [An analysis of long term prophylaxis of virus recurrence with antiviral treatment in HBV infected liver transplant recipient patients].
Dai, J; Gu, M; Jin, SJ; Lai, W; Li, B; Lu, SC; Tao, CM; Wen, TF; Yan, LN; Zeng, Y; Zhang, XH; Zhao, J; Zhao, JC, 2007
)
0.34
" Antiretroviral nucleoside reverse transcriptase inhibitor (NRTI) toxicity is currently under investigation in Erythrocebus patas monkeys, and whereas NRTI pharmacokinetics have been studied in other monkey species, pharmacokinetics for Zidovudine plus Lamivudine (AZT/3TC) dosing have not been reported in the patas."( Metabolism and pharmacokinetics of the combination Zidovudine plus Lamivudine in the adult Erythrocebus patas monkey determined by liquid chromatography-tandem mass spectrometric analysis.
Divi, RL; Doerge, DR; Harbaugh, JW; Harbaugh, SW; Poirier, MC; Shockley, ME; St Claire, MC; Twaddle, NC, 2008
)
0.76
" Peak PEG-IFN-alpha2b levels were reached approximately one day after administration and subsequently declined exponentially, consistent with a viral load rebound near to baseline levels at the end of the dosing period in most patients receiving PEG-IFN-alpha2b monotherapy."( Modelling of early viral kinetics and pegylated interferon-alpha2b pharmacokinetics in patients with HBeag-positive chronic hepatitis B.
Cakaloglu, Y; de Man, RA; Flisiak, R; Haagmans, BL; Hansen, BE; Herrmann, E; Janssen, HL; Karayalcin, S; Schalm, SW; ter Borg, MJ; van' t Veen, A; Zeuzem, S, 2007
)
0.34
" A good outcome is possible after liver transplantation for HBV liver disease using HBIG dosed by pharmacokinetic parameters in combination with lamivudine."( Prevention of hepatitis B recurrence after liver transplantation using lamivudine and hepatitis B immune globulin.
Foroncewicz, B; Górnicka, B; Krawczyk, M; Mucha, K; Nyckowski, P; Ołdakowska-Jedynak, U; Paczek, L; Paczkowska, A; Patkowski, W; Pilecki, T; Ziarkiewicz-Wróblewska, B; Zieniewicz, K; Ziółkowski, J, 2007
)
0.77
"To evaluate the short-term (12 wks) safety and tolerability of a once-daily, fixed-dose abacavir-lamivudine combination versus twice-daily dosing of the separate components, both with background antiretroviral therapy."( Short-term safety and tolerability of a once-daily fixed-dose abacavir-lamivudine combination versus twice-daily dosing of abacavir and lamivudine as separate components: findings from the ALOHA study.
Balu, RB; Brachman, PS; Cohen, CJ; Harley, WB; Kubota, M; Lim, ML; Schneider, S; Shaefer, MS; Sutherland-Phillips, DH; Williams, VC, 2008
)
0.8
" The incidence of HCC correlated with serum HBV DNA level at entry in a dose-response relationship."( Active antiviral therapy for chronic hepatitis B and hepatocellular carcinoma.
Hann, HW, 2008
)
0.35
"Seventy-one Zambian children were treated with Triomune Baby or Junior dosed according to weight bands."( Nevirapine, stavudine and lamivudine pharmacokinetics in African children on paediatric fixed-dose combination tablets.
Burger, DM; Chintu, C; Ewings, FM; Gibb, DM; Kabamba, D; Kankasa, C; L'homme, RF; Mulenga, V; Thomason, MJ; Walker, AS, 2008
)
0.65
"The results reported here for CBA/CaJ mice describe the effects of regular dosing with a common antiretroviral drug combination on outer hair cell (OHC) function using measures of 2f1-f2 distortion product otoacoustic emissions (DPOAEs) and auditory brainstem responses (ABRs)."( Noise-induced hearing loss in mice treated with antiretroviral drugs.
Bektas, D; Lonsbury-Martin, BL; Martin, GK; Stagner, BB, 2008
)
0.35
" We studied the safety, antiviral effect, and pharmacokinetics of NFV and its M8 metabolite with two dosing regimens in combination with zidovudine (ZDV) and lamivudine (3TC) in HIV-infected pregnant women."( Pharmacokinetics and safety of nelfinavir when used in combination with zidovudine and lamivudine in HIV-infected pregnant women: Pediatric AIDS Clinical Trials Group (PACTG) Protocol 353.
Asfaw, Y; Bryson, YJ; Capparelli, E; Connor, J; Huang, S; Hughes, MD; Kaiser, K; Keller, M; Mirochnick, M; Mofenson, LM; Purdue, L; Smith, E; Stek, A; Watts, DH,
)
0.55
"One hundred and forty-seven patients were randomized 2:2:1 to one of two APL dosing regimens or efavirenz (EFV)."( Antiviral activity and safety of aplaviroc with lamivudine/zidovudine in HIV-infected, therapy-naive patients: the ASCENT (CCR102881) study.
Bonny, T; Clumeck, N; Currier, J; Kleim, JP; Lazzarin, A; McCarty, D; Millard, J; Slims, J; Sloan, L; Steel, H, 2008
)
0.6
" In addition to the hepatic findings, there was an apparent dose-response relationship in the incidence of diarrhoea."( Antiviral activity and safety of aplaviroc with lamivudine/zidovudine in HIV-infected, therapy-naive patients: the ASCENT (CCR102881) study.
Bonny, T; Clumeck, N; Currier, J; Kleim, JP; Lazzarin, A; McCarty, D; Millard, J; Slims, J; Sloan, L; Steel, H, 2008
)
0.6
"In antiretroviral (ARV) therapy, pill burden, dosing frequency, and regimen complexity adversely affect adherence."( Randomization to once-daily stavudine extended release/lamivudine/efavirenz versus a more frequent regimen improves adherence while maintaining viral suppression.
Boyle, BA; Grimm, K; Jayaweera, D; Maa, JF; Seekins, DW; Witt, MD,
)
0.38
"5 mg and 1 mg, respectively, with 33% of patients in each dosing group achieving <400 copies/mL."( Efficacy and safety of entecavir in lamivudine-refractory patients with chronic hepatitis B: randomized controlled trial in Japanese patients.
Imazeki, F; Kage, M; Katano, Y; Kumada, H; Moriyama, M; Omata, M; Sata, M; Seriu, T; Suzuki, F; Toyoda, J, 2008
)
0.62
" Pharmacokinetic profiles were also determined in HIV-1-infected patients dosed with raltegravir monotherapy versus raltegravir in combination with TDF and lamivudine."( Lack of a significant drug interaction between raltegravir and tenofovir.
Breidinger, SA; Chen, J; Friedman, EJ; Gottesdiener, KM; Iwamoto, M; Kost, JT; Lasseter, KC; Stek, JE; Stone, JA; Teppler, H; Wagner, JA; Wenning, LA, 2008
)
0.54
"Patients prefer fewer pills and once-daily (qd) dosing without food restrictions."( Switching from twice-daily abacavir and lamivudine to the once-daily fixed-dose combination tablet of abacavir and lamivudine improves patient adherence and satisfaction with therapy.
Gazzard, BG; Jackson, A; Maitland, D; Mandalia, S; Moyle, GJ; Osorio, J, 2008
)
0.61
"017); dosing compliance 97."( Switching from twice-daily abacavir and lamivudine to the once-daily fixed-dose combination tablet of abacavir and lamivudine improves patient adherence and satisfaction with therapy.
Gazzard, BG; Jackson, A; Maitland, D; Mandalia, S; Moyle, GJ; Osorio, J, 2008
)
0.61
" Further exploration of regimens and dosing of antiretrovirals for children in these settings is needed."( Two-year outcomes of children on non-nucleoside reverse transcriptase inhibitor and protease inhibitor regimens in a South African pediatric antiretroviral program.
Berrisford, AE; Boulle, AM; Jaspan, HB, 2008
)
0.35
"In view of the lack of suitable paediatric antiretroviral formulations on the market, a novel fixed dose combination (FDC) tablet containing 300mg zidovudine (AZT) and 160mg lamivudine (3TC) was developed to improve dosing accuracy and allow flexible drug dosing in function of the body weight of paediatric HIV patients as recommended by WHO."( Development of fixed dose combination tablets containing zidovudine and lamivudine for paediatric applications.
Bortel, V; Kayitare, E; Ntawukulilyayo, JD; Remon, JP; Seminega, B; Vervaet, C, 2009
)
0.78
" The pharmacokinetic profile of GS-9160 in healthy human volunteers revealed that once-daily dosing was not likely to achieve antiviral efficacy; hence, the clinical development of this compound was discontinued."( Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
Chen, J; Chen, X; Geleziunas, R; Hesselgesser, J; Jin, H; Jones, GS; Kim, CU; Tsiang, M; Wright, M; Yu, F; Zeynalzadegan, A, 2009
)
0.35
" To attain a better antiviral response the dosage of entecavir was increased to 2mg daily in two patients, resulting in further viral load decline for both of them."( Entecavir shows limited efficacy in HBeAg-positive hepatitis B patients with a partial virologic response to adefovir therapy.
de Man, RA; Janssen, HL; Pas, SD; Reijnders, JG; Schutten, M, 2009
)
0.35
"Entecavir monotherapy dosed at 1mg resulted in a slow reduction of viral load in both lamivudine-experienced and -naïve patients with persistently high HBV DNA during adefovir therapy."( Entecavir shows limited efficacy in HBeAg-positive hepatitis B patients with a partial virologic response to adefovir therapy.
de Man, RA; Janssen, HL; Pas, SD; Reijnders, JG; Schutten, M, 2009
)
0.58
" Statistical analyses were performed on pharmacokinetic parameters: the area under the concentration-time curve from 0 to 4 h (AUC(0-4)), the maximum concentration of the drug (C(max)), and the residual concentration of the drug at the end of the dosing interval (C(trough)) for plasma and the AUC(0-4) and C(trough) for intracellular data."( Pilot pharmacokinetic study of human immunodeficiency virus-infected patients receiving tenofovir disoproxil fumarate (TDF): investigation of systemic and intracellular interactions between TDF and abacavir, lamivudine, or lopinavir-ritonavir.
Ayen, R; Clotet, B; Grassi, J; Levi, M; Negredo, E; Pruvost, A; Puig, J; Théodoro, F, 2009
)
0.54
" However, the dosing interval of ADV should be adjusted according to renal function and serum phosphate levels in patients receiving long-term treatment."( Add-on combination therapy with adefovir dipivoxil induces renal impairment in patients with lamivudine-refractory hepatitis B virus.
Enomoto, M; Habu, D; Imanishi, Y; Iwai, S; Kawada, N; Kobayashi, S; Morikawa, H; Sakaguchi, H; Shiomi, S; Tamori, A, 2010
)
0.58
"A total of 136 antiretroviral-naïve patients, with a CD4 cell count above 100 cells/microL and a plasma HIV RNA below 100,000 HIV-1 RNA copies/mL, were randomized and dosed with either lopinavir/ritonavir monotherapy (n = 83) or lopinavir/ritonavir + zidovudine/lamivudine (n = 53)."( Long-term (96-week) follow-up of antiretroviral-naïve HIV-infected patients treated with first-line lopinavir/ritonavir monotherapy in the MONARK trial.
Chaix, ML; Cohen-Codar, I; Delfraissy, JF; Dellamonica, P; Flandre, P; Ghosn, J; Girard, PM; Ngovan, P; Norton, M; Raffi, F, 2010
)
0.54
"Once-daily treatment with ritonavir-boosted saquinavir was well tolerated and resulted in similar saquinavir drug exposure despite much lower ritonavir concentrations when compared with a twice-daily dosing schedule."( Once-daily treatment with saquinavir mesylate (2000 mg) and ritonavir (100 mg) together with a fixed-dose combination of abacavir/lamivudine (600/300 mg) or tenofovir/emtricitabine (245/200 mg) in HIV-1-infected patients.
Bickel, M; Bodtländer, A; Gute, P; Klauke, S; Knecht, GK; Kurowski, M; Lutz, T; Stephan, C; von Hentig, N, 2009
)
0.56
"Children were recruited in weight-based dosage bands and nutritional status classified according to weight for height."( Pharmacokinetics of nevirapine in HIV-infected children with and without malnutrition receiving divided adult fixed-dose combination tablets.
Back, D; Else, L; Fraser, W; Khoo, S; Molyneux, E; Moons, P; Poerksen, G; Pollock, L; Walker, S, 2009
)
0.35
"5 mg orally, daily) or lamivudine (100 mg orally, daily) together with a long-term low dosage of HBIG to prevent hepatitis B recurrence after transplantation."( The role of entecavir in preventing hepatitis B recurrence after liver transplantation.
Chen, XS; Han, LZ; Luo, Y; Qiu, DK; Shen, CH; Wang, SY; Wang, X; Xi, ZF; Xia, Q; Xin, TY; Zhang, JJ, 2009
)
0.66
" It is a highly effective agent that can be dosed once or twice daily due to its long intracellular half-life."( Lamivudine for the treatment of HIV.
Kumar, PN; Patel, P, 2010
)
1.8
"To determine the impact of once-nightly versus twice-daily dosing and beliefs about highly active antiretroviral therapy (HAART) on adherence to efavirenz-based HAART in antiretroviral-naive patients."( The impact of once-nightly versus twice-daily dosing and baseline beliefs about HAART on adherence to efavirenz-based HAART over 48 weeks: the NOCTE study.
Cooper, V; Fisher, M; Gellaitry, G; Horne, R; Lange, AC; Vrijens, B; White, D, 2010
)
0.36
"The difference in adherence observed between once-nightly and twice-daily dosing was driven by a difference in persistence with treatment."( The impact of once-nightly versus twice-daily dosing and baseline beliefs about HAART on adherence to efavirenz-based HAART over 48 weeks: the NOCTE study.
Cooper, V; Fisher, M; Gellaitry, G; Horne, R; Lange, AC; Vrijens, B; White, D, 2010
)
0.36
" The present method was successfully applied to the pharmacokinetic study of lamivudine after oral dosing of lamivudine (100 mg tablet) to male healthy volunteers."( Quantification of lamivudine in human plasma by hydrophilic interaction chromatography-tandem mass spectrometry.
Ji, HY; Lee, HS; Lee, HW; Yoon, YR, 2010
)
0.92
" Children were stratified by weight and dosing was weight-based."( A chewable pediatric fixed-dose combination tablet of stavudine, lamivudine, and nevirapine: pharmacokinetics and safety compared with the individual liquid formulations in human immunodeficiency virus-infected children in Thailand.
Capparelli, E; Chokephaibulkit, K; Chotpitayasunondh, T; Cressey, TR; Eksaengsri, A; Hongsiriwan, S; McIntosh, K; Muresan, P; Plipat, N; Prasitsuebsai, W; Sirisanthana, V; Smith, ME; Toye, M; Vanprapar, N; Yogev, R, 2010
)
0.6
"CHAP2 (Children with HIV Antibiotic Prophylaxis 2) is a prospective cohort of Zambian children using d4T/3TC/NVP adult Triomune30 dosed according to WHO guidelines."( Drug resistance in human immunodeficiency virus type-1 infected Zambian children using adult fixed dose combination stavudine, lamivudine, and nevirapine.
Chintu, C; Ferrier, A; Ford, D; Gibb, DM; Grant, PR; Gupta, RK; Kabamba, D; Kalumbi, M; Mulenga, V; Pillay, D; Walker, AS, 2010
)
0.57
"Once-daily dosing of abacavir and lamivudine has been approved for adults, but paediatric data are insufficient."( Pharmacokinetic study of once-daily versus twice-daily abacavir and lamivudine in HIV type-1-infected children aged 3-<36 months.
, 2010
)
0.88
" Children taking T30 for > 6 weeks from each dosing weight band (<5, 5-<8, 8-<12, 12-<14, 14-<19, 19-<26, 26-<30 and > or = 30 kg) were recruited."( Steady-state nevirapine, lamivudine and stavudine levels in Malawian HIV-infected children on antiretroviral therapy using split Triomune 30 tablets.
Burger, D; Chesshyre, E; Khoo, S; Molyneux, E; Moons, P; Poerksen, G; Pollock, L, 2010
)
0.66
"Children were randomized to initiate antiretroviral therapy with full-dose (FD) nevirapine (Triomune Baby or Junior in the morning and evening) versus DE (half-dose nevirapine for 14 days [Triomune in the morning and stavudine-lamivudine {Lamivir-S} in the evening], then FD), in accordance with World Health Organization weight-band dosing tables."( Strategies for nevirapine initiation in HIV-infected children taking pediatric fixed-dose combination "baby pills" in Zambia: a randomized controlled trial.
Burger, D; Chijoka, C; Chintu, C; Cook, A; Ferrier, A; Gibb, DM; Kabamba, D; Kalengo, C; Kankasa, C; Kityo, C; Mulenga, V; Thomason, M; Walker, AS, 2010
)
0.54
"The present study aimed to compare the pharmacokinetics of lamivudine in 300 mg once-daily and 150 mg twice-daily dosing regimens in HIV-infected Chinese patients."( Steady-state pharmacokinetics of lamivudine once-daily versus twice-daily dosing in Chinese HIV-infected patients.
Fu, Q; Li, P; Li, T; Wang, L; Ye, M; Zhu, Z,
)
0.66
" The pharmacokinetics of once-daily versus twice-daily dosing was evaluated by noncompartment models."( Steady-state pharmacokinetics of lamivudine once-daily versus twice-daily dosing in Chinese HIV-infected patients.
Fu, Q; Li, P; Li, T; Wang, L; Ye, M; Zhu, Z,
)
0.41
"This study assessed the effect of stavudine (d4T) 30 mg dosage on lipoatrophy in HIV-infected patients on antiretroviral treatment."( Reduced dose of stavudine and lipoatrophy in HIV-infected patients in Cameroon.
Biwolé-Sida, M; Bork, K; Coudray, M; Cournil, A; Delaporte, E; Essomba, CN; Kouanfack, C; Laurent, C; Tonfack, CA, 2010
)
0.36
"The use of d4T at a lower dosage might increase safety with regard to its effect on lipoatrophy."( Reduced dose of stavudine and lipoatrophy in HIV-infected patients in Cameroon.
Biwolé-Sida, M; Bork, K; Coudray, M; Cournil, A; Delaporte, E; Essomba, CN; Kouanfack, C; Laurent, C; Tonfack, CA, 2010
)
0.36
"No data on once-daily dosing of nucleoside analogues in African children currently exist."( Pharmacokinetics and acceptability of once- versus twice-daily lamivudine and abacavir in HIV type-1-infected Ugandan children in the ARROW Trial.
Adkison, K; Bakeera-Kitaka, S; Burger, D; Gibb, DM; Kekitiinwa, A; Kendall, L; Mugyenyi, P; Musiime, V; Musoke, P; Odongo, F; Snowden, WB; Thomason, M; Walker, AS, 2010
)
0.6
" For both children and caregivers, once-daily dosing of lamivudine plus abacavir was highly acceptable and strongly preferred over twice-daily."( Pharmacokinetics and acceptability of once- versus twice-daily lamivudine and abacavir in HIV type-1-infected Ugandan children in the ARROW Trial.
Adkison, K; Bakeera-Kitaka, S; Burger, D; Gibb, DM; Kekitiinwa, A; Kendall, L; Mugyenyi, P; Musiime, V; Musoke, P; Odongo, F; Snowden, WB; Thomason, M; Walker, AS, 2010
)
0.85
" Once-daily dosing of abacavir and lamivudine could provide an alternative dosing strategy for HIV-1-infected children, with high acceptability and strong preference suggesting the potential for improved adherence."( Pharmacokinetics and acceptability of once- versus twice-daily lamivudine and abacavir in HIV type-1-infected Ugandan children in the ARROW Trial.
Adkison, K; Bakeera-Kitaka, S; Burger, D; Gibb, DM; Kekitiinwa, A; Kendall, L; Mugyenyi, P; Musiime, V; Musoke, P; Odongo, F; Snowden, WB; Thomason, M; Walker, AS, 2010
)
0.88
" Healthy volunteer studies have demonstrated a decrease in glucose disposal associated with dosing with specific antiretrovirals."( Effect of boosted fosamprenavir or lopinavir-based combinations on whole-body insulin sensitivity and lipids in treatment-naive HIV-type-1-positive men.
Back, DJ; Boffito, M; Jackson, AG; Mandalia, S; Moyle, GJ; Randell, PA; Taylor, J; Tjia, JF, 2010
)
0.36
"The lamivudine dosage used for treatment of patients with hepatitis B virus (HBV) chronic liver disease is one-third of the dose used in patients infected with human immunodeficiency virus."( Initial high dose of lamivudine delays the appearance of viral resistance in chronic hepatitis B patients.
Basso, M; Fazio, V; Giannini, EG; Picciotto, A; Savarino, V; Torre, F, 2011
)
1.25
"Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing lamivudine as the only active pharmaceutical ingredient were reviewed."( Biowaiver monographs for immediate release solid oral dosage forms: lamivudine.
Barends, DM; Dressman, JB; Jantratid, E; Junginger, HE; Kopp, S; Midha, KK; Shah, VP; Stavchansky, S; Strauch, S, 2011
)
0.8
"Among the 3 trials, 522 subjects were treated with FTC dosed once daily and 841 subjects were treated with 3TC dosed twice daily."( Reduced emergence of the M184V/I resistance mutation when antiretroviral-naïve subjects use emtricitabine versus lamivudine in regimens composed of two NRTIs plus the NNRTI efavirenz.
Borroto-Esoda, K; Chen, SS; Harris, J; Margot, N; McColl, DJ; Miller, MD,
)
0.34
"Lamivudine concentration-time courses were described for a very large range of ages to study the effects of body weight and maturation on lamivudine pharmacokinetics and to check the consistency of dosing recommendations."( Developmental pharmacokinetics of lamivudine in 580 pediatric patients ranging from neonates to adolescents.
Blanche, S; Bouazza, N; Frange, P; Hirt, D; Rey, E; Tréluyer, JM; Urien, S, 2011
)
2.09
" Simulation with the model of plasma and intracellular concentrations for once- versus twice-daily regimens suggested that a daily dosing regimen with double doses could be appropriate."( Joint population pharmacokinetic analysis of zidovudine, lamivudine, and their active intracellular metabolites in HIV patients.
Bazzoli, C; Bénech, H; Duval, X; Mentré, F; Retout, S; Rey, E; Salmon, D; Tréluyer, JM, 2011
)
0.61
" We proposed a systematic classification scheme using FDA-approved drug labeling to assess the DILI potential of drugs, which yielded a benchmark dataset with 287 drugs representing a wide range of therapeutic categories and daily dosage amounts."( FDA-approved drug labeling for the study of drug-induced liver injury.
Chen, M; Fang, H; Liu, Z; Shi, Q; Tong, W; Vijay, V, 2011
)
0.37
" For patients receiving HBIG and LAM, a lower frequency of HBV recurrence was associated with a high HBIG dosage (≥10,000 IU/day) versus a low HBIG dosage (<10,000 IU/day) during the first week after LT [3."( Hepatitis B immunoglobulin and/or nucleos(t)ide analogues for prophylaxis against hepatitis b virus recurrence after liver transplantation: a systematic review.
Akriviadis, E; Cholongitas, E; Goulis, J; Papatheodoridis, GV, 2011
)
0.37
"There are no previous data describing nelfinavir and lamivudine pharmacokinetics in neonates treated with weight-band dosing regimens."( Nelfinavir and Lamivudine pharmacokinetics during the first two weeks of life.
Bryson, Y; Camarca, M; Mirochnick, M; Mofenson, L; Moye, J; Nielsen-Saines, K; Pilotto, JH; Pinto, J; Rossi, S; Veloso, VG; Watts, DH, 2011
)
0.97
"Pharmacokinetic study of nelfinavir and lamivudine pharmacokinetics in infants during the first 2 weeks of life treated with weight-band dosing regimens."( Nelfinavir and Lamivudine pharmacokinetics during the first two weeks of life.
Bryson, Y; Camarca, M; Mirochnick, M; Mofenson, L; Moye, J; Nielsen-Saines, K; Pilotto, JH; Pinto, J; Rossi, S; Veloso, VG; Watts, DH, 2011
)
0.99
" The first trial began in April 1991 and assessed zidovudine (ZDV) versus placebo and since then, the type, dosage and duration of drugs to be compared has been modified in each subsequent trial."( Antiretrovirals for reducing the risk of mother-to-child transmission of HIV infection.
Brocklehurst, P; Siegfried, N; Sint, TT; van der Merwe, L, 2011
)
0.37
" Modification of the dosing interval or discontinuation of ADV was required in seven and three patients, respectively, and none of them showed a further decline in the eGFR."( Frequency and risk factors of renal impairment during long-term adefovir dipivoxil treatment in chronic hepatitis B patients.
Cho, HC; Choi, MS; Gwak, GY; Kim, YJ; Koh, KC; Lee, JH; Paik, SW; Sinn, DH; Yoo, BC, 2012
)
0.38
"To evaluate international pediatric efavirenz dosing recommendations using full pharmacokinetic (PK) information."( Pediatric underdosing of efavirenz: a pharmacokinetic study in Uganda.
Balungi, J; Burger, DM; Bwakura-Dangarembizi, M; Ferrier, A; Fillekes, Q; Gibb, DM; Keishanyu, R; Kendall, L; Lutakome, J; Natukunda, E; Walker, AS, 2011
)
0.37
"African children aged 3-12 years, on efavirenz dosed according to 2006 WHO/manufacturer's recommendations, had lower and highly variable efavirenz PK parameters compared with adult data from manufacturer's leaflet."( Pediatric underdosing of efavirenz: a pharmacokinetic study in Uganda.
Balungi, J; Burger, DM; Bwakura-Dangarembizi, M; Ferrier, A; Fillekes, Q; Gibb, DM; Keishanyu, R; Kendall, L; Lutakome, J; Natukunda, E; Walker, AS, 2011
)
0.37
" Pregnant women had a 22% higher apparent clearance than nonpregnant and parturient women; however, this increase did not lead to subexposure and should not require a dosage adjustment."( Pregnancy-related effects on lamivudine pharmacokinetics in a population study with 228 women.
Benaboud, S; Blanche, S; Bouazza, N; Chappuy, H; Firtion, G; Hirt, D; Launay, O; Pannier, E; Rey, E; Tréluyer, JM; Urien, S, 2012
)
0.67
" Dosing was weight-based."( Pharmacokinetics and safety of a new paediatric fixed-dose combination of zidovudine/lamivudine/nevirapine in HIV-infected children.
Aurpibul, L; Capparelli, E; Chokephaibulkit, K; Cressey, TR; Eksaengsri, A; Hongsiriwon, S; Kabat, B; Limwongse, C; McIntosh, K; Muresan, P; Ngampiyaskul, C; Sirisanthana, V; Smith, ME; Toye, M; Wittawatmongkol, O; Yogev, R, 2011
)
0.59
" Monte Carlo simulations were used to compare the lamivudine exposure achieved with World Health Organization (WHO) weight band and Food and Drug Administration (FDA) label dosing recommendations."( Developmental pharmacokinetic changes of Lamivudine in infants and children.
Capparelli, EV; Chokephaibulkit, K; Cressey, TR; McKinney, R; Mirochnick, M; Nikanjam, M; Tremoulet, AH, 2012
)
0.9
"In this study, a slight but not significant decrease in the plasma lopinavir C(trough) was found during the third trimester of pregnancy, suggesting that standard dosing of the tablet formulation is also appropriate during the later stages of pregnancy."( Lopinavir/ritonavir trough concentrations with the tablet formulation in HIV-1-infected women during the third trimester of pregnancy.
Borderi, M; Calza, L; Colangeli, V; Grossi, G; Manfredi, R; Motta, R; Salvadori, C; Trapani, F; Viale, P, 2012
)
0.38
" Information on how polymorphisms influence drug metabolism and transport to target sites is important in guiding dosage or selection of appropriate alternative therapies."( Prevalence of MDR1 C3435T and CYP2B6 G516T polymorphisms among HIV-1 infected South African patients.
Bessong, PO; Masebe, TM; Meyer, D; Ndip, RN; Nwobegahay, J, 2012
)
0.38
" The mean (± SD) dosing duration was 32±22 months."( Reassessing the role for lamivudine in chronic hepatitis B infection: a four-year cohort analysis.
Cooper, C; Shaikh, T, 2012
)
0.68
" With strict dosing adherence and monitoring for virological breakthrough, sustained virological suppression can be reliably achieved with lamivudine in carefully selected patients."( Reassessing the role for lamivudine in chronic hepatitis B infection: a four-year cohort analysis.
Cooper, C; Shaikh, T, 2012
)
0.88
" Factors that may have contributed to the suboptimal results with nevirapine include elevated viral load at baseline, selection for nevirapine resistance, background regimen of nucleoside reverse-transcriptase inhibitors, and the standard ramp-up dosing strategy."( Nevirapine versus ritonavir-boosted lopinavir for HIV-infected children.
Abrams, EJ; Barlow-Mosha, L; Bobat, R; Chi, BH; Cotton, MF; Eshleman, SH; Hughes, MD; Jean-Philippe, P; Kamthunzi, P; Khadse, S; Lindsey, JC; Millar, L; Mofenson, LM; Moultrie, H; Mujuru, HA; Palumbo, P; Petzold, E; Purdue, L; Schimana, W; Violari, A, 2012
)
0.38
"In this highly adherent population, the number of daily pills was related to self-reported health status but not to self-reported adherence, whereas the dosing interval did not influence self-reported adherence or health status."( Number of daily pills, dosing schedule, self-reported adherence and health status in 2010: a large cross-sectional study of HIV-infected patients on antiretroviral therapy.
Bocchiola, B; Cahua, T; Castagna, A; Danise, A; Galli, L; Gianotti, N; Lazzarin, A; Maillard, M; Panzini, P; Pazzi, A; Salpietro, S; Zandonà, D, 2013
)
0.39
" Model-predicated area under the concentration-time curve during the dosing interval (AUC(τ)) and exposure ratios of CVF AUC(τ):BP AUC(τ) were calculated for each drug."( Pharmacokinetic modelling of efavirenz, atazanavir, lamivudine and tenofovir in the female genital tract of HIV-infected pre-menopausal women.
Cohen, MS; Dumond, JB; Forrest, A; Garonzik, SM; Kashuba, AD; Kendrick, RN; Nicol, MR; Patterson, KB, 2012
)
0.63
" In April 2011 due to an augmentation in creatinine plasma levels, a reduction in lamivudine dosage to 100 mg/day and the prescription of abacavir 300 mg/day became necessary."( A case of adverse drug reaction induced by dispensing error.
Caroleo, B; De Sarro, G; Di Mizio, G; Gallelli, L; Palleria, C; Staltari, O, 2012
)
0.6
"Standard LPV dosing achieved therapeutic levels in pregnancy and no appreciable concentrations in breast milk."( Therapeutic levels of lopinavir in late pregnancy and abacavir passage into breast milk in the Mma Bana Study, Botswana.
Capparelli, E; Essex, M; Leidner, J; Lockman, S; Makhema, J; Moffat, C; Moss, M; Moyo, S; Ogwu, A; Rossi, S; Shapiro, RL, 2013
)
0.39
" A fixed-dose combination (FDC) formulation of lamivudine/adefovir dipivoxil for the treatment of CHB may provide dosing convenience and improve adherence."( Pharmacokinetic properties of single-dose lamivudine/adefovir dipivoxil fixed-dose combination in healthy Chinese male volunteers.
Chan, JC; Chen, S; Chu, TT; Fok, BS; Gardner, S; Piscitelli, S; Tomlinson, B, 2013
)
0.91
" Blood samples were collected immediately before and after dosing for 48 hours for plasma drug concentration measurement."( Pharmacokinetic properties of single-dose lamivudine/adefovir dipivoxil fixed-dose combination in healthy Chinese male volunteers.
Chan, JC; Chen, S; Chu, TT; Fok, BS; Gardner, S; Piscitelli, S; Tomlinson, B, 2013
)
0.65
" Until then, guidelines for drug-drug interactions and dosing in renal and hepatic impairment should be followed in older HIV-infected individuals."( Clinical pharmacokinetics of antiretroviral drugs in older persons.
Anderson, PL; Erlandson, KM; Schoen, JC, 2013
)
0.39
" Fixed-dose combination anti-retroviral therapy provides adequate suppression of HIV-1 replication, provides barrier to the development of resistance, simplifies dosage regimen and improves adherence."( A randomized pahse I bioequivalence clinincal trial of a paediatric fixed-dose combination antiretroviral reconstitutable suspension in healthy adult volunteers.
Adeyeye, M; Edowhorhu, G; Esseku, F; Gbadero, D; Joshi, A; Oyegbile, Y, 2013
)
0.39
" A total of 15 blood samples were collected before dosing and up to 96 h post dosing."( A randomized pahse I bioequivalence clinincal trial of a paediatric fixed-dose combination antiretroviral reconstitutable suspension in healthy adult volunteers.
Adeyeye, M; Edowhorhu, G; Esseku, F; Gbadero, D; Joshi, A; Oyegbile, Y, 2013
)
0.39
"Regimen simplification can be defined as a change in established effective therapy to reduce pill burden and dosing frequency, to enhance tolerability, or to decrease specific food and fluid requirements."( Abacavir-based triple nucleoside regimens for maintenance therapy in patients with HIV.
Bosco, O; Cruciani, M; Malena, M; Mengoli, C; Parisi, SG; Serpelloni, G, 2013
)
0.39
" Once-daily dosing without requirement for a pharmacokinetic booster makes dolutegravir-based therapy an attractive treatment option for HIV-1-infected treatment-naive patients."( Once-daily dolutegravir versus twice-daily raltegravir in antiretroviral-naive adults with HIV-1 infection (SPRING-2 study): 96 week results from a randomised, double-blind, non-inferiority trial.
Albrecht, H; Almond, S; Baril, JG; Belonosova, E; Brennan, C; Domingo, P; Gatell, JM; Jaeger, H; Min, S; Quiros-Roldan, E; Raffi, F, 2013
)
0.39
" In this context, an evaluation of the role of covariates on pharmacokinetics is required to establish the impact of differences in dosing regimens."( A model-based approach for the evaluation of once daily dosing of lamivudine in HIV-infected children.
Adkison, K; Burger, D; Danhof, M; Della Pasqua, O; Jacqz-Aigrain, E; Piana, C; Zhao, W, 2014
)
0.64
"The simulations show that once daily dosing of lamivudine yields comparable exposure to historical values observed in children and adults, both for liquid and solid dosage forms."( A model-based approach for the evaluation of once daily dosing of lamivudine in HIV-infected children.
Adkison, K; Burger, D; Danhof, M; Della Pasqua, O; Jacqz-Aigrain, E; Piana, C; Zhao, W, 2014
)
0.9
"Our findings illustrate how dosing regimens can be evaluated taking into account the effects of developmental growth on drug disposition."( A model-based approach for the evaluation of once daily dosing of lamivudine in HIV-infected children.
Adkison, K; Burger, D; Danhof, M; Della Pasqua, O; Jacqz-Aigrain, E; Piana, C; Zhao, W, 2014
)
0.64
" defining dosing recommendations for children)."( Covariate effects and population pharmacokinetics of lamivudine in HIV-infected children.
Adkison, K; Burger, D; Danhof, M; Della Pasqua, O; Jacqz-Aigrain, E; Piana, C; Zhao, W, 2014
)
0.65
" Replacing a FDAC with the individual components of that combination should only be permitted when the substituting medication has the same qualitative and quantitative composition of active ingredients, pharmaceutical form, method of administration, dosage and presentation as the medication being replaced, and a randomized study has demonstrated its non-inferiority."( Legal, ethical, and economic implications of breaking down once-daily fixed-dose antiretroviral combinations into their single components for cost reduction.
Llibre, JM; Ramiro, MA, 2014
)
0.4
"Dissolution testing has a very vital importance for a quality control test and prediction of the in vivo behavior of the oral dosage formulation."( Continuous wavelet transforms for the simultaneous quantitative analysis and dissolution testing of lamivudine-zidovudine tablets.
Dinç, E; Özdemir, N; Tilkan, MG; Üstündağ, Ö, 2013
)
0.61
"NAs are cleared by kidneys and their dosage should be adjusted in patients with creatinine clearance <50 mL/min."( Review article: nucleos(t)ide analogues in patients with chronic hepatitis B virus infection and chronic kidney disease.
Cholongitas, E; Papatheodoridis, G; Pipili, C, 2014
)
0.4
" Mice were dosed twice daily until PND 28."( Toxicology and Carcinogenesis Studies of Mixtures of 3'-Azido-3'-Deoxythymidine (AZT), Lamivudine (3TC), and Nevirapine (NVP) (CAS Nos. 30516-87-1, 134678-17-4, 129618-40-2) in Genetically Modified C3B6.129F1-Trp53(tm1Brd) N12 Haploinsufficient Mice (in u
, 2013
)
0.61
" Antiviral treatments were withdrawn in patients who met all of the following 7 criteria: (i) no clinical and histologic evidence of cirrhosis, (ii) normal liver biochemistry, (iii) negative for both HBV DNA and hepatitis B envelope antigen (HBeAg), (iv) no resistance to antiviral agent, (v) antiviral therapy > 9 months, (vi) maintenance dosage of immunosuppressant for > 3 months, and (vii) no history of acute rejection during recent 6 months."( Successful withdrawal of antiviral treatment in kidney transplant recipients with chronic hepatitis B viral infection.
Cho, JH; Choi, JY; Huh, S; Kang, YJ; Kim, CD; Kim, HK; Kim, JS; Kim, YL; Kwon, O; Lim, JH; Park, GY; Park, SH, 2014
)
0.4
" Once-a-day dolutegravir dosing also does not require a pharmacokinetic booster like elvitegravir which minimizes the drug-drug interaction potential of dolutegravir."( Dolutegravir for the treatment of adult patients with HIV-1 infection.
Abraham, T; Saad, N; Wu, G, 2014
)
0.4
" Six patients (13%) reported problems with the switch including confusion around dosing and new side effects."( The financial and service implications of splitting fixed-dose antiretroviral drugs - a case study.
Adams, EJ; Ahmed, I; Carlin, E; Sadique, Z; Taylor, R, 2015
)
0.42
"This study aimed to describe lamivudine pharmacokinetics in patients with impaired renal function and to evaluate the consistency of current dosing recommendations."( Evaluation of effect of impaired renal function on lamivudine pharmacokinetics.
Benaboud, S; Bouazza, N; Foissac, F; Ghosn, J; Hirt, D; Tréluyer, JM; Urien, S; Viard, JP, 2014
)
0.95
"Atazanavir/ritonavir 200/100 mg dosing provided adequate ATV AUC 0-24 when used with TDF in HIV-infected Thai children weighing between 25 and 50 kg."( Pharmacokinetics of atazanavir/ritonavir among HIV-infected Thai children concomitantly taking tenofovir disoproxil fumarate.
Ananworanich, J; Bunupuradah, T; Keadpudsa, S; Prasitsuebsai, W; Puthanakit, T; Sahakijpicharn, T; Srimuan, A; Techasaensiri, C; Thammajaruk, N, 2014
)
0.4
"In total, 128 patients with a decompensated state and lamivudine-resistant HBV were treated with ADV at a dosage of 10 mg/day for a median of 33 months in this multicenter cohort study."( Rescue therapy with adefovir in decompensated liver cirrhosis patients with lamivudine-resistant hepatitis B virus.
Cho, M; Choi, JY; Han, KH; Hwang, JS; Kim, BI; Kim, DJ; Lee, CK; Lee, HJ; Paik, SW; Suh, DJ; Um, SH; Woo, HY; Yoon, SK, 2014
)
0.88
" This work aimed to develop appropriate drug ratios and dosing for each FDC."( Lopinavir/ritonavir plus lamivudine and abacavir or zidovudine dose ratios for paediatric fixed-dose combinations.
Bouazza, N; Burger, D; Capparelli, EV; Fauchet, F; Foissac, F; Kiechel, JR; Lallemant, M; Treluyer, JM; Urien, S, 2015
)
0.72
" Monte-Carlo simulations of WHO and FDA dosing recommendations were performed to assess their ability to provide optimal exposure in children weighing 4 to 25 kg based on consensus plasma targets."( Lopinavir/ritonavir plus lamivudine and abacavir or zidovudine dose ratios for paediatric fixed-dose combinations.
Bouazza, N; Burger, D; Capparelli, EV; Fauchet, F; Foissac, F; Kiechel, JR; Lallemant, M; Treluyer, JM; Urien, S, 2015
)
0.72
" Given the recommended drug ratios, the dosage for the 4-5."( Lopinavir/ritonavir plus lamivudine and abacavir or zidovudine dose ratios for paediatric fixed-dose combinations.
Bouazza, N; Burger, D; Capparelli, EV; Fauchet, F; Foissac, F; Kiechel, JR; Lallemant, M; Treluyer, JM; Urien, S, 2015
)
0.72
" Sub-optimal dosing can lead to acquired rifamycin resistance (ARR)."( Randomized pharmacokinetic evaluation of different rifabutin doses in African HIV- infected tuberculosis patients on lopinavir/ritonavir-based antiretroviral therapy.
Connolly, C; Harries, A; Kellerman, T; Lienhardt, C; McIlleron, H; Naiker, S; Pym, A; Reddy, T; Wiesner, L, 2014
)
0.4
" Plasma d-RBT concentrations increased 5-fold with tiw rifabutin dosing and 15-fold with daily doses of rifabutin."( Randomized pharmacokinetic evaluation of different rifabutin doses in African HIV- infected tuberculosis patients on lopinavir/ritonavir-based antiretroviral therapy.
Connolly, C; Harries, A; Kellerman, T; Lienhardt, C; McIlleron, H; Naiker, S; Pym, A; Reddy, T; Wiesner, L, 2014
)
0.4
" Adefovir is not active against HIV using HBV dosing and is no longer recommended as HBV therapy given its limited antiviral effect."( Advances in treating drug-resistant hepatitis B virus in HIV-infected patients.
Barreiro, P; de Mendoza, C; Peña, JM; Soriano, V, 2015
)
0.42
"Using non-linear regression models, dose-response curves of cloned HBV strains from patients pre-treated with RT inhibitors were established in human hepatoma cell lines after transfection with HBV genomes containing HBV polymerase genes from patient isolates."( Entecavir allows an unexpectedly high residual replication of HBV mutants resistant to lamivudine.
Geipel, A; Gerlich, WH; Glebe, D; Kaiser, R; Neumann-Fraune, M; Niekamp, H; Protzer, U; Seiz, PL; Zhang, K, 2015
)
0.64
"The entecavir dose-response curve of lamivudine-resistant HBV RT mutants rtM204 for the replication of HBV decreased less than expected with increasing drug dose."( Entecavir allows an unexpectedly high residual replication of HBV mutants resistant to lamivudine.
Geipel, A; Gerlich, WH; Glebe, D; Kaiser, R; Neumann-Fraune, M; Niekamp, H; Protzer, U; Seiz, PL; Zhang, K, 2015
)
0.91
" Stavudine and lamivudine are administered as fixed combination while nevirapine as separate dosage form which often results in poor compliance and adherence to therapy by patients and therefore, there is a need to develop dosage forms that can overcome the problems of currently available dosage forms for treatment of HIV infection."( Simultaneous And Extended Delivery Of Stavudine, Lamivudine And Nevirapine In Fixed Dose Combination Using Sandwiched Osmotic Tablets For Hiv Therapy.
Priya, MR; Rajendran, NN, 2015
)
1.02
" These models can be applied to evaluate alternative dosing regimens to optimize drug therapy during pregnancy."( Physiologically-based pharmacokinetic modeling of renally excreted antiretroviral drugs in pregnant women.
Benaboud, S; Blanche, S; Bouazza, N; De Sousa Mendes, M; Foissac, F; Hirt, D; Treluyer, JM; Urien, S; Valade, E, 2015
)
0.42
"In the development strategies of new drug products and generic drug products, the simultaneous in-vitro dissolution behavior of oral dosage formulations is the most important indication for the quantitative estimation of efficiency and biopharmaceutical characteristics of drug substances."( Comparative Application of PLS and PCR Methods to Simultaneous Quantitative Estimation and Simultaneous Dissolution Test of Zidovudine - Lamivudine Tablets.
Dinç, E; Özdemir, N; Tilkan, MG; Üstündağ, Ö, 2015
)
0.62
"The histological alterations occurred in both the maternal livers and the maternal kidneys, particularly in group E3, which received the greatest therapeutic dosage (nine times)."( Chronic action of lamivudine and ritonavir on maternal and fetal liver and kidney of albino pregnant rats (Rattus norvegicus albinus, Rodentia, Mammalia): morphological and biochemical aspects.
Amed, AM; Araujo Júnior, E; Júnior, LK; Nakamura, MU; Simões, J; Vangelotti, AM, 2015
)
0.75
" Absence of hypersensitivity reactions, superior resistance profile and once-daily dosing favours abacavir for African children, supporting WHO 2013 guidelines."( Abacavir, zidovudine, or stavudine as paediatric tablets for African HIV-infected children (CHAPAS-3): an open-label, parallel-group, randomised controlled trial.
Abongomera, G; Asiimwe, A; Burger, D; Chabala, C; Chintu, C; Cook, AD; Gibb, DM; Kekitiinwa, A; Kenny, J; Kityo, C; Klein, N; McIlleron, H; Mirembe, G; Mulenga, V; Musiime, V; Owen-Powell, E; Thomason, MJ; Walker, AS, 2016
)
0.43
" And while the drug elvitegravir has been inserted into a four-drug combination pill providing a once-daily dosing alternative, dolutegravir has demonstrated superiority in terms of its efficacy and resistance."( The preclinical discovery and development of dolutegravir for the treatment of HIV.
Bailly, F; Cotelle, P, 2015
)
0.42
"Around 450 and 250 mg daily doses might meet EFV dosing needs of HIV-TB infected Ugandans in general and CYP2B6*6/*6 genotypes, respectively."( CYP2B6 genotype-based efavirenz dose recommendations during rifampicin-based antituberculosis cotreatment for a sub-Saharan Africa population.
Aklillu, E; Bisaso, RK; Gustafsson, LL; Mukonzo, JK; Ogwal-Okeng, J; Owen, JS, 2016
)
0.43
" Once-daily dosing could improve adherence."( Once vs twice-daily abacavir and lamivudine in African children.
Cook, A; Gibb, DM; Kasirye, P; Mhute, T; Mugarura, L; Munjoma, M; Musiime, V; Nahirya-Ntege, P; Naidoo-James, B; Nankya, I; Ndashimye, E; Snowden, W; Spyer, MJ; Thomason, MJ; Thoofer, NK; Walker, AS, 2016
)
0.72
"The first-generation integrase inhibitors (INIs) raltegravir (RAL) and elvitegravir (EVG) have shown efficacy against HIV infection, but they have the limitations of once-more daily dosing and extensive cross-resistance."( Dolutegravir(DTG, S/GSK1349572) combined with other ARTs is superior to RAL- or EFV-based regimens for treatment of HIV-1 infection: a meta-analysis of randomized controlled trials.
Chen, H; Guo, W; Huang, J; Jiang, J; Liang, B; Liang, H; Liao, Y; Su, J; Xu, X; Ye, L; Zang, N, 2016
)
0.43
"According to simulations, a paediatric efavirenz/lamivudine/abacavir fixed-dose formulation of 150 mg efavirenz, 75 mg lamivudine and 150 mg abacavir provided the most effective and safe concentrations across WHO weight bands, with the flexibility of dosage required across the paediatric population."( Optimization of the strength of the efavirenz/lamivudine/abacavir fixed-dose combination for paediatric patients.
Bienczak, A; Bouazza, N; Burger, D; Capparelli, EV; Cressey, TR; Denti, P; Foissac, F; Lallemant, M; McIlleron, H; Penazzato, M; Treluyer, JM; Urien, S, 2017
)
0.97
" For treatment, the WHO dosing guidelines should be suitable to maintain values above the therapeutic pharmacokinetic targets in most infants."( Are Prophylactic and Therapeutic Target Concentrations Different?: the Case of Lopinavir-Ritonavir or Lamivudine Administered to Infants for Prevention of Mother-to-Child HIV-1 Transmission during Breastfeeding.
Blanche, S; Blume, J; Bouazza, N; Foissac, F; Harper, K; Hirt, D; Illamola, SM; Kankasa, C; Meda, N; Nagot, N; Singata-Madliki, M; Tréluyer, JM; Tumwine, JK; Tylleskär, T; Van de Perre, P, 2017
)
0.67
" This boosting effect of atazanavir could be used to optimize dolutegravir dosing in particular clinical settings."( Dolutegravir plasma concentrations according to companion antiretroviral drug: unwanted drug interaction or desirable boosting effect?
Cattaneo, D; Clementi, E; Cozzi, V; Galli, M; Gervasoni, C; Meraviglia, P; Minisci, D; Riva, A, 2017
)
0.46
" Monitoring of renal function showed no case of the Fanconi syndrome, no significant alterations of median serum creatinine, eGFR and phosphate levels, although a reduction of TDF dosage was required in five patients (8."( Long-term efficacy and safety of switching from lamivudine+adefovir to tenofovir disoproxil fumarate in virologically suppressed patients.
Angarano, G; Fasano, M; Fiore, JR; Leone, A; Maggi, P; Santantonio, TA; Volpe, A, 2017
)
0.71
"Simplified dosing regimens are important for patients who face challenges in adhering to HIV-1 therapy."( Dolutegravir/abacavir/lamivudine versus current ART in virally suppressed patients (STRIIVING): a 48-week, randomized, non-inferiority, open-label, Phase IIIb study.
Aboud, M; Brennan, C; Brinson, C; Granier, C; Hopking, J; Koteff, JA; Lake, JE; Logue, K; Santiago, L; Trottier, B; Wynne, B, 2017
)
0.77
" We evaluated current World Health Organization (WHO) weight-band NVP prophylactic dosing recommendations and investigated optimal therapeutic NVP dosing for neonates."( Assessment of Nevirapine Prophylactic and Therapeutic Dosing Regimens for Neonates.
Aarons, L; Borkird, T; Capparelli, EV; Cressey, TR; Jittayanun, K; Jourdain, G; Lallemant, M; Le Coeur, S; Luvira, A; Phanomcheong, S; Puangsombat, A; Punyawudho, B; Saenjum, C; Sukrakanchana, PO; Urien, S, 2017
)
0.46
"0 mg/L) using different infant dosing strategies."( Assessment of Nevirapine Prophylactic and Therapeutic Dosing Regimens for Neonates.
Aarons, L; Borkird, T; Capparelli, EV; Cressey, TR; Jittayanun, K; Jourdain, G; Lallemant, M; Le Coeur, S; Luvira, A; Phanomcheong, S; Puangsombat, A; Punyawudho, B; Saenjum, C; Sukrakanchana, PO; Urien, S, 2017
)
0.46
" Several studies provided insights on dosing and safety of antiretroviral therapy to prevent mother-to-child transmission through pharmacokinetic analysis."( CROI 2017: Advances in Antiretroviral Therapy.
Jones, J; Taylor, BS; Tieu, HV; Wilkin, TJ,
)
0.13
" The objective of this study was to select an intramuscular dosing regimen based on a comparison of the antiviral activity, tolerability, and safety of the two intramuscular dosing regimens relative to oral cabotegravir plus abacavir-lamivudine."( Long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection (LATTE-2): 96-week results of a randomised, open-label, phase 2b, non-inferiority trial.
Angel, JB; Clair, MS; Clotet, B; Crauwels, H; Dorey, D; Eron, JJ; Ford, SL; Gonzalez-Garcia, J; Griffith, SK; Gutierrez, F; Lutz, T; Margolis, DA; Mrus, J; Murray, M; Patel, P; Podzamczer, D; Richmond, GJ; Sloan, L; Smith, KY; Spreen, WR; Stellbrink, HJ; Sutton, KC; Williams, PE; Yazdanpanah, Y, 2017
)
0.64
"Regimen switching in virally suppressed HIV-1-infected patients may be considered to reduce pill burden or dosing frequency, decrease short- or long-term toxicity, prevent or manage drug-drug interactions, and/or decrease cost."( Dolutegravir Dual Therapy as Maintenance Treatment in HIV-Infected Patients: A Review.
Boswell, R; Foisy, MM; Hughes, CA, 2018
)
0.48
" In 4 macaques dosed subcutaneously, drug levels over 5 weeks in plasma, lymph node mononuclear cells (LNMCs), and peripheral blood mononuclear cells (PBMCs) were analyzed by liquid chromatography-tandem mass spectrometry."( Long-Acting Profile of 4 Drugs in 1 Anti-HIV Nanosuspension in Nonhuman Primates for 5 Weeks After a Single Subcutaneous Injection.
Collier, AC; Ho, RJY; Kinman, LM; Koehn, J; Kraft, JC; Lane, S; Lee, W; McConnachie, LA, 2018
)
0.48
"Mannosylated polymeric nanoparticles (NPs) enable improvement of brain bioavailability and reduction of dosing due to efficient drug delivery at the target site."( Targeted delivery of mannosylated-PLGA nanoparticles of antiretroviral drug to brain.
Parikh, RH; Patel, BK; Patel, N, 2018
)
0.48
") and the bioperformance (both pre-clinical and clinical) before testing the efficacy of the final dosage form."( 3D printed capsules for quantitative regional absorption studies in the GI tract.
Gustafson, TP; Hermans, A; Kapoor, Y; Kesisoglou, F; Nofsinger, R; Procopio, A; Smith, D, 2018
)
0.48
" Alternative formulations with acceptable palatability and convenient dosing are needed for children who require smaller doses and have difficulty swallowing tablets."( Effects of Low- and High-Mineral Content Water on the Relative Bioavailability of a Coformulated Abacavir/Dolutegravir/Lamivudine Dispersible Tablet in Healthy Adults.
Buchanan, AM; Casillas, L; Joshi, S; Shaik, JSB; Shreeves, T; Singh, RP; Skoura, N, 2018
)
0.69
"A phase 1, open-label, randomized study was conducted in healthy adults to evaluate the relative bioavailability of a novel dispersible FDC tablet of abacavir 150 mg/dolutegravir 10 mg/lamivudine 75 mg administered under 4 different dosing conditions compared with dolutegravir plus abacavir/lamivudine nondispersible, film-coated tablets."( Effects of Low- and High-Mineral Content Water on the Relative Bioavailability of a Coformulated Abacavir/Dolutegravir/Lamivudine Dispersible Tablet in Healthy Adults.
Buchanan, AM; Casillas, L; Joshi, S; Shaik, JSB; Shreeves, T; Singh, RP; Skoura, N, 2018
)
0.88
" Neither the mineral content of the water nor dosing times affected the pharmacokinetics of individual components."( Effects of Low- and High-Mineral Content Water on the Relative Bioavailability of a Coformulated Abacavir/Dolutegravir/Lamivudine Dispersible Tablet in Healthy Adults.
Buchanan, AM; Casillas, L; Joshi, S; Shaik, JSB; Shreeves, T; Singh, RP; Skoura, N, 2018
)
0.69
" Model simulations demonstrated comparable systemic profiles across patient cohorts, supporting the proposed dosage adjustment scheme."( Using PBPK Modeling to Predict Drug Exposure and Support Dosage Adjustments in Patients With Renal Impairment: An Example with Lamivudine.
Cha, A; Fischetti, B; Shah, K; Taft, DR, 2020
)
0.76
"This study illustrates how PBPK modeling can help verify dosing guidelines for patients with varying levels of renal impairment."( Using PBPK Modeling to Predict Drug Exposure and Support Dosage Adjustments in Patients With Renal Impairment: An Example with Lamivudine.
Cha, A; Fischetti, B; Shah, K; Taft, DR, 2020
)
0.76
" The study supports the use of weight-band dosage tables."( Population pharmacokinetics of abacavir and lamivudine in severely malnourished human immunodeficiency virus-infected children in relation to treatment outcomes.
Archary, M; Bobat, R; Hennig, S; LaRussa, P; Mcllleron, H; Sibaya, T; Wiesner, L, 2019
)
0.78
" The method was validated according to International Conference on Harmonization guidelines, and it was successively applied for the determination of the studied drugs in their different pharmaceutical dosage forms and gave excellent percent of recovery."( Silver Nanoparticles Synthesis for Sensitive Spectrophotometric Determination of Sofosbuvir, Lamivudine, and Ritonavir in Pure Forms and Pharmaceutical Dosage Forms.
Elhenawee, M; Saleh, H; Saraya, RE, 2020
)
0.78
"The development of antiretroviral associations in a single dosage form aims to ensure improved efficacy, low costs and better adherence to treatment."( Formulation, Development and Scale-Up of Fixed-Dose Combination Tablets Containing Zidovudine, Lamivudine and Nevirapine.
Barros Silva, LCPB; da Silva, RMF; de Lima, LG; de Medeiros, FPM; de Sousa, ALMD; Lavra, ZMM; Neto, PJR; Rolim, LA; Rosa, TA; Wanderley Sales, VA, 2019
)
0.73
" This study predicted the pharmacokinetics (PK) of three renally excreted antiretroviral drugs in the elderly population and compared them with known exposures in renal impairment, to evaluate the need for dosing adjustments."( Are Standard Doses of Renally-Excreted Antiretrovirals in Older Patients Appropriate: A PBPK Study Comparing Exposures in the Elderly Population With Those in Renal Impairment.
Chetty, M; De Sousa Mendes, M, 2019
)
0.51
" The majority of virtual patients had exposures that did not require dosage adjustments."( Are Standard Doses of Renally-Excreted Antiretrovirals in Older Patients Appropriate: A PBPK Study Comparing Exposures in the Elderly Population With Those in Renal Impairment.
Chetty, M; De Sousa Mendes, M, 2019
)
0.51
"Comparison of the exposure in the elderly with exposure observed in patients with different levels of renal impairment, indicated that a dosage adjustment may not be required in elderly patients on lamivudine, emtricitabine and the majority of the patients on tenofovir."( Are Standard Doses of Renally-Excreted Antiretrovirals in Older Patients Appropriate: A PBPK Study Comparing Exposures in the Elderly Population With Those in Renal Impairment.
Chetty, M; De Sousa Mendes, M, 2019
)
0.7
"Islatravir (4'-ethynyl-2-fluoro-2'-deoxyadenosine, MK-8591) is a long-acting first-in-class nucleoside reverse transcriptase translocation inhibitor with the potential for versatile dosing routes and dosing intervals."( Islatravir for the treatment and prevention of infection with the human immunodeficiency virus type 1.
Grobler, JA; Markowitz, M, 2020
)
0.56
"A retrospective analysis of the randomized controlled DART (Development of AntiRetroviral Therapy in Africa; ISRCTN13968779) trial in HIV-1-positive adults initiating antiretroviral therapy with co-formulated zidovudine/lamivudine plus either tenofovir, abacavir, or nevirapine was conducted to evaluate the safety of initiating standard lamivudine dosing in patients with impaired creatinine clearance (CLcr)."( Changes over time in creatinine clearance and comparison of emergent adverse events for HIV-positive adults receiving standard doses (300 mg/day) of lamivudine-containing antiretroviral therapy with baseline creatinine clearance of 30-49 vs ≥50 mL/min.
Cutrell, A; Double, J; Gibb, DM; Gilks, C; Grosskurth, H; Hakim, J; Kityo, CM; Lou, Y; McCoig, CC; Mugyenyi, PN; Munderi, P; Musoro, G; Perger, T; Ross, LL; Shaefer, MS; Tenorio, AR; Walker, AS, 2019
)
0.9
" Multivariable linear regression was used to evaluate the associations of hair lamivudine concentration with age, sex, ethnicity, height, weight, body mass index, duration of HIV diagnosis, duration of current regimen, dosing schedule, concomitant antiretroviral medications, frequency of hair washing, hair care products use, hair cosmetic treatment and self-reported adherence."( Factors influencing hair lamivudine concentration among people living with HIV in Guangxi, China.
Li, X; Qiao, S; Shen, Z; Zhang, Q; Zhou, Y, 2020
)
1.09
"001), dosing schedule (β=0."( Factors influencing hair lamivudine concentration among people living with HIV in Guangxi, China.
Li, X; Qiao, S; Shen, Z; Zhang, Q; Zhou, Y, 2020
)
0.86
"We observed that, among those potential factors, hair lamivudine concentration was influenced by frequency of hair washing and dosing schedule."( Factors influencing hair lamivudine concentration among people living with HIV in Guangxi, China.
Li, X; Qiao, S; Shen, Z; Zhang, Q; Zhou, Y, 2020
)
1.11
"Findings will provide timely information on the safety, efficacy, and optimal dosing of t-PA to treat moderate/severe COVID-19-induced ARDS, which can be rapidly adapted to a phase III trial (NCT04357730; FDA IND 149634)."(
Abbasi, S; Abd El-Wahab, A; Abdallah, M; Abebe, G; Aca-Aca, G; Adama, S; Adefegha, SA; Adidigue-Ndiome, R; Adiseshaiah, P; Adrario, E; Aghajanian, C; Agnese, W; Ahmad, A; Ahmad, I; Ahmed, MFE; Akcay, OF; Akinmoladun, AC; Akutagawa, T; Alakavuklar, MA; Álava-Rabasa, S; Albaladejo-Florín, MJ; Alexandra, AJE; Alfawares, R; Alferiev, IS; Alghamdi, HS; Ali, I; Allard, B; Allen, JD; Almada, E; Alobaid, A; Alonso, GL; Alqahtani, YS; Alqarawi, W; Alsaleh, H; Alyami, BA; Amaral, BPD; Amaro, JT; Amin, SAW; Amodio, E; Amoo, ZA; Andia Biraro, I; Angiolella, L; Anheyer, D; Anlay, DZ; Annex, BH; Antonio-Aguirre, B; Apple, S; Arbuznikov, AV; Arinsoy, T; Armstrong, DK; Ash, S; Aslam, M; Asrie, F; Astur, DC; Atzrodt, J; Au, DW; Aucoin, M; Auerbach, EJ; Azarian, S; Ba, D; Bai, Z; Baisch, PRM; Balkissou, AD; Baltzopoulos, V; Banaszewski, M; Banerjee, S; Bao, Y; Baradwan, A; Barandika, JF; Barger, PM; Barion, MRL; Barrett, CD; Basudan, AM; Baur, LE; Baz-Rodríguez, SA; Beamer, P; Beaulant, A; Becker, DF; Beckers, C; Bedel, J; Bedlack, R; Bermúdez de Castro, JM; Berry, JD; Berthier, C; Bhattacharya, D; Biadgo, B; Bianco, G; Bianco, M; Bibi, S; Bigliardi, AP; Billheimer, D; Birnie, DH; Biswas, K; Blair, HC; Bognetti, P; Bolan, PJ; Bolla, JR; Bolze, A; Bonnaillie, P; Borlimi, R; Bórquez, J; Bottari, NB; Boulleys-Nana, JR; Brighetti, G; Brodeur, GM; Budnyak, T; Budnyk, S; Bukirwa, VD; Bulman, DM; Burm, R; Busman-Sahay, K; Butcher, TW; Cai, C; Cai, H; Cai, L; Cairati, M; Calvano, CD; Camacho-Ordóñez, A; Camela, E; Cameron, T; Campbell, BS; Cansian, RL; Cao, Y; Caporale, AS; Carciofi, AC; Cardozo, V; Carè, J; Carlos, AF; Carozza, R; Carroll, CJW; Carsetti, A; Carubelli, V; Casarotta, E; Casas, M; Caselli, G; Castillo-Lora, J; Cataldi, TRI; Cavalcante, ELB; Cavaleiro, A; Cayci, Z; Cebrián-Tarancón, C; Cedrone, E; Cella, D; Cereda, C; Ceretti, A; Ceroni, M; Cha, YH; Chai, X; Chang, EF; Chang, TS; Chanteux, H; Chao, M; Chaplin, BP; Chaturvedi, S; Chaturvedi, V; Chaudhary, DK; Chen, A; Chen, C; Chen, HY; Chen, J; Chen, JJ; Chen, K; Chen, L; Chen, Q; Chen, R; Chen, SY; Chen, TY; Chen, WM; Chen, X; Chen, Y; Cheng, G; Cheng, GJ; Cheng, J; Cheng, YH; Cheon, HG; Chew, KW; Chhoker, S; Chiu, WN; Choi, ES; Choi, MJ; Choi, SD; Chokshi, S; Chorny, M; Chu, KI; Chu, WJ; Church, AL; Cirrincione, A; Clamp, AR; Cleff, MB; Cohen, M; Coleman, RL; Collins, SL; Colombo, N; Conduit, N; Cong, WL; Connelly, MA; Connor, J; Cooley, K; Correa Ramos Leal, I; Cose, S; Costantino, C; Cottrell, M; Cui, L; Cundall, J; Cutaia, C; Cutler, CW; Cuypers, ML; da Silva Júnior, FMR; Dahal, RH; Damiani, E; Damtie, D; Dan-Li, W; Dang, Z; Dasa, SSK; Davin, A; Davis, DR; de Andrade, CM; de Jong, PL; de Oliveira, D; de Paula Dorigam, JC; Dean, A; Deepa, M; Delatour, C; Dell'Aiera, S; Delley, MF; den Boer, RB; Deng, L; Deng, Q; Depner, RM; Derdau, V; Derici, U; DeSantis, AJ; Desmarini, D; Diffo-Sonkoue, L; Divizia, M; Djenabou, A; Djordjevic, JT; Dobrovolskaia, MA; Domizi, R; Donati, A; Dong, Y; Dos Santos, M; Dos Santos, MP; Douglas, RG; Duarte, PF; Dullaart, RPF; Duscha, BD; Edwards, LA; Edwards, TE; Eichenwald, EC; El-Baba, TJ; Elashiry, M; Elashiry, MM; Elashry, SH; Elliott, A; Elsayed, R; Emerson, MS; Emmanuel, YO; Emory, TH; Endale-Mangamba, LM; Enten, GA; Estefanía-Fernández, K; Estes, JD; Estrada-Mena, FJ; Evans, S; Ezra, L; Faria de, RO; Farraj, AK; Favre, C; Feng, B; Feng, J; Feng, L; Feng, W; Feng, X; Feng, Z; Fernandes, CLF; Fernández-Cuadros, ME; Fernie, AR; Ferrari, D; Florindo, PR; Fong, PC; Fontes, EPB; Fontinha, D; Fornari, VJ; Fox, NP; Fu, Q; Fujitaka, Y; Fukuhara, K; Fumeaux, T; Fuqua, C; Fustinoni, S; Gabbanelli, V; Gaikwad, S; Gall, ET; Galli, A; Gancedo, MA; Gandhi, MM; Gao, D; Gao, K; Gao, M; Gao, Q; Gao, X; Gao, Y; Gaponenko, V; Garber, A; Garcia, EM; García-Campos, C; García-Donas, J; García-Pérez, AL; Gasparri, F; Ge, C; Ge, D; Ge, JB; Ge, X; George, I; George, LA; Germani, G; Ghassemi Tabrizi, S; Gibon, Y; Gillent, E; Gillies, RS; Gilmour, MI; Goble, S; Goh, JC; Goiri, F; Goldfinger, LE; Golian, M; Gómez, MA; Gonçalves, J; Góngora-García, OR; Gonul, I; González, MA; Govers, TM; Grant, PC; Gray, EH; Gray, JE; Green, MS; Greenwald, I; Gregory, MJ; Gretzke, D; Griffin-Nolan, RJ; Griffith, DC; Gruppen, EG; Guaita, A; Guan, P; Guan, X; Guerci, P; Guerrero, DT; Guo, M; Guo, P; Guo, R; Guo, X; Gupta, J; Guz, G; Hajizadeh, N; Hamada, H; Haman-Wabi, AB; Han, TT; Hannan, N; Hao, S; Harjola, VP; Harmon, M; Hartmann, MSM; Hartwig, JF; Hasani, M; Hawthorne, WJ; Haykal-Coates, N; Hazari, MS; He, DL; He, P; He, SG; Héau, C; Hebbar Kannur, K; Helvaci, O; Heuberger, DM; Hidalgo, F; Hilty, MP; Hirata, K; Hirsch, A; Hoffman, AM; Hoffmann, JF; Holloway, RW; Holmes, RK; Hong, S; Hongisto, M; Hopf, NB; Hörlein, R; Hoshino, N; Hou, Y; Hoven, NF; Hsieh, YY; Hsu, CT; Hu, CW; Hu, JH; Hu, MY; Hu, Y; Hu, Z; Huang, C; Huang, D; Huang, DQ; Huang, L; Huang, Q; Huang, R; Huang, S; Huang, SC; Huang, W; Huang, Y; Huffman, KM; Hung, CH; Hung, CT; Huurman, R; Hwang, SM; Hyun, S; Ibrahim, AM; Iddi-Faical, A; Immordino, P; Isla, MI; Jacquemond, V; Jacques, T; Jankowska, E; Jansen, JA; Jäntti, T; Jaque-Fernandez, F; Jarvis, GA; Jatt, LP; Jeon, JW; Jeong, SH; Jhunjhunwala, R; Ji, F; Jia, X; Jia, Y; Jian-Bo, Z; Jiang, GD; Jiang, L; Jiang, W; Jiang, WD; Jiang, Z; Jiménez-Hoyos, CA; Jin, S; Jobling, MG; John, CM; John, T; Johnson, CB; Jones, KI; Jones, WS; Joseph, OO; Ju, C; Judeinstein, P; Junges, A; Junnarkar, M; Jurkko, R; Kaleka, CC; Kamath, AV; Kang, X; Kantsadi, AL; Kapoor, M; Karim, Z; Kashuba, ADM; Kassa, E; Kasztura, M; Kataja, A; Katoh, T; Kaufman, JS; Kaupp, M; Kehinde, O; Kehrenberg, C; Kemper, N; Kerr, CW; Khan, AU; Khan, MF; Khan, ZUH; Khojasteh, SC; Kilburn, S; Kim, CG; Kim, DU; Kim, DY; Kim, HJ; Kim, J; Kim, OH; Kim, YH; King, C; Klein, A; Klingler, L; Knapp, AK; Ko, TK; Kodavanti, UP; Kolla, V; Kong, L; Kong, RY; Kong, X; Kore, S; Kortz, U; Korucu, B; Kovacs, A; Krahnert, I; Kraus, WE; Kuang, SY; Kuehn-Hajder, JE; Kurz, M; Kuśtrowski, P; Kwak, YD; Kyttaris, VC; Laga, SM; Laguerre, A; Laloo, A; Langaro, MC; Langham, MC; Lao, X; Larocca, MC; Lassus, J; Lattimer, TA; Lazar, S; Le, MH; Leal, DB; Leal, M; Leary, A; Ledermann, JA; Lee, JF; Lee, MV; Lee, NH; Leeds, CM; Leeds, JS; Lefrandt, JD; Leicht, AS; Leonard, M; Lev, S; Levy, K; Li, B; Li, C; Li, CM; Li, DH; Li, H; Li, J; Li, L; Li, LJ; Li, N; Li, P; Li, T; Li, X; Li, XH; Li, XQ; Li, XX; Li, Y; Li, Z; Li, ZY; Liao, YF; Lin, CC; Lin, MH; Lin, Y; Ling, Y; Links, TP; Lira-Romero, E; Liu, C; Liu, D; Liu, H; Liu, J; Liu, L; Liu, LP; Liu, M; Liu, T; Liu, W; Liu, X; Liu, XH; Liu, Y; Liuwantara, D; Ljumanovic, N; Lobo, L; Lokhande, K; Lopes, A; Lopes, RMRM; López-Gutiérrez, JC; López-Muñoz, MJ; López-Santamaría, M; Lorenzo, C; Lorusso, D; Losito, I; Lu, C; Lu, H; Lu, HZ; Lu, SH; Lu, SN; Lu, Y; Lu, ZY; Luboga, F; Luo, JJ; Luo, KL; Luo, Y; Lutomski, CA; Lv, W; M Piedade, MF; Ma, J; Ma, JQ; Ma, JX; Ma, N; Ma, P; Ma, S; Maciel, M; Madureira, M; Maganaris, C; Maginn, EJ; Mahnashi, MH; Maierhofer, M; Majetschak, M; Malla, TR; Maloney, L; Mann, DL; Mansuri, A; Marelli, E; Margulis, CJ; Marrella, A; Martin, BL; Martín-Francés, L; Martínez de Pinillos, M; Martínez-Navarro, EM; Martinez-Quintanilla Jimenez, D; Martínez-Velasco, A; Martínez-Villaseñor, L; Martinón-Torres, M; Martins, BA; Massongo, M; Mathew, AP; Mathews, D; Matsui, J; Matsumoto, KI; Mau, T; Maves, RC; Mayclin, SJ; Mayer, JM; Maynard, ND; Mayr, T; Mboowa, MG; McEvoy, MP; McIntyre, RC; McKay, JA; McPhail, MJW; McVeigh, AL; Mebazaa, A; Medici, V; Medina, DN; Mehmood, T; Mei-Li, C; Melku, M; Meloncelli, S; Mendes, GC; Mendoza-Velásquez, C; Mercadante, R; Mercado, MI; Merenda, MEZ; Meunier, J; Mi, SL; Michels, M; Mijatovic, V; Mikhailov, V; Milheiro, SA; Miller, DC; Ming, F; Mitsuishi, M; Miyashita, T; Mo, J; Mo, S; Modesto-Mata, M; Moeller, S; Monte, A; Monteiro, L; Montomoli, J; Moore, EE; Moore, HB; Moore, PK; Mor, MK; Moratalla-López, N; Moratilla Lapeña, L; Moreira, R; Moreno, MA; Mörk, AC; Morton, M; Mosier, JM; Mou, LH; Mougharbel, AS; Muccillo-Baisch, AL; Muñoz-Serrano, AJ; Mustafa, B; Nair, GM; Nakanishi, I; Nakanjako, D; Naraparaju, K; Nawani, N; Neffati, R; Neil, EC; Neilipovitz, D; Neira-Borrajo, I; Nelson, MT; Nery, PB; Nese, M; Nguyen, F; Nguyen, MH; Niazy, AA; Nicolaï, J; Nogueira, F; Norbäck, D; Novaretti, JV; O'Donnell, T; O'Dowd, A; O'Malley, DM; Oaknin, A; Ogata, K; Ohkubo, K; Ojha, M; Olaleye, MT; Olawande, B; Olomo, EJ; Ong, EWY; Ono, A; Onwumere, J; Ortiz Bibriesca, DM; Ou, X; Oza, AM; Ozturk, K; Özütemiz, C; Palacio-Pastrana, C; Palaparthi, A; Palevsky, PM; Pan, K; Pantanetti, S; Papachristou, DJ; Pariani, A; Parikh, CR; Parissis, J; Paroul, N; Parry, S; Patel, N; Patel, SM; Patel, VC; Pawar, S; Pefura-Yone, EW; Peixoto Andrade, BCO; Pelepenko, LE; Peña-Lora, D; Peng, S; Pérez-Moro, OS; Perez-Ortiz, AC; Perry, LM; Peter, CM; Phillips, NJ; Phillips, P; Pia Tek, J; Piner, LW; Pinto, EA; Pinto, SN; Piyachaturawat, P; Poka-Mayap, V; Polledri, E; Poloni, TE; Ponessa, G; Poole, ST; Post, AK; Potter, TM; Pressly, BB; Prouty, MG; Prudêncio, M; Pulkki, K; Pupier, C; Qian, H; Qian, ZP; Qiu, Y; Qu, G; Rahimi, S; Rahman, AU; Ramadan, H; Ramanna, S; Ramirez, I; Randolph, GJ; Rasheed, A; Rault, J; Raviprakash, V; Reale, E; Redpath, C; Rema, V; Remucal, CK; Remy, D; Ren, T; Ribeiro, LB; Riboli, G; Richards, J; Rieger, V; Rieusset, J; Riva, A; Rivabella Maknis, T; Robbins, JL; Robinson, CV; Roche-Campo, F; Rodriguez, R; Rodríguez-de-Cía, J; Rollenhagen, JE; Rosen, EP; Rub, D; Rubin, N; Rubin, NT; Ruurda, JP; Saad, O; Sabell, T; Saber, SE; Sabet, M; Sadek, MM; Saejio, A; Salinas, RM; Saliu, IO; Sande, D; Sang, D; Sangenito, LS; Santos, ALSD; Sarmiento Caldas, MC; Sassaroli, S; Sassi, V; Sato, J; Sauaia, A; Saunders, K; Saunders, PR; Savarino, SJ; Scambia, G; Scanlon, N; Schetinger, MR; Schinkel, AFL; Schladweiler, MC; Schofield, CJ; Schuepbach, RA; Schulz, J; Schwartz, N; Scorcella, C; Seeley, J; Seemann, F; Seinige, D; Sengoku, T; Seravalli, J; Sgromo, B; Shaheen, MY; Shan, L; Shanmugam, S; Shao, H; Sharma, S; Shaw, KJ; Shen, BQ; Shen, CH; Shen, P; Shen, S; Shen, Y; Shen, Z; Shi, J; Shi-Li, L; Shimoda, K; Shoji, Y; Shun, C; Silva, MA; Silva-Cardoso, J; Simas, NK; Simirgiotis, MJ; Sincock, SA; Singh, MP; Sionis, A; Siu, J; Sivieri, EM; Sjerps, MJ; Skoczen, SL; Slabon, A; Slette, IJ; Smith, MD; Smith, S; Smith, TG; Snapp, KS; Snow, SJ; Soares, MCF; Soberman, D; Solares, MD; Soliman, I; Song, J; Sorooshian, A; Sorrell, TC; Spinar, J; Staudt, A; Steinhart, C; Stern, ST; Stevens, DM; Stiers, KM; Stimming, U; Su, YG; Subbian, V; Suga, H; Sukhija-Cohen, A; Suksamrarn, A; Suksen, K; Sun, J; Sun, M; Sun, P; Sun, W; Sun, XF; Sun, Y; Sundell, J; Susan, LF; Sutjarit, N; Swamy, KV; Swisher, EM; Sykes, C; Takahashi, JA; Talmor, DS; Tan, B; Tan, ZK; Tang, L; Tang, S; Tanner, JJ; Tanwar, M; Tarazi, Z; Tarvasmäki, T; Tay, FR; Teketel, A; Temitayo, GI; Thersleff, T; Thiessen Philbrook, H; Thompson, LC; Thongon, N; Tian, B; Tian, F; Tian, Q; Timothy, AT; Tingle, MD; Titze, IR; Tolppanen, H; Tong, W; Toyoda, H; Tronconi, L; Tseng, CH; Tu, H; Tu, YJ; Tung, SY; Turpault, S; Tuynman, JB; Uemoto, AT; Ugurlu, M; Ullah, S; Underwood, RS; Ungell, AL; Usandizaga-Elio, I; Vakonakis, I; van Boxel, GI; van den Beucken, JJJP; van der Boom, T; van Slegtenhorst, MA; Vanni, JR; Vaquera, A; Vasconcellos, RS; Velayos, M; Vena, R; Ventura, G; Verso, MG; Vincent, RP; Vitale, F; Vitali, S; Vlek, SL; Vleugels, MPH; Volkmann, N; Vukelic, M; Wagner Mackenzie, B; Wairagala, P; Waller, SB; Wan, J; Wan, MT; Wan, Y; Wang, CC; Wang, H; Wang, J; Wang, JF; Wang, K; Wang, L; Wang, M; Wang, S; Wang, WM; Wang, X; Wang, Y; Wang, YD; Wang, YF; Wang, Z; Wang, ZG; Warriner, K; Weberpals, JI; Weerachayaphorn, J; Wehrli, FW; Wei, J; Wei, KL; Weinheimer, CJ; Weisbord, SD; Wen, S; Wendel Garcia, PD; Williams, JW; Williams, R; Winkler, C; Wirman, AP; Wong, S; Woods, CM; Wu, B; Wu, C; Wu, F; Wu, P; Wu, S; Wu, Y; Wu, YN; Wu, ZH; Wurtzel, JGT; Xia, L; Xia, Z; Xia, ZZ; Xiao, H; Xie, C; Xin, ZM; Xing, Y; Xing, Z; Xu, S; Xu, SB; Xu, T; Xu, X; Xu, Y; Xue, L; Xun, J; Yaffe, MB; Yalew, A; Yamamoto, S; Yan, D; Yan, H; Yan, S; Yan, X; Yang, AD; Yang, E; Yang, H; Yang, J; Yang, JL; Yang, K; Yang, M; Yang, P; Yang, Q; Yang, S; Yang, W; Yang, X; Yang, Y; Yao, JC; Yao, WL; Yao, Y; Yaqub, TB; Ye, J; Ye, W; Yen, CW; Yeter, HH; Yin, C; Yip, V; Yong-Yi, J; Yu, HJ; Yu, MF; Yu, S; Yu, W; Yu, WW; Yu, X; Yuan, P; Yuan, Q; Yue, XY; Zaia, AA; Zakhary, SY; Zalwango, F; Zamalloa, A; Zamparo, P; Zampini, IC; Zani, JL; Zeitoun, R; Zeng, N; Zenteno, JC; Zepeda-Palacio, C; Zhai, C; Zhang, B; Zhang, G; Zhang, J; Zhang, K; Zhang, Q; Zhang, R; Zhang, T; Zhang, X; Zhang, Y; Zhang, YY; Zhao, B; Zhao, D; Zhao, G; Zhao, H; Zhao, Q; Zhao, R; Zhao, S; Zhao, T; Zhao, X; Zhao, XA; Zhao, Y; Zhao, Z; Zheng, Z; Zhi-Min, G; Zhou, CL; Zhou, HD; Zhou, J; Zhou, W; Zhou, XQ; Zhou, Z; Zhu, C; Zhu, H; Zhu, L; Zhu, Y; Zitzmann, N; Zou, L; Zou, Y, 2022
)
0.72
" Treatment of resistant tuberculosis (TB) was streamlined with the World Health Organization (WHO) recommendations, and new tables on immune reconstitution inflammatory syndrome, on when to start ART in the presence of opportunistic infections and on TB drug dosing were included."( 2019 update of the European AIDS Clinical Society Guidelines for treatment of people living with HIV version 10.0.
Arribas, JR; Battegay, M; Béguelin, C; Bhagani, S; Cinque, P; Collins, S; Cotter, A; De Miguel, R; Guaraldi, G; Kirk, O; Kowalska, JD; Mallon, P; Marzolini, C; Molina, JM; Podlekareva, D; Rauch, A; Ryom, L; Winston, A, 2020
)
0.56
"PK and safety findings for ZDV, 3TC, and LPV/r support current WHO weight band dosing of syrup formulations in children with SAM."( Pharmacokinetics and Safety of Zidovudine, Lamivudine, and Lopinavir/Ritonavir in HIV-infected Children With Severe Acute Malnutrition in Sub-Saharan Africa: IMPAACT Protocol P1092.
Aweeka, F; Bradford, S; Browning, R; Coletti, A; Costello, D; Graham, B; Hughes, E; Kamthunzi, P; Kawalazira, R; Mmbaga, BT; Moye, J; Musoke, P; Nathoo, K; Norman, J; Owor, M; Purdue, L; Reding, C; Tierney, C; Whalen, ME; Wiesner, L; Ziemba, L, 2021
)
0.88
"A novel method was developed for the simultaneous estimation of the doravirine, lamivudine, and tenofovir disoproxil fumarate in the pharmaceutical dosage form."( A simple alternative and improved HPLC method for the estimation of doravirine, lamivudine, and tenofovir disoproxil fumarate in solid oral dosage form.
Alegete, P; Kancherla, P; Kokkirala, TK; Suryakala, D, 2021
)
1.08
" Dosing with raltegravir alone provided modest ex vivo HIV protection with higher drug levels in rectal tissue and vaginal tissue than in plasma on and off PrEP."( Pharmacokinetic/pharmacodynamic investigation of raltegravir with or without lamivudine in the context of HIV-1 pre-exposure prophylaxis (PrEP).
Amara, A; Boffito, M; Challenger, E; Dickinson, L; Egan, D; Else, L; Fox, J; Herrera, C; Khoo, S; Lee, M; Lwanga, J; Mantori, S; Penchala, SD; Shattock, R, 2021
)
0.85
" partial least square (PLS) and genetic algorithm (GA) were utilized for the simultaneous determination of the vital ternary antiretroviral therapy dolutegravir (DTG), lamivudine (LMV), and abacavir (ACV) in their combined dosage form."( Analysis of the ternary antiretroviral therapy dolutegravir, lamivudine and abacavir using UV spectrophotometry and chemometric tools.
Abdelzaher, AM; Elmaaty, AA; Hasan, MA; Serag, A; Tolba, EH, 2022
)
1.16
"This is an open-label, randomized, fixed sequence single intravenous dosing study to assess pharmacokinetic interactions between remdesivir and TDF/3TC (Study A, crossover design) or TDF/3TC plus ATV/r (Study B)."( An open-label, randomized, single intravenous dosing study to investigate the effect of fixed-dose combinations of tenofovir/lamivudine or atazanavir/ritonavir on the pharmacokinetics of remdesivir in Ugandan healthy volunteers (RemTLAR).
Byakika-Kibwika, P; D'Avolio, A; Kaboggoza, JP; Lamorde, M; Waitt, C; Walimbwa, SI, 2021
)
0.83
" There is an urgent need for optimal pediatric formulations of dolutegravir as single-entity (SE) and fixed-dose combination (FDC) to ensure correct dosing and adherence for swallowing and palatability."( Development of Dolutegravir Single-entity and Fixed-dose Combination Formulations for Children.
Adkison, KK; Baker, M; Brothers, C; Buchanan, AM; Davies, M; Parasrampuria, R; Sewell, N; Singh, RP; Wolstenholme, A, 2022
)
0.72
"These studies demonstrate the successful development of pediatric dolutegravir-containing formulations as SE and FDC that permit pediatric dosing in line with WHO recommendations."( Development of Dolutegravir Single-entity and Fixed-dose Combination Formulations for Children.
Adkison, KK; Baker, M; Brothers, C; Buchanan, AM; Davies, M; Parasrampuria, R; Sewell, N; Singh, RP; Wolstenholme, A, 2022
)
0.72
"A simple, selective and rapid ultra performance liquid chromatography-tandem mass spectrometry method was developed and validated for the simultaneous estimation of dolutegravir, lamivudine and tenofovir in bulk and tablet dosage form."( Development and validation of ultra performance liquid chromatography-tandem mass spectrometry method for the simultaneous estimation of dolutegravir, lamivudine and tenofovir in bulk and tablet dosage form.
Dodda, S; Gangarapu, K; Veerareddy, V, 2021
)
1.01
" This study aimed to develop a population pharmacokinetic model for oral lamivudine in Chinese HIV-infected adults and to determine the optimal lamivudine dosage regimens."( Population pharmacokinetics and model-informed precision dosing of lamivudine in Chinese HIV-infected patients with mild and moderate impaired renal function.
Jiao, Z; Liu, L; Liu, X; Lu, H; Meng, X; Sun, T; Wang, J; Wen, H; Xing, Y; Xu, F; Yin, L; Zhang, L; Zhang, M; Zhang, R, 2022
)
1.19
" Additionally, a model-informed dosage regimen is recommended for patients with impaired renal function."( Population pharmacokinetics and model-informed precision dosing of lamivudine in Chinese HIV-infected patients with mild and moderate impaired renal function.
Jiao, Z; Liu, L; Liu, X; Lu, H; Meng, X; Sun, T; Wang, J; Wen, H; Xing, Y; Xu, F; Yin, L; Zhang, L; Zhang, M; Zhang, R, 2022
)
0.96
"Dolutegravir concentrations are reduced by efavirenz induction effect necessitating twice-daily dolutegravir dosing when coadministered."( Initial Supplementary Dose of Dolutegravir in Second-Line Antiretroviral Therapy: A Noncomparative, Double-Blind, Randomized Placebo-Controlled Trial.
Griesel, R; Hill, A; Keene, C; Maartens, G; Meintjes, G; Omar, Z; Simmons, B; van Zyl, G; Zhao, Y, 2023
)
0.91
"To develop an injectable dosage form of the daily oral HIV drugs, tenofovir (T), lamivudine (L), and dolutegravir (D), creating a single, complete, all-in-one TLD 3-drug-combination that demonstrates long-acting pharmacokinetics."( A novel formulation enabled transformation of 3-HIV drugs tenofovir-lamivudine-dolutegravir from short-acting to long-acting all-in-one injectable.
Collier, AC; Delle Fratte, R; Eguchi, M; Ho, RJY; Melvin, AJ; Perazzolo, S; Stephen, ZR; Xu, X, 2023
)
1.37
"One of the main challenges in the development of long-acting injectables for HIV treatment is the limited duration of drug release, which results in the need for frequent dosing and reduced patient adherence."( Constructing Antiretroviral Supramolecular Polymers as Long-Acting Injectables through Rational Design of Drug Amphiphiles with Alternating Antiretroviral-Based and Hydrophobic Residues.
Cui, H; Flexner, C; Monroe, MK; Sun, M; Wang, F; Wang, H, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (6)

RoleDescription
HIV-1 reverse transcriptase inhibitorAn entity which inhibits the activity of HIV-1 reverse transcriptase.
antiviral drugA substance used in the prophylaxis or therapy of virus diseases.
anti-HBV agentAn antiviral agent that destroys or inhibits the replication of the hepatitis B virus.
allergenA chemical compound, or part thereof, which causes the onset of an allergic reaction by interacting with any of the molecular pathways involved in an allergy.
prodrugA compound that, on administration, must undergo chemical conversion by metabolic processes before becoming the pharmacologically active drug for which it is a prodrug.
EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitorA DNA polymerase inhibitor that interferes with the activity of reverse transcriptase, EC 2.7.7.49, a viral DNA polymerase enzyme that retroviruses need in order to reproduce.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (4)

ClassDescription
monothioacetalA thioacetal having the structure R2C(OR')(SR'). The term includes monothioketals, R =/= H, as a subclass.
primary alcoholA primary alcohol is a compound in which a hydroxy group, -OH, is attached to a saturated carbon atom which has either three hydrogen atoms attached to it or only one other carbon atom and two hydrogen atoms attached to it.
oxacycleAny organic heterocyclic compound containing at least one ring oxygen atom.
nucleoside analogueAn analogue of a nucleoside, being an N-glycosyl compound in which the nitrogen-containing moiety is a modified nucleotide base. They are commonly used as antiviral products to prevent viral replication in infected cells.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (2)

PathwayProteinsCompounds
Lamivudine Metabolism Pathway1816
Lamivudine Action Pathway05

Protein Targets (22)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Microtubule-associated protein tauHomo sapiens (human)Potency3.54810.180013.557439.8107AID1468
lamin isoform A-delta10Homo sapiens (human)Potency35.48130.891312.067628.1838AID1487
Chain A, MAJOR APURINIC/APYRIMIDINIC ENDONUCLEASEHomo sapiens (human)Potency0.79430.003245.467312,589.2998AID2517
TDP1 proteinHomo sapiens (human)Potency17.09800.000811.382244.6684AID686978; AID686979
AR proteinHomo sapiens (human)Potency10.00000.000221.22318,912.5098AID588516
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency2.53730.000214.376460.0339AID720691
estrogen nuclear receptor alphaHomo sapiens (human)Potency10.68220.000229.305416,493.5996AID743069
chromobox protein homolog 1Homo sapiens (human)Potency89.12510.006026.168889.1251AID540317
potassium voltage-gated channel subfamily H member 2 isoform dHomo sapiens (human)Potency14.12540.01789.637444.6684AID588834
thyroid hormone receptor beta isoform 2Rattus norvegicus (Norway rat)Potency27.30600.000323.4451159.6830AID743065
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
ATP-binding cassette sub-family C member 3Homo sapiens (human)IC50 (µMol)133.00000.63154.45319.3000AID1473740
Multidrug resistance-associated protein 4Homo sapiens (human)IC50 (µMol)133.00000.20005.677410.0000AID1473741
Voltage-dependent L-type calcium channel subunit alpha-1FHomo sapiens (human)IC50 (µMol)54.20000.00032.63119.0000AID1207746
Bile salt export pumpHomo sapiens (human)IC50 (µMol)133.00000.11007.190310.0000AID1473738
Voltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)IC50 (µMol)54.20000.00032.59559.0000AID1207746
Capsid protein Hepatitis B virusIC50 (µMol)50.05000.10000.26500.4300AID1555312; AID1555320
Voltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)IC50 (µMol)54.20000.00032.63119.0000AID1207746
Voltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)IC50 (µMol)54.20000.00032.25459.6000AID1207746
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Hsf1 proteinMus musculus (house mouse)EC50 (µMol)0.28700.160024.4900236.5000AID2382
AlbuminHomo sapiens (human)Kd44.00000.08933.31358.0000AID1238542
Capsid protein Hepatitis B virusEC50 (µMol)5.18500.00020.26030.8194AID1377846; AID1771356
Reverse transcriptase/RNaseH Human immunodeficiency virus 1EC50 (µMol)25.02100.00040.61539.7000AID200001; AID200002
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (88)

Processvia Protein(s)Taxonomy
xenobiotic metabolic processATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
bile acid and bile salt transportATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transportATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
leukotriene transportATP-binding cassette sub-family C member 3Homo sapiens (human)
monoatomic anion transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transport across blood-brain barrierATP-binding cassette sub-family C member 3Homo sapiens (human)
prostaglandin secretionMultidrug resistance-associated protein 4Homo sapiens (human)
cilium assemblyMultidrug resistance-associated protein 4Homo sapiens (human)
platelet degranulationMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic metabolic processMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
bile acid and bile salt transportMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transportMultidrug resistance-associated protein 4Homo sapiens (human)
urate transportMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cAMP transportMultidrug resistance-associated protein 4Homo sapiens (human)
leukotriene transportMultidrug resistance-associated protein 4Homo sapiens (human)
monoatomic anion transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
export across plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
transport across blood-brain barrierMultidrug resistance-associated protein 4Homo sapiens (human)
guanine nucleotide transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
visual perceptionVoltage-dependent L-type calcium channel subunit alpha-1FHomo sapiens (human)
detection of light stimulus involved in visual perceptionVoltage-dependent L-type calcium channel subunit alpha-1FHomo sapiens (human)
calcium ion import across plasma membraneVoltage-dependent L-type calcium channel subunit alpha-1FHomo sapiens (human)
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
cellular response to starvationAlbuminHomo sapiens (human)
negative regulation of mitochondrial depolarizationAlbuminHomo sapiens (human)
cellular response to calcium ion starvationAlbuminHomo sapiens (human)
cellular oxidant detoxificationAlbuminHomo sapiens (human)
transportAlbuminHomo sapiens (human)
calcium ion transportVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathwayVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
sensory perception of soundVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
positive regulation of adenylate cyclase activityVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
positive regulation of calcium ion transportVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
regulation of atrial cardiac muscle cell membrane repolarizationVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
calcium ion importVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
calcium ion transmembrane transportVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
cardiac muscle cell action potential involved in contractionVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
membrane depolarization during cardiac muscle cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
membrane depolarization during SA node cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
regulation of heart rate by cardiac conductionVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
regulation of potassium ion transmembrane transporter activityVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
regulation of potassium ion transmembrane transportVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
calcium ion import across plasma membraneVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
skeletal system developmentVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
extraocular skeletal muscle developmentVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
calcium ion transportVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
muscle contractionVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
striated muscle contractionVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
endoplasmic reticulum organizationVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
myoblast fusionVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
neuromuscular junction developmentVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
skeletal muscle adaptationVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
positive regulation of muscle contractionVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
skeletal muscle fiber developmentVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
release of sequestered calcium ion into cytosolVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
calcium ion transmembrane transportVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
cellular response to caffeineVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
calcium ion import across plasma membraneVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
immune system developmentVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
positive regulation of cytosolic calcium ion concentrationVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
heart developmentVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
regulation of cardiac muscle contraction by regulation of the release of sequestered calcium ionVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
embryonic forelimb morphogenesisVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
camera-type eye developmentVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
positive regulation of adenylate cyclase activityVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
positive regulation of muscle contractionVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
calcium ion transport into cytosolVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
cardiac conductionVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
calcium ion transmembrane transport via high voltage-gated calcium channelVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
calcium ion transmembrane transportVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
cardiac muscle cell action potential involved in contractionVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
membrane depolarization during cardiac muscle cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
membrane depolarization during AV node cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
cell communication by electrical coupling involved in cardiac conductionVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
regulation of heart rate by cardiac conductionVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
regulation of ventricular cardiac muscle cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
membrane depolarization during atrial cardiac muscle cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
calcium ion import across plasma membraneVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
xenobiotic metabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of gene expressionCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bile acid and bile salt transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
heme catabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic export from cellCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transepithelial transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
leukotriene transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
monoatomic anion transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (47)

Processvia Protein(s)Taxonomy
ATP bindingATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type bile acid transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATP hydrolysis activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
icosanoid transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
guanine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ATP bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type xenobiotic transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
urate transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
purine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type bile acid transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
efflux transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATP hydrolysis activityMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
voltage-gated calcium channel activityVoltage-dependent L-type calcium channel subunit alpha-1FHomo sapiens (human)
metal ion bindingVoltage-dependent L-type calcium channel subunit alpha-1FHomo sapiens (human)
high voltage-gated calcium channel activityVoltage-dependent L-type calcium channel subunit alpha-1FHomo sapiens (human)
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
oxygen bindingAlbuminHomo sapiens (human)
DNA bindingAlbuminHomo sapiens (human)
fatty acid bindingAlbuminHomo sapiens (human)
copper ion bindingAlbuminHomo sapiens (human)
protein bindingAlbuminHomo sapiens (human)
toxic substance bindingAlbuminHomo sapiens (human)
antioxidant activityAlbuminHomo sapiens (human)
pyridoxal phosphate bindingAlbuminHomo sapiens (human)
identical protein bindingAlbuminHomo sapiens (human)
protein-folding chaperone bindingAlbuminHomo sapiens (human)
exogenous protein bindingAlbuminHomo sapiens (human)
enterobactin bindingAlbuminHomo sapiens (human)
high voltage-gated calcium channel activityVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
voltage-gated calcium channel activityVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
calcium channel activityVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
protein bindingVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
ankyrin bindingVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
metal ion bindingVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
alpha-actinin bindingVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
voltage-gated calcium channel activity involved in cardiac muscle cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
voltage-gated calcium channel activity involved SA node cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
voltage-gated calcium channel activityVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
protein bindingVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
calmodulin bindingVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
high voltage-gated calcium channel activityVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
small molecule bindingVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
metal ion bindingVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
molecular function activator activityVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
high voltage-gated calcium channel activityVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
voltage-gated calcium channel activity involved in cardiac muscle cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
voltage-gated calcium channel activityVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
protein bindingVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
calmodulin bindingVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
high voltage-gated calcium channel activityVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
metal ion bindingVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
alpha-actinin bindingVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
voltage-gated calcium channel activity involved in cardiac muscle cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
voltage-gated calcium channel activity involved in AV node cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
protein bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
organic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type xenobiotic transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP hydrolysis activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (37)

Processvia Protein(s)Taxonomy
plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basal plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basolateral plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
nucleolusMultidrug resistance-associated protein 4Homo sapiens (human)
Golgi apparatusMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
platelet dense granule membraneMultidrug resistance-associated protein 4Homo sapiens (human)
external side of apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
photoreceptor outer segmentVoltage-dependent L-type calcium channel subunit alpha-1FHomo sapiens (human)
membraneVoltage-dependent L-type calcium channel subunit alpha-1FHomo sapiens (human)
perikaryonVoltage-dependent L-type calcium channel subunit alpha-1FHomo sapiens (human)
voltage-gated calcium channel complexVoltage-dependent L-type calcium channel subunit alpha-1FHomo sapiens (human)
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
extracellular regionAlbuminHomo sapiens (human)
extracellular spaceAlbuminHomo sapiens (human)
nucleusAlbuminHomo sapiens (human)
endoplasmic reticulumAlbuminHomo sapiens (human)
endoplasmic reticulum lumenAlbuminHomo sapiens (human)
Golgi apparatusAlbuminHomo sapiens (human)
platelet alpha granule lumenAlbuminHomo sapiens (human)
extracellular exosomeAlbuminHomo sapiens (human)
blood microparticleAlbuminHomo sapiens (human)
protein-containing complexAlbuminHomo sapiens (human)
cytoplasmAlbuminHomo sapiens (human)
plasma membraneVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
Z discVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
voltage-gated calcium channel complexVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
L-type voltage-gated calcium channel complexVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
cytoplasmVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
plasma membraneVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
sarcoplasmic reticulumVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
T-tubuleVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
I bandVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
L-type voltage-gated calcium channel complexVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
voltage-gated calcium channel complexVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
cytoplasmVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
plasma membraneVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
postsynaptic densityVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
membraneVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
Z discVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
dendriteVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
perikaryonVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
postsynaptic density membraneVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
L-type voltage-gated calcium channel complexVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
voltage-gated calcium channel complexVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell surfaceCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
intercellular canaliculusCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (1418)

Assay IDTitleYearJournalArticle
AID358077Cytotoxicity against HBV transfected human adriamycin-resistant wild type HepW10 cells by MTT assay2007Proceedings of the National Academy of Sciences of the United States of America, May-15, Volume: 104, Issue:20
Unique antiviral mechanism discovered in anti-hepatitis B virus research with a natural product analogue.
AID266288Antiviral activity against HBV M204I mutant transfected in B1 cell line at 10 ug/mL2006Journal of medicinal chemistry, Jun-15, Volume: 49, Issue:12
Effect of various pyrimidines possessing the 1-[(2-hydroxy-1-(hydroxymethyl)ethoxy)methyl] moiety, able to mimic natural 2'-deoxyribose, on wild-type and mutant hepatitis B virus replication.
AID519860Antiviral activity against HIV1 subtype B-SF-2 infected in 1 hr-pretreated human MT2 cells assessed as inhibition of multicycle replication measured on day 5 postinfection by RT SPA2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID1351358Antiviral activity against HBV infected in human HepG2(2.2.15) cells assessed as inhibition of viral DNA replication at 100 uM after 72 hrs by RT-PCR method relative to control2018European journal of medicinal chemistry, Jan-20, Volume: 144Design, synthesis and evaluation of novel phenyl propionamide derivatives as non-nucleoside hepatitis B virus inhibitors.
AID353553Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for HBV early antigen secretion2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Anti-HBV agents. Part 2: synthesis and in vitro anti-hepatitis B virus activities of alisol A derivatives.
AID246422In vitro effective concentration against Lamivudine resistant HIV-1 mutant M184V in human peripheral blood mononuclear cells2005Journal of medicinal chemistry, Jun-02, Volume: 48, Issue:11
Synthesis, antiviral activity, and mechanism of drug resistance of D- and L-2',3'-didehydro-2',3'-dideoxy-2'-fluorocarbocyclic nucleosides.
AID1320784Antiviral activity against HBV ayw1 infected in human HepG2(2.2.15) cells assessed as reduction in viral replication by measuring intracellular viral DNA copy number after 6 days by real-time qPCR method2016Journal of medicinal chemistry, Oct-27, Volume: 59, Issue:20
Amidate Prodrugs of Deoxythreosyl Nucleoside Phosphonates as Dual Inhibitors of HIV and HBV Replication.
AID404999Antiviral activity against HBeAg-deficient HBV genotype D with precore G1896A mutation and reverse transcriptase M204I mutation in human Huh7 cells assessed as viral replication yield at 1 uM after 5 days relative to control2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID1555319Inhibition of capsid protein in wild type Hepatitis B virus infected in human HepG2.2.15 cells assessed as reduction in viral DNA level at 100 uM measured after 72 hrs by PCR analysis relative to control2019European journal of medicinal chemistry, Aug-15, Volume: 176Assessment of quinazolinone derivatives as novel non-nucleoside hepatitis B virus inhibitors.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID235481Selectivity index is the ratio of CC50 to EC50 values2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Potent nonclassical nucleoside antiviral drugs based on the N,N-diarylformamidine concept.
AID558373Drug level in HIV-infected pregnant woman cord blood plasma at 150 mg, po BID by LC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Genital tract, cord blood, and amniotic fluid exposures of seven antiretroviral drugs during and after pregnancy in human immunodeficiency virus type 1-infected women.
AID1636357Drug activation in human Hep3B cells assessed as human CYP3A4-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 300 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of NA2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID574198Cytotoxicity against human skeletal muscle Myotube assessed as change in POLG mitochondrial RNA level on day 5 by RT-PCR relative to untreated control2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Impact of nucleoside reverse transcriptase inhibitors on mitochondrial DNA and RNA in human skeletal muscle cells.
AID450971Cytotoxicity against human PBMC after 7 days by sulforhodamine B assay2009Bioorganic & medicinal chemistry, Sep-01, Volume: 17, Issue:17
Synthesis and anti-HIV activity of novel 2',3'-dideoxy-3'-thiacytidine prodrugs.
AID682494Antiviral activity against multidrug-resistant HIV1 4755-5 clade B clinical isolate infected in PHA-stimulated human PBMC assessed as inhibition of viral replication incubated for 6 hrs followed by compound-wash out measured after 6 days by liquid scintil2012Journal of medicinal chemistry, May-24, Volume: 55, Issue:10
Synthesis and biological evaluation of fatty acyl ester derivatives of (-)-2',3'-dideoxy-3'-thiacytidine.
AID1228533Antiviral activity against duck Hepatitis B virus infected in duck assessed as inhibition of viral DNA replication in liver at 20 mg/kg/day, po measured after 3 days of treatment withdrawal2015Journal of medicinal chemistry, May-14, Volume: 58, Issue:9
Synthesis and biological evaluation of 4-substituted fluoronucleoside analogs for the treatment of hepatitis B virus infection.
AID1869632Antiviral activity against wild type HBV infected in human HepG2 2.2.15 cells assessed as reduction in viral replication by DNA HYB (RI)/neutral red (Tox) assay2022Journal of medicinal chemistry, 07-14, Volume: 65, Issue:13
Reshaping an Acyclic Nucleoside Phosphonate into a Selective Anti-hepatitis B Virus Compound.
AID404991Antiviral activity against HBV genotype D in human Huh7 cells assessed as viral replication yield at 1 uM after 5 days relative to control2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID519963Antiviral activity against HIV1 3B infected in MOLT-4/3B cells assessed as inhibition of mature virus release measured after 4 days of infection by RT assay2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID685498Antiviral activity against HIV1 3B assessed as inhibition of infection in HeLa P4/R5 cells expressing CD4 receptor and beta-gal incubated for 2 hrs followed by compound-wash out measured after 46 hrs by single round infection MAGI assay2012Journal of medicinal chemistry, May-24, Volume: 55, Issue:10
Synthesis and biological evaluation of fatty acyl ester derivatives of (-)-2',3'-dideoxy-3'-thiacytidine.
AID1693334Antiviral activity against HBV infected in human HepG2 2.2.15 cells assessed as decrease in extracellular viral DNA level at 0.8 uM measured after incubation of 6 days by RT-PCR analysis2021Bioorganic & medicinal chemistry, 01-01, Volume: 29Synthesis and evaluation of new phenyl acrylamide derivatives as potent non-nucleoside anti-HBV agents.
AID423215Antiviral activity against HBV infected in human HepG2 2.2.15 cells assessed as inhibition of HBeAg secretion at 200 ug/mL after 9 days by ELISA2009Journal of natural products, Apr, Volume: 72, Issue:4
Schisanwilsonenes A-C, anti-HBV Carotane sesquiterpenoids from the fruits of Schisandra wilsoniana.
AID454485Antiviral activity against HBV infected in human HepG2.2.15 cells assessed as inhibition of viral DNA replication2010Bioorganic & medicinal chemistry letters, Jan-01, Volume: 20, Issue:1
2,4-Diaryl-4,6,7,8-tetrahydroquinazolin-5(1H)-one derivatives as anti-HBV agents targeting at capsid assembly.
AID1599855Cytotoxicity against human HepG2.2.15 cells infected with HBV2019ACS medicinal chemistry letters, Jun-13, Volume: 10, Issue:6
Design, Synthesis, and Anti-HBV Activity of New Bis(l-amino acid) Ester Tenofovir Prodrugs.
AID1055510Antiviral activity against HIV2 ROD infected in human CEM cells assessed as virus-induced giant cell formation after 4 days by microscopic analysis2013European journal of medicinal chemistry, , Volume: 70Design, synthesis and biological evaluation of phosphorodiamidate prodrugs of antiviral and anticancer nucleosides.
AID527282Antiviral activity against HBV infected in duck primary hepatocytes2010Bioorganic & medicinal chemistry letters, Nov-15, Volume: 20, Issue:22
Antiviral activity of 2,3'-anhydro and related pyrimidine nucleosides against hepatitis B virus.
AID1197452Antiviral activity against HBV infected in human HepG2(2.2.15) cells assessed as inhibition of viral DNA replication2015Bioorganic & medicinal chemistry, Feb-15, Volume: 23, Issue:4
Synthesis and anti-hepatitis B virus activity of C4 amide-substituted isosteviol derivatives.
AID576240Cmin in HIV-1 infected children aged 8.5 to 12.3 years at 4 mg/kg, po every 12 hrs by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID563941Antiviral activity against HIV1 pNL4-3 harboring Reverse transcriptase P119S/M184V mutant gene infected in TZM-bl cells after 72 hrs by luciferase assay2009Antimicrobial agents and chemotherapy, Nov, Volume: 53, Issue:11
Impact of novel human immunodeficiency virus type 1 reverse transcriptase mutations P119S and T165A on 4'-ethynylthymidine analog resistance profile.
AID311524Oral bioavailability in human2007Bioorganic & medicinal chemistry, Dec-15, Volume: 15, Issue:24
Hologram QSAR model for the prediction of human oral bioavailability.
AID1565093Selectivity index, ratio of CC50 for human MT4 cells to EC50 for antiviral activity against HIV IIIB
AID1862269Cytotoxicity against human MT4 cells assessed as reduction in cell viability measured after 5 days by MTT assay2022European journal of medicinal chemistry, Oct-05, Volume: 240Design, synthesis, and biological evaluation of novel double-winged galloyl derivatives as HIV-1 RNase H inhibitors.
AID1226104Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBsAg secretion at 37.5 uM after 9 days by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID1449529Mitochondrial toxicity in human HepG2 cells assessed as cytochrome c oxidase subunit 2 DNA levels at 10 uM measured on day 14 by RT-PCR method relative to nuclear beta-actin DNA levels2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID563936Antiviral activity against wild-type HIV1 pNL4-3 infected in TZM-bl cells by luciferase assay2009Antimicrobial agents and chemotherapy, Nov, Volume: 53, Issue:11
Impact of novel human immunodeficiency virus type 1 reverse transcriptase mutations P119S and T165A on 4'-ethynylthymidine analog resistance profile.
AID738969Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBeAg secretion after 12 days by ELISA2013Bioorganic & medicinal chemistry letters, Apr-01, Volume: 23, Issue:7
Anti-hepatitis B virus lignans from the root of Streblus asper.
AID1055514Cytostatic activity against human Caco2 cells assessed as growth inhibition after 3 days by particle counting analysis2013European journal of medicinal chemistry, , Volume: 70Design, synthesis and biological evaluation of phosphorodiamidate prodrugs of antiviral and anticancer nucleosides.
AID404909Cytotoxicity against human HepG2 cells after 3 days by MTT assay2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
Strong and selective inhibitors of hepatitis B virus replication among novel N4-hydroxy- and 5-methyl-beta-L-deoxycytidine analogues.
AID557045Antiviral activity against HIV1 CRF17_BF harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID517944Antiviral activity against HIV1 expressing reverse transcriptase K103N/Y181C/G190A mutant infected in HEK293 cells assessed as inhibition of virus replication after 72 hrs2010Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6
Telbivudine exhibits no inhibitory activity against HIV-1 clinical isolates in vitro.
AID586263Antiviral activity against Human immunodeficiency virus 1 3B infected in human MT2 cells assessed as inhibition of virus induced cytopathic effect measured after 2 to 3 days by PCR2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID541157Selectivity ratio of EC50 for antiviral activity against GS-9160-resistant HIV1 selected after 6 low passages to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID626003Fold resistance, ratio of EC90 for adefovir-resistant Hepatitis B virus harboring reverse transcriptase N236T mutant to EC90 for wild type Hepatitis B virus2011Bioorganic & medicinal chemistry letters, Nov-01, Volume: 21, Issue:21
Antiviral activity of novel 2'-fluoro-6'-methylene-carbocyclic adenosine against wild-type and drug-resistant hepatitis B virus mutants.
AID245894Cytotoxic concentration to inhibit replication in 2.2.15 cells2005Journal of medicinal chemistry, Jan-13, Volume: 48, Issue:1
Nucleotides and pronucleotides of 2,2-bis(hydroxymethyl)methylenecyclopropane analogues of purine nucleosides: synthesis and antiviral activity.
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID252413Fold increase in ratio of EC50 against HIV-1 M184V to that of EC50 against HIV-1wild type2005Journal of medicinal chemistry, Jun-02, Volume: 48, Issue:11
Synthesis, antiviral activity, and mechanism of drug resistance of D- and L-2',3'-didehydro-2',3'-dideoxy-2'-fluorocarbocyclic nucleosides.
AID322851Fold resistance, ratio of entecavir-resistant HBV with reverse transcriptase L180M/S202G/M204V mutant to wild-type HBV genotype H2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID444058Volume of distribution at steady state in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1693335Antiviral activity against HBV infected in human HepG2 2.2.15 cells assessed as decrease in extracellular viral DNA level measured after incubation of 6 days by RT-PCR analysis2021Bioorganic & medicinal chemistry, 01-01, Volume: 29Synthesis and evaluation of new phenyl acrylamide derivatives as potent non-nucleoside anti-HBV agents.
AID410758Antiviral activity against adefovir-resistant HBV reverse transcriptase M204I mutant in human Huh7 cells after 4 days by intracellular HBV DNA replication assay2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Synthesis and anti-hepatitis B virus and anti-hepatitis C virus activities of 7-deazaneplanocin A analogues in vitro.
AID467613Volume of distribution at steady state in human2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Prediction of volume of distribution values in human using immobilized artificial membrane partitioning coefficients, the fraction of compound ionized and plasma protein binding data.
AID226233Fold increase ratio of HIV-1M184V to HIV-1XXBRU2003Journal of medicinal chemistry, Jul-17, Volume: 46, Issue:15
l-2',3'-Didehydro-2',3'-dideoxy-3'-fluoronucleosides: synthesis, anti-HIV activity, chemical and enzymatic stability, and mechanism of resistance.
AID410760Antiviral activity against adefovir-resistant HBV reverse transcriptase 236T mutant in human Huh7 cells after 4 days by intracellular HBV DNA replication assay2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Synthesis and anti-hepatitis B virus and anti-hepatitis C virus activities of 7-deazaneplanocin A analogues in vitro.
AID1226112Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBeAg secretion at 37.5 uM after 3 days by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID358085Inhibition of HBV promoter in human HepG2 cells by luciferase reporter gene assay2007Proceedings of the National Academy of Sciences of the United States of America, May-15, Volume: 104, Issue:20
Unique antiviral mechanism discovered in anti-hepatitis B virus research with a natural product analogue.
AID626001Antiviral activity against adefovir-resistant Hepatitis B virus harboring reverse transcriptase N236T mutant infected in human HepG2(2.2.15) cells assessed as inhibition of virus replication treated daily for 9 days by quantitative blot hybridization meth2011Bioorganic & medicinal chemistry letters, Nov-01, Volume: 21, Issue:21
Antiviral activity of novel 2'-fluoro-6'-methylene-carbocyclic adenosine against wild-type and drug-resistant hepatitis B virus mutants.
AID517842Cytotoxicity against HuH7 cells2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Antiviral activity of various 1-(2'-deoxy-β-D-lyxofuranosyl), 1-(2'-fluoro-β-D-xylofuranosyl), 1-(3'-fluoro-β-D-arabinofuranosyl), and 2'-fluoro-2',3'-didehydro-2',3'-dideoxyribose pyrimidine nucleoside analogues against duck hepatitis B virus (DHBV) and
AID105891Cytotoxicity against uninfected MT-4 cells1995Journal of medicinal chemistry, May-12, Volume: 38, Issue:10
Benzophenone derivatives: a novel series of potent and selective inhibitors of human immunodeficiency virus type 1 reverse transcriptase.
AID354454Cytotoxicity against human HOG.R5 cells at 40 ug/ml after 4 days2004Journal of natural products, Jun, Volume: 67, Issue:6
New 3-O-acyl betulinic acids from Strychnos vanprukii Craib.
AID152656Inhibition of cell growth against HIV-1 infected PBM (Human peripheral blood mononuclear) cells1993Journal of medicinal chemistry, Sep-03, Volume: 36, Issue:18
Structure-activity relationships of beta-D-(2S,5R)- and alpha-D-(2S,5S)-1,3-oxathiolanyl nucleosides as potential anti-HIV agents.
AID1200846Selectivity index, ratio of CC50 for mock-infected human MT4 cells to EC50 for HIV1 3B infected in human MT4 cells2015European journal of medicinal chemistry, Mar-26, Volume: 93Fused heterocycles bearing bridgehead nitrogen as potent HIV-1 NNRTIs. Part 4: design, synthesis and biological evaluation of novel imidazo[1,2-a]pyrazines.
AID154956Anti-HIV-1 activity against human peripheral blood mononuclear (PBM) cells infected with HIV-1 strain LAV1993Journal of medicinal chemistry, Jan-22, Volume: 36, Issue:2
Asymmetric synthesis and biological evaluation of beta-L-(2R,5S)- and alpha-L-(2R,5R)-1,3-oxathiolane-pyrimidine and -purine nucleosides as potential anti-HIV agents.
AID1507022Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of viral DNA replication at 0.8 uM after 8 days by real time fluorescent PCR method relative to control2017European journal of medicinal chemistry, Aug-18, Volume: 136Design, synthesis and primary biological evaluation of the novel 2-pyridone derivatives as potent non-nucleoside HBV inhibitors.
AID266280Antiviral activity against HBV M204I mutant transfected in B1 cell line2006Journal of medicinal chemistry, Jun-15, Volume: 49, Issue:12
Effect of various pyrimidines possessing the 1-[(2-hydroxy-1-(hydroxymethyl)ethoxy)methyl] moiety, able to mimic natural 2'-deoxyribose, on wild-type and mutant hepatitis B virus replication.
AID105715Antiviral activity against HIV-1 resistant to 2-(2-Benzoyl-4-chloro-phenyl)-N-[4-(3-dimethylamino-propoxy)-2-methyl-phenyl]-acetamide in MT-4 cells1995Journal of medicinal chemistry, May-12, Volume: 38, Issue:10
Benzophenone derivatives: a novel series of potent and selective inhibitors of human immunodeficiency virus type 1 reverse transcriptase.
AID414790Antiviral activity against HBV in human HepG2(2.2.15) cells assessed as inhibition of viral genome replication after 9 days by Southern blot hybridization2009Bioorganic & medicinal chemistry, Apr-15, Volume: 17, Issue:8
Synthesis and anti-hepatitis B virus activities of Matijing-Su derivatives.
AID322825Inhibition of wild type HBV replication in Huh7 cells2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID732668Immunoregulatory activity in Hepatitis B virus infected transgenic mouse assessed as increase in CD4+/CD8+ population in peripheral blood at 100 mg/kg qd for 1 month by flow cytometry (Rvb = 0.9 +/-0.2%)2013Bioorganic & medicinal chemistry letters, Mar-01, Volume: 23, Issue:5
Synthesis and biological evaluation of nucleoside analogues than contain silatrane on the basis of the structure of acyclovir (ACV) as novel inhibitors of hepatitis B virus (HBV).
AID1687681Antiviral activity against HIV-1 K103N mutant strain infected in human MT4 cells assessed as reduction in virus-induced cytopathogenicity by MTT assay2020European journal of medicinal chemistry, Jan-15, Volume: 186Indazolyl-substituted piperidin-4-yl-aminopyrimidines as HIV-1 NNRTIs: Design, synthesis and biological activities.
AID444053Renal clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1401779Antiviral activity against Hepatitis B virus harboring rtV173L/L180M/M204V mutant infected in HepGRL1 cells assessed as inhibition of intracellular HBV DNA level at 20 uM measured on day 9 by FQ-PCR analysis relative to control2018European journal of medicinal chemistry, Jan-01, Volume: 143Design, synthesis, and biological evaluation of new 1,2,3-triazolo-2'-deoxy-2'-fluoro- 4'-azido nucleoside derivatives as potent anti-HBV agents.
AID1555321Selectivity index, ratio of CC50 for human HepG2.2.15 cells to IC50 for capsid protein in lamivudine/entecavir-resistant Hepatitis B virus harboring rtL180M/rtM204V/rt184L mutant infected in human HepG2.2.15 cells assessed as reduction in viral DNA level2019European journal of medicinal chemistry, Aug-15, Volume: 176Assessment of quinazolinone derivatives as novel non-nucleoside hepatitis B virus inhibitors.
AID458526Antiviral activity against Hepatitis B virus ayw in human 1.3ES2 cells stably transfected with 1.3 fold wild type HBV ayw strain genome cells assessed as reduction of viral DNA level after 6 days by RT-PCR2010Bioorganic & medicinal chemistry, Feb, Volume: 18, Issue:3
Synthesis and the biological evaluation of arylnaphthalene lignans as anti-hepatitis B virus agents.
AID427239Cytotoxicity against human HepG2(2.2.15) cells after 24 hrs by neutral red dye staining2009Bioorganic & medicinal chemistry, Jul-01, Volume: 17, Issue:13
Synthesis and in vitro anti-hepatitis B virus activity of 6H-[1]benzothiopyrano[4,3-b]quinolin-9-ols.
AID1226126Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBV DNA copies per uL at 150 uM after 6 days by real-time fluorescence quantitative PCR analysis2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID540097Cytotoxicity against human HepG2(2.2.15) after 9 days by neutral dye uptake method2010Bioorganic & medicinal chemistry letters, Dec-15, Volume: 20, Issue:24
Synthesis and biological evaluation of 1H-benzimidazol-5-ols as potent HBV inhibitors.
AID519866Antiviral activity against HIV1 subtype B-93US143 infected in 1 hr-pretreated PBMC cells assessed as inhibition of p24 antigen production measured on day 5 postinfection by ELISA2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID341746Drug level in human resting PBMC at 2.6 uM after 24 hrs2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
In vitro interactions between apricitabine and other deoxycytidine analogues.
AID1815394Resistance fold, ratio of EC50 for HIV1 harboring reverse transcriptase F227L/V106A double mutant infected MV4 cells to EC50 for wild type HIV1 infected MV4 cells2021European journal of medicinal chemistry, Dec-15, Volume: 226Design of the naphthyl-diarylpyrimidines as potent non-nucleoside reverse transcriptase inhibitors (NNRTIs) via structure-based extension into the entrance channel.
AID257335Inhibition of synthesis of extracellular virion DNA release in cultured human hepatoblastoma 2.2.15 cells2005Bioorganic & medicinal chemistry letters, Dec-15, Volume: 15, Issue:24
Synthesis and in vitro anti-hepatitis B and C virus activities of ring-expanded ('fat') nucleobase analogues containing the imidazo[4,5-e][1,3]diazepine-4,8-dione ring system.
AID322840Antiviral activity against Lamivudine -adenofir-resistant HBV with reverse transcriptase V173L/L180M/A181V/M204V mutant2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID1191974Selectivity index, ratio of CC50 for mock-infected human HeLa cells to EC50 for HIV2 ROD infected in human MT4 cells2015Bioorganic & medicinal chemistry letters, Mar-15, Volume: 25, Issue:6
Design, synthesis of new β-carboline derivatives and their selective anti-HIV-2 activity.
AID1363964Antiviral activity against lamivudine-resistant hepatitis B virus harboring reverse transcriptase M204I mutant infected in human Huh7 cells assessed as reduction in intracellular DNA levels measured on day 7 by real-time PCR analysis2017Bioorganic & medicinal chemistry, 02-01, Volume: 25, Issue:3
Discovery of hepatitis B virus capsid assembly inhibitors leading to a heteroaryldihydropyrimidine based clinical candidate (GLS4).
AID322831Fold resistance, ratio of EC50 for adenofir-resistant HBV with reverse transcriptase N236T mutant to EC50 for wild-type HBV2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID322850Fold resistance, ratio of Lamivudine -adenofir-resistant with HBV reverse transcriptase V173L/L180M/A181V/N236T mutant to wildtype HBV genotype E2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID541159Selectivity ratio of EC50 for antiviral activity against GS-9160-resistant HIV1 selected after 8 passages to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID682495Cytotoxicity against PHA-stimulated human PBMC incubated for 6 hrs followed by compound-wash out measured after 6 days2012Journal of medicinal chemistry, May-24, Volume: 55, Issue:10
Synthesis and biological evaluation of fatty acyl ester derivatives of (-)-2',3'-dideoxy-3'-thiacytidine.
AID1901998Cytotoxicity against human HepG2 2.2.15 cells infected with Hepatitis B virus assessed as reduction in cell growth by CCK8 assay2022European journal of medicinal chemistry, Mar-05, Volume: 231Design and synthesis of novel quinazolinone derivatives as anti-HBV agents with TLR8 agonist effect.
AID340711AUC (0 to 12 hrs) in healthy human PBMC assessed as intracellular apricitabine triphosphate level per 10'6 cells at 300 mg, po administered once daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID301051Antiviral activity against HBV transfected Hep G2.2.15 cells assessed as inhibition of surface antigen HBsAg secretion2007Bioorganic & medicinal chemistry letters, Oct-01, Volume: 17, Issue:19
Two new alkaloids and active anti-hepatitis B virus constituents from Hypserpa nitida.
AID1351354Antiviral activity against HBV infected in human HepG2(2.2.15) cells assessed as inhibition of viral DNA replication at 20 uM after 6 days by RT-PCR method relative to control2018European journal of medicinal chemistry, Jan-20, Volume: 144Design, synthesis and evaluation of novel phenyl propionamide derivatives as non-nucleoside hepatitis B virus inhibitors.
AID580188Cytotoxicity against human HepG2 cells after 3 days by neutral red dye uptake assay2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Antiviral agents 3. Discovery of a novel small molecule non-nucleoside inhibitor of hepatitis B virus (HBV).
AID358595Antiviral activity against Hepatitis B virus cell culture assay2001Journal of natural products, Nov, Volume: 64, Issue:11
Isolation and biological evaluation of filiformin, plakortide F, and plakortone G from the Caribbean sponge Plakortis sp.
AID1226091Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBV DNA replication by real-time fluorescence quantitative PCR analysis2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID410752Antiviral activity against lamivudine-resistant HBV reverse transcriptase M204I mutant in human Huh7 cells after 4 days by intracellular HBV DNA replication assay2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Synthesis and anti-hepatitis B virus and anti-hepatitis C virus activities of 7-deazaneplanocin A analogues in vitro.
AID1869627Antiviral activity against wild type HBV infected in human HepG2 2.2.15 cells assessed as reduction in viral replication pre incubated for 3 days followed by replacement with fresh compounds for another 3 days prior to pronase treatment by RT-qPCR analysi2022Journal of medicinal chemistry, 07-14, Volume: 65, Issue:13
Reshaping an Acyclic Nucleoside Phosphonate into a Selective Anti-hepatitis B Virus Compound.
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID1815380Antiviral activity against HIV1 harboring reverse transcriptase L100I mutant infected in human MT4 cells assessed as protection against virus-induced cytopathic effect incubated for 5 days by MTT assay2021European journal of medicinal chemistry, Dec-15, Volume: 226Design of the naphthyl-diarylpyrimidines as potent non-nucleoside reverse transcriptase inhibitors (NNRTIs) via structure-based extension into the entrance channel.
AID464070Antiviral activity against 3TC-resistant HBV with polymerase M204I mutation infected in HepG2.2.15 cells assessed as nucleic acid and protein levels dosed daily for 9 days and measured 24 hrs after last treatment by Southern blot hybridization2010Bioorganic & medicinal chemistry letters, Mar-01, Volume: 20, Issue:5
Orally bioavailable anti-HBV dinucleotide acyloxyalkyl prodrugs.
AID1187820Antiviral activity against hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of viral replication2014Bioorganic & medicinal chemistry letters, Sep-01, Volume: 24, Issue:17
A new series of HAPs as anti-HBV agents targeting at capsid assembly.
AID1156487Cytotoxicity against human MT4 cells after 5 days by MTT assay2014European journal of medicinal chemistry, Jul-23, Volume: 82Design and synthesis of a new series of modified CH-diarylpyrimidines as drug-resistant HIV non-nucleoside reverse transcriptase inhibitors.
AID323408Reduction in dexelvucitabine diphosphate choline level in human CEM cells at 1 uM2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
Antiviral and cellular metabolism interactions between Dexelvucitabine and lamivudine.
AID1535522Antiviral activity against wild type HIV1 3B infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 5 days by MTT assay2019Bioorganic & medicinal chemistry, 02-01, Volume: 27, Issue:3
Design, synthesis and biological evaluation of novel acetamide-substituted doravirine and its prodrugs as potent HIV-1 NNRTIs.
AID625939Antiviral activity against lamivudine-resistant Hepatitis B virus harboring reverse transcriptase M204I mutant infected in human HepG2(2.2.15) cells assessed as reduction of infectious virus titer treated daily for 9 days by quantitative Southern blot hyb2011Bioorganic & medicinal chemistry letters, Nov-01, Volume: 21, Issue:21
Antiviral activity of novel 2'-fluoro-6'-methylene-carbocyclic adenosine against wild-type and drug-resistant hepatitis B virus mutants.
AID582425Toxicity in Woodchuck hepatitis virus infected woodchuck assessed as increase of liver sorbitol dehydrogenase activity at 15 mg/kg, po qd measured on 4 to 24 weeks on 48 week study2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID517941Antiviral activity against HIV1 subtype C isolate 7 infected in HEK293 cells assessed as inhibition of virus replication after 72 hrs2010Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6
Telbivudine exhibits no inhibitory activity against HIV-1 clinical isolates in vitro.
AID572774Antiviral activity against HIV1 harboring reverse transcriptase K65R mutant infected in human HeLa P4/R5 cells assessed as inhibition of viral replication2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Anti-human immunodeficiency virus activity, cross-resistance, cytotoxicity, and intracellular pharmacology of the 3'-azido-2',3'-dideoxypurine nucleosides.
AID417250Cmin in HIV-infected human assessed as Lamivudine triphosphate level in PBMC at 300 mg QD for 7 days measured per 10'6 cells in presence of zidovudine2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Intracellular pharmacokinetics of once versus twice daily zidovudine and lamivudine in adolescents.
AID557050Antiviral activity against HIV1 clade H harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID682493Antiviral activity against NRTI-resistant HIV1 71361-1 clade B clinical isolate infected in PHA-stimulated human PBMC assessed as inhibition of viral replication incubated for 6 hrs followed by compound-wash out measured after 6 days by liquid scintillati2012Journal of medicinal chemistry, May-24, Volume: 55, Issue:10
Synthesis and biological evaluation of fatty acyl ester derivatives of (-)-2',3'-dideoxy-3'-thiacytidine.
AID1888691Toxicity in mock-infected human MT4 cells assessed as reduction in cell viability by MTT assay
AID464072Antiviral activity against ADV-resistant HBV N236T mutation infected in HepG2.2.15 cells assessed as nucleic acid and protein levels dosed daily for 9 days and measured 24 hrs after last treatment by Southern blot hybridization2010Bioorganic & medicinal chemistry letters, Mar-01, Volume: 20, Issue:5
Orally bioavailable anti-HBV dinucleotide acyloxyalkyl prodrugs.
AID246791In vitro effective concentration against Lamivudine resistant HIV-1 mutant M184V in human peripheral blood mononuclear cells2005Journal of medicinal chemistry, Jun-02, Volume: 48, Issue:11
Synthesis, antiviral activity, and mechanism of drug resistance of D- and L-2',3'-didehydro-2',3'-dideoxy-2'-fluorocarbocyclic nucleosides.
AID322834Antiviral activity against wild type HBV genotype H assessed as inhibition of replication2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID437963Cytotoxicity against human HepG2(2.2.15) cells2009Bioorganic & medicinal chemistry letters, Dec-01, Volume: 19, Issue:23
Anti-HBV agents. Part 3: preliminary structure-activity relationships of tetra-acylalisol A derivatives as potent hepatitis B virus inhibitors.
AID200001In vitro antiviral activity against HIV-1 Reverse transcriptase M184V mutant2003Bioorganic & medicinal chemistry letters, Jun-16, Volume: 13, Issue:12
The role of 2',3'-unsaturation on the antiviral activity of anti-HIV nucleosides against 3TC-resistant mutant (M184V).
AID340716Ratio of Cmax to Cmin in healthy human PBMC assessed as intracellular apricitabine triphosphate level per 10'6 cells at 300 mg, po once daily coadministered with 600 mg, po apricitabine twice daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID1191294Decrease in HBV viral DNA replication in human HepG2(2.2.15) cells at 0.75 to 3 uM after 72 hrs by real-time PCR analysis2015European journal of medicinal chemistry, Jan-27, Volume: 90Design, synthesis, and bioevaluation of paeonol derivatives as potential anti-HBV agents.
AID1152370Antiviral activity against HIV1 3B infected in human MT4 cells assessed as inhibition of virus-induced cytopathicity measured 5 days post viral infection by MTT assay2014Bioorganic & medicinal chemistry, Jun-15, Volume: 22, Issue:12
Synthesis and biological evaluation of CHX-DAPYs as HIV-1 non-nucleoside reverse transcriptase inhibitors.
AID1631596Antiviral activity against HIV-1 NL4-3 infected in human U87 cells expressing CD4.CXCR4 assessed as inhibition of p24 production at 10 uM measured after 4 days by p24 ELISA2016Bioorganic & medicinal chemistry, 09-01, Volume: 24, Issue:17
Characterization and in vitro activity of a branched peptide boronic acid that interacts with HIV-1 RRE RNA.
AID417064Drug metabolism in HIV-infected human PBMC assessed as zidovudine diphosphate level at 300 mg administered in two courses, first BID for 7 to 14 days followed by QD for 7 days and second course the subjects were switched to the other regimen measured per 2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Intracellular pharmacokinetics of once versus twice daily zidovudine and lamivudine in adolescents.
AID105370In vitro concentration required to cause death of uninfected MT-4 cell2003Bioorganic & medicinal chemistry letters, Aug-04, Volume: 13, Issue:15
Are 5'-O-carbamate-2',3'-dideoxythiacytidine new anti-HIV and anti-HBV nucleoside drugs or prodrugs?
AID675188Antiviral activity against HIV-1 subtype 3B infected in CEM-SS cells assessed as inhibition of viral replication after 6 days by XTT assay2012Bioorganic & medicinal chemistry letters, Sep-01, Volume: 22, Issue:17
Synthesis and anti-HIV activities of symmetrical dicarboxylate esters of dinucleoside reverse transcriptase inhibitors.
AID322829Antiviral activity against lamivudine-resistant HBV with reverse transcriptase L180M/M204V mutant assessed as inhibition of replication2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID1741378Antiviral activity against HBV infected in human HepG2.2.15 cells assessed as reduction in HBeAg secretion incubated for 4 days prior to compound washout followed by compound addition and measured after 4 days by ELISA2020European journal of medicinal chemistry, Sep-15, Volume: 202Design, diversity-oriented synthesis and biological evaluation of novel heterocycle derivatives as non-nucleoside HBV capsid protein inhibitors.
AID574195Cytotoxicity against human skeletal muscle Myoblast assessed as change in Tfam mitochondrial RNA level on day 2 by RT-PCR relative to untreated control2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Impact of nucleoside reverse transcriptase inhibitors on mitochondrial DNA and RNA in human skeletal muscle cells.
AID580186Cytotoxicity against human HuH7 cells after 4 days by neutral red dye uptake assay2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Antiviral agents 3. Discovery of a novel small molecule non-nucleoside inhibitor of hepatitis B virus (HBV).
AID1729159Antiviral activity against HIV1 harboring Y188L mutant infected in human MT4 cells assessed as reduction in virus-induced cytopathic effect by MTT assay2021European journal of medicinal chemistry, Mar-05, Volume: 213Exploiting the tolerant region I of the non-nucleoside reverse transcriptase inhibitor (NNRTI) binding pocket. Part 2: Discovery of diarylpyrimidine derivatives as potent HIV-1 NNRTIs with high Fsp
AID340717AUC (0 to 12 hrs) in healthy human PBMC assessed as intracellular apricitabine triphosphate level per 10'6 cells at 300 mg, po once daily coadministered with 600 mg, po apricitabine twice daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID218241In vitro cytotoxicity against Vero cells2000Journal of medicinal chemistry, Oct-19, Volume: 43, Issue:21
Synthesis and antiviral activity of oxaselenolane nucleosides.
AID588214FDA HLAED, liver enzyme composite activity2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID548577Antiviral activity against HIV1 isolate 066 harboring reverse transcriptase 184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID520605Cytotoxicity against human WI38 cells by neutral red assay2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
Anti-BK virus activity of nucleoside analogs.
AID358067Antiviral activity against HBV in mouse ayw wild type HBV-Met cells assessed as inhibition of viral DNA replication2007Proceedings of the National Academy of Sciences of the United States of America, May-15, Volume: 104, Issue:20
Unique antiviral mechanism discovered in anti-hepatitis B virus research with a natural product analogue.
AID572769Antiviral activity against HIV1 infected in human PBMC assessed as inhibition of viral replication2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Anti-human immunodeficiency virus activity, cross-resistance, cytotoxicity, and intracellular pharmacology of the 3'-azido-2',3'-dideoxypurine nucleosides.
AID340712Half life in healthy human PBMC assessed as intracellular apricitabine triphosphate level per 10'6 cells at 300 mg, po administered once daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID558394Ratio of drug level in HIV-infected pregnant woman amniotic fluid to maternal blood plasma at 150 mg, po BID by LC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Genital tract, cord blood, and amniotic fluid exposures of seven antiretroviral drugs during and after pregnancy in human immunodeficiency virus type 1-infected women.
AID519883Antiviral activity against 0.02 MOI wild type HIV1 NL4-3 infected in human MT2 cells measured after 5 days by MTS assay2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID1741375Selectivity index, ratio of CC50 for human HepG2.2.15 cells to IC50 for antiviral activity against HBV infected in human HepG2.2.15 cells assessed as reduction in intracellular viral DNA level2020European journal of medicinal chemistry, Sep-15, Volume: 202Design, diversity-oriented synthesis and biological evaluation of novel heterocycle derivatives as non-nucleoside HBV capsid protein inhibitors.
AID1661349Elimination half life in monkey plasma at 20 mg/kg, po administered as single dose by LC-MS/MS analysis2020Journal of medicinal chemistry, 08-13, Volume: 63, Issue:15
Mechanistic Insight into Antiretroviral Potency of 2'-Deoxy-2'-β-fluoro-4'-azidocytidine (FNC) with a Long-Lasting Effect on HIV-1 Prevention.
AID297680Antimycobacterial activity against Mycobacterium avium ATCC 25291 at 100 uM by microplate alamar blue assay2007Journal of medicinal chemistry, Sep-20, Volume: 50, Issue:19
Inhibition of Mycobacterium tuberculosis, Mycobacterium bovis, and Mycobacterium avium by novel dideoxy nucleosides.
AID1902003Antiviral activity against lamivudine/entecavir- resistant Hepatitis B virus infected in human HepG2 A64 cells assessed as inhibition of DNA replication2022European journal of medicinal chemistry, Mar-05, Volume: 231Design and synthesis of novel quinazolinone derivatives as anti-HBV agents with TLR8 agonist effect.
AID519861Antiviral activity against HIV1 subtype B-3B infected in 1 hr-pretreated human MT2 cells assessed as inhibition of multicycle replication measured on day 5 postinfection by RT SPA2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID246535Effective concentration to inhibit 50 % of herpes simplex virus type 1 replication in a cell culture model;ND=Not determined2005Journal of medicinal chemistry, Jan-27, Volume: 48, Issue:2
Synthesis and antiviral activity of helioxanthin analogues.
AID574200Cytotoxicity against human skeletal muscle Myoblast at 100 uL on day 5 by WST-1 assay2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Impact of nucleoside reverse transcriptase inhibitors on mitochondrial DNA and RNA in human skeletal muscle cells.
AID691385Antiviral activity against Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as inhibition of viral replication at 0.5 to 1 ug/mL2012Bioorganic & medicinal chemistry letters, Oct-15, Volume: 22, Issue:20
A new class of pyrimidine nucleosides: inhibitors of hepatitis B and C viruses.
AID1401769Cytotoxicity against human HepG2.2.15 cells after 9 days by MTT assay2018European journal of medicinal chemistry, Jan-01, Volume: 143Design, synthesis, and biological evaluation of new 1,2,3-triazolo-2'-deoxy-2'-fluoro- 4'-azido nucleoside derivatives as potent anti-HBV agents.
AID492272Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for Hepatitis B virus2010Bioorganic & medicinal chemistry, Jul-15, Volume: 18, Issue:14
Design and synthesis of novel benzimidazole derivatives as inhibitors of hepatitis B virus.
AID541160Selectivity ratio of EC50 for antiviral activity against GS-9160-resistant HIV1 selected after 9 passages to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID517942Antiviral activity against HIV1 subtype D isolate 8 infected in HEK293 cells assessed as inhibition of virus replication after 72 hrs2010Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6
Telbivudine exhibits no inhibitory activity against HIV-1 clinical isolates in vitro.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID576238AUC (0 to tau) in HIV-1 infected children aged 2.5 to 4.8 years at 4 mg/kg, po every 12 hrs by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID548584Antiviral activity against HIV1 isolate 160 harboring reverse transcriptase S68G/V75(I/T)/F77L/Y115F/F116Y /Q151M mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID541150Selectivity ratio of EC50 for antiviral activity against 3TC-resistant HIV1 selected after 4 passages to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID322830Antiviral activity against lamivudine-adefovir-resistant HBV with reverse transcriptase L180M/M204V/N236T mutant assessed as inhibition of replication2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID548830Antiviral activity against HIV1 isolate 192 harboring reverse transcriptase M41L/T215Y mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1199052Antiviral activity against Human immunodeficiency virus 1 3b infected in human MT4 cells assessed as inhibition of virus replication after 5 days by MTT assay2014Journal of natural products, Jun-27, Volume: 77, Issue:6
Jatrophane diterpenes as inhibitors of chikungunya virus replication: structure-activity relationship and discovery of a potent lead.
AID1565092Cytotoxicity against human MT4 cells assessed as reduction in cell viability incubated for 5 days by MTT assay
AID1192273Antiviral activity against hepatitis B viral in human HepG2(2.2.15) cells assessed as decrease in surface antigen HBsAg secretion at 25 ug/ml after 7 days2015Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7
A coumarin lignanoid from the stems of Kadsura heteroclita.
AID405002Antiviral activity against HBeAg-deficient HBV genotype D with precore G1896A mutation and reverse transcriptase L80I/L180M/M204I mutation in human Huh7 cells assessed as viral replication yield at 1 uM after 5 days relative to control2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID565982Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as inhibition of viral surface antigen secretion2011European journal of medicinal chemistry, Jan, Volume: 46, Issue:1
Structure-activity relationships study of 6-chloro-4-(2-chlorophenyl)-3-(2-hydroxyethyl) quinolin-2(1H)-one derivatives as novel non-nucleoside anti-hepatitis B virus agents.
AID340697Renal clearance in healthy human at 300 mg, po administered once daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID1661348AUC (0 to 24 hrs) in monkey plasma at 20 mg/kg, po administered as single dose by LC-MS/MS analysis2020Journal of medicinal chemistry, 08-13, Volume: 63, Issue:15
Mechanistic Insight into Antiretroviral Potency of 2'-Deoxy-2'-β-fluoro-4'-azidocytidine (FNC) with a Long-Lasting Effect on HIV-1 Prevention.
AID1869718Cytotoxicity against human HepG2 cells assessed as reduction in cell growth incubated for 3 days by MTT assay
AID406546Selectivity index, ratio of TC50 for human HepG2.2.15 cells to IC50 for HBV DNA replication2008Bioorganic & medicinal chemistry, Jul-01, Volume: 16, Issue:13
Synthesis and anti-hepatitis B virus evaluation of novel ethyl 6-hydroxyquinoline-3-carboxylates in vitro.
AID572778Ratio of IC50 for HIV1 harboring reverse transcriptase K65R mutant infected in human HeLa P4/R5 cells to wild type HIV1 infected in human HeLa P4/R5 cells2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Anti-human immunodeficiency virus activity, cross-resistance, cytotoxicity, and intracellular pharmacology of the 3'-azido-2',3'-dideoxypurine nucleosides.
AID417245Tmax in HIV-infected human assessed as Lamivudine diphosphate level in PBMC at 300 mg QD for 7 days in presence of zidovudine2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Intracellular pharmacokinetics of once versus twice daily zidovudine and lamivudine in adolescents.
AID548832Antiviral activity against HIV1 isolate 200 harboring reverse transcriptase M41L/L210W/T215Y mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID392504Antiviral activity against Cowpox virus2009Bioorganic & medicinal chemistry, Jan-15, Volume: 17, Issue:2
Unified QSAR approach to antimicrobials. 4. Multi-target QSAR modeling and comparative multi-distance study of the giant components of antiviral drug-drug complex networks.
AID423283Selectivity ratio of EC50 for wild type HIV2 ROD to EC50 for wild type HIV1 NL4-3 M184V variant2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Human immunodeficiency virus types 1 and 2 exhibit comparable sensitivities to Zidovudine and other nucleoside analog inhibitors in vitro.
AID1387674Antiviral activity against HBV infected in human HepG2.2.15 cells assessed as inhibition of HBsAg secretion at 1 mM supplemented with fresh medium containing compound every 3 days for 9 days measured after 9 days by ELISA relative to control2018Journal of natural products, 10-26, Volume: 81, Issue:10
Matrine-Type Alkaloids from the Roots of Sophora flavescens and Their Antiviral Activities against the Hepatitis B Virus.
AID105716Antiviral activity against HIV-1 (strain RF) infected MT-4 cells1995Journal of medicinal chemistry, May-12, Volume: 38, Issue:10
Benzophenone derivatives: a novel series of potent and selective inhibitors of human immunodeficiency virus type 1 reverse transcriptase.
AID1199053Selectivity index, ratio of CC50 for human MT4 cells to IC50 for Human immunodeficiency virus 1 3b infected in human MT4 cells2014Journal of natural products, Jun-27, Volume: 77, Issue:6
Jatrophane diterpenes as inhibitors of chikungunya virus replication: structure-activity relationship and discovery of a potent lead.
AID246536Effective concentration to inhibit 50 % of herpes simplex virus type 2 replication in a cell culture model;ND=Not determined2005Journal of medicinal chemistry, Jan-27, Volume: 48, Issue:2
Synthesis and antiviral activity of helioxanthin analogues.
AID444056Fraction escaping gut-wall elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID155793In vitro anti-HIV activity in peripheral blood mononuclear cells.1997Journal of medicinal chemistry, Sep-12, Volume: 40, Issue:19
Synthesis, anti-human immunodeficiency virus and anti-hepatitis B virus activities of novel oxaselenolane nucleosides.
AID1363962Cytotoxicity in human HepG2.215 cells assessed as reduction in cell viability after 5 days by CCK8 assay2017Bioorganic & medicinal chemistry, 02-01, Volume: 25, Issue:3
Discovery of hepatitis B virus capsid assembly inhibitors leading to a heteroaryldihydropyrimidine based clinical candidate (GLS4).
AID517940Antiviral activity against HIV1 subtype C isolate 6 infected in HEK293 cells assessed as inhibition of virus replication after 72 hrs2010Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6
Telbivudine exhibits no inhibitory activity against HIV-1 clinical isolates in vitro.
AID1771367Antiviral activity against HBV infected in human HepG2.2.15 cells assessed as inhibition of viral replication incubated for 8 days by southern blotting analysis2021European journal of medicinal chemistry, Dec-05, Volume: 225Design, synthesis and evaluation of heteroaryldihydropyrimidine analogues bearing spiro ring as hepatitis B virus capsid protein inhibitors.
AID89029Antiviral activity against wild type HIV virus(xxBRU) in Human peripheral blood mononuclear (PBM) cells2004Journal of medicinal chemistry, Mar-25, Volume: 47, Issue:7
Synthesis, structure-activity relationships, and mechanism of drug resistance of D- and L-beta-3'-fluoro-2',3'-unsaturated-4'-thionucleosides as anti-HIV agents.
AID217731Cytotoxicity was determined in the vero cells infected with HIV-I1993Journal of medicinal chemistry, Jan-22, Volume: 36, Issue:2
Asymmetric synthesis and biological evaluation of beta-L-(2R,5S)- and alpha-L-(2R,5R)-1,3-oxathiolane-pyrimidine and -purine nucleosides as potential anti-HIV agents.
AID596754Antiviral activity against HBV transfected in human HepG2(2.2.15) cells assessed as inhibition of HBsAg secretion by ELISA2011Journal of natural products, Apr-25, Volume: 74, Issue:4
Homoflavonoid glucosides from Ophioglossum pedunculosum and their anti-HBV activity.
AID323411Reduction in dexelvucitabine diphosphate choline level in human PBMC at 33.3 uM2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
Antiviral and cellular metabolism interactions between Dexelvucitabine and lamivudine.
AID732670Immunoregulatory activity in Hepatitis B virus infected transgenic mouse assessed as increase in CD4+ population in peripheral blood at 100 mg/kg qd for 1 month by flow cytometry (Rvb = 13.6 +/-2.7%)2013Bioorganic & medicinal chemistry letters, Mar-01, Volume: 23, Issue:5
Synthesis and biological evaluation of nucleoside analogues than contain silatrane on the basis of the structure of acyclovir (ACV) as novel inhibitors of hepatitis B virus (HBV).
AID1401791Antiviral activity against DHBV infected in duck assessed as inhibition of viral DNA level in serum at 10 mg/kg, po administered once daily measured on day 10 by SYBR Green I dye-based FQ-PCR analysis relative to control2018European journal of medicinal chemistry, Jan-01, Volume: 143Design, synthesis, and biological evaluation of new 1,2,3-triazolo-2'-deoxy-2'-fluoro- 4'-azido nucleoside derivatives as potent anti-HBV agents.
AID675187Antiviral activity against HIV-1 subtype B US/92/727 infected in PBMC assessed as inhibition of viral replication after 7 days by XTT assay2012Bioorganic & medicinal chemistry letters, Sep-01, Volume: 22, Issue:17
Synthesis and anti-HIV activities of symmetrical dicarboxylate esters of dinucleoside reverse transcriptase inhibitors.
AID517938Antiviral activity against HIV1 subtype B isolate 4 infected in HEK293 cells assessed as inhibition of virus replication after 72 hrs2010Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6
Telbivudine exhibits no inhibitory activity against HIV-1 clinical isolates in vitro.
AID1649795Cytotoxicity in human HepG2 cells assessed as induction of cell killing2020Journal of medicinal chemistry, 06-11, Volume: 63, Issue:11
Discovery of (1
AID423157Antiviral activity against wild type HIV1 NL4-3 produced from full length pR9deltaApa infected in human MAGIC-5A cells assessed as inhibition of Lac+ foci expression after 40 hrs2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Human immunodeficiency virus types 1 and 2 exhibit comparable sensitivities to Zidovudine and other nucleoside analog inhibitors in vitro.
AID417240AUC in HIV-infected human assessed as Lamivudine monophosphate level in PBMC at 300 mg QD for 7 days in presence of zidovudine2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Intracellular pharmacokinetics of once versus twice daily zidovudine and lamivudine in adolescents.
AID1535525Cytotoxicity against mock-infected human MT4 cells assessed as reduction in cell viability after 5 days by MTT assay2019Bioorganic & medicinal chemistry, 02-01, Volume: 27, Issue:3
Design, synthesis and biological evaluation of novel acetamide-substituted doravirine and its prodrugs as potent HIV-1 NNRTIs.
AID588215FDA HLAED, alkaline phosphatase increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1228536Volume of distribution in Sprague-Dawley rat at 2.5 mg/kg, iv2015Journal of medicinal chemistry, May-14, Volume: 58, Issue:9
Synthesis and biological evaluation of 4-substituted fluoronucleoside analogs for the treatment of hepatitis B virus infection.
AID212881Toxic activity against peripheral blood mononuclear cells.1997Journal of medicinal chemistry, Sep-12, Volume: 40, Issue:19
Synthesis, anti-human immunodeficiency virus and anti-hepatitis B virus activities of novel oxaselenolane nucleosides.
AID664470Antiviral activity against wild type HIV1 clade C 98USMSC5016 clinical isolate infected in PHA-P-stimulated human PBMC assessed as reverse transcriptase activity incubated for 6 hrs followed by incubated in drug-free medium for 6 days by multiround infect2012Journal of medicinal chemistry, Mar-22, Volume: 55, Issue:6
Synthesis and anti-HIV activities of glutamate and peptide conjugates of nucleoside reverse transcriptase inhibitors.
AID582426Toxicity in Woodchuck hepatitis virus infected woodchuck assessed as increase of liver alanine aminotransferase activity at 15 mg/kg, po qd measured on 4 to 24 weeks on 48 week study2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID614130Antiviral activity against HBV infected in human HepG2(2.2.15) cells assessed as reduction in HBsAg antigen secretion after 72 hrs by ELISA2011Journal of natural products, Aug-26, Volume: 74, Issue:8
Swerilactones L-O, secoiridoids with C₁₂ and C₁₃ skeletons from Swertia mileensis.
AID1729151Cytotoxicity against human MT4 cells assessed as reduction in cell viability by MTT assay2021European journal of medicinal chemistry, Mar-05, Volume: 213Exploiting the tolerant region I of the non-nucleoside reverse transcriptase inhibitor (NNRTI) binding pocket. Part 2: Discovery of diarylpyrimidine derivatives as potent HIV-1 NNRTIs with high Fsp
AID541158Selectivity ratio of EC50 for antiviral activity against GS-9160-resistant HIV1 selected after 6 passages to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID781025Cytotoxicity against human MT4 cells after 5 days by MTT assay2013Bioorganic & medicinal chemistry, Nov-15, Volume: 21, Issue:22
Design, synthesis and biological evaluation of N2,N4-disubstituted-1,1,3-trioxo-2H,4H-pyrrolo[1,2-b][1,2,4,6]thiatriazine derivatives as HIV-1 NNRTIs.
AID582429Toxicity in Woodchuck hepatitis virus infected woodchuck assessed as increase of liver alanine aminotransferase activity at 15 mg/kg, po qd for 48 weeks2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID1599856Antiviral activity against HBV infected in human HepG2.2.15 cells assessed as reduction in cytoplasmic DNA synthesis by reed and munch method2019ACS medicinal chemistry letters, Jun-13, Volume: 10, Issue:6
Design, Synthesis, and Anti-HBV Activity of New Bis(l-amino acid) Ester Tenofovir Prodrugs.
AID664472Antiviral activity against multidrug-resistant HIV1 clade B 4775-5 clinical isolate infected in PHA-P-stimulated human PBMC assessed as reverse transcriptase activity incubated for 6 hrs followed by incubated in drug-free medium for 6 days by multiround i2012Journal of medicinal chemistry, Mar-22, Volume: 55, Issue:6
Synthesis and anti-HIV activities of glutamate and peptide conjugates of nucleoside reverse transcriptase inhibitors.
AID582400Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral antigen level in serum at 15 mg/kg, po qd measured on 12th week on 48 weeks study (Rvb = 4.3 +/- 1.5 log10 ng/ml)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID576236Cmin in HIV-1 infected children aged 2.5 to 4.8 years at 4 mg/kg, po every 12 hrs by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID1320863Antiviral activity against HIV1 3B expressing wild type reverse transcriptase infected in human MT4 cells assessed as protection against virus-induced cytopathic effect after 5 days by MTT assay2016European journal of medicinal chemistry, Oct-04, Volume: 121Structural optimization of pyridine-type DAPY derivatives to exploit the tolerant regions of the NNRTI binding pocket.
AID1815387Resistance fold, ratio of EC50 for HIV1 harboring reverse transcriptase L100I mutant infected MV4 cells to EC50 for wild type HIV1 infected MV4 cells2021European journal of medicinal chemistry, Dec-15, Volume: 226Design of the naphthyl-diarylpyrimidines as potent non-nucleoside reverse transcriptase inhibitors (NNRTIs) via structure-based extension into the entrance channel.
AID517831Antiviral activity against HBV assessed as inhibition of viral DNA replication2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Antiviral activity of various 1-(2'-deoxy-β-D-lyxofuranosyl), 1-(2'-fluoro-β-D-xylofuranosyl), 1-(3'-fluoro-β-D-arabinofuranosyl), and 2'-fluoro-2',3'-didehydro-2',3'-dideoxyribose pyrimidine nucleoside analogues against duck hepatitis B virus (DHBV) and
AID322835Antiviral activity against wild type HBV genotype E assessed as inhibition of replication2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID1587129Oral bioavailability in human administered once daily2019Journal of medicinal chemistry, 05-09, Volume: 62, Issue:9
A Survey of the Structures of US FDA Approved Combination Drugs.
AID404996Antiviral activity against HBV genotype D with reverse transcriptase L80I/L180M/M204I mutation in human Huh7 cells assessed as viral replication yield at 1 uM after 5 days relative to control2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID572995Mitochondrial toxicity in human HepG2 cells assessed as percent lactic acid production at 10 uM after 14 days by real-time PCR relative to beta-actin DNA2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Anti-human immunodeficiency virus activity, cross-resistance, cytotoxicity, and intracellular pharmacology of the 3'-azido-2',3'-dideoxypurine nucleosides.
AID154974Concentration required for antiviral activity in PBMC (human peripheral blood mononuclear cells) infected with HIV-1 strain LAV1993Journal of medicinal chemistry, Sep-03, Volume: 36, Issue:18
Structure-activity relationships of beta-D-(2S,5R)- and alpha-D-(2S,5S)-1,3-oxathiolanyl nucleosides as potential anti-HIV agents.
AID586326Cytotoxicity against PHA-stimutated human PBMC after 24 hrs by MTS assay2011Bioorganic & medicinal chemistry, Mar-15, Volume: 19, Issue:6
Antiviral activity of seed extract from Citrus bergamia towards human retroviruses.
AID572779Ratio of IC50 for HIV1 harboring reverse transcriptase L74V mutant infected in human HeLa P4/R5 cells to wild type HIV1 infected in human HeLa P4/R5 cells2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Anti-human immunodeficiency virus activity, cross-resistance, cytotoxicity, and intracellular pharmacology of the 3'-azido-2',3'-dideoxypurine nucleosides.
AID548820Antiviral activity against HIV1 isolate 071 harboring reverse transcriptase 65R/S68N/184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1544317Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of extracellular HBV DNA replication at 20 uM measured on day 3 by FQ-PCR analysis relative to control2019Bioorganic & medicinal chemistry letters, 06-01, Volume: 29, Issue:11
Design, synthesis, and biological evaluation of novel 2'-deoxy-2'-fluoro-2'-C-methyl 8-azanebularine derivatives as potent anti-HBV agents.
AID422691Ratio of IC50 for HIV1 with reverse transcriptase K70E/M184V mutation to IC50 for wild type HIV12007Antimicrobial agents and chemotherapy, Dec, Volume: 51, Issue:12
Novel drug resistance pattern associated with the mutations K70G and M184V in human immunodeficiency virus type 1 reverse transcriptase.
AID1191399Antiviral activity against wild type HIV-1 3B infected in human MT4 cells assessed as reduction of virus-induced cytopathic effect after 5 days by MTT assay2015Bioorganic & medicinal chemistry, Feb-01, Volume: 23, Issue:3
Synthesis and biological evaluation of DAPY-DPEs hybrids as non-nucleoside inhibitors of HIV-1 reverse transcriptase.
AID444051Total clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID322839Antiviral activity against lamivudine-adenofir-resistant HBV with reverse transcriptase V173L/L180M/A181V mutant2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID1729152Selectivity index, ratio of CC50 for human MT4 cells to EC50 for antiviral activity against HIV 3B infected in human MT4 cells2021European journal of medicinal chemistry, Mar-05, Volume: 213Exploiting the tolerant region I of the non-nucleoside reverse transcriptase inhibitor (NNRTI) binding pocket. Part 2: Discovery of diarylpyrimidine derivatives as potent HIV-1 NNRTIs with high Fsp
AID576251Apparent oral clearance in HIV-1 infected children aged 2.1 to 12.8 years at 4 mg/kg, po every 24 hrs coadministered with 8 mg/kg abacavir by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID1351357Antiviral activity against lamivudine/entecavir resistant HBV harboring reverse transcriptase L180M/M204V/T184L mutant infected in human HepG2(2.2.15) cells assessed as inhibition of viral DNA replication at 100 uM after 72 hrs by RT-PCR method relative t2018European journal of medicinal chemistry, Jan-20, Volume: 144Design, synthesis and evaluation of novel phenyl propionamide derivatives as non-nucleoside hepatitis B virus inhibitors.
AID423281Selectivity ratio of EC50 for multinucleoside-resistant HIV1 NL4-3 harboring A62V, V75I, F77L, F116Y, Q151M mutation in viral reverse transcriptase to EC50 for wild type HIV1 NL4-32008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Human immunodeficiency virus types 1 and 2 exhibit comparable sensitivities to Zidovudine and other nucleoside analog inhibitors in vitro.
AID1377846Inhibition of capsid in HBV infected in human HepAD38 cells assessed as reduction in tetracycline-induced cccDNA formation by measuring reduction in HBe antigen secretion after 14 days by ELISA2017European journal of medicinal chemistry, Sep-29, Volume: 138Synthesis of sulfamoylbenzamide derivatives as HBV capsid assembly effector.
AID1152374Selectivity index, ratio CC50 for human MT4 cells to EC50 for HIV 1 3B2014Bioorganic & medicinal chemistry, Jun-15, Volume: 22, Issue:12
Synthesis and biological evaluation of CHX-DAPYs as HIV-1 non-nucleoside reverse transcriptase inhibitors.
AID404986Antiviral activity against HBeAg-deficient HBV genotype D with precore G1896A mutation and reverse transcriptase L80I mutation in human Huh7 cells assessed as inhibition of viral replication after 5 days2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID1226119Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBeAg secretion at 75 uM after 9 days by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID257336Inhibition of synthesis of intracellular HBV DNA replicative intermediates in cultured human hepatoblastoma 2.2.15 cells2005Bioorganic & medicinal chemistry letters, Dec-15, Volume: 15, Issue:24
Synthesis and in vitro anti-hepatitis B and C virus activities of ring-expanded ('fat') nucleobase analogues containing the imidazo[4,5-e][1,3]diazepine-4,8-dione ring system.
AID519886Antiviral activity against 0.01 MOI wild type HIV1 NL4-3 infected in 2 hr-pretreated human MT2 cells measured after 5 days by MTS assay2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID1191971Antiviral activity against HIV1 3B infected infected in human MT4 cells assessed as protection against virus-induced cytotoxicity after 5 days by MTT assay2015Bioorganic & medicinal chemistry letters, Mar-15, Volume: 25, Issue:6
Design, synthesis of new β-carboline derivatives and their selective anti-HIV-2 activity.
AID404984Antiviral activity against HBV genotype D with reverse transcriptase L80I/L180M/M204I mutation in human Huh7 cells assessed as inhibition of viral replication after 5 days2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID727265Mitochondrial toxicity in human HepG2 cells assessed as lactate dehydrogenase release up to 200 uM2013Bioorganic & medicinal chemistry letters, Jan-15, Volume: 23, Issue:2
2'-Fluoro-6'-methylene-carbocyclic adenosine phosphoramidate (FMCAP) prodrug: in vitro anti-HBV activity against the lamivudine-entecavir resistant triple mutant and its mechanism of action.
AID358068Antiviral activity against HBV in human HepG2(2.2.15) cells assessed as inhibition of viral pre-genomic RNA replication2007Proceedings of the National Academy of Sciences of the United States of America, May-15, Volume: 104, Issue:20
Unique antiviral mechanism discovered in anti-hepatitis B virus research with a natural product analogue.
AID417061Drug metabolism in HIV-infected human PBMC assessed as zidovudine monophosphate level at 300 mg administered in two courses, first QD for 7 days followed by BID for 7 to 14 days and second course the subjects were switched to the other regimen measured pe2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Intracellular pharmacokinetics of once versus twice daily zidovudine and lamivudine in adolescents.
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID1555311Inhibition of capsid protein in Hepatitis B virus infected in human HepG2.2.15 cells assessed as reduction in viral DNA level supplemented with fresh medium containing compound every 2 days and measured after 6 days by RT-PCR analysis relative to control2019European journal of medicinal chemistry, Aug-15, Volume: 176Assessment of quinazolinone derivatives as novel non-nucleoside hepatitis B virus inhibitors.
AID1203823Mitochondrial toxicity in human HepG2 cells assessed as effect on nuclear beta-actin DNA level incubated for 14 days by real-time PCR method2015Journal of medicinal chemistry, Apr-23, Volume: 58, Issue:8
β-D-2'-C-Methyl-2,6-diaminopurine Ribonucleoside Phosphoramidates are Potent and Selective Inhibitors of Hepatitis C Virus (HCV) and Are Bioconverted Intracellularly to Bioactive 2,6-Diaminopurine and Guanosine 5'-Triphosphate Forms.
AID404979Antiviral activity against HBV genotype D in human Huh7 cells assessed as inhibition of viral replication after 5 days2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID1449516Mitochondrial toxicity in human HepG2 cells assessed as inhibition of cytochrome c oxidase subunit 2 DNA levels at 10 uM measured on day 14 by RT-PCR method relative to nuclear beta-actin DNA levels2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID404993Antiviral activity against HBV genotype D with reverse transcriptase M204I mutation in human Huh7 cells assessed as viral replication yield at 1 uM after 5 days relative to control2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID1555320Inhibition of capsid protein in lamivudine/entecavir-resistant Hepatitis B virus harboring rtL180M/rtM204V/rt184L mutant infected in human HepG2.2.15 cells assessed as reduction in viral DNA level measured after 72 hrs by PCR analysis2019European journal of medicinal chemistry, Aug-15, Volume: 176Assessment of quinazolinone derivatives as novel non-nucleoside hepatitis B virus inhibitors.
AID152654In vitro cytotoxicity against PBM cells2000Journal of medicinal chemistry, Oct-19, Volume: 43, Issue:21
Synthesis and antiviral activity of oxaselenolane nucleosides.
AID410756Antiviral activity against adefovir-resistant HBV reverse transcriptase L180M mutant in human Huh7 cells after 4 days by intracellular HBV DNA replication assay2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Synthesis and anti-hepatitis B virus and anti-hepatitis C virus activities of 7-deazaneplanocin A analogues in vitro.
AID588217FDA HLAED, serum glutamic pyruvic transaminase (SGPT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1226105Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as cell survival at 300 uM after 9 days (Rvb = 100%)2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID47429In vitro cytotoxicity against CEM cells2000Journal of medicinal chemistry, Oct-19, Volume: 43, Issue:21
Synthesis and antiviral activity of oxaselenolane nucleosides.
AID1503177Cytotoxicity against human SupT1 cells assessed as decrease in cell viability after 48 hrs by CCK-8 assay2017Journal of natural products, 10-27, Volume: 80, Issue:10
Metabolites from the Plant Endophytic Fungus Aspergillus sp. CPCC 400735 and Their Anti-HIV Activities.
AID417234Drug metabolism in HIV-infected human PBMC assessed as zidovudine triphosphate level at 300 mg administered in two courses, first QD for 7 days followed by BID for 7 to 14 days and second course the subjects were switched to the other regimen measured per2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Intracellular pharmacokinetics of once versus twice daily zidovudine and lamivudine in adolescents.
AID1815385Antiviral activity against HIV1 harboring reverse transcriptase F227L/V106A mutant infected in human MT4 cells assessed as protection against virus-induced cytopathic effect incubated for 5 days by MTT assay2021European journal of medicinal chemistry, Dec-15, Volume: 226Design of the naphthyl-diarylpyrimidines as potent non-nucleoside reverse transcriptase inhibitors (NNRTIs) via structure-based extension into the entrance channel.
AID266284Antiviral activity against duck HBV in primary duck hepatocytes2006Journal of medicinal chemistry, Jun-15, Volume: 49, Issue:12
Effect of various pyrimidines possessing the 1-[(2-hydroxy-1-(hydroxymethyl)ethoxy)methyl] moiety, able to mimic natural 2'-deoxyribose, on wild-type and mutant hepatitis B virus replication.
AID557047Antiviral activity against HIV1 clade D harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID523460Decrease in HscA70-mRNA expression in Hepatitis B virus infected in human HepG2(2.2.15) cells at 13 uM after 24-36 hrs by RT-PCR analysis2010Antimicrobial agents and chemotherapy, May, Volume: 54, Issue:5
Heat stress cognate 70 host protein as a potential drug target against drug resistance in hepatitis B virus.
AID598201Selectivity index, ratio of CC50 for human HepG2.2.15 cells to IC50 for Hepatitis B virus2011Bioorganic & medicinal chemistry, May-15, Volume: 19, Issue:10
Tryptamine derivatives as novel non-nucleosidic inhibitors against hepatitis B virus.
AID417251Cmin in HIV-infected human assessed as Lamivudine diphosphate level in PBMC at 300 mg QD for 7 days measured per 10'6 cells in presence of zidovudine2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Intracellular pharmacokinetics of once versus twice daily zidovudine and lamivudine in adolescents.
AID1694157Antiviral activity against Hepatitis B virus infected in human HePAD38 cells assessed as reduction in viral DNA replication incubated for 7 days by RT-PCR analysis2021Bioorganic & medicinal chemistry, 02-01, Volume: 31Discovery and structure activity relationship of glyoxamide derivatives as anti-hepatitis B virus agents.
AID576248Cmin in HIV-1 infected children aged 2.1 to 12.8 years at 4 mg/kg, po every 24 hrs coadministered with 8 mg/kg abacavir by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID246787In vitro effective concentration against Lamivudine resistant wild type HIV-1 in human peripheral blood mononuclear cells2005Journal of medicinal chemistry, Jun-02, Volume: 48, Issue:11
Synthesis, antiviral activity, and mechanism of drug resistance of D- and L-2',3'-didehydro-2',3'-dideoxy-2'-fluorocarbocyclic nucleosides.
AID407142Selectivity index, ratio of CC50 for human Hep G2.2.15 cells to IC50 for HBV e antigen secretion2008Bioorganic & medicinal chemistry letters, Jul-01, Volume: 18, Issue:13
Synthesis and in vitro anti-hepatitis B virus activities of 4-aryl-6-chloro-quinolin-2-one and 5-aryl-7-chloro-1,4-benzodiazepine derivatives.
AID405001Antiviral activity against HBeAg-deficient HBV genotype D with precore G1896A mutation and reverse transcriptase L180M/M204I mutation in human Huh7 cells assessed as viral replication yield at 1 uM after 5 days relative to control2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID1330730Cytotoxicity against human HepG2.2.15 cells assessed as decrease in cell viability after 8 days by CCK-8 assay2016European journal of medicinal chemistry, Nov-10, Volume: 123Design, synthesis and evaluation of pyrazole derivatives as non-nucleoside hepatitis B virus inhibitors.
AID1649791Inhibition of reverse transcriptase in HBV infected in human HepG2.2.15 cells assessed as induction of intracellular viral RNA accumulation at 2 uM for 4 days by qPCR or qRT-PCR relative to control2020Journal of medicinal chemistry, 06-11, Volume: 63, Issue:11
Discovery of (1
AID1544341Antiviral activity against lamivudine-resistant Hepatitis B virus harboring L180M/M204V mutant infected in human HepG2.2.15 cells assessed as inhibition of extracellular HBV DNA replication at 20 uM supplemented with fresh medium containing compound every2019Bioorganic & medicinal chemistry letters, 06-01, Volume: 29, Issue:11
Design, synthesis, and biological evaluation of novel 2'-deoxy-2'-fluoro-2'-C-methyl 8-azanebularine derivatives as potent anti-HBV agents.
AID1457761Antiviral activity against HBV ayw1 infected in human HepG2(2.2.15) cells assessed as reduction in viral replication by measuring extracellular viral DNA copy number after 6 days by real-time qPCR method2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Expanding the Antiviral Spectrum of 3-Fluoro-2-(phosphonomethoxy)propyl Acyclic Nucleoside Phosphonates: Diamyl Aspartate Amidate Prodrugs.
AID1401787Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as intracellular HBV DNA levels at 20 uM measured on day 6 by FQ-PCR analysis2018European journal of medicinal chemistry, Jan-01, Volume: 143Design, synthesis, and biological evaluation of new 1,2,3-triazolo-2'-deoxy-2'-fluoro- 4'-azido nucleoside derivatives as potent anti-HBV agents.
AID548576Antiviral activity against HIV1 isolate 063 harboring reverse transcriptase M41L/D67N/K70R/M184V/L210W/T215Y/K219E mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID341757Drug level in human phytohemagglutininin-activated PBMC assessed as Lamivudine diphosphate level at 2.6 uM after 24 hrs2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
In vitro interactions between apricitabine and other deoxycytidine analogues.
AID1888694Antiviral activity against HIV1 with RT L100I mutant infected in human MT4 cells cells assessed as protection against viral-induced cytopathogenecity by MTT assay
AID1228735Antiviral activity against HIV1-3B infected in human MT4 cells assessed as inhibition of virus induced cell death measured after 5 days of infection by MTT assay2015Journal of natural products, May-22, Volume: 78, Issue:5
Antiviral Activity of Flexibilane and Tigliane Diterpenoids from Stillingia lineata.
AID1380574Resistance index, ratio of IC50 for antiviral activity against HIV1 virions containing reverse transcriptase E138K/M184V mutant derived from HIV/VSG-G or HIV/HA virions infected 293T cells using human A549 cells as target cells to IC50 for antiviral activ2018Bioorganic & medicinal chemistry letters, 06-01, Volume: 28, Issue:10
Design, synthesis and biological evaluation of substituted (+)-SG-1 derivatives as novel anti-HIV agents.
AID1226117Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBeAg secretion at 300 uM after 9 days by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID1661387Inhibition of HIV1 HA-tagged Vif expressed in HEK293T cells co-expressing eGFP-tagged pcDNA-APOBEC3G assessed as reduction in Vif-mediated A3G degradation at 10000 nM measured after 48 hrs by flow cytometry2020Journal of medicinal chemistry, 08-13, Volume: 63, Issue:15
Mechanistic Insight into Antiretroviral Potency of 2'-Deoxy-2'-β-fluoro-4'-azidocytidine (FNC) with a Long-Lasting Effect on HIV-1 Prevention.
AID301050Cytotoxicity against human Hep G2.2.15 cells2007Bioorganic & medicinal chemistry letters, Oct-01, Volume: 17, Issue:19
Two new alkaloids and active anti-hepatitis B virus constituents from Hypserpa nitida.
AID1743621Selectivity index, ratio of CC50 for human MT4 cells to EC50 for antiviral activity against HIV1 3B infected in human MT4 cells2020European journal of medicinal chemistry, Nov-15, Volume: 206Targeting dual tolerant regions of binding pocket: Discovery of novel morpholine-substituted diarylpyrimidines as potent HIV-1 NNRTIs with significantly improved water solubility.
AID548829Antiviral activity against HIV1 isolate 188 harboring reverse transcriptase T215Y/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID582396Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral DNA replicative intermediate level per ug of total cell DNA at 15 mg/kg, po qd measured on 12th week on 48 weeks study (Rvb = 1495 +/- 890 pg)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID1631598Antiviral activity against HIV-1 NL4-3 infected in human U87 cells expressing CD4.CXCR4 assessed as inhibition of p24 production at 100 uM measured after 4 days by p24 ELISA2016Bioorganic & medicinal chemistry, 09-01, Volume: 24, Issue:17
Characterization and in vitro activity of a branched peptide boronic acid that interacts with HIV-1 RRE RNA.
AID519858Antiviral activity against HIV1 subtype B-HXB2 infected in 1 hr-pretreated human MT2 cells assessed as inhibition of multicycle replication measured on day 5 postinfection by RT SPA2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID588209Literature-mined public compounds from Greene et al multi-species hepatotoxicity modelling dataset2010Chemical research in toxicology, Jul-19, Volume: 23, Issue:7
Developing structure-activity relationships for the prediction of hepatotoxicity.
AID358080Cytotoxicity against HBV transfected human HepG2 cells by MTT assay2007Proceedings of the National Academy of Sciences of the United States of America, May-15, Volume: 104, Issue:20
Unique antiviral mechanism discovered in anti-hepatitis B virus research with a natural product analogue.
AID358065Antiviral activity against HBV in adriamycin-resistant wild type HepW10 cells assessed as inhibition of viral DNA replication2007Proceedings of the National Academy of Sciences of the United States of America, May-15, Volume: 104, Issue:20
Unique antiviral mechanism discovered in anti-hepatitis B virus research with a natural product analogue.
AID1449524Cytotoxicity against human HepG2 cells assessed as inhibition of nuclear DNA levels at 10 uM measured on day 14 by RT-PCR method relative to nuclear beta-actin DNA levels2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1226086Cytotoxicity against human HepG2.2.15 cells assessed as cell death after 9 days by MTT assay2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID664469Antiviral activity against wild type HIV1 clade B 94US3393IN clinical isolate infected in PHA-P-stimulated human PBMC assessed as reverse transcriptase activity incubated for 6 hrs followed by incubated in drug-free medium for 6 days by multiround infecti2012Journal of medicinal chemistry, Mar-22, Volume: 55, Issue:6
Synthesis and anti-HIV activities of glutamate and peptide conjugates of nucleoside reverse transcriptase inhibitors.
AID1226115Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBeAg secretion at 75 uM after 6 days by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID437965Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for HBV surface antigen secretion2009Bioorganic & medicinal chemistry letters, Dec-01, Volume: 19, Issue:23
Anti-HBV agents. Part 3: preliminary structure-activity relationships of tetra-acylalisol A derivatives as potent hepatitis B virus inhibitors.
AID565914Antiviral activity against Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as inhibition of viral surface antigen secretion after 6 days by ELISA2011European journal of medicinal chemistry, Jan, Volume: 46, Issue:1
Structure-activity relationships study of 6-chloro-4-(2-chlorophenyl)-3-(2-hydroxyethyl) quinolin-2(1H)-one derivatives as novel non-nucleoside anti-hepatitis B virus agents.
AID410754Antiviral activity against lamivudine-resistant HBV reverse transcriptase 236T mutant in human Huh7 cells after 4 days by intracellular HBV DNA replication assay2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Synthesis and anti-hepatitis B virus and anti-hepatitis C virus activities of 7-deazaneplanocin A analogues in vitro.
AID478520Cytotoxicity against human HepG2(2.2.15) cells after 9 days by MTT assay2010European journal of medicinal chemistry, May, Volume: 45, Issue:5
Synthesis and antiviral activity of new acrylamide derivatives containing 1,2,3-thiadiazole as inhibitors of hepatitis B virus replication.
AID1693338Antiviral activity against HBV infected in human HepG2 2.2.15 cells assessed as inhibition of pregenomic RNA expression at 1 uM measured after incubation of 6 by RT-PCR analysis relative to control2021Bioorganic & medicinal chemistry, 01-01, Volume: 29Synthesis and evaluation of new phenyl acrylamide derivatives as potent non-nucleoside anti-HBV agents.
AID1661335Cytotoxicity against HEK293 cells assessed as cell viability by MTT assay2020Journal of medicinal chemistry, 08-13, Volume: 63, Issue:15
Mechanistic Insight into Antiretroviral Potency of 2'-Deoxy-2'-β-fluoro-4'-azidocytidine (FNC) with a Long-Lasting Effect on HIV-1 Prevention.
AID464067Antiviral activity against wild type HBV infected in HepG2.2.15 cells assessed as nucleic acid and protein levels dosed daily for 9 days and measured 24 hrs after last treatment by Southern blot hybridization2010Bioorganic & medicinal chemistry letters, Mar-01, Volume: 20, Issue:5
Orally bioavailable anti-HBV dinucleotide acyloxyalkyl prodrugs.
AID740215Antiviral activity against Hepatitis B virus-infected human HepG2(2.2.15) cells assessed as inhibition of HBsAg secretion2013Bioorganic & medicinal chemistry letters, Apr-01, Volume: 23, Issue:7
Anti-HBV active constituents from Piper longum.
AID384984Selectivity index, ratio of CC50 for human HepG2.2.15 cells to IC50 for HBV surface antigen secretion2008Journal of natural products, May, Volume: 71, Issue:5
Periglaucines A-D, anti-HBV and -HIV-1 alkaloids from Pericampylus glaucus.
AID417244Tmax in HIV-infected human assessed as Lamivudine triphosphate level in PBMC at 300 mg QD for 7 days in presence of zidovudine2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Intracellular pharmacokinetics of once versus twice daily zidovudine and lamivudine in adolescents.
AID322828Antiviral activity against adenofir-resistant HBV with reverse transcriptase N236T mutant assessed as inhibition of replication2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID1351364Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for antiviral activity against lamivudine/entecavir resistant HBV harboring reverse transcriptase L180M/M204V/T184L mutant infected in human HepG2(2.2.15) cells2018European journal of medicinal chemistry, Jan-20, Volume: 144Design, synthesis and evaluation of novel phenyl propionamide derivatives as non-nucleoside hepatitis B virus inhibitors.
AID1457789Selectivity index, ratio of CC50 for HepG2.2.15 cells to EC50 for HBV ayw1 infected in human HepG2(2.2.15) cells assessed as reduction in viral replication by measuring intracellular viral DNA copy2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Expanding the Antiviral Spectrum of 3-Fluoro-2-(phosphonomethoxy)propyl Acyclic Nucleoside Phosphonates: Diamyl Aspartate Amidate Prodrugs.
AID586277Antiviral activity against Human immunodeficiency virus 1 3B harboring reverse transcriptase M184V, M184I mutant infected in human MT2 cells assessed as inhibition of virus induced cytopathic effect selected on day 14 after 4 passages by PCR analysis2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID664467Antiviral activity against HIV1 BaL infected in HeLa P4/R5 cells assessed as reduction of viral infection incubated for 2 hrs followed by incubated in drug-free medium for 46 hrs by single round infection beta-galactosidase reporter gene assay2012Journal of medicinal chemistry, Mar-22, Volume: 55, Issue:6
Synthesis and anti-HIV activities of glutamate and peptide conjugates of nucleoside reverse transcriptase inhibitors.
AID540220Clearance in human after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID1377842Antiviral activity against HBV infected in human HepAD38 cells assessed as reduction in viral replication by RT-PCR method2017European journal of medicinal chemistry, Sep-29, Volume: 138Synthesis of sulfamoylbenzamide derivatives as HBV capsid assembly effector.
AID1422387Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as reduction in extracellular viral DNA levels after 6 days by qPCR/TaqMan assay2018Journal of medicinal chemistry, 12-13, Volume: 61, Issue:23
Discovery of RG7834: The First-in-Class Selective and Orally Available Small Molecule Hepatitis B Virus Expression Inhibitor with Novel Mechanism of Action.
AID417256Cmax in HIV-infected human assessed as Lamivudine triphosphate level in PBMC at 300 mg QD for 7 days measured per 10'6 cells in presence of zidovudine2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Intracellular pharmacokinetics of once versus twice daily zidovudine and lamivudine in adolescents.
AID574194Cytotoxicity against human skeletal muscle Myoblast assessed as change in POLG mitochondrial RNA level on day 2 by RT-PCR relative to untreated control2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Impact of nucleoside reverse transcriptase inhibitors on mitochondrial DNA and RNA in human skeletal muscle cells.
AID105557In vitro concentration required to inhibit the cytopathicity of HIV-1 IIIB on MT-4 cell2003Bioorganic & medicinal chemistry letters, Aug-04, Volume: 13, Issue:15
Are 5'-O-carbamate-2',3'-dideoxythiacytidine new anti-HIV and anti-HBV nucleoside drugs or prodrugs?
AID105880Concentration required to inhibit syntica formation by 50% in HIV-1 infected MT-4 cells1994Journal of medicinal chemistry, Jul-08, Volume: 37, Issue:14
Inhibition of human immunodeficiency virus type 1 replication by phosphonoformate- and phosphonoacetate-2',3'-dideoxy-3'-thiacytidine conjugates.
AID358079Cytotoxicity against HBV transfected mouse ayw wild type HBV-Met cells by MTT assay2007Proceedings of the National Academy of Sciences of the United States of America, May-15, Volume: 104, Issue:20
Unique antiviral mechanism discovered in anti-hepatitis B virus research with a natural product analogue.
AID1055520Cytostatic activity against mouse L1210 cells assessed as growth inhibition after 2 days by particle counting analysis2013European journal of medicinal chemistry, , Volume: 70Design, synthesis and biological evaluation of phosphorodiamidate prodrugs of antiviral and anticancer nucleosides.
AID1888699Antiviral activity against HIV1 with RT RES056 mutant infected in human MT4 cells cells assessed as protection against viral-induced cytopathogenecity by MTT assay
AID1316334Selectivity index, ratio of CC50 for human mock-infected MT4 cells to EC50 for wild type HIV1 3B harboring reverse transcriptase infected in human MT4 cells2016Journal of medicinal chemistry, 09-08, Volume: 59, Issue:17
Design, Synthesis, and Evaluation of Thiophene[3,2-d]pyrimidine Derivatives as HIV-1 Non-nucleoside Reverse Transcriptase Inhibitors with Significantly Improved Drug Resistance Profiles.
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID89158Effective concentration against M184V HIV-1 virus in human peripheral blood mononuclear cells2004Journal of medicinal chemistry, Jun-17, Volume: 47, Issue:13
Synthesis, structure-activity relationships, and drug resistance of beta-d-3'-fluoro-2',3'-unsaturated nucleosides as anti-HIV Agents.
AID1729160Antiviral activity against HIV1 harboring E138K mutant infected in human MT4 cells assessed as reduction in virus-induced cytopathic effect by MTT assay2021European journal of medicinal chemistry, Mar-05, Volume: 213Exploiting the tolerant region I of the non-nucleoside reverse transcriptase inhibitor (NNRTI) binding pocket. Part 2: Discovery of diarylpyrimidine derivatives as potent HIV-1 NNRTIs with high Fsp
AID586318Antiviral activity against HIV1 infected in human PBMC assessed as inhibition of gag gene expression at 0.23 ug/ml after 5 days post infection by quantitative real time RT-PCR2011Bioorganic & medicinal chemistry, Mar-15, Volume: 19, Issue:6
Antiviral activity of seed extract from Citrus bergamia towards human retroviruses.
AID1661366Ratio of Cmax in monkey plasma at 20 mg/kg, po administered as single dose measured after 1 hr to Cmax in monkey plasma at 20 mg/kg, po administered as single dose measured after 24 hrs2020Journal of medicinal chemistry, 08-13, Volume: 63, Issue:15
Mechanistic Insight into Antiretroviral Potency of 2'-Deoxy-2'-β-fluoro-4'-azidocytidine (FNC) with a Long-Lasting Effect on HIV-1 Prevention.
AID519867Antiviral activity against HIV1 subtype B-ASM 034 infected in 1 hr-pretreated PBMC cells assessed as inhibition of p24 antigen production measured on day 5 postinfection by ELISA2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID548819Antiviral activity against HIV1 isolate 070 harboring reverse transcriptase 65R/S68G mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1377854Antiviral activity against HBV infected in human HepAD38 cells assessed as reduction in intracellular viral DNA level at 10 uM by RT-PCR method relative to control2017European journal of medicinal chemistry, Sep-29, Volume: 138Synthesis of sulfamoylbenzamide derivatives as HBV capsid assembly effector.
AID1055518Cytostatic activity against human CEM cells assessed as growth inhibition after 3 days by particle counting analysis2013European journal of medicinal chemistry, , Volume: 70Design, synthesis and biological evaluation of phosphorodiamidate prodrugs of antiviral and anticancer nucleosides.
AID1565094Selectivity index, ratio of CC50 for human MT4 cells to EC50 for antiviral activity against HIV RES056
AID588219FDA HLAED, gamma-glutamyl transferase (GGT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1320776Antiviral activity against HIV2 ROD infected in human MT4 cells assessed as protection against virus-induced cytopathic effect after 5 days by MTT assay2016Journal of medicinal chemistry, Oct-27, Volume: 59, Issue:20
Amidate Prodrugs of Deoxythreosyl Nucleoside Phosphonates as Dual Inhibitors of HIV and HBV Replication.
AID1555310Cytotoxicity against human HepG2.2.15 cells assessed as cell viability measured after 72 hrs by MTT assay2019European journal of medicinal chemistry, Aug-15, Volume: 176Assessment of quinazolinone derivatives as novel non-nucleoside hepatitis B virus inhibitors.
AID1070444Antiviral activity against HIV-1 3B/H9 infected in human HOG.R5 cells transfected with HIV1 LTR-GFP assessed as inhibition of viral replication by fluorescence analysis2014Journal of natural products, Mar-28, Volume: 77, Issue:3
Bioactive compounds from Vitex leptobotrys.
AID1661351Cmax in monkey plasma at 20 mg/kg, po administered as single dose by LC-MS/MS analysis2020Journal of medicinal chemistry, 08-13, Volume: 63, Issue:15
Mechanistic Insight into Antiretroviral Potency of 2'-Deoxy-2'-β-fluoro-4'-azidocytidine (FNC) with a Long-Lasting Effect on HIV-1 Prevention.
AID618859Cytotoxicity against human CEM cells after 6 days by trypan blue exclusion assay2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Synthesis, antiviral activity, cytotoxicity and cellular pharmacology of l-3'-azido-2',3'-dideoxypurine nucleosides.
AID152626Activity against Lamivudine-resistant virus (HIV-1M184V) in human PBM cells, expressed as EC902003Journal of medicinal chemistry, Jul-17, Volume: 46, Issue:15
l-2',3'-Didehydro-2',3'-dideoxy-3'-fluoronucleosides: synthesis, anti-HIV activity, chemical and enzymatic stability, and mechanism of resistance.
AID1869626Selectivity index, ratio of CC50 for cytotoxicity against human MT4 cells assessed as reduction in cell viability by MTT assay to EC50 for anti-HIV activity against wild type HIV-2 ROD infected in human MT4 cells assessed as inhibition of HIV-induced cyto2022Journal of medicinal chemistry, 07-14, Volume: 65, Issue:13
Reshaping an Acyclic Nucleoside Phosphonate into a Selective Anti-hepatitis B Virus Compound.
AID328845Inhibition of human MRP3 expressed in MDCK2 cells assessed as increase in intracellular CMF fluorescence at 10 uM by CMFDA assay2007Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 35, Issue:3
Inhibition of MRP1/ABCC1, MRP2/ABCC2, and MRP3/ABCC3 by nucleoside, nucleotide, and non-nucleoside reverse transcriptase inhibitors.
AID675189Cytotoxicity against human CEM-SS cells by XTT method2012Bioorganic & medicinal chemistry letters, Sep-01, Volume: 22, Issue:17
Synthesis and anti-HIV activities of symmetrical dicarboxylate esters of dinucleoside reverse transcriptase inhibitors.
AID1555312Inhibition of capsid protein in Hepatitis B virus infected in human HepG2.2.15 cells assessed as reduction in viral DNA level at 4 uM supplemented with fresh medium containing compound every 2 days and measured after 6 days by RT-PCR analysis2019European journal of medicinal chemistry, Aug-15, Volume: 176Assessment of quinazolinone derivatives as novel non-nucleoside hepatitis B virus inhibitors.
AID358066Antiviral activity against HBV in adriamycin-resistant HepD2 cells with RTM20V and RTV180M mutation assessed as inhibition of viral DNA replication2007Proceedings of the National Academy of Sciences of the United States of America, May-15, Volume: 104, Issue:20
Unique antiviral mechanism discovered in anti-hepatitis B virus research with a natural product analogue.
AID1226106Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as cell survival at 150 uM after 9 days (Rvb = 100%)2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID1729158Antiviral activity against HIV1 harboring Y181C mutant infected in human MT4 cells assessed as reduction in virus-induced cytopathic effect by MTT assay2021European journal of medicinal chemistry, Mar-05, Volume: 213Exploiting the tolerant region I of the non-nucleoside reverse transcriptase inhibitor (NNRTI) binding pocket. Part 2: Discovery of diarylpyrimidine derivatives as potent HIV-1 NNRTIs with high Fsp
AID152967Concentration required to cause death of PBMC cells was determined in vitro2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Potent nonclassical nucleoside antiviral drugs based on the N,N-diarylformamidine concept.
AID1473738Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID405007Effect on replication efficiency of HBeAg-deficient HBV genotype D with precore G1896A mutation and reverse transcriptase L80I/M204I mutation in human Huh7 cells assessed as decrease in viral replication yield at 1 uM after 5 days relative to control2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID625276FDA Liver Toxicity Knowledge Base Benchmark Dataset (LTKB-BD) drugs of most concern for DILI2011Drug discovery today, Aug, Volume: 16, Issue:15-16
FDA-approved drug labeling for the study of drug-induced liver injury.
AID1687683Antiviral activity against HIV-1 E138K mutant strain infected in human MT4 cells assessed as reduction in virus-induced cytopathogenicity by MTT assay2020European journal of medicinal chemistry, Jan-15, Volume: 186Indazolyl-substituted piperidin-4-yl-aminopyrimidines as HIV-1 NNRTIs: Design, synthesis and biological activities.
AID548827Antiviral activity against HIV1 isolate 180 harboring reverse transcriptase K65R mutant gene obtained as site-directed mutant of NL4-3 by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID781024Selectivity index, ratio of CC50 for human MT4 cells to EC50 for HIV-1 3B infected in human MT4 cells2013Bioorganic & medicinal chemistry, Nov-15, Volume: 21, Issue:22
Design, synthesis and biological evaluation of N2,N4-disubstituted-1,1,3-trioxo-2H,4H-pyrrolo[1,2-b][1,2,4,6]thiatriazine derivatives as HIV-1 NNRTIs.
AID282662Inhibition of HBV replication in 2.2.15 cells by DNA hybridization assay2004Journal of medicinal chemistry, Dec-30, Volume: 47, Issue:27
(Z)- and (E)-[2-Fluoro-2-(hydroxymethyl)cyclopropylidene]methylpurines and -pyrimidines, a new class of methylenecyclopropane analogues of nucleosides: synthesis and antiviral activity.
AID614564Cytotoxicity against human HepG2(2.2.15) cells after 24 hours following 9 days of treatment by neutral red dye uptake assay2011Bioorganic & medicinal chemistry, Sep-15, Volume: 19, Issue:18
Synthesis and biological evaluation of Matijing-Su derivatives as potent anti-HBV agents.
AID1507018Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBeAg secretion after 8 days by ELISA2017European journal of medicinal chemistry, Aug-18, Volume: 136Design, synthesis and primary biological evaluation of the novel 2-pyridone derivatives as potent non-nucleoside HBV inhibitors.
AID1351353Cytotoxicity against human HepG2(2.2.15) cells assessed as reduction in cell viability after 72 hrs by MTT assay2018European journal of medicinal chemistry, Jan-20, Volume: 144Design, synthesis and evaluation of novel phenyl propionamide derivatives as non-nucleoside hepatitis B virus inhibitors.
AID582398Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as frequency of hepatocytes expressing viral antigen at 15 mg/kg, po qd for 48 weeks measured on 60th week2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID1888690Antiviral activity against HIV1 3B infected in human MT4 cells cells assessed as protection against viral-induced cytopathogenecity by MTT assay
AID527284Antiviral activity against HBV infected in human 2.2.15 cell2010Bioorganic & medicinal chemistry letters, Nov-15, Volume: 20, Issue:22
Antiviral activity of 2,3'-anhydro and related pyrimidine nucleosides against hepatitis B virus.
AID1320785Selectivity ratio of CC50 for human HepG2(2.2.15) cells to EC50 for reduction in HBV ayw1 intracellular DNA copy number2016Journal of medicinal chemistry, Oct-27, Volume: 59, Issue:20
Amidate Prodrugs of Deoxythreosyl Nucleoside Phosphonates as Dual Inhibitors of HIV and HBV Replication.
AID323406Reduction in [3H]dexelvucitabine triphosphate in human CEM cells per 10^6 cells at 33.3 uM2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
Antiviral and cellular metabolism interactions between Dexelvucitabine and lamivudine.
AID1888704Resistance index, ratio of EC50 for antiviral activity against HIV1 with RT F227L + V106A mutant infected in human MT4 cells to EC50 for antiviral activity against wild type HIV1 infected in human MT4 cells
AID598199Antiviral activity against Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as inhibition of viral DNA replication after 4 days by RT-PCR analysis2011Bioorganic & medicinal chemistry, May-15, Volume: 19, Issue:10
Tryptamine derivatives as novel non-nucleosidic inhibitors against hepatitis B virus.
AID548803Antiviral activity against HIV1 isolate 201 harboring reverse transcriptase M41L/L210W/T215Y mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1636440Drug activation in human Hep3B cells assessed as human CYP2D6-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 300 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of NA2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID89159Effective concentration against Wild Type HIV-1 virus in human peripheral blood mononuclear cells2004Journal of medicinal chemistry, Jun-17, Volume: 47, Issue:13
Synthesis, structure-activity relationships, and drug resistance of beta-d-3'-fluoro-2',3'-unsaturated nucleosides as anti-HIV Agents.
AID586325Cytotoxicity against human MOLT3 cells after 24 hrs by MTS assay2011Bioorganic & medicinal chemistry, Mar-15, Volume: 19, Issue:6
Antiviral activity of seed extract from Citrus bergamia towards human retroviruses.
AID1055519Cytostatic activity against thymidine kinase-deficient mouse L1210 cells assessed as growth inhibition after 2 days by particle counting analysis2013European journal of medicinal chemistry, , Volume: 70Design, synthesis and biological evaluation of phosphorodiamidate prodrugs of antiviral and anticancer nucleosides.
AID1199054Antiviral activity against Human immunodeficiency virus type 2 ROD infected in human MT4 cells assessed as inhibition of virus replication after 5 days by MTT assay2014Journal of natural products, Jun-27, Volume: 77, Issue:6
Jatrophane diterpenes as inhibitors of chikungunya virus replication: structure-activity relationship and discovery of a potent lead.
AID384986Selectivity index, ratio of CC50 for human HepG2.2.15 cells to IC50 for HBV e-antigen secretion2008Journal of natural products, May, Volume: 71, Issue:5
Periglaucines A-D, anti-HBV and -HIV-1 alkaloids from Pericampylus glaucus.
AID588216FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID404983Antiviral activity against HBV genotype D with reverse transcriptase L180M/M204I mutation in human Huh7 cells assessed as inhibition of viral replication after 5 days2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID341759Drug level in human phytohemagglutininin-activated PBMC assessed as Lamivudine triphosphate level at 2.6 uM after 24 hrs2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
In vitro interactions between apricitabine and other deoxycytidine analogues.
AID1226098Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBsAg secretion at 150 uM after 6 days by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID738968Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBV DNA replication after 72 hrs by PCR analysis2013Bioorganic & medicinal chemistry letters, Apr-01, Volume: 23, Issue:7
Anti-hepatitis B virus lignans from the root of Streblus asper.
AID1743622Selectivity index, ratio of CC50 for human MT4 cells to EC50 for antiviral activity against HIV1 RES056 infected in human MT4 cells2020European journal of medicinal chemistry, Nov-15, Volume: 206Targeting dual tolerant regions of binding pocket: Discovery of novel morpholine-substituted diarylpyrimidines as potent HIV-1 NNRTIs with significantly improved water solubility.
AID1152372Antiviral activity against HIV1 RES056 harboring RT K103N,Y181C double mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathicity measured 5 days post viral infection by MTT assay2014Bioorganic & medicinal chemistry, Jun-15, Volume: 22, Issue:12
Synthesis and biological evaluation of CHX-DAPYs as HIV-1 non-nucleoside reverse transcriptase inhibitors.
AID520604Antimicrobial activity against BK polyomavirus ATCC VR837 infected in human WI38 cells assessed as reduction in viral titer after 7 days by PCR analysis2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
Anti-BK virus activity of nucleoside analogs.
AID614565Selectivity index, ratio of TC50 for human HepG2(2.2.15) cells to IC50 for HBV2011Bioorganic & medicinal chemistry, Sep-15, Volume: 19, Issue:18
Synthesis and biological evaluation of Matijing-Su derivatives as potent anti-HBV agents.
AID541154Selectivity ratio of EC50 for antiviral activity against APV-resistant HIV1 selected after 2 passages to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID1199051Cytotoxicity against human MT4 cells assessed as inhibition of overall cell metabolism after 5 days by MTT assay2014Journal of natural products, Jun-27, Volume: 77, Issue:6
Jatrophane diterpenes as inhibitors of chikungunya virus replication: structure-activity relationship and discovery of a potent lead.
AID2997In vitro effective concentration against hepatitis B virus was determined in 2.2.15 cells1997Journal of medicinal chemistry, Sep-12, Volume: 40, Issue:19
Synthesis, anti-human immunodeficiency virus and anti-hepatitis B virus activities of novel oxaselenolane nucleosides.
AID410601Antiviral activity against HBV in human HepG2(2.2.15) cells assessed as replication intermediates after 24 hrs2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Synthesis and anti-hepatitis B virus and anti-hepatitis C virus activities of 7-deazaneplanocin A analogues in vitro.
AID560903Antiviral activity against wild type HBV infected in human HuH7 cells assessed as decrease in viral transient transfection after 24 hrs2009Antimicrobial agents and chemotherapy, Jul, Volume: 53, Issue:7
Alkoxyalkyl esters of 9-(s)-(3-hydroxy-2-phosphonomethoxypropyl) adenine are potent and selective inhibitors of hepatitis B virus (HBV) replication in vitro and in HBV transgenic mice in vivo.
AID740216Cytotoxicity against human HepG2(2.2.15) cells2013Bioorganic & medicinal chemistry letters, Apr-01, Volume: 23, Issue:7
Anti-HBV active constituents from Piper longum.
AID340703Apparent total oral clearance in healthy human at 300 mg, po once daily coadministered with 600 mg, po apricitabine twice daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID580187Antiviral activity against Hepatitis B virus infected in human HepG2 cells assessed as reduction in viral DNA after 3 days by Southern blotting2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Antiviral agents 3. Discovery of a novel small molecule non-nucleoside inhibitor of hepatitis B virus (HBV).
AID1741367Antiviral activity against HBV infected in human HepG2.2.15 cells assessed as reduction in intracellular viral DNA level at 100 uM incubated for 4 days prior to compound washout followed by compound addition and measured after 4 days by fluorogenic probe 2020European journal of medicinal chemistry, Sep-15, Volume: 202Design, diversity-oriented synthesis and biological evaluation of novel heterocycle derivatives as non-nucleoside HBV capsid protein inhibitors.
AID261857Inhibition of wild type HBV transfected in human hepatoblastoma 2.2.15 cells2006Journal of medicinal chemistry, Mar-23, Volume: 49, Issue:6
Inhibition of hepatitis B virus (HBV) replication by pyrimidines bearing an acyclic moiety: effect on wild-type and mutant HBV.
AID86871Cytotoxic concentration against Hepatitis B virus in human hepatoblastoma cell line1998Journal of medicinal chemistry, Jun-04, Volume: 41, Issue:12
Does the anti-hepatitis B virus activity of (+)-5'-noraristeromycin exist in its 4'-epimer and 4'-deoxygenated derivatives?
AID1743620Cytotoxicity against human MT4 cells assessed as reduction in cell viability incubated for 5 days by MTT assay2020European journal of medicinal chemistry, Nov-15, Volume: 206Targeting dual tolerant regions of binding pocket: Discovery of novel morpholine-substituted diarylpyrimidines as potent HIV-1 NNRTIs with significantly improved water solubility.
AID358076Cytotoxicity against HBV transfected human ayw wild type HepG2(2.2.15) cells by MTT assay2007Proceedings of the National Academy of Sciences of the United States of America, May-15, Volume: 104, Issue:20
Unique antiviral mechanism discovered in anti-hepatitis B virus research with a natural product analogue.
AID519887Antiviral activity against 0.02 MOI wild type HIV1 NL4-3 infected in 2 hr-pretreated human MT2 cells measured after 5 days by MTS assay2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID658564Antiviral activity against multidrug-resistant HIV1 695-RT infected in HEK293T cells assessed as inhibition of viral replication after 4 days by beta-galactosidase reporter gene assay2012Journal of natural products, Mar-23, Volume: 75, Issue:3
Library-based discovery and characterization of daphnane diterpenes as potent and selective HIV inhibitors in Daphne gnidium.
AID423211Antiviral activity against HBV infected in human HepG2 2.2.15 cells assessed as inhibition of HBsAg secretion at 200 ug/mL after 9 days by ELISA2009Journal of natural products, Apr, Volume: 72, Issue:4
Schisanwilsonenes A-C, anti-HBV Carotane sesquiterpenoids from the fruits of Schisandra wilsoniana.
AID1649794Antiviral activity against HBV infected in human HepG2.2.15 cells assessed as reduction in viral DNA levels incubated for 6 days by PCR analysis2020Journal of medicinal chemistry, 06-11, Volume: 63, Issue:11
Discovery of (1
AID301054Selectivity index, ratio of CC50 for human Hep G2.2.15 cells to IC50 for HBV e antigen secretion in HBV transfected Hep G2.2.15 cells2007Bioorganic & medicinal chemistry letters, Oct-01, Volume: 17, Issue:19
Two new alkaloids and active anti-hepatitis B virus constituents from Hypserpa nitida.
AID548838Antiviral activity against HIV1 isolate 212 harboring reverse transcriptase L210W/T215Y mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID340709Cmin in healthy human PBMC assessed as intracellular apricitabine triphosphate level per 10'6 cells at 300 mg, po administered once daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID1377841Cytotoxicity against African green monkey Vero cells by CellTiter 96 non-radioactive cell proliferation colorimetric assay2017European journal of medicinal chemistry, Sep-29, Volume: 138Synthesis of sulfamoylbenzamide derivatives as HBV capsid assembly effector.
AID1156488Selectivity index, ratio of CC50 for human MT4 cells to IC50 for wild type HIV1 3B2014European journal of medicinal chemistry, Jul-23, Volume: 82Design and synthesis of a new series of modified CH-diarylpyrimidines as drug-resistant HIV non-nucleoside reverse transcriptase inhibitors.
AID1330732Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBeAg secretion by ELISA2016European journal of medicinal chemistry, Nov-10, Volume: 123Design, synthesis and evaluation of pyrazole derivatives as non-nucleoside hepatitis B virus inhibitors.
AID1072514Antiviral activity against Hepatitis B virus assessed as inhibition of Hepatitis B virus DNA replication2014European journal of medicinal chemistry, Mar-21, Volume: 75A review of non-nucleoside anti-hepatitis B virus agents.
AID1226100Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBsAg secretion at 37.5 uM after 6 days by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID322842Antiviral activity against lamivudine-adenofir-resistant HBV with reverse transcriptase V173L/L180M/A181V/N236T mutant2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID572776Antiviral activity against HIV1 harboring reverse transcriptase M184V mutant infected in human HeLa P4/R5 cells assessed as inhibition of viral replication2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Anti-human immunodeficiency virus activity, cross-resistance, cytotoxicity, and intracellular pharmacology of the 3'-azido-2',3'-dideoxypurine nucleosides.
AID626002Antiviral activity against adefovir-resistant Hepatitis B virus harboring reverse transcriptase N236T mutant infected in human HepG2(2.2.15) cells assessed as reduction of infectious virus titer treated daily for 9 days by quantitative Southern blot hybri2011Bioorganic & medicinal chemistry letters, Nov-01, Volume: 21, Issue:21
Antiviral activity of novel 2'-fluoro-6'-methylene-carbocyclic adenosine against wild-type and drug-resistant hepatitis B virus mutants.
AID582430Toxicity in Woodchuck hepatitis virus infected woodchuck assessed as increase of liver aspartate aminotransferase activity at 15 mg/kg, po qd for 48 weeks2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID1434728Cytotoxicity against human CEM cells assessed as growth inhibition by CellTiter 96 non-radioactive cell proliferation colorimetric assay2017Bioorganic & medicinal chemistry letters, 02-15, Volume: 27, Issue:4
Synthesis and antiviral evaluation of novel heteroarylpyrimidines analogs as HBV capsid effectors.
AID519868Antiviral activity against HIV1 subtype B-92US076 infected in 1 hr-pretreated PBMC cells assessed as inhibition of p24 antigen production measured on day 5 postinfection by ELISA2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID301052Antiviral activity against HBV transfected Hep G2.2.15 cells assessed as inhibition of e antigen HBsAg secretion2007Bioorganic & medicinal chemistry letters, Oct-01, Volume: 17, Issue:19
Two new alkaloids and active anti-hepatitis B virus constituents from Hypserpa nitida.
AID417238AUC in HIV-infected human assessed as Lamivudine triphosphate level in PBMC at 300 mg QD for 7 days in presence of zidovudine2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Intracellular pharmacokinetics of once versus twice daily zidovudine and lamivudine in adolescents.
AID527720Antiviral activity against HBV infected in human HepG2(2.2.15) cells assessed as inhibition of viral replication at 0.5 to 1 ug/ml after 2 days relative to control2010Bioorganic & medicinal chemistry, Nov-01, Volume: 18, Issue:21
Synthesis and in vitro antiviral activities of 3'-fluoro (or chloro) and 2',3'-difluoro 2',3'-dideoxynucleoside analogs against hepatitis B and C viruses.
AID519863Antiviral activity against HIV1 subtype B-NL4-3 infected in 1 hr-pretreated human MT2 cells assessed as inhibition of multicycle replication measured on day 5 postinfection by RT SPA2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID582415Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as frequency of hepatocytes expressing viral antigen at 15 mg/kg, po qd for 48 weeks2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID548831Antiviral activity against HIV1 isolate 194 harboring reverse transcriptase M41L/T215Y/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1197447Antiviral activity against HBV infected in human HepG2(2.2.15) cells assessed as inhibition of surface antigen secretion by EIA2015Bioorganic & medicinal chemistry, Feb-15, Volume: 23, Issue:4
Synthesis and anti-hepatitis B virus activity of C4 amide-substituted isosteviol derivatives.
AID1888689Antiviral activity against HIV1 with RT F227L + V106A mutant infected in human MT4 cells cells assessed as protection against viral-induced cytopathogenecity by MTT assay
AID478524Antiviral activity against HBV infected in HepG2(2.2.15) cells assessed as inhibition of viral DNA replication after 8 days by radio immunoassay2010European journal of medicinal chemistry, May, Volume: 45, Issue:5
Synthesis and antiviral activity of new acrylamide derivatives containing 1,2,3-thiadiazole as inhibitors of hepatitis B virus replication.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1661392Antiviral activity against JRFL pseudotyped HIV1 infected in human Hut/CCR5 cells assessed as time needed to reach 50% reduction of virus infection at 1000 nM incubated with cells for 4 hrs prior to compound washout followed by viral infection and measure2020Journal of medicinal chemistry, 08-13, Volume: 63, Issue:15
Mechanistic Insight into Antiretroviral Potency of 2'-Deoxy-2'-β-fluoro-4'-azidocytidine (FNC) with a Long-Lasting Effect on HIV-1 Prevention.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID425652Total body clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID1330731Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBsAg secretion by ELISA2016European journal of medicinal chemistry, Nov-10, Volume: 123Design, synthesis and evaluation of pyrazole derivatives as non-nucleoside hepatitis B virus inhibitors.
AID410602Cytotoxicity against human HepG2(2.2.15) cells assessed as uptake of neutral red dye after 24 hrs2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Synthesis and anti-hepatitis B virus and anti-hepatitis C virus activities of 7-deazaneplanocin A analogues in vitro.
AID444052Hepatic clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1694158Cytotoxicity against human PBMC cells assessed as reduction in cell viability by MTT assay2021Bioorganic & medicinal chemistry, 02-01, Volume: 31Discovery and structure activity relationship of glyoxamide derivatives as anti-hepatitis B virus agents.
AID1507021Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of viral DNA replication at 4 uM after 8 days by real time fluorescent PCR method relative to control2017European journal of medicinal chemistry, Aug-18, Volume: 136Design, synthesis and primary biological evaluation of the novel 2-pyridone derivatives as potent non-nucleoside HBV inhibitors.
AID732680Antiviral activity against Hepatitis B virus transfected in human HepG2.2.15 cells assessed as inhibition of HBeAg secretion after 6 days by ELISA2013Bioorganic & medicinal chemistry letters, Mar-01, Volume: 23, Issue:5
Synthesis and biological evaluation of nucleoside analogues than contain silatrane on the basis of the structure of acyclovir (ACV) as novel inhibitors of hepatitis B virus (HBV).
AID1742102Antiviral activity against lamivudine and entecavir-resistant HBV harboring rtL180 M/rtM204V/rtT184L mutant infected in human HepG2.2.15 cells assessed as inhibition of DNA replication at 100 uM supplemented with fresh medium containing compound every 2 d2020European journal of medicinal chemistry, Nov-01, Volume: 205Discovery of novel quinazolinone derivatives as potential anti-HBV and anti-HCC agents.
AID563944Antiviral activity against HIV1 pNL4-3 harboring chimeric pTKD infected in TZM-bl cells after 72 hrs by luciferase assay2009Antimicrobial agents and chemotherapy, Nov, Volume: 53, Issue:11
Impact of novel human immunodeficiency virus type 1 reverse transcriptase mutations P119S and T165A on 4'-ethynylthymidine analog resistance profile.
AID1226096Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBsAg secretion at 37.5 uM after 3 days by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID1687684Antiviral activity against HIV-1 RES056 mutant strain infected in human MT4 cells assessed as reduction in virus-induced cytopathogenicity by MTT assay2020European journal of medicinal chemistry, Jan-15, Volume: 186Indazolyl-substituted piperidin-4-yl-aminopyrimidines as HIV-1 NNRTIs: Design, synthesis and biological activities.
AID519971Selectivity ratio of EC50 for 0.005 MOI HIV1 NL4-3 harboring M184V mutant RT to EC50 for 0.005 MOI HIV1 NL4-3 harboring wild type RT infected in human MT2 cells2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID1303216Antiviral activity against HIV1 3B infected in human MT4 cells assessed as protection against virus-induced cytopathogenic effect after 5 days by MTT assay2016European journal of medicinal chemistry, Jul-19, Volume: 117Design, synthesis and anti-HIV activity of novel quinoxaline derivatives.
AID1226087Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBsAg secretion by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID1473739Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1771364Inhibition of capsid protein in HBV infected in human HepDES19 cells assessed as inhibition of viral replication by measuring minus polarity DNA level at 5 uM incubated for 3 days by strand preferential qPCR analysis relative to control2021European journal of medicinal chemistry, Dec-05, Volume: 225Design, synthesis and evaluation of heteroaryldihydropyrimidine analogues bearing spiro ring as hepatitis B virus capsid protein inhibitors.
AID1377853Antiviral activity against HBV infected in human HepAD38 cells assessed as reduction in intracellular viral DNA level by RT-PCR method2017European journal of medicinal chemistry, Sep-29, Volume: 138Synthesis of sulfamoylbenzamide derivatives as HBV capsid assembly effector.
AID519961Selectivity ratio of EC50 for 0.02 MOI HIV1 NL4-3 infected in 2 hrs pretreated human MT2 cells by MTS assay to EC50 for 0.02 MOI HIV1 NL4-3 infected in 2 hrs pretreated human MT2 cells by RT assay2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID582397Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as frequency of hepatocytes expressing viral antigen at 15 mg/kg, po qd measured on 12th week on 48 weeks study2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID519856Antiviral activity against pseudotype HIV1 NL-RLuc infected in human MT2 cells measured on day 5 postinfection by luciferase reporter gene assay2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID558380Drug level in HIV-infected pregnant woman amniotic fluid at 150 mg, po BID by LC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Genital tract, cord blood, and amniotic fluid exposures of seven antiretroviral drugs during and after pregnancy in human immunodeficiency virus type 1-infected women.
AID517836Antiviral activity against HBV assessed as inhibition of viral DNA replication at 0.5 to 1 ug/mL2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Antiviral activity of various 1-(2'-deoxy-β-D-lyxofuranosyl), 1-(2'-fluoro-β-D-xylofuranosyl), 1-(3'-fluoro-β-D-arabinofuranosyl), and 2'-fluoro-2',3'-didehydro-2',3'-dideoxyribose pyrimidine nucleoside analogues against duck hepatitis B virus (DHBV) and
AID218507Concentration required to inhibit plaque formation by HSV-1 strain KOSSB (TK-) in monolayers of vero cells; ND means Not determined2001Bioorganic & medicinal chemistry letters, Nov-19, Volume: 11, Issue:22
Novel 5-vinyl pyrimidine nucleosides with potent anti-hepatitis B virus activity.
AID548816Antiviral activity against HIV1 isolate 066 harboring reverse transcriptase 184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID682492Antiviral activity against NNTRI-resistant HIV1 A-17 clade B clinical isolate infected in PHA-stimulated human PBMC assessed as inhibition of viral replication incubated for 6 hrs followed by compound-wash out measured after 6 days by liquid scintillation2012Journal of medicinal chemistry, May-24, Volume: 55, Issue:10
Synthesis and biological evaluation of fatty acyl ester derivatives of (-)-2',3'-dideoxy-3'-thiacytidine.
AID1055513Cytostatic activity against human COLO320 cells assessed as growth inhibition after 3 days by particle counting analysis2013European journal of medicinal chemistry, , Volume: 70Design, synthesis and biological evaluation of phosphorodiamidate prodrugs of antiviral and anticancer nucleosides.
AID574189Cytotoxicity against human skeletal muscle Myoblast assessed as change in MTCYB mitochondrial RNA level on day 2 by RT-PCR relative to untreated control2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Impact of nucleoside reverse transcriptase inhibitors on mitochondrial DNA and RNA in human skeletal muscle cells.
AID586354Antiviral activity against Human immunodeficiency virus 1 3B harboring reverse transcriptase M184V, M184I, K82N mutant infected in human MT2 cells assessed as inhibition of virus induced cytopathic effect selected on day 14 after 4 passages by PCR analysi2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID548840Antiviral activity against HIV1 isolate 217 harboring reverse transcriptase D67N/K70E/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548821Antiviral activity against HIV1 isolate 153 harboring reverse transcriptase L74V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID410759Antiviral activity against adefovir-resistant HBV reverse transcriptase M204V mutant in human Huh7 cells after 4 days by intracellular HBV DNA replication assay2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Synthesis and anti-hepatitis B virus and anti-hepatitis C virus activities of 7-deazaneplanocin A analogues in vitro.
AID1743630Antiviral activity against HIV1 harboring RT E138K mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect incubated for 5 days by MTT assay2020European journal of medicinal chemistry, Nov-15, Volume: 206Targeting dual tolerant regions of binding pocket: Discovery of novel morpholine-substituted diarylpyrimidines as potent HIV-1 NNRTIs with significantly improved water solubility.
AID1869634Selectivity index, ratio of CC50 cytotoxicity against human HepG2.2.15 cells assessed as reduction in cell viability to EC50 for antiviral activity against wild type HBV infected in human HepG2 2.2.15 cells assessed as reduction in viral replication by DN2022Journal of medicinal chemistry, 07-14, Volume: 65, Issue:13
Reshaping an Acyclic Nucleoside Phosphonate into a Selective Anti-hepatitis B Virus Compound.
AID1544304Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBeAg secretion at 20 uM supplemented with fresh medium containing compound every 3 days for 6 days and measured on day 9 by ELISA relative to contro2019Bioorganic & medicinal chemistry letters, 06-01, Volume: 29, Issue:11
Design, synthesis, and biological evaluation of novel 2'-deoxy-2'-fluoro-2'-C-methyl 8-azanebularine derivatives as potent anti-HBV agents.
AID576256AUC in HIV-1 infected children with body weight <17 kg at 10 mg/kg, po every 24 hrs coadministered with 240 mg/m2 of didanosine and efavirenz by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID257338Selectivity index (CC50/EC50) for inhibition of HBV virion DNA synthesis in human hepatoblastoma 2.2.15 cells2005Bioorganic & medicinal chemistry letters, Dec-15, Volume: 15, Issue:24
Synthesis and in vitro anti-hepatitis B and C virus activities of ring-expanded ('fat') nucleobase analogues containing the imidazo[4,5-e][1,3]diazepine-4,8-dione ring system.
AID476929Human intestinal absorption in po dosed human2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Neural computational prediction of oral drug absorption based on CODES 2D descriptors.
AID1503175Antiviral activity against VSV-G pseudotyped HIV1 infected in human SupT1 cells at 100 uM after 48 hrs by luciferase reporter gene assay relative to control2017Journal of natural products, 10-27, Volume: 80, Issue:10
Metabolites from the Plant Endophytic Fungus Aspergillus sp. CPCC 400735 and Their Anti-HIV Activities.
AID1888698Antiviral activity against HIV1 with RT E138K mutant infected in human MT4 cells cells assessed as protection against viral-induced cytopathogenecity by MTT assay
AID586319Antiviral activity against Human T-cell leukemia/lymphoma virus type 1 infected in human PBMC assessed as inhibition of tax/rex gene expression after 3 weeks post infection by quantitative real time RT-PCR2011Bioorganic & medicinal chemistry, Mar-15, Volume: 19, Issue:6
Antiviral activity of seed extract from Citrus bergamia towards human retroviruses.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1226118Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBeAg secretion at 150 uM after 9 days by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID1187821Cytotoxicity against human HepG2.2.15 cells after 48 hrs2014Bioorganic & medicinal chemistry letters, Sep-01, Volume: 24, Issue:17
A new series of HAPs as anti-HBV agents targeting at capsid assembly.
AID405412Antiviral activity against PERV infected in human 293T cells assessed as inhibition of proximal DNA synthesis after 24 hrs by RT-PCR2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
Selective inhibition of porcine endogenous retrovirus replication in human cells by acyclic nucleoside phosphonates.
AID548836Antiviral activity against HIV1 isolate 206 harboring reverse transcriptase D67N/K70R mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID588220Literature-mined public compounds from Kruhlak et al phospholipidosis modelling dataset2008Toxicology mechanisms and methods, , Volume: 18, Issue:2-3
Development of a phospholipidosis database and predictive quantitative structure-activity relationship (QSAR) models.
AID307877Selectivity index, ratio of CC50 for HepG2.2.15 cells to IC50 for HBV
AID340695AUC (0 to 24 hrs) in healthy human at 300 mg, po administered once daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID548806Antiviral activity against HIV1 isolate 206 harboring reverse transcriptase D67N/K70R mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548822Antiviral activity against HIV1 isolate 157 harboring reverse transcriptase L74V/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID574190Cytotoxicity against human skeletal muscle Myoblast assessed as change in MTCO3 mitochondrial RNA level on day 2 by RT-PCR relative to untreated control2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Impact of nucleoside reverse transcriptase inhibitors on mitochondrial DNA and RNA in human skeletal muscle cells.
AID1228521Antiviral activity against duck Hepatitis B virus infected in duck assessed as inhibition of viral DNA replication in serum at 20 mg/kg/day, po measured after 3 days of treatment withdrawal2015Journal of medicinal chemistry, May-14, Volume: 58, Issue:9
Synthesis and biological evaluation of 4-substituted fluoronucleoside analogs for the treatment of hepatitis B virus infection.
AID548587Antiviral activity against HIV1 isolate 174 harboring reverse transcriptase M184V mutant gene obtained as site-directed mutant of NL4-3 by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1769750Cytotoxicity against human H9 cells assessed as cell viability incubated for 7 days by MTT colorimetric assay2021European journal of medicinal chemistry, Nov-15, Volume: 224Lead optimization to improve the antiviral potency of 2-aminobenzamide derivatives targeting HIV-1 Vif-A3G axis.
AID1197834Selectivity index, ratio of CC50 for mock-infected human MT4 cells to EC50 for HIV1 RES056 expressing reverse transcriptase K103N + Y181C double mutant2015European journal of medicinal chemistry, Mar-06, Volume: 92Fused heterocycles bearing bridgehead nitrogen as potent HIV-1 NNRTIs. Part 3: optimization of [1,2,4]triazolo[1,5-a]pyrimidine core via structure-based and physicochemical property-driven approaches.
AID727270Antiviral activity against wild type Hepatitis B virus infected in human HuH7 cells2013Bioorganic & medicinal chemistry letters, Jan-15, Volume: 23, Issue:2
2'-Fluoro-6'-methylene-carbocyclic adenosine phosphoramidate (FMCAP) prodrug: in vitro anti-HBV activity against the lamivudine-entecavir resistant triple mutant and its mechanism of action.
AID582404Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral DNA replicative intermediate level per ug of total cell DNA at 15 mg/kg, po qd for 48 weeks (Rvb = 995 +/- 736 pg)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID417252Cmin in HIV-infected human assessed as Lamivudine monophosphate level in PBMC at 300 mg QD for 7 days measured per 10'6 cells in presence of zidovudine2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Intracellular pharmacokinetics of once versus twice daily zidovudine and lamivudine in adolescents.
AID1457764Antiviral activity against HBV ayw1 infected in human HepG2(2.2.15) cells assessed as reduction in viral replication by measuring intracellular viral DNA copy number after 6 days byr by real-time qPCR assay2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Expanding the Antiviral Spectrum of 3-Fluoro-2-(phosphonomethoxy)propyl Acyclic Nucleoside Phosphonates: Diamyl Aspartate Amidate Prodrugs.
AID1741374Antiviral activity against HBV infected in human HepG2.2.15 cells assessed as reduction in intracellular viral DNA level incubated for 4 days prior to compound washout followed by compound addition and measured after 4 days by fluorogenic probe based RT-q2020European journal of medicinal chemistry, Sep-15, Volume: 202Design, diversity-oriented synthesis and biological evaluation of novel heterocycle derivatives as non-nucleoside HBV capsid protein inhibitors.
AID1661381Binding affinity to HIV1 Vif and CBFbeta-ELOB-ELOC complex (unknown origin) by CM5 chip based assay2020Journal of medicinal chemistry, 08-13, Volume: 63, Issue:15
Mechanistic Insight into Antiretroviral Potency of 2'-Deoxy-2'-β-fluoro-4'-azidocytidine (FNC) with a Long-Lasting Effect on HIV-1 Prevention.
AID1769749Antiviral activity against HIV13B infected in human H9 cells assessed as p24 level incubated for 7 days by ELISA2021European journal of medicinal chemistry, Nov-15, Volume: 224Lead optimization to improve the antiviral potency of 2-aminobenzamide derivatives targeting HIV-1 Vif-A3G axis.
AID340696Apparent total oral clearance in healthy human at 300 mg, po administered once daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID322826Effect on cell viability in human Huh7 cells2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID567091Drug absorption in human assessed as human intestinal absorption rate2011European journal of medicinal chemistry, Jan, Volume: 46, Issue:1
Prediction of drug intestinal absorption by new linear and non-linear QSPR.
AID572780Ratio of IC50 for HIV1 harboring reverse transcriptase M184V mutant infected in human HeLa P4/R5 cells to wild type HIV1 infected in human HeLa P4/R5 cells2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Anti-human immunodeficiency virus activity, cross-resistance, cytotoxicity, and intracellular pharmacology of the 3'-azido-2',3'-dideoxypurine nucleosides.
AID1165076Antiviral activity against HIV1 RES056 expressing reverse transcriptase K103N + Y181C mutant infected in human MT4 cells assessed as inhibition of virus-induced syncytium formation after 5 days by MTT assay2014European journal of medicinal chemistry, Nov-24, Volume: 87Design, synthesis and anti-HIV evaluation of novel diarylnicotinamide derivatives (DANAs) targeting the entrance channel of the NNRTI binding pocket through structure-guided molecular hybridization.
AID582414Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as frequency of hepatocytes expressing viral antigen at 15 mg/kg, po qd measured on 36th week on 48 weeks study2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID519889Selectivity ratio of EC50 for 0.005 MOI HIV1 NL4-3 infected in human MT2 cells by MTS assay to EC50 for 0.005 MOI HIV1 NL4-3 infected in human MT2 cells by RT assay2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID781026Antiviral activity against HIV1 3B infected in human MT4 cells assessed as protection against viral-induced cytotoxicity after 5 days by MTT assay2013Bioorganic & medicinal chemistry, Nov-15, Volume: 21, Issue:22
Design, synthesis and biological evaluation of N2,N4-disubstituted-1,1,3-trioxo-2H,4H-pyrrolo[1,2-b][1,2,4,6]thiatriazine derivatives as HIV-1 NNRTIs.
AID664471Antiviral activity against NNRTI-resistant HIV1 clade B A-17 clinical isolate infected in PHA-P-stimulated human PBMC assessed as reverse transcriptase activity incubated for 6 hrs followed by incubated in drug-free medium for 6 days by multiround infecti2012Journal of medicinal chemistry, Mar-22, Volume: 55, Issue:6
Synthesis and anti-HIV activities of glutamate and peptide conjugates of nucleoside reverse transcriptase inhibitors.
AID1226128Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBV DNA copies per uL at 37.5 uM after 6 days by real-time fluorescence quantitative PCR analysis2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID1449528Cytotoxicity against human HepG2 cells assessed as inhibition of nuclear DNA levels measured on day 14 by RT-PCR method2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID246417Effective concentrations at which 10-fold depression of intracellular intermediates of HBV DNA was observed in 2.2.15 Cells2005Journal of medicinal chemistry, Jul-28, Volume: 48, Issue:15
5'-Homoneplanocin A inhibits hepatitis B and hepatitis C.
AID1238542Binding affinity to human serum albumin with excitation at 280 nm after 2 hrs by spectrofluorimetric analysis2015Bioorganic & medicinal chemistry letters, Aug-15, Volume: 25, Issue:16
Ionic derivatives of betulinic acid exhibit antiviral activity against herpes simplex virus type-2 (HSV-2), but not HIV-1 reverse transcriptase.
AID1862267Antiviral activity against HIV1 3B infected in human MT4 cells assessed as protection against virus-induced cytopathic effect incubated for 5 days by MTT assay2022European journal of medicinal chemistry, Oct-05, Volume: 240Design, synthesis, and biological evaluation of novel double-winged galloyl derivatives as HIV-1 RNase H inhibitors.
AID557023Antiviral activity against HIV1 clade A harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID397589Antiviral activity against HIV1 3B in human H9 cells assessed as inhibition of virus-induced cytopathic effect by formazan-based conventional colorimetric technique2001Journal of natural products, Feb, Volume: 64, Issue:2
Natural product-based anti-HIV drug discovery and development facilitated by the NCI developmental therapeutics program.
AID417263Half life in HIV-infected human adult2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Intracellular pharmacokinetics of once versus twice daily zidovudine and lamivudine in adolescents.
AID1401765Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBeAg secretion at 20 uM after 9 days by ELISA relative to control2018European journal of medicinal chemistry, Jan-01, Volume: 143Design, synthesis, and biological evaluation of new 1,2,3-triazolo-2'-deoxy-2'-fluoro- 4'-azido nucleoside derivatives as potent anti-HBV agents.
AID410757Antiviral activity against adefovir-resistant HBV reverse transcriptase LM/reverse transcriptase MV double mutant in human Huh7 cells after 4 days by intracellular HBV DNA replication assay2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Synthesis and anti-hepatitis B virus and anti-hepatitis C virus activities of 7-deazaneplanocin A analogues in vitro.
AID1544305Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBsAg secretion at 20 uM supplemented with fresh medium containing compound every 3 days for 6 days and measured on day 9 by ELISA relative to contro2019Bioorganic & medicinal chemistry letters, 06-01, Volume: 29, Issue:11
Design, synthesis, and biological evaluation of novel 2'-deoxy-2'-fluoro-2'-C-methyl 8-azanebularine derivatives as potent anti-HBV agents.
AID576249Cmax in HIV-1 infected children aged 2.1 to 12.8 years at 4 mg/kg, po every 24 hrs coadministered with 8 mg/kg abacavir by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID325079Drug level in human PBMC assessed as concentration of Lamivudine triphosphate per 10^6 cells2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
Evidence and possible consequences of the phosphorylation of nucleoside reverse transcriptase inhibitors in human red blood cells.
AID1320782Cytotoxicity against human HepG2(2.2.15) cells assessed as reduction in cell viability by MTS assay2016Journal of medicinal chemistry, Oct-27, Volume: 59, Issue:20
Amidate Prodrugs of Deoxythreosyl Nucleoside Phosphonates as Dual Inhibitors of HIV and HBV Replication.
AID464071Antiviral activity against 3TC-resistant HBV with polymerase LMMV mutation infected in HepG2.2.15 cells assessed as nucleic acid and protein levels dosed daily for 9 days and measured 24 hrs after last treatment by Southern blot hybridization2010Bioorganic & medicinal chemistry letters, Mar-01, Volume: 20, Issue:5
Orally bioavailable anti-HBV dinucleotide acyloxyalkyl prodrugs.
AID527283Antiviral activity against HBV infected in human 2.2.15 cell at 10 ug/ml2010Bioorganic & medicinal chemistry letters, Nov-15, Volume: 20, Issue:22
Antiviral activity of 2,3'-anhydro and related pyrimidine nucleosides against hepatitis B virus.
AID548575Antiviral activity against HIV1 isolate 061 harboring reverse transcriptase M41L/D67N/K70R/M184V/L210W/T215Y/K219E mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID209952Concentration required to reduce the proliferation of PHA stimulated human peripheral blood T lymphocytes to 50% of untreated PHA Stimulated control2001Bioorganic & medicinal chemistry letters, Nov-19, Volume: 11, Issue:22
Novel 5-vinyl pyrimidine nucleosides with potent anti-hepatitis B virus activity.
AID582401Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral antigen level in serum at 15 mg/kg, po qd measured on 36th week on 48 weeks study (Rvb = 3.8 +/- 1.3 log10 ng/ml)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID548581Antiviral activity against HIV1 isolate 071 harboring reverse transcriptase 65R/S68N/184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID541156Selectivity ratio of EC50 for antiviral activity against GS-9160-resistant HIV1 selected after 5 passages to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID1316331Antiviral activity against HIV2 ROD harboring reverse transcriptase infected in human MT4 cells assessed as protection against virus induced cytotoxicity after 5 days by MTT assay2016Journal of medicinal chemistry, 09-08, Volume: 59, Issue:17
Design, Synthesis, and Evaluation of Thiophene[3,2-d]pyrimidine Derivatives as HIV-1 Non-nucleoside Reverse Transcriptase Inhibitors with Significantly Improved Drug Resistance Profiles.
AID244629Selectivity index of intracellular intermediates as the ratio of CC50 and EC902005Journal of medicinal chemistry, Jul-28, Volume: 48, Issue:15
5'-Homoneplanocin A inhibits hepatitis B and hepatitis C.
AID1226125Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBV DNA copies per uL at 300 uM after 6 days by real-time fluorescence quantitative PCR analysis2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID1543319Therapeutic index, ratio of CC50 for toxicity in C8166 cells to EC50 for antiviral activity against HIV1 3B infected in human C8166 cells2019Journal of natural products, 07-26, Volume: 82, Issue:7
Dimeric Pyranonaphthoquinone Glycosides with Anti-HIV and Cytotoxic Activities from a Soil-Derived
AID582410Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral antigen positive hepatocytes at 15 mg/kg, po qd measured on 12th week on 48 weeks study (Rvb = 55 +/- 32 %)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID548579Antiviral activity against HIV1 isolate 069 harboring reverse transcriptase D67E/T69SSG/V75M/M184V/L210W/T215Y mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1351356Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for antiviral activity against HBV infected in human HepG2(2.2.15) cells assessed as inhibition of viral DNA replication2018European journal of medicinal chemistry, Jan-20, Volume: 144Design, synthesis and evaluation of novel phenyl propionamide derivatives as non-nucleoside hepatitis B virus inhibitors.
AID517829Antiviral activity against DHBV infected in duck hepatocytes assessed as inhibition of viral DNA replication at 0.01 to 0.05 ug/mL2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Antiviral activity of various 1-(2'-deoxy-β-D-lyxofuranosyl), 1-(2'-fluoro-β-D-xylofuranosyl), 1-(3'-fluoro-β-D-arabinofuranosyl), and 2'-fluoro-2',3'-didehydro-2',3'-dideoxyribose pyrimidine nucleoside analogues against duck hepatitis B virus (DHBV) and
AID572992Mitochondrial toxicity in human HepG2 cells assessed as percent inhibition of mitochondrial DNA at 100 uM after 14 days by real-time PCR2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Anti-human immunodeficiency virus activity, cross-resistance, cytotoxicity, and intracellular pharmacology of the 3'-azido-2',3'-dideoxypurine nucleosides.
AID588218FDA HLAED, lactate dehydrogenase (LDH) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID565915Antiviral activity against Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as inhibition of viral e antigen secretion after 6 days by ELISA2011European journal of medicinal chemistry, Jan, Volume: 46, Issue:1
Structure-activity relationships study of 6-chloro-4-(2-chlorophenyl)-3-(2-hydroxyethyl) quinolin-2(1H)-one derivatives as novel non-nucleoside anti-hepatitis B virus agents.
AID405000Antiviral activity against HBeAg-deficient HBV genotype D with precore G1896A mutation and reverse transcriptase L80I/M204I mutation in human Huh7 cells assessed as viral replication yield at 1 uM after 5 days relative to control2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID576230Cmax in HIV-1 infected children aged 2.5 to 14 years at 8 mg/kg, po every 24 hrs coadministered with 240 mg/m2 of didanosine and efavirenz by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID1614368Mitochondrial toxicity in human HepG2 cells assessed as inhibition of nuclear ribosomal-DNA level at 10 uM followed by medium plus drugs replenishment every 3 to 4 days for 14 days relative to control2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID340710Ratio of Cmax to Cmin in healthy human PBMC assessed as intracellular apricitabine triphosphate level per 10'6 cells at 300 mg, po administered once daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID527717Antiviral activity against DHBV infected in duck hepatocytes assessed as inhibition of viral DNA replication after 2 days2010Bioorganic & medicinal chemistry, Nov-01, Volume: 18, Issue:21
Synthesis and in vitro antiviral activities of 3'-fluoro (or chloro) and 2',3'-difluoro 2',3'-dideoxynucleoside analogs against hepatitis B and C viruses.
AID1636356Drug activation in human Hep3B cells assessed as human CYP2C9-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 300 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of NA2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID618793Antiviral activity against HIV1 LAV1 infected in phytohemagglutininin-stimulated human PBMC assessed as RT level after 6 days by microdilution plate assay2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Synthesis, antiviral activity, cytotoxicity and cellular pharmacology of l-3'-azido-2',3'-dideoxypurine nucleosides.
AID414791Selectivity index, ratio of TC50 for human HepG2(2.2.15) cells to IC50 for HBV2009Bioorganic & medicinal chemistry, Apr-15, Volume: 17, Issue:8
Synthesis and anti-hepatitis B virus activities of Matijing-Su derivatives.
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID563939Antiviral activity against HIV1 pNL4-3 harboring Reverse transcriptase M184V mutant gene infected in TZM-bl cells after 72 hrs by luciferase assay2009Antimicrobial agents and chemotherapy, Nov, Volume: 53, Issue:11
Impact of novel human immunodeficiency virus type 1 reverse transcriptase mutations P119S and T165A on 4'-ethynylthymidine analog resistance profile.
AID323407Reduction in [3H]dexelvucitabine triphosphate in human CEM cells per 10^6 cells at 100 uM2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
Antiviral and cellular metabolism interactions between Dexelvucitabine and lamivudine.
AID1661334Antiviral activity against VSVG pseudotyped HIV1 infected in HEK293 cells preincubated for 3 hrs followed by compound washout and subsequent compound redosing and measured after 72 hrs by luciferase reporter gene based assay2020Journal of medicinal chemistry, 08-13, Volume: 63, Issue:15
Mechanistic Insight into Antiretroviral Potency of 2'-Deoxy-2'-β-fluoro-4'-azidocytidine (FNC) with a Long-Lasting Effect on HIV-1 Prevention.
AID358069Antiviral activity against HBV in human HepW10 cells assessed as inhibition of viral pre genomic RNA replication2007Proceedings of the National Academy of Sciences of the United States of America, May-15, Volume: 104, Issue:20
Unique antiviral mechanism discovered in anti-hepatitis B virus research with a natural product analogue.
AID682491Antiviral activity against HIV1 98USMSC5016 clade C clinical isolate infected in PHA-stimulated human PBMC assessed as inhibition of viral replication incubated for 6 hrs followed by compound-wash out measured after 6 days by liquid scintillation counting2012Journal of medicinal chemistry, May-24, Volume: 55, Issue:10
Synthesis and biological evaluation of fatty acyl ester derivatives of (-)-2',3'-dideoxy-3'-thiacytidine.
AID1401795Antiviral activity against DHBV infected in duck assessed as inhibition of viral DNA level in serum at 10 mg/kg, po administered once daily measured on day 15 by SYBR Green I dye-based FQ-PCR analysis relative to control2018European journal of medicinal chemistry, Jan-01, Volume: 143Design, synthesis, and biological evaluation of new 1,2,3-triazolo-2'-deoxy-2'-fluoro- 4'-azido nucleoside derivatives as potent anti-HBV agents.
AID548573Antiviral activity against HIV1 isolate 058 harboring reverse transcriptase M41L/D67N/K70R/L210W/T215F/K219Q mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1380573Antiviral activity against HIV1 virions containing reverse transcriptase E138K/M184V mutant derived from HIV/VSG-G or HIV/HA virions infected 293T cells using human A549 cells as target cells assessed as inhibition of viral replication using compound pre-2018Bioorganic & medicinal chemistry letters, 06-01, Volume: 28, Issue:10
Design, synthesis and biological evaluation of substituted (+)-SG-1 derivatives as novel anti-HIV agents.
AID574199Cytotoxicity against human skeletal muscle Myotube assessed as change in Tfam mitochondrial RNA level on day 5 by RT-PCR relative to untreated control2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Impact of nucleoside reverse transcriptase inhibitors on mitochondrial DNA and RNA in human skeletal muscle cells.
AID582412Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral antigen positive hepatocytes at 15 mg/kg, po qd for 48 weeks study (Rvb = 35 +/- 27 %)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID588964Substrates of transporters of clinical importance in the absorption and disposition of drugs, OAT12010Nature reviews. Drug discovery, Mar, Volume: 9, Issue:3
Membrane transporters in drug development.
AID1815377Anti-HIV activity against HIV-1 IIIB infected in human MT4 cells assessed as reduction in virus-induced cytopathic effect incubated for 5 days by MTT assay2021European journal of medicinal chemistry, Dec-15, Volume: 226Design of the naphthyl-diarylpyrimidines as potent non-nucleoside reverse transcriptase inhibitors (NNRTIs) via structure-based extension into the entrance channel.
AID410604Antiviral activity against lamivudine-resistant HBV reverse transcriptase L180M mutant in human Huh7 cells after 4 days by intracellular HBV DNA replication assay2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Synthesis and anti-hepatitis B virus and anti-hepatitis C virus activities of 7-deazaneplanocin A analogues in vitro.
AID341753Drug level in human phytohemagglutininin-activated PBMC at 2.6 uM after 24 hrs2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
In vitro interactions between apricitabine and other deoxycytidine analogues.
AID1055517Cytostatic activity against thymidine kinase-deficient human CEM cells assessed as growth inhibition after 3 days by particle counting analysis2013European journal of medicinal chemistry, , Volume: 70Design, synthesis and biological evaluation of phosphorodiamidate prodrugs of antiviral and anticancer nucleosides.
AID1401799Antiviral activity against DHBV infected in duck assessed as inhibition of viral DNA level in liver at 10 mg/kg, po administered once daily measured on day 10 by SYBR Green I dye-based FQ-PCR analysis relative to control2018European journal of medicinal chemistry, Jan-01, Volume: 143Design, synthesis, and biological evaluation of new 1,2,3-triazolo-2'-deoxy-2'-fluoro- 4'-azido nucleoside derivatives as potent anti-HBV agents.
AID1447282Inhibition of HIV1 3B dinucleoside reverse transcriptase infected in human P4R5 MAGI cells assessed as reduction in viral infection after 2 hrs by Galacto-Star beta-galactosidase reporter gene assay2017Bioorganic & medicinal chemistry letters, 05-01, Volume: 27, Issue:9
Synthesis and anti-HIV activities of unsymmetrical long chain dicarboxylate esters of dinucleoside reverse transcriptase inhibitors.
AID1320778Selectivity index, ratio of CC50 for human MT4 cells to EC50 for HIV1 3B infected in human MT4 cells2016Journal of medicinal chemistry, Oct-27, Volume: 59, Issue:20
Amidate Prodrugs of Deoxythreosyl Nucleoside Phosphonates as Dual Inhibitors of HIV and HBV Replication.
AID519965Antiviral activity against 0.005 MOI HIV1 NL4-3 harboring M184V mutant RT infected in human MT2 cells2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID1226131Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBV DNA copies per uL at 75 uM after 9 days by real-time fluorescence quantitative PCR analysis2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID106422Therapeutic index was measured as concentration required to cause 50% death of uninfected MT-4- cells to IC50 concentration required to inhibit syncytia formation by 50% in HIV-1 infected MT-4 cells1994Journal of medicinal chemistry, Jul-08, Volume: 37, Issue:14
Inhibition of human immunodeficiency virus type 1 replication by phosphonoformate- and phosphonoacetate-2',3'-dideoxy-3'-thiacytidine conjugates.
AID1200844Antiviral activity against HIV1 RES056 expressing reverse transcriptase K103N/Y181C double mutant infected in human MT4 cells assessed as reduction in virus-induced cytopathic effect after 5 days by MTT assay2015European journal of medicinal chemistry, Mar-26, Volume: 93Fused heterocycles bearing bridgehead nitrogen as potent HIV-1 NNRTIs. Part 4: design, synthesis and biological evaluation of novel imidazo[1,2-a]pyrazines.
AID1351365Antiviral activity against HBV infected in human HepG2(2.2.15) cells assessed as inhibition of intracellular viral pregenomic RNA expression at 1 uM after 6 days by TRIzol reagent based RT-PCR method relative to control2018European journal of medicinal chemistry, Jan-20, Volume: 144Design, synthesis and evaluation of novel phenyl propionamide derivatives as non-nucleoside hepatitis B virus inhibitors.
AID1544335Antiviral activity against lamivudine-resistant Hepatitis B virus harboring L180M/M204V mutant infected in human HepG2.2.15 cells assessed as inhibition of intracellular HBV DNA replication at 20 uM supplemented with fresh medium containing compound every2019Bioorganic & medicinal chemistry letters, 06-01, Volume: 29, Issue:11
Design, synthesis, and biological evaluation of novel 2'-deoxy-2'-fluoro-2'-C-methyl 8-azanebularine derivatives as potent anti-HBV agents.
AID740213Antiviral activity against Hepatitis B virus-infected human HepG2(2.2.15) cells assessed as inhibition of HBeAg secretion2013Bioorganic & medicinal chemistry letters, Apr-01, Volume: 23, Issue:7
Anti-HBV active constituents from Piper longum.
AID261858Inhibition of HBV M204I mutant transfected in B1 cell line at 10 ug/mL2006Journal of medicinal chemistry, Mar-23, Volume: 49, Issue:6
Inhibition of hepatitis B virus (HBV) replication by pyrimidines bearing an acyclic moiety: effect on wild-type and mutant HBV.
AID563938Antiviral activity against HIV1 pNL4-3 harboring Reverse transcriptase T165A mutant gene infected in TZM-bl cells after 72 hrs by luciferase assay2009Antimicrobial agents and chemotherapy, Nov, Volume: 53, Issue:11
Impact of novel human immunodeficiency virus type 1 reverse transcriptase mutations P119S and T165A on 4'-ethynylthymidine analog resistance profile.
AID540221Volume of distribution at steady state in human after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID1363968Antiviral activity against lamivudine-resistant hepatitis B virus harboring reverse transcriptase M204I/V173L double mutant infected in human Huh7 cells assessed as reduction in secreted DNA levels measured on day 7 by real-time PCR analysis2017Bioorganic & medicinal chemistry, 02-01, Volume: 25, Issue:3
Discovery of hepatitis B virus capsid assembly inhibitors leading to a heteroaryldihydropyrimidine based clinical candidate (GLS4).
AID576253Apparent oral clearance in HIV-1 infected children with body weight >17 kg at 8 mg/kg, po every 24 hrs coadministered with 240 mg/m2 of didanosine and efavirenz by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID1226101Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBsAg secretion at 300 uM after 9 days by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID576235AUC (0 to tau) in HIV-1 infected children aged 6.9 years at 4 mg/kg, po every 12 hrs coadministered with nevirapine and stavudine by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID458527Antiviral activity against Hepatitis B virus ayw in human M33 cells containing Lamivudine resistant HBV genome with DNA polymerase L515M/M539V mutation genome cells assessed as reduction of viral DNA level after 6 days by RT-PCR2010Bioorganic & medicinal chemistry, Feb, Volume: 18, Issue:3
Synthesis and the biological evaluation of arylnaphthalene lignans as anti-hepatitis B virus agents.
AID685499Antiviral activity against HIV1 BaL assessed as inhibition of infection in HeLa P4/R5 cells expressing CD4 receptor and beta-gal incubated for 2 hrs followed by compound-wash out measured after 46 hrs by single round infection MAGI assay2012Journal of medicinal chemistry, May-24, Volume: 55, Issue:10
Synthesis and biological evaluation of fatty acyl ester derivatives of (-)-2',3'-dideoxy-3'-thiacytidine.
AID226232Fold increase of EC50 HIV M184v to that of EC90 HIV-1xxBRU was determined2004Journal of medicinal chemistry, Mar-25, Volume: 47, Issue:7
Synthesis, structure-activity relationships, and mechanism of drug resistance of D- and L-beta-3'-fluoro-2',3'-unsaturated-4'-thionucleosides as anti-HIV agents.
AID1320781Antiviral activity against HBV ayw1 infected in human HepG2(2.2.15) cells assessed as reduction in viral replication by measuring extracellular viral DNA copy number after 6 days by real-time qPCR method2016Journal of medicinal chemistry, Oct-27, Volume: 59, Issue:20
Amidate Prodrugs of Deoxythreosyl Nucleoside Phosphonates as Dual Inhibitors of HIV and HBV Replication.
AID1771360Selectivity index, ratio of CC50 for human HepDES19 cells to EC50 for inhibition of capsid protein-mediated antiviral activity against HBV infected in human HepDES19 cells assessed as inhibition of DNA replication2021European journal of medicinal chemistry, Dec-05, Volume: 225Design, synthesis and evaluation of heteroaryldihydropyrimidine analogues bearing spiro ring as hepatitis B virus capsid protein inhibitors.
AID417235Half life in HIV-infected human assessed as Lamivudine triphosphate level in PBMC at 300 mg QD for 7 days in presence of zidovudine2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Intracellular pharmacokinetics of once versus twice daily zidovudine and lamivudine in adolescents.
AID1363967Antiviral activity against lamivudine-resistant hepatitis B virus harboring reverse transcriptase M204I mutant infected in human Huh7 cells assessed as reduction in secreted DNA levels measured on day 7 by real-time PCR analysis2017Bioorganic & medicinal chemistry, 02-01, Volume: 25, Issue:3
Discovery of hepatitis B virus capsid assembly inhibitors leading to a heteroaryldihydropyrimidine based clinical candidate (GLS4).
AID586353Antiviral activity against Human immunodeficiency virus 1 3B harboring reverse transcriptase M184V mutant infected in human MT2 cells assessed as inhibition of virus induced cytopathic effect selected on day 14 after 4 passages by PCR analysis2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID1226109Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBeAg secretion at 300 uM after 3 days by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID1387678Antiviral activity against HBV infected in human HepG2.2.15 cells assessed as inhibition of HBeAg secretion at 1 mM supplemented with fresh medium containing compound every 3 days for 9 days measured after 9 days by ELISA relative to control2018Journal of natural products, 10-26, Volume: 81, Issue:10
Matrine-Type Alkaloids from the Roots of Sophora flavescens and Their Antiviral Activities against the Hepatitis B Virus.
AID1320865Cytotoxicity against mock-infected human MT4 cells assessed as reduction in cell viability after 5 days by MTT assay2016European journal of medicinal chemistry, Oct-04, Volume: 121Structural optimization of pyridine-type DAPY derivatives to exploit the tolerant regions of the NNRTI binding pocket.
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID417062Drug metabolism in HIV-infected human PBMC assessed as zidovudine monophosphate level at 300 mg administered in two courses, first BID for 7 to 14 days followed by QD for 7 days and second course the subjects were switched to the other regimen measured pe2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Intracellular pharmacokinetics of once versus twice daily zidovudine and lamivudine in adolescents.
AID548837Antiviral activity against HIV1 isolate 211 harboring reverse transcriptase D67N/K70R/T215F/K219E/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1587128Half-life in human serum administered once daily2019Journal of medicinal chemistry, 05-09, Volume: 62, Issue:9
A Survey of the Structures of US FDA Approved Combination Drugs.
AID572993Mitochondrial toxicity in human HepG2 cells assessed as percent mitochondrial DNA production at 10 uM after 14 days by real-time PCR relative to control2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Anti-human immunodeficiency virus activity, cross-resistance, cytotoxicity, and intracellular pharmacology of the 3'-azido-2',3'-dideoxypurine nucleosides.
AID246456Effective concentration to inhibit 50 % of hepatitis C virus replication in a cell culture model;ND=Not determined2005Journal of medicinal chemistry, Jan-27, Volume: 48, Issue:2
Synthesis and antiviral activity of helioxanthin analogues.
AID353551Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for HBV surface antigen secretion2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Anti-HBV agents. Part 2: synthesis and in vitro anti-hepatitis B virus activities of alisol A derivatives.
AID1192274Antiviral activity against hepatitis B viral in human HepG2(2.2.15) cells assessed as decrease in surface antigen HBeAg secretion at 25 ug/ml after 7 days2015Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7
A coumarin lignanoid from the stems of Kadsura heteroclita.
AID572767Antiviral activity against HIV1 infected in human HeLa P4/R5 cells assessed as inhibition of viral replication2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Anti-human immunodeficiency virus activity, cross-resistance, cytotoxicity, and intracellular pharmacology of the 3'-azido-2',3'-dideoxypurine nucleosides.
AID1507023Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of viral DNA replication at 0.16 uM after 8 days by real time fluorescent PCR method relative to control2017European journal of medicinal chemistry, Aug-18, Volume: 136Design, synthesis and primary biological evaluation of the novel 2-pyridone derivatives as potent non-nucleoside HBV inhibitors.
AID548834Antiviral activity against HIV1 isolate 203 harboring reverse transcriptase M41L/L210W/T215Y/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1743627Antiviral activity against HIV1 harboring RT K103N mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect incubated for 5 days by MTT assay2020European journal of medicinal chemistry, Nov-15, Volume: 206Targeting dual tolerant regions of binding pocket: Discovery of novel morpholine-substituted diarylpyrimidines as potent HIV-1 NNRTIs with significantly improved water solubility.
AID1869629Cytotoxicity against human HepG2.2.15 cells assessed as reduction in cell viability by neutral red uptake assay2022Journal of medicinal chemistry, 07-14, Volume: 65, Issue:13
Reshaping an Acyclic Nucleoside Phosphonate into a Selective Anti-hepatitis B Virus Compound.
AID1228538Tmax in Sprague-Dawley rat at 32 mg/kg, po2015Journal of medicinal chemistry, May-14, Volume: 58, Issue:9
Synthesis and biological evaluation of 4-substituted fluoronucleoside analogs for the treatment of hepatitis B virus infection.
AID1869630Cytotoxicity against human HepG2.2.15 cells assessed as reduction in cell viability2022Journal of medicinal chemistry, 07-14, Volume: 65, Issue:13
Reshaping an Acyclic Nucleoside Phosphonate into a Selective Anti-hepatitis B Virus Compound.
AID1072523Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as decrease in HBV DNA production2014European journal of medicinal chemistry, Mar-21, Volume: 75A review of non-nucleoside anti-hepatitis B virus agents.
AID301053Selectivity index, ratio of CC50 for human Hep G2.2.15 cells to IC50 for surface antigen HBsAg secretion in HBV transfected Hep G2.2.15 cells2007Bioorganic & medicinal chemistry letters, Oct-01, Volume: 17, Issue:19
Two new alkaloids and active anti-hepatitis B virus constituents from Hypserpa nitida.
AID86718Effective concentration to inhibit hepatitis B virus cytopathicity in HepG2.2.15 cells was determined in vitro2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Potent nonclassical nucleoside antiviral drugs based on the N,N-diarylformamidine concept.
AID1535524Antiviral activity against HIV2 ROD infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 5 days by MTT assay2019Bioorganic & medicinal chemistry, 02-01, Volume: 27, Issue:3
Design, synthesis and biological evaluation of novel acetamide-substituted doravirine and its prodrugs as potent HIV-1 NNRTIs.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID1729149Antiviral activity against HIV1 3B infected in human MT4 cells assessed as reduction in virus-induced cytopathic effect by MTT assay2021European journal of medicinal chemistry, Mar-05, Volume: 213Exploiting the tolerant region I of the non-nucleoside reverse transcriptase inhibitor (NNRTI) binding pocket. Part 2: Discovery of diarylpyrimidine derivatives as potent HIV-1 NNRTIs with high Fsp
AID548583Antiviral activity against HIV1 isolate 157 harboring reverse transcriptase L74V/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1649792Antiviral activity against HBV infected in human HepG2.A64 cells containing reverse transcriptase L180M/T184L/M204V mutant assessed as reduction in viral replication incubated for 6 days by PCR analysis2020Journal of medicinal chemistry, 06-11, Volume: 63, Issue:11
Discovery of (1
AID437964Antiviral activity against HBV assessed as inhibition of viral surface antigen secretion2009Bioorganic & medicinal chemistry letters, Dec-01, Volume: 19, Issue:23
Anti-HBV agents. Part 3: preliminary structure-activity relationships of tetra-acylalisol A derivatives as potent hepatitis B virus inhibitors.
AID46753The cytotoxicity against CEM cells1997Journal of medicinal chemistry, Sep-12, Volume: 40, Issue:19
Synthesis, anti-human immunodeficiency virus and anti-hepatitis B virus activities of novel oxaselenolane nucleosides.
AID1661362Cmax in monkey PBMC assessed as 3TC-TP level at 20 mg/kg, po administered as single dose by LC-MS/MS analysis2020Journal of medicinal chemistry, 08-13, Volume: 63, Issue:15
Mechanistic Insight into Antiretroviral Potency of 2'-Deoxy-2'-β-fluoro-4'-azidocytidine (FNC) with a Long-Lasting Effect on HIV-1 Prevention.
AID1228736Antiviral activity against HIV2-ROD infected in human MT4 cells assessed as inhibition of virus induced cell death measured after 5 days of infection by MTT assay2015Journal of natural products, May-22, Volume: 78, Issue:5
Antiviral Activity of Flexibilane and Tigliane Diterpenoids from Stillingia lineata.
AID341748Drug level in human resting PBMC assessed as Lamivudine monophosphate level at 2.6 uM after 24 hrs2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
In vitro interactions between apricitabine and other deoxycytidine analogues.
AID152628Antiviral activity against HIV-1xxBRU mutant strain in human PBM cells2002Journal of medicinal chemistry, Oct-24, Volume: 45, Issue:22
Stereoselective synthesis and antiviral activity of D-2',3'-didehydro-2',3'-dideoxy-2'-fluoro-4'-thionucleosides.
AID1228737Selectivity index, ratio of CC50 for human MT4 cells to EC50 for HIV1-3B2015Journal of natural products, May-22, Volume: 78, Issue:5
Antiviral Activity of Flexibilane and Tigliane Diterpenoids from Stillingia lineata.
AID417257Cmax in HIV-infected human assessed as Lamivudine diphosphate level in PBMC at 300 mg QD for 7 days measured per 10'6 cells in presence of zidovudine2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Intracellular pharmacokinetics of once versus twice daily zidovudine and lamivudine in adolescents.
AID548801Antiviral activity against HIV1 isolate 194 harboring reverse transcriptase M41L/T215Y/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID582405Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral DNA replicative intermediate level per ug of total cell DNA at 15 mg/kg, po qd for 48 weeks measured on 60th week (Rvb = 979 pg)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID548811Antiviral activity against HIV1 isolate 220 harboring reverse transcriptase K70E/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1228738Selectivity index, ratio of CC50 for human MT4 cells to EC50 for HIV2-ROD2015Journal of natural products, May-22, Volume: 78, Issue:5
Antiviral Activity of Flexibilane and Tigliane Diterpenoids from Stillingia lineata.
AID1351363Antiviral activity against lamivudine/entecavir resistant HBV harboring reverse transcriptase L180M/M204V/T184L mutant infected in human HepG2(2.2.15) cells assessed as inhibition of viral DNA replication after 72 hrs by RT-PCR method2018European journal of medicinal chemistry, Jan-20, Volume: 144Design, synthesis and evaluation of novel phenyl propionamide derivatives as non-nucleoside hepatitis B virus inhibitors.
AID447658Antiviral activity against Hepatitis B virus infected human HepG2.2.15 cells assessed as HBsAg secretion at 200 ug/kg after 9 days by ELISA2009Bioorganic & medicinal chemistry letters, Sep-01, Volume: 19, Issue:17
Schisanwilsonins A-G and related anti-HBV lignans from the fruits of Schisandra wilsoniana.
AID1743637Resistance index, ratio of EC50 for antiviral activity against HIV1 expressing RT Y188L mutant infected in human MT4 cells to EC50 for antiviral activity against HIV1 3B infected in human MT4 cells2020European journal of medicinal chemistry, Nov-15, Volume: 206Targeting dual tolerant regions of binding pocket: Discovery of novel morpholine-substituted diarylpyrimidines as potent HIV-1 NNRTIs with significantly improved water solubility.
AID261854Inhibition of duck HBV transfected in primary duck hepatocytes at 10 ug/mL2006Journal of medicinal chemistry, Mar-23, Volume: 49, Issue:6
Inhibition of hepatitis B virus (HBV) replication by pyrimidines bearing an acyclic moiety: effect on wild-type and mutant HBV.
AID1741368Cytotoxicity against human HepG2.2.15 cells assessed as reduction in cell viability at 100 uM incubated for 4 days prior to compound washout followed by compound addition and measured after 4 days by CCK8 assay relative to control2020European journal of medicinal chemistry, Sep-15, Volume: 202Design, diversity-oriented synthesis and biological evaluation of novel heterocycle derivatives as non-nucleoside HBV capsid protein inhibitors.
AID519960Selectivity ratio of EC50 for 0.01 MOI HIV1 NL4-3 infected in 2 hrs pretreated human MT2 cells by MTS assay to EC50 for 0.01 MOI HIV1 NL4-3 infected in 2 hrs pretreated human MT2 cells by RT assay2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID354458Cytotoxicity against human CEM-SS cells at 40 ug/ml after 6 days by MTS assay2004Journal of natural products, Jun, Volume: 67, Issue:6
New 3-O-acyl betulinic acids from Strychnos vanprukii Craib.
AID540100Antiviral activity against Hepatitis B virus infected in HepG2.2.15 assessed as inhibition of HBV replication by quantitative Southern blot hybridization analysis2010Bioorganic & medicinal chemistry letters, Dec-15, Volume: 20, Issue:24
Synthesis and biological evaluation of 1H-benzimidazol-5-ols as potent HBV inhibitors.
AID576254AUC in HIV-1 infected children with body weight <17 kg at 8 mg/kg, po every 24 hrs coadministered with 240 mg/m2 of didanosine and efavirenz by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID1742097Antiviral activity against HBV infected in human HepG2.2.15 cells assessed as inhibition of DNA replication supplemented with fresh medium containing compound every 2 days for 6 days by RT-PCR analysis2020European journal of medicinal chemistry, Nov-01, Volume: 205Discovery of novel quinazolinone derivatives as potential anti-HBV and anti-HCC agents.
AID519967Antiviral activity against 0.005 MOI HIV1 NL4-3 harboring M184V mutant RT infected in human MT2 cells by phenosense assay2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID1661385Inhibition of HIV1 HA-tagged Vif expressed in HEK293T cells co-expressing Myc-tagged pcDNA-APOBEC3G assessed as reduction in Vif-mediated A3G degradation at 10000 nM measured after 48 hrs by Western blot analysis2020Journal of medicinal chemistry, 08-13, Volume: 63, Issue:15
Mechanistic Insight into Antiretroviral Potency of 2'-Deoxy-2'-β-fluoro-4'-azidocytidine (FNC) with a Long-Lasting Effect on HIV-1 Prevention.
AID297676Antimycobacterial activity against Mycobacterium bovis BCG at 100 uM by microplate alamar blue assay2007Journal of medicinal chemistry, Sep-20, Volume: 50, Issue:19
Inhibition of Mycobacterium tuberculosis, Mycobacterium bovis, and Mycobacterium avium by novel dideoxy nucleosides.
AID548833Antiviral activity against HIV1 isolate 201 harboring reverse transcriptase M41L/L210W/T215Y mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID235642Selectivity index was evaluated [Selectivity = (CC50 / EC50) against Hepatitis B virus in human hepatoblastoma cell line]1998Journal of medicinal chemistry, Jun-04, Volume: 41, Issue:12
Does the anti-hepatitis B virus activity of (+)-5'-noraristeromycin exist in its 4'-epimer and 4'-deoxygenated derivatives?
AID626000Fold resistance, ratio of EC90 for lamivudine-resistant Hepatitis B virus harboring reverse transcriptase L180M/M204V double mutant to EC90 for wild type Hepatitis B virus2011Bioorganic & medicinal chemistry letters, Nov-01, Volume: 21, Issue:21
Antiviral activity of novel 2'-fluoro-6'-methylene-carbocyclic adenosine against wild-type and drug-resistant hepatitis B virus mutants.
AID517934Antiviral activity against HIV1 NL4-3 infected in HEK293 cells assessed as inhibition of virus replication after 72 hrs2010Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6
Telbivudine exhibits no inhibitory activity against HIV-1 clinical isolates in vitro.
AID681296TP_TRANSPORTER: inhibition of Calcein efflux (Calcein: 0.05 micro;M, Lamivudine: 0.55 uM) in UMCC-1/VP cells2002AIDS (London, England), Sep-06, Volume: 16, Issue:13
The protease inhibitor ritonavir inhibits the functional activity of the multidrug resistance related-protein 1 (MRP-1).
AID1888695Antiviral activity against HIV1 with RT K103N mutant infected in human MT4 cells cells assessed as protection against viral-induced cytopathogenecity by MTT assay
AID781022Selectivity index, ratio of CC50 for human MT4 cells to EC50 for HIV-2 ROD infected in human MT4 cells2013Bioorganic & medicinal chemistry, Nov-15, Volume: 21, Issue:22
Design, synthesis and biological evaluation of N2,N4-disubstituted-1,1,3-trioxo-2H,4H-pyrrolo[1,2-b][1,2,4,6]thiatriazine derivatives as HIV-1 NNRTIs.
AID1869628Cytotoxicity against human HepG2.2.15 cells assessed as reduction in cell viability incubated for 1 to 4 hrs by MTS uptake assay2022Journal of medicinal chemistry, 07-14, Volume: 65, Issue:13
Reshaping an Acyclic Nucleoside Phosphonate into a Selective Anti-hepatitis B Virus Compound.
AID558387Ratio of drug level in HIV-infected pregnant woman cord blood plasma to maternal blood plasma at 150 mg, po BID by LC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Genital tract, cord blood, and amniotic fluid exposures of seven antiretroviral drugs during and after pregnancy in human immunodeficiency virus type 1-infected women.
AID1743638Resistance index, ratio of EC50 for antiviral activity against HIV1 expressing RT E138K mutant infected in human MT4 cells to EC50 for antiviral activity against HIV1 3B infected in human MT4 cells2020European journal of medicinal chemistry, Nov-15, Volume: 206Targeting dual tolerant regions of binding pocket: Discovery of novel morpholine-substituted diarylpyrimidines as potent HIV-1 NNRTIs with significantly improved water solubility.
AID625996Antiviral activity against lamivudine-resistant Hepatitis B virus harboring reverse transcriptase L180M mutant infected in human HepG2(2.2.15) cells assessed as reduction of infectious virus titer treated daily for 9 days by quantitative Southern blot hyb2011Bioorganic & medicinal chemistry letters, Nov-01, Volume: 21, Issue:21
Antiviral activity of novel 2'-fluoro-6'-methylene-carbocyclic adenosine against wild-type and drug-resistant hepatitis B virus mutants.
AID1156484Antiviral activity against wild type HIV1 3B infected in human MT4 cells assessed as inhibition of virus-induced cytopathogenicity after 5 days by MTT assay2014European journal of medicinal chemistry, Jul-23, Volume: 82Design and synthesis of a new series of modified CH-diarylpyrimidines as drug-resistant HIV non-nucleoside reverse transcriptase inhibitors.
AID574201Cytotoxicity against human skeletal muscle Myotube at 100 uL on day 5 by WST-1 assay2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Impact of nucleoside reverse transcriptase inhibitors on mitochondrial DNA and RNA in human skeletal muscle cells.
AID106425Concentration required to cause death of MT-4 cells was determined in vitro2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Potent nonclassical nucleoside antiviral drugs based on the N,N-diarylformamidine concept.
AID1869741Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of viral DNA replication at 20 uM measured after 6 days by FQ-PCR analysis relative to control
AID1565097Antiviral activity against drug resistant HIV-1 harboring reverse transcriptase K103N mutant infected in human MT4 cells assessed as reduction in virus-induced cytopathic effect incubated for 5 days by MTT assay
AID1364091Antiviral activity against hepatitis B virus infected in human HepG2.215 cells assessed as reduction in viral DNA replication measured on day 7 by real time PCR analysis2017Bioorganic & medicinal chemistry, 02-01, Volume: 25, Issue:3
Discovery of hepatitis B virus capsid assembly inhibitors leading to a heteroaryldihydropyrimidine based clinical candidate (GLS4).
AID249056Cytotoxicity against CEM cell lines of human2005Journal of medicinal chemistry, Jan-27, Volume: 48, Issue:2
Synthesis and antiviral activity of helioxanthin analogues.
AID548808Antiviral activity against HIV1 isolate 212 harboring reverse transcriptase L210W/T215Y mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID447663Antiviral activity against Hepatitis B virus infected human HepG2.2.15 cells assessed as HBeAg secretion at 200 ug/kg after 9 days by ELISA2009Bioorganic & medicinal chemistry letters, Sep-01, Volume: 19, Issue:17
Schisanwilsonins A-G and related anti-HBV lignans from the fruits of Schisandra wilsoniana.
AID1431334Antiviral activity against Hepatitis B virus subtype adw2 infected in human HuH7 cells assessed as reduction in HBcAg level at 5 ug/ml after 2 days by immunoblot method relative to control2016Journal of natural products, Dec-23, Volume: 79, Issue:12
Synthesis of C-4-Substituted Steviol Derivatives and Their Inhibitory Effects against Hepatitis B Virus.
AID519881Antiviral activity against 0.005 MOI wild type HIV1 NL4-3 infected in human MT2 cells measured after 5 days by MTS assay2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID1165074Antiviral activity against HIV1 3B infected in human MT4 cells assessed as inhibition of virus-induced syncytium formation after 5 days by MTT assay2014European journal of medicinal chemistry, Nov-24, Volume: 87Design, synthesis and anti-HIV evaluation of novel diarylnicotinamide derivatives (DANAs) targeting the entrance channel of the NNRTI binding pocket through structure-guided molecular hybridization.
AID625937Fold resistance, ratio of EC90 for lamivudine-resistant Hepatitis B virus harboring reverse transcriptase M204V mutant to EC90 for wild type Hepatitis B virus2011Bioorganic & medicinal chemistry letters, Nov-01, Volume: 21, Issue:21
Antiviral activity of novel 2'-fluoro-6'-methylene-carbocyclic adenosine against wild-type and drug-resistant hepatitis B virus mutants.
AID556526Antiviral activity against Human immunodeficiency virus 1 clone Q9016 harboring K122E, Q145M, I202V, F214L mutation in reverse transcriptase by phenosense assay relative to wild type2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Human immunodeficiency virus type 1 isolates with the reverse transcriptase (RT) mutation Q145M retain nucleoside and nonnucleoside RT inhibitor susceptibility.
AID1572521Selectivity index, ratio of CC50 for human MT4 cells to EC50 for HIV1 3B infected in human MT4 cells
AID86873Effective concentration against Hepatitis B virus in human hepatoblastoma cell line1998Journal of medicinal chemistry, Jun-04, Volume: 41, Issue:12
Does the anti-hepatitis B virus activity of (+)-5'-noraristeromycin exist in its 4'-epimer and 4'-deoxygenated derivatives?
AID217737Inhibition of cell growth in vero cells1993Journal of medicinal chemistry, Sep-03, Volume: 36, Issue:18
Structure-activity relationships of beta-D-(2S,5R)- and alpha-D-(2S,5S)-1,3-oxathiolanyl nucleosides as potential anti-HIV agents.
AID1743634Resistance index, ratio of EC50 for antiviral activity against HIV1 expressing RT L100I mutant infected in human MT4 cells to EC50 for antiviral activity against HIV1 3B infected in human MT4 cells2020European journal of medicinal chemistry, Nov-15, Volume: 206Targeting dual tolerant regions of binding pocket: Discovery of novel morpholine-substituted diarylpyrimidines as potent HIV-1 NNRTIs with significantly improved water solubility.
AID478525Selectivity index, ratio of TC50 for human HepG2(2.2.15) cells to IC50 for Hepatitis B virus DNA replication2010European journal of medicinal chemistry, May, Volume: 45, Issue:5
Synthesis and antiviral activity of new acrylamide derivatives containing 1,2,3-thiadiazole as inhibitors of hepatitis B virus replication.
AID444057Fraction escaping hepatic elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1902002Selectivity index, ratio of CC50 for human HepG2.2.2.15 cells to IC50 for Hepatitis B virus infected in human HepG2.2.2.15 cells2022European journal of medicinal chemistry, Mar-05, Volume: 231Design and synthesis of novel quinazolinone derivatives as anti-HBV agents with TLR8 agonist effect.
AID1743629Antiviral activity against HIV1 harboring RT Y188L mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect incubated for 5 days by MTT assay2020European journal of medicinal chemistry, Nov-15, Volume: 206Targeting dual tolerant regions of binding pocket: Discovery of novel morpholine-substituted diarylpyrimidines as potent HIV-1 NNRTIs with significantly improved water solubility.
AID1320864Antiviral activity against HIV1 RES056 expressing reverse transcriptase K103N/Y181C double mutant infected in human MT4 cells assessed as protection against virus-induced cytopathic effect after 5 days by MTT assay2016European journal of medicinal chemistry, Oct-04, Volume: 121Structural optimization of pyridine-type DAPY derivatives to exploit the tolerant regions of the NNRTI binding pocket.
AID1203825Mitochondrial toxicity in human HepG2 cells assessed as induction of lactic acid levels at 10 uM incubated for 14 days2015Journal of medicinal chemistry, Apr-23, Volume: 58, Issue:8
β-D-2'-C-Methyl-2,6-diaminopurine Ribonucleoside Phosphoramidates are Potent and Selective Inhibitors of Hepatitis C Virus (HCV) and Are Bioconverted Intracellularly to Bioactive 2,6-Diaminopurine and Guanosine 5'-Triphosphate Forms.
AID384982Cytotoxicity against human HepG2.2.15 cells by MTT assay2008Journal of natural products, May, Volume: 71, Issue:5
Periglaucines A-D, anti-HBV and -HIV-1 alkaloids from Pericampylus glaucus.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID548813Antiviral activity against HIV1 isolate 060 harboring reverse transcriptase M41L/D67N/K70R/L210W/T215Y/K219E mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID625998Antiviral activity against lamivudine-resistant Hepatitis B virus harboring reverse transcriptase L180M/M204V double mutant infected in human HepG2(2.2.15) cells assessed as inhibition of virus replication treated daily for 9 days by quantitative blot hyb2011Bioorganic & medicinal chemistry letters, Nov-01, Volume: 21, Issue:21
Antiviral activity of novel 2'-fluoro-6'-methylene-carbocyclic adenosine against wild-type and drug-resistant hepatitis B virus mutants.
AID1226111Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBeAg secretion at 75 uM after 3 days by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID540114Antiviral activity against Hepatitis B virus infected in HepG2.2.15 assessed as inhibition of HBsAg production at <2183.1 +/- 4.1 by EIA2010Bioorganic & medicinal chemistry letters, Dec-15, Volume: 20, Issue:24
Synthesis and biological evaluation of 1H-benzimidazol-5-ols as potent HBV inhibitors.
AID1742096Antiviral activity against HBV infected in human HepG2.2.15 cells assessed as inhibition of DNA replication at 0.8 uM supplemented with fresh medium containing compound every 2 days for 6 days by RT-PCR analysis relative to control2020European journal of medicinal chemistry, Nov-01, Volume: 205Discovery of novel quinazolinone derivatives as potential anti-HBV and anti-HCC agents.
AID404907Antiviral activity against HBV in HepG2.2.15 cells assessed as decrease in extracellular viral DNA level at 0.3 uM by PCR2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
Strong and selective inhibitors of hepatitis B virus replication among novel N4-hydroxy- and 5-methyl-beta-L-deoxycytidine analogues.
AID560905Antiviral activity against HBV harboring RNA polymerase M204V mutant gene infected in human HuH7 cells assessed as decrease in viral transient transfection after 24 hrs2009Antimicrobial agents and chemotherapy, Jul, Volume: 53, Issue:7
Alkoxyalkyl esters of 9-(s)-(3-hydroxy-2-phosphonomethoxypropyl) adenine are potent and selective inhibitors of hepatitis B virus (HBV) replication in vitro and in HBV transgenic mice in vivo.
AID1320777Cytotoxicity against human MT4 cells assessed as decrease in cell viability after 5 days by MTT assay2016Journal of medicinal chemistry, Oct-27, Volume: 59, Issue:20
Amidate Prodrugs of Deoxythreosyl Nucleoside Phosphonates as Dual Inhibitors of HIV and HBV Replication.
AID560907Antiviral activity against HBV harboring RNA polymerase L180M/M204V mutant gene infected in human HuH7 cells assessed as decrease in viral transient transfection after 24 hrs2009Antimicrobial agents and chemotherapy, Jul, Volume: 53, Issue:7
Alkoxyalkyl esters of 9-(s)-(3-hydroxy-2-phosphonomethoxypropyl) adenine are potent and selective inhibitors of hepatitis B virus (HBV) replication in vitro and in HBV transgenic mice in vivo.
AID404912Antiviral activity against HBV in HepG2.2.15 cells assessed as decrease in extracellular viral DNA level by RT-PCR2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
Strong and selective inhibitors of hepatitis B virus replication among novel N4-hydroxy- and 5-methyl-beta-L-deoxycytidine analogues.
AID540217Volume of distribution at steady state in dog after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID53755Concentration required to reduce the viral DNA in infected cells to 50% of untreated infected controls of Hepatitis B virus in primary duck hepatocyte (DHBV) cultures2002Journal of medicinal chemistry, May-09, Volume: 45, Issue:10
Design and synthesis of novel 5-substituted acyclic pyrimidine nucleosides as potent and selective inhibitors of hepatitis B virus.
AID548582Antiviral activity against HIV1 isolate 153 harboring reverse transcriptase L74V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID55962Concentration required to reduce the proliferation of Daudi cells to 50% of untreated controls; ND means not determined2002Journal of medicinal chemistry, May-09, Volume: 45, Issue:10
Design and synthesis of novel 5-substituted acyclic pyrimidine nucleosides as potent and selective inhibitors of hepatitis B virus.
AID1152373Cytotoxicity against human MT4 cells by MTT assay2014Bioorganic & medicinal chemistry, Jun-15, Volume: 22, Issue:12
Synthesis and biological evaluation of CHX-DAPYs as HIV-1 non-nucleoside reverse transcriptase inhibitors.
AID558366Drug level in HIV-infected pregnant woman maternal blood plasma at 150 mg, po BID by LC/MS/MS analysis2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Genital tract, cord blood, and amniotic fluid exposures of seven antiretroviral drugs during and after pregnancy in human immunodeficiency virus type 1-infected women.
AID576231AUC (0 to tau) in HIV-1 infected children aged 2.5 to 14 years at 8 mg/kg, po every 24 hrs coadministered with 240 mg/m2 of didanosine and efavirenz by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID82124Antiviral activity against Immunodeficiency virus type-1 (HIV-1) in peripheral blood mononuclear cells2000Journal of medicinal chemistry, Oct-19, Volume: 43, Issue:21
Synthesis and antiviral activity of oxaselenolane nucleosides.
AID1401767Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBsAg secretion at 20 uM after 9 days by ELISA relative to control2018European journal of medicinal chemistry, Jan-01, Volume: 143Design, synthesis, and biological evaluation of new 1,2,3-triazolo-2'-deoxy-2'-fluoro- 4'-azido nucleoside derivatives as potent anti-HBV agents.
AID576234Cmax in HIV-1 infected children aged 6.9 years at 4 mg/kg, po every 12 hrs coadministered with nevirapine and stavudine by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID1743636Resistance index, ratio of EC50 for antiviral activity against HIV1 expressing RT Y181C mutant infected in human MT4 cells to EC50 for antiviral activity against HIV1 3B infected in human MT4 cells2020European journal of medicinal chemistry, Nov-15, Volume: 206Targeting dual tolerant regions of binding pocket: Discovery of novel morpholine-substituted diarylpyrimidines as potent HIV-1 NNRTIs with significantly improved water solubility.
AID1055512Antiviral activity against HIV1 3B infected in human CEM cells assessed as virus-induced giant cell formation after 4 days by microscopic analysis2013European journal of medicinal chemistry, , Volume: 70Design, synthesis and biological evaluation of phosphorodiamidate prodrugs of antiviral and anticancer nucleosides.
AID1457762Cytotoxicity against human HepG2.2.15 cells assessed as cell viability by tetrazolium dye uptake assay2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Expanding the Antiviral Spectrum of 3-Fluoro-2-(phosphonomethoxy)propyl Acyclic Nucleoside Phosphonates: Diamyl Aspartate Amidate Prodrugs.
AID81903Cytotoxic concentration required to reduce the uptake of neutral red stain by uninfected cell monolayers to 50% of untreated uninfected human foreskin fibroblasts (HFF); ND means not determined2002Journal of medicinal chemistry, May-09, Volume: 45, Issue:10
Design and synthesis of novel 5-substituted acyclic pyrimidine nucleosides as potent and selective inhibitors of hepatitis B virus.
AID1228535Total blood clearance rate in Sprague-Dawley rat at 2.5 mg/kg, iv2015Journal of medicinal chemistry, May-14, Volume: 58, Issue:9
Synthesis and biological evaluation of 4-substituted fluoronucleoside analogs for the treatment of hepatitis B virus infection.
AID570170Antiviral activity against lamivudine-resistant HBV infected in human Huh7.5 cells assessed as reduction of viral replication at 0.16 ug/ml after 36 hrs2011Journal of medicinal chemistry, Feb-10, Volume: 54, Issue:3
Design and synthesis of oxymatrine analogues overcoming drug resistance in hepatitis B virus through targeting host heat stress cognate 70.
AID576245Cmax in HIV-1 infected children aged 2.1 to 12.8 years at 4 mg/kg, po every 12 hrs coadministered with 8 mg/kg abacavir by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID1862265Inhibition of wild-type recombinant HIV-1 group M subtype B BH10 reverse transcriptase RNase-associated RNase H activity expressed in Escherichia coli XL1 blue using 32P-labeled 5'-UUUUUUUUUAGGAUACAUAUGGUUAAAGUAU-3'/5'-ATACTTTAACCATATGTATCC-3' RNA/DNA tem2022European journal of medicinal chemistry, Oct-05, Volume: 240Design, synthesis, and biological evaluation of novel double-winged galloyl derivatives as HIV-1 RNase H inhibitors.
AID323409Reduction in dexelvucitabine diphosphate choline level in human CEM cells at 33.3 uM2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
Antiviral and cellular metabolism interactions between Dexelvucitabine and lamivudine.
AID557048Antiviral activity against HIV1 clade F1 harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID246785Effective concentrations at which 2-fold depression of extracellular virion DNA (HBV) was observed in 2.2.15 Cells2005Journal of medicinal chemistry, Jul-28, Volume: 48, Issue:15
5'-Homoneplanocin A inhibits hepatitis B and hepatitis C.
AID618860Cytotoxicity against african green monkey Vero cells after 3 days by hemocytometry2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Synthesis, antiviral activity, cytotoxicity and cellular pharmacology of l-3'-azido-2',3'-dideoxypurine nucleosides.
AID582411Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral antigen positive hepatocytes at 15 mg/kg, po qd measured on 36th week on 48 weeks study (Rvb = 41 +/- 25 %)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID1743618Antiviral activity against HIV1 3B infected in human MT4 cells assessed as virus-induced cytopathic effect incubated for 5 days by MTT assay2020European journal of medicinal chemistry, Nov-15, Volume: 206Targeting dual tolerant regions of binding pocket: Discovery of novel morpholine-substituted diarylpyrimidines as potent HIV-1 NNRTIs with significantly improved water solubility.
AID574196Cytotoxicity against human skeletal muscle Myoblast assessed as change in POLG mitochondrial RNA level on day 5 by RT-PCR relative to untreated control2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Impact of nucleoside reverse transcriptase inhibitors on mitochondrial DNA and RNA in human skeletal muscle cells.
AID358084Inhibition of HBV promoter in human HepG2(2.2.15) cells by luciferase reporter gene assay2007Proceedings of the National Academy of Sciences of the United States of America, May-15, Volume: 104, Issue:20
Unique antiviral mechanism discovered in anti-hepatitis B virus research with a natural product analogue.
AID572997Mitochondrial toxicity in human HepG2 cells assessed as percent inhibition of beta-actin DNA at 10 uM after 14 days by real-time PCR2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Anti-human immunodeficiency virus activity, cross-resistance, cytotoxicity, and intracellular pharmacology of the 3'-azido-2',3'-dideoxypurine nucleosides.
AID781023Antiviral activity against HIV2 ROD infected in human MT4 cells assessed as protection against viral-induced cytotoxicity after 5 days by MTT assay2013Bioorganic & medicinal chemistry, Nov-15, Volume: 21, Issue:22
Design, synthesis and biological evaluation of N2,N4-disubstituted-1,1,3-trioxo-2H,4H-pyrrolo[1,2-b][1,2,4,6]thiatriazine derivatives as HIV-1 NNRTIs.
AID1565095Antiviral activity against drug resistant HIV-1 harboring reverse transcriptase E138K mutant infected in human MT4 cells assessed as reduction in virus-induced cytopathic effect incubated for 5 days by MTT assay
AID1191402Cytotoxicity against human MT4 cells after 5 days MTT assay2015Bioorganic & medicinal chemistry, Feb-01, Volume: 23, Issue:3
Synthesis and biological evaluation of DAPY-DPEs hybrids as non-nucleoside inhibitors of HIV-1 reverse transcriptase.
AID1191403Selectivity index, ratio of CC50 for human MT4 cells to EC50 for wild type HIV-1 3B infected in human MT4 cells2015Bioorganic & medicinal chemistry, Feb-01, Volume: 23, Issue:3
Synthesis and biological evaluation of DAPY-DPEs hybrids as non-nucleoside inhibitors of HIV-1 reverse transcriptase.
AID392536Antiviral activity against Vaccinia virus2009Bioorganic & medicinal chemistry, Jan-15, Volume: 17, Issue:2
Unified QSAR approach to antimicrobials. 4. Multi-target QSAR modeling and comparative multi-distance study of the giant components of antiviral drug-drug complex networks.
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID1473741Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1200845Cytotoxicity against mock-infected human MT4 cells assessed as reduction in cell viability after 4 days by MTT assay2015European journal of medicinal chemistry, Mar-26, Volume: 93Fused heterocycles bearing bridgehead nitrogen as potent HIV-1 NNRTIs. Part 4: design, synthesis and biological evaluation of novel imidazo[1,2-a]pyrazines.
AID1769751Therapeutic index, ratio of CC50 for cytotoxicity against human H9 cells to EC50 for antiviral activity against HIV13B2021European journal of medicinal chemistry, Nov-15, Volume: 224Lead optimization to improve the antiviral potency of 2-aminobenzamide derivatives targeting HIV-1 Vif-A3G axis.
AID1869631Antiviral activity against wild type HBV infected in human HepG2 2.2.15 cells assessed as reduction in viral replication by DNA HYB (Vision)/neutral red (Tox) assay2022Journal of medicinal chemistry, 07-14, Volume: 65, Issue:13
Reshaping an Acyclic Nucleoside Phosphonate into a Selective Anti-hepatitis B Virus Compound.
AID582431Toxicity in Woodchuck hepatitis virus infected woodchuck assessed as increase of liver alkaline phosphatase activity at 15 mg/kg, po qd for 48 weeks2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID340698Volume of distribution at steady state in healthy human at 300 mg, po administered once daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID576239Apparent oral clearance in HIV-1 infected children aged 2.5 to 4.8 years at 4 mg/kg, po every 12 hrs by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID1487262Cytotoxicity against human MT4 cells assessed as reduction in cell viability after 5 days by MTT assay2017Bioorganic & medicinal chemistry, 08-15, Volume: 25, Issue:16
Discovery of novel DAPY-IAS hybrid derivatives as potential HIV-1 inhibitors using molecular hybridization based on crystallographic overlays.
AID1815390Selectivity index, ratio of CC50 for cytotoxicity against human MT4 cells to EC50 of Anti-HIV activity against HIV-1 IIIB infected in human MT42021European journal of medicinal chemistry, Dec-15, Volume: 226Design of the naphthyl-diarylpyrimidines as potent non-nucleoside reverse transcriptase inhibitors (NNRTIs) via structure-based extension into the entrance channel.
AID519874Antiviral activity against 0.005 MOI wild type HIV1 NL4-3 infected in 2 hr-pretreated human MT2 cells measured after 5 days by RT SPA2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID618866Cytotoxicity against human HepAD38 cells2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Synthesis, antiviral activity, cytotoxicity and cellular pharmacology of l-3'-azido-2',3'-dideoxypurine nucleosides.
AID323397Antiviral activity against HIV1 LAI in human PBM cells2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
Antiviral and cellular metabolism interactions between Dexelvucitabine and lamivudine.
AID691382Antiviral activity against Duck hepatitis B virus infected in pekin duck primary hepatocytes assessed as inhibition of viral replication at 0.5 to 1 ug/mL2012Bioorganic & medicinal chemistry letters, Oct-15, Volume: 22, Issue:20
A new class of pyrimidine nucleosides: inhibitors of hepatitis B and C viruses.
AID548572Antiviral activity against HIV1 isolate 057 expressing wild type reverse transcriptase gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID341752Drug level in human resting PBMC assessed as Lamivudine triphosphate level at 2.6 uM after 24 hrs2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
In vitro interactions between apricitabine and other deoxycytidine analogues.
AID1320775Antiviral activity against HIV1 3B infected in human MT4 cells assessed as protection against virus-induced cytopathic effect after 5 days by MTT assay2016Journal of medicinal chemistry, Oct-27, Volume: 59, Issue:20
Amidate Prodrugs of Deoxythreosyl Nucleoside Phosphonates as Dual Inhibitors of HIV and HBV Replication.
AID81902Concentration required to reduce the proliferation of HFF (human foreskin fibroblasts) cells to 50% of untreated controls; ND means not determined2002Journal of medicinal chemistry, May-09, Volume: 45, Issue:10
Design and synthesis of novel 5-substituted acyclic pyrimidine nucleosides as potent and selective inhibitors of hepatitis B virus.
AID527281Antiviral activity against HBV infected in duck primary hepatocytes at 10 ug/ml2010Bioorganic & medicinal chemistry letters, Nov-15, Volume: 20, Issue:22
Antiviral activity of 2,3'-anhydro and related pyrimidine nucleosides against hepatitis B virus.
AID1447283Inhibition of HIV1 BaL dinucleoside reverse transcriptase infected in human P4R5 MAGI cells assessed as reduction in viral infection after 2 hrs by Galacto-Star beta-galactosidase reporter gene assay2017Bioorganic & medicinal chemistry letters, 05-01, Volume: 27, Issue:9
Synthesis and anti-HIV activities of unsymmetrical long chain dicarboxylate esters of dinucleoside reverse transcriptase inhibitors.
AID1627277Antiviral activity against HBV infected in human HepG2.2.15.7 cells assessed as inhibition of viral DNA level after 9 days by real time PCR method2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Synthesis and anti-HBV activity of α-stereoisomer of aristeromycin based analogs.
AID1599883Toxicity against Pekin duck infected with HBV assessed as change in body weight at 0.2 to 0.4 mmol/kg, po once daily for 14 days and measured every day during compound dosing2019ACS medicinal chemistry letters, Jun-13, Volume: 10, Issue:6
Design, Synthesis, and Anti-HBV Activity of New Bis(l-amino acid) Ester Tenofovir Prodrugs.
AID1228537Cmax in Sprague-Dawley rat at 32 mg/kg, po2015Journal of medicinal chemistry, May-14, Volume: 58, Issue:9
Synthesis and biological evaluation of 4-substituted fluoronucleoside analogs for the treatment of hepatitis B virus infection.
AID691392Cytotoxicity against human HuH7 cells after 2 days by XTT assay2012Bioorganic & medicinal chemistry letters, Oct-15, Volume: 22, Issue:20
A new class of pyrimidine nucleosides: inhibitors of hepatitis B and C viruses.
AID519859Antiviral activity against HIV1 subtype B-RF infected in 1 hr-pretreated human MT2 cells assessed as inhibition of multicycle replication measured on day 5 postinfection by RT SPA2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID576252Apparent oral clearance in HIV-1 infected children with body weight <17 kg at 8 mg/kg, po every 24 hrs coadministered with 240 mg/m2 of didanosine and efavirenz by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID152644Cytotoxicity against human peripheral blood mononuclear (PBM) cells infected with HIV-I1993Journal of medicinal chemistry, Jan-22, Volume: 36, Issue:2
Asymmetric synthesis and biological evaluation of beta-L-(2R,5S)- and alpha-L-(2R,5R)-1,3-oxathiolane-pyrimidine and -purine nucleosides as potential anti-HIV agents.
AID1401803Antiviral activity against DHBV infected in duck assessed as inhibition of viral DNA level in liver at 10 mg/kg, po administered once daily measured on day 15 by SYBR Green I dye-based FQ-PCR analysis relative to control2018European journal of medicinal chemistry, Jan-01, Volume: 143Design, synthesis, and biological evaluation of new 1,2,3-triazolo-2'-deoxy-2'-fluoro- 4'-azido nucleoside derivatives as potent anti-HBV agents.
AID576241Cmax in HIV-1 infected children aged 8.5 to 12.3 years at 4 mg/kg, po every 12 hrs by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID1241025Antiviral activity against HBV infected in human HepG22.2.15 cells after 3 days by neutral red dye-based plaque reduction assay2015Bioorganic & medicinal chemistry, Sep-01, Volume: 23, Issue:17
2- and 3-Fluoro-3-deazaneplanocins, 2-fluoro-3-deazaaristeromycins, and 3-methyl-3-deazaneplanocin: Synthesis and antiviral properties.
AID1226093Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBsAg secretion at 300 uM after 3 days by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID1226122Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBV DNA copies per uL at 150 uM after 3 days by real-time fluorescence quantitative PCR analysis2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID1434727Cytotoxicity against human PBMC assessed as growth inhibition by CellTiter 96 non-radioactive cell proliferation colorimetric assay2017Bioorganic & medicinal chemistry letters, 02-15, Volume: 27, Issue:4
Synthesis and antiviral evaluation of novel heteroarylpyrimidines analogs as HBV capsid effectors.
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID738970Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for Hepatitis B virus infected in human HepG2.2.15 cells assessed as HBeAg secretion inhibition assay2013Bioorganic & medicinal chemistry letters, Apr-01, Volume: 23, Issue:7
Anti-hepatitis B virus lignans from the root of Streblus asper.
AID1320779Selectivity index, ratio of CC50 for human MT4 cells to EC50 for HIV2 ROD infected in human MT4 cells2016Journal of medicinal chemistry, Oct-27, Volume: 59, Issue:20
Amidate Prodrugs of Deoxythreosyl Nucleoside Phosphonates as Dual Inhibitors of HIV and HBV Replication.
AID353550Antiviral activity against HBV assessed as inhibition of viral surface antigen secretion2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Anti-HBV agents. Part 2: synthesis and in vitro anti-hepatitis B virus activities of alisol A derivatives.
AID548574Antiviral activity against HIV1 isolate 060 harboring reverse transcriptase M41L/D67N/K70R/L210W/T215Y/K219E mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1687680Antiviral activity against wild type HIV-1 strain 3B infected in human MT4 cells assessed as reduction in virus-induced cytopathogenicity by MTT assay2020European journal of medicinal chemistry, Jan-15, Volume: 186Indazolyl-substituted piperidin-4-yl-aminopyrimidines as HIV-1 NNRTIs: Design, synthesis and biological activities.
AID625938Antiviral activity against lamivudine-resistant Hepatitis B virus harboring reverse transcriptase M204I mutant infected in human HepG2(2.2.15) cells assessed as inhibition of virus replication treated daily for 9 days by quantitative blot hybridization me2011Bioorganic & medicinal chemistry letters, Nov-01, Volume: 21, Issue:21
Antiviral activity of novel 2'-fluoro-6'-methylene-carbocyclic adenosine against wild-type and drug-resistant hepatitis B virus mutants.
AID1191400Antiviral activity against HIV-1 RES056 harboring reverse transcriptase K103N/Y181C double mutant infected in human MT4 cells assessed as reduction of virus-induced cytopathic effect after 5 days by MTT assay2015Bioorganic & medicinal chemistry, Feb-01, Volume: 23, Issue:3
Synthesis and biological evaluation of DAPY-DPEs hybrids as non-nucleoside inhibitors of HIV-1 reverse transcriptase.
AID664468Cytotoxicity against human HeLa P4/R5 cells after 48 hrs by MTT assay2012Journal of medicinal chemistry, Mar-22, Volume: 55, Issue:6
Synthesis and anti-HIV activities of glutamate and peptide conjugates of nucleoside reverse transcriptase inhibitors.
AID1363965Antiviral activity against lamivudine-resistant hepatitis B virus harboring reverse transcriptase M204I/V173L double mutant infected in human Huh7 cells assessed as reduction in intracellular DNA levels measured on day 7 by real-time PCR analysis2017Bioorganic & medicinal chemistry, 02-01, Volume: 25, Issue:3
Discovery of hepatitis B virus capsid assembly inhibitors leading to a heteroaryldihydropyrimidine based clinical candidate (GLS4).
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID152975Effective concentration to inhibit HIV-1 LAI cytopathicity in PBMC cells was determined in vitro2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Potent nonclassical nucleoside antiviral drugs based on the N,N-diarylformamidine concept.
AID153114In vitro concentration required to inhibit the HIV-1 LA1 replication on PBMCs cell (peripheral blood mononuclear cells)2003Bioorganic & medicinal chemistry letters, Aug-04, Volume: 13, Issue:15
Are 5'-O-carbamate-2',3'-dideoxythiacytidine new anti-HIV and anti-HBV nucleoside drugs or prodrugs?
AID1228517Antiviral activity against duck Hepatitis B virus infected in duck assessed as inhibition of viral DNA replication in serum at 20 mg/kg/day, po treatment initiated at day 10 after infection relative to control2015Journal of medicinal chemistry, May-14, Volume: 58, Issue:9
Synthesis and biological evaluation of 4-substituted fluoronucleoside analogs for the treatment of hepatitis B virus infection.
AID1544338Antiviral activity against lamivudine-resistant Hepatitis B virus harboring L180M/M204V mutant infected in human HepG2.2.15 cells assessed as inhibition of extracellular HBV DNA replication at 20 uM measured on day 3 by FQ-PCR analysis relative to control2019Bioorganic & medicinal chemistry letters, 06-01, Volume: 29, Issue:11
Design, synthesis, and biological evaluation of novel 2'-deoxy-2'-fluoro-2'-C-methyl 8-azanebularine derivatives as potent anti-HBV agents.
AID658566Resistance factor, ratio of EC50 for multidrug-resistant HIV1 695-RT infected in HEK293T cells to wildtype HIV1 infected in HEK293T cells2012Journal of natural products, Mar-23, Volume: 75, Issue:3
Library-based discovery and characterization of daphnane diterpenes as potent and selective HIV inhibitors in Daphne gnidium.
AID540219Volume of distribution at steady state in monkey after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID410603Antiviral activity against lamivudine-resistant wild type HBV in human Huh7 cells after 4 days by intracellular HBV DNA replication assay2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Synthesis and anti-hepatitis B virus and anti-hepatitis C virus activities of 7-deazaneplanocin A analogues in vitro.
AID1555313Selectivity index, ratio of CC50 for human HepG2.2.15 cells to IC50 for capsid protein in Hepatitis B virus infected in human HepG2.2.15 cells assessed as reduction in viral DNA level2019European journal of medicinal chemistry, Aug-15, Volume: 176Assessment of quinazolinone derivatives as novel non-nucleoside hepatitis B virus inhibitors.
AID323415Reduction in dexelvucitabine diphosphate choline level in PHA-stimulated human PBMC at 1 uM2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
Antiviral and cellular metabolism interactions between Dexelvucitabine and lamivudine.
AID1228513Antiviral activity against duck Hepatitis B virus infected in duck assessed as inhibition of viral DNA replication in serum at 20 mg/kg/day, po treatment initiated at day 5 after infection relative to control2015Journal of medicinal chemistry, May-14, Volume: 58, Issue:9
Synthesis and biological evaluation of 4-substituted fluoronucleoside analogs for the treatment of hepatitis B virus infection.
AID249057Cytotoxicity against MT-2 cell lines of human2005Journal of medicinal chemistry, Jan-27, Volume: 48, Issue:2
Synthesis and antiviral activity of helioxanthin analogues.
AID732681Antiviral activity against Hepatitis B virus transfected in human HepG2.2.15 cells assessed as inhibition of HBsAg secretion after 6 days by ELISA2013Bioorganic & medicinal chemistry letters, Mar-01, Volume: 23, Issue:5
Synthesis and biological evaluation of nucleoside analogues than contain silatrane on the basis of the structure of acyclovir (ACV) as novel inhibitors of hepatitis B virus (HBV).
AID1544306Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of intracellular HBV DNA replication at 20 uM measured on day 3 by FQ-PCR analysis relative to control2019Bioorganic & medicinal chemistry letters, 06-01, Volume: 29, Issue:11
Design, synthesis, and biological evaluation of novel 2'-deoxy-2'-fluoro-2'-C-methyl 8-azanebularine derivatives as potent anti-HBV agents.
AID417063Drug metabolism in HIV-infected human PBMC assessed as zidovudine diphosphate level at 300 mg administered in two courses, first QD for 7 days followed by BID for 7 to 14 days and second course the subjects were switched to the other regimen measured per 2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Intracellular pharmacokinetics of once versus twice daily zidovudine and lamivudine in adolescents.
AID322827Antiviral activity against wild type HBV assessed as inhibition of replication2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID1197448Selectivity index, ratio of TC50 for human HepG2(2.2.15) cells to IC50 for HBV infected in human HepG2(2.2.15) cells assessed as inhibition of surface antigen secretion2015Bioorganic & medicinal chemistry, Feb-15, Volume: 23, Issue:4
Synthesis and anti-hepatitis B virus activity of C4 amide-substituted isosteviol derivatives.
AID266278Antiviral activity against duck HBV in primary duck hepatocytes at 10 ug/mL2006Journal of medicinal chemistry, Jun-15, Volume: 49, Issue:12
Effect of various pyrimidines possessing the 1-[(2-hydroxy-1-(hydroxymethyl)ethoxy)methyl] moiety, able to mimic natural 2'-deoxyribose, on wild-type and mutant hepatitis B virus replication.
AID1743619Antiviral activity against HIV1 RES056 infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect incubated for 5 days by MTT assay2020European journal of medicinal chemistry, Nov-15, Volume: 206Targeting dual tolerant regions of binding pocket: Discovery of novel morpholine-substituted diarylpyrimidines as potent HIV-1 NNRTIs with significantly improved water solubility.
AID464069Antiviral activity against 3TC-resistant HBV with polymerase M204V mutation infected in HepG2.2.15 cells assessed as nucleic acid and protein levels dosed daily for 9 days and measured 24 hrs after last treatment by Southern blot hybridization2010Bioorganic & medicinal chemistry letters, Mar-01, Volume: 20, Issue:5
Orally bioavailable anti-HBV dinucleotide acyloxyalkyl prodrugs.
AID268267Inhibition of HBV DNA replication2006Journal of medicinal chemistry, Jul-27, Volume: 49, Issue:15
Synthesis and anti-hepatitis B virus activity of novel benzimidazole derivatives.
AID340705Volume of distribution at steady state in healthy human at 300 mg, po once daily coadministered with 600 mg, po apricitabine twice daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID519873Antiviral activity against 0.05 MOI wild type HIV1 NL4-3 infected in human MT2 cells measured after 5 days by RT SPA2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID340694Tmax in healthy human at 300 mg, po administered once daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID614134Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for HBeAg antigen secretion in HBV infected in human HepG2(2.2.15) cells2011Journal of natural products, Aug-26, Volume: 74, Issue:8
Swerilactones L-O, secoiridoids with C₁₂ and C₁₃ skeletons from Swertia mileensis.
AID560906Antiviral activity against HBV harboring RNA polymerase M204I mutant gene infected in human HuH7 cells assessed as decrease in viral transient transfection after 24 hrs2009Antimicrobial agents and chemotherapy, Jul, Volume: 53, Issue:7
Alkoxyalkyl esters of 9-(s)-(3-hydroxy-2-phosphonomethoxypropyl) adenine are potent and selective inhibitors of hepatitis B virus (HBV) replication in vitro and in HBV transgenic mice in vivo.
AID417261Half life in HIV-infected children2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Intracellular pharmacokinetics of once versus twice daily zidovudine and lamivudine in adolescents.
AID576244Cmin in HIV-1 infected children aged 2.1 to 12.8 years at 4 mg/kg, po every 12 hrs coadministered with 8 mg/kg abacavir by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID1649793Antiviral activity against multidrug-resistant HBV infected in human HepG2.1403F cells assessed as reduction in viral replication incubated for 6 days by PCR analysis2020Journal of medicinal chemistry, 06-11, Volume: 63, Issue:11
Discovery of (1
AID626005Antiviral activity against lamivudine/entecavir-resistant Hepatitis B virus harboring reverse transcriptase L180M/M204V/S202G infected in human HepG2(2.2.15) cells assessed as reduction of infectious virus titer treated daily for 9 days by quantitative So2011Bioorganic & medicinal chemistry letters, Nov-01, Volume: 21, Issue:21
Antiviral activity of novel 2'-fluoro-6'-methylene-carbocyclic adenosine against wild-type and drug-resistant hepatitis B virus mutants.
AID323410Reduction in dexelvucitabine diphosphate choline level in human CEM cells at 100 uM2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
Antiviral and cellular metabolism interactions between Dexelvucitabine and lamivudine.
AID1742100Antiviral activity against HBV infected in human HepG2.2.15 cells assessed as inhibition of DNA replication at 100 uM supplemented with fresh medium containing compound every 2 days for 6 days by RT-PCR analysis relative to control2020European journal of medicinal chemistry, Nov-01, Volume: 205Discovery of novel quinazolinone derivatives as potential anti-HBV and anti-HCC agents.
AID1447284Cytotoxicity against human P4R5 MAGI cells after 2 hrs by MTT assay2017Bioorganic & medicinal chemistry letters, 05-01, Volume: 27, Issue:9
Synthesis and anti-HIV activities of unsymmetrical long chain dicarboxylate esters of dinucleoside reverse transcriptase inhibitors.
AID407139Antiviral activity against hepatitis B virus infected Hep G2.2.15 cells assessed as inhibition of HBsAg secretion2008Bioorganic & medicinal chemistry letters, Jul-01, Volume: 18, Issue:13
Synthesis and in vitro anti-hepatitis B virus activities of 4-aryl-6-chloro-quinolin-2-one and 5-aryl-7-chloro-1,4-benzodiazepine derivatives.
AID1544323Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of extracellular HBV DNA replication at 20 uM supplemented with fresh medium containing compound every 3 days for 9 days measured post-last dose by FQ-P2019Bioorganic & medicinal chemistry letters, 06-01, Volume: 29, Issue:11
Design, synthesis, and biological evaluation of novel 2'-deoxy-2'-fluoro-2'-C-methyl 8-azanebularine derivatives as potent anti-HBV agents.
AID519884Antiviral activity against 0.05 MOI wild type HIV1 NL4-3 infected in human MT2 cells measured after 5 days by MTS assay2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID572777Antiviral activity against HIV1 harboring reverse transcriptase Q151M mutant infected in human HeLa P4/R5 cells assessed as inhibition of viral replication2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Anti-human immunodeficiency virus activity, cross-resistance, cytotoxicity, and intracellular pharmacology of the 3'-azido-2',3'-dideoxypurine nucleosides.
AID1377844Cytotoxicity against human PBMC by CellTiter 96 non-radioactive cell proliferation colorimetric assay2017European journal of medicinal chemistry, Sep-29, Volume: 138Synthesis of sulfamoylbenzamide derivatives as HBV capsid assembly effector.
AID425653Renal clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID576232Apparent oral clearance in HIV-1 infected children aged 2.5 to 14 years at 8 mg/kg, po every 24 hrs coadministered with 240 mg/m2 of didanosine and efavirenz by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID732672Immunoregulatory activity in Hepatitis B virus infected transgenic mouse assessed as increase in cytokine IL-2 level in serum at 100 mg/kg qd for 1 month by ELISA2013Bioorganic & medicinal chemistry letters, Mar-01, Volume: 23, Issue:5
Synthesis and biological evaluation of nucleoside analogues than contain silatrane on the basis of the structure of acyclovir (ACV) as novel inhibitors of hepatitis B virus (HBV).
AID1380567Antiviral activity against HIV1 virions derived from HIV/VSG-G or HIV/HA virions infected 293T cells using human A549 cells as target cells assessed as inhibition of viral replication using compound pre-mixed virions followed by incubation with target cel2018Bioorganic & medicinal chemistry letters, 06-01, Volume: 28, Issue:10
Design, synthesis and biological evaluation of substituted (+)-SG-1 derivatives as novel anti-HIV agents.
AID246366Effective concentration required to inhibit hepatitis B virus replication in 2.2.15 cells in DNA hybridization assay2005Journal of medicinal chemistry, Jan-13, Volume: 48, Issue:1
Nucleotides and pronucleotides of 2,2-bis(hydroxymethyl)methylenecyclopropane analogues of purine nucleosides: synthesis and antiviral activity.
AID576233Cmin in HIV-1 infected children aged 6.9 years at 4 mg/kg, po every 12 hrs coadministered with nevirapine and stavudine by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID406547Antiviral activity against HBV assessed as inhibition of viral DNA replication by Southern blot2008Bioorganic & medicinal chemistry, Jul-01, Volume: 16, Issue:13
Synthesis and anti-hepatitis B virus evaluation of novel ethyl 6-hydroxyquinoline-3-carboxylates in vitro.
AID527285Cytotoxicity against human HuH7 cells2010Bioorganic & medicinal chemistry letters, Nov-15, Volume: 20, Issue:22
Antiviral activity of 2,3'-anhydro and related pyrimidine nucleosides against hepatitis B virus.
AID340708Cmax in healthy human PBMC assessed as intracellular apricitabine triphosphate level per 10'6 cells at 300 mg, po administered once daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID1055509Cytotoxicity against human CEM cells2013European journal of medicinal chemistry, , Volume: 70Design, synthesis and biological evaluation of phosphorodiamidate prodrugs of antiviral and anticancer nucleosides.
AID340714Cmax in healthy human PBMC assessed as intracellular apricitabine triphosphate level per 10'6 cells at 300 mg, po once daily coadministered with 600 mg, po apricitabine twice daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID1888701Resistance index, ratio of EC50 for antiviral activity against HIV1 with RT Y181C mutant infected in human MT4 cells to EC50 for antiviral activity against wild type HIV1 infected in human MT4 cells
AID404987Antiviral activity against HBeAg-deficient HBV genotype D with precore G1896A mutation and reverse transcriptase M204I mutation in human Huh7 cells assessed as inhibition of viral replication after 5 days2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID732679Cytotoxicity against human HepG2.2.15 cells assessed as reduction in number of viable cells after 3 days by MTT assay2013Bioorganic & medicinal chemistry letters, Mar-01, Volume: 23, Issue:5
Synthesis and biological evaluation of nucleoside analogues than contain silatrane on the basis of the structure of acyclovir (ACV) as novel inhibitors of hepatitis B virus (HBV).
AID1503176Antiviral activity against VSV-G pseudotyped HIV1 infected in human SupT1 cells after 48 hrs by luciferase reporter gene assay2017Journal of natural products, 10-27, Volume: 80, Issue:10
Metabolites from the Plant Endophytic Fungus Aspergillus sp. CPCC 400735 and Their Anti-HIV Activities.
AID1055515Cytostatic activity against thymidine kinase-deficient human HeLa cells assessed as growth inhibition after 3 days by particle counting analysis2013European journal of medicinal chemistry, , Volume: 70Design, synthesis and biological evaluation of phosphorodiamidate prodrugs of antiviral and anticancer nucleosides.
AID548814Antiviral activity against HIV1 isolate 061 harboring reverse transcriptase M41L/D67N/K70R/M184V/L210W/T215Y/K219E mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID322846Fold resistance, ratio of lamivudine-resistant HBV with reverse transcriptase V173L/L180/M204V mutant to wild-type HBV genotype H2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID1377851Antiviral activity against HBV infected in human HepAD38 cells assessed as reduction in extracellular viral DNA level by RT-PCR method2017European journal of medicinal chemistry, Sep-29, Volume: 138Synthesis of sulfamoylbenzamide derivatives as HBV capsid assembly effector.
AID1226110Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBeAg secretion at 150 uM after 3 days by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID664466Antiviral activity against HIV1 3B infected in HeLa P4/R5 cells assessed as reduction of viral infection incubated for 2 hrs followed by incubated in drug-free medium for 46 hrs by single round infection beta-galactosidase reporter gene assay2012Journal of medicinal chemistry, Mar-22, Volume: 55, Issue:6
Synthesis and anti-HIV activities of glutamate and peptide conjugates of nucleoside reverse transcriptase inhibitors.
AID540101Selectivity index, ratio of CC50 for human HepG2.2.15 cells to IC50 for inhibition of Hepatitis B virus DNA replication2010Bioorganic & medicinal chemistry letters, Dec-15, Volume: 20, Issue:24
Synthesis and biological evaluation of 1H-benzimidazol-5-ols as potent HBV inhibitors.
AID407140Cytotoxicity against human Hep G2.2.15 cells2008Bioorganic & medicinal chemistry letters, Jul-01, Volume: 18, Issue:13
Synthesis and in vitro anti-hepatitis B virus activities of 4-aryl-6-chloro-quinolin-2-one and 5-aryl-7-chloro-1,4-benzodiazepine derivatives.
AID1693333Cytotoxicity against human HepG2 2.2.15 cell line assessed as cell viability measured after 72 hrs by MTT assay2021Bioorganic & medicinal chemistry, 01-01, Volume: 29Synthesis and evaluation of new phenyl acrylamide derivatives as potent non-nucleoside anti-HBV agents.
AID582408Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral RNA level per ug of total cell DNA at 15 mg/kg, po qd for 48 weeks (Rvb = 34 +/- 20 pg)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID340713Tmax in healthy human PBMC assessed as intracellular apricitabine triphosphate level at 300 mg, po once daily coadministered with 600 mg, po apricitabine twice daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID1614371Mitochondrial toxicity in human HepG2 cells 10 uM followed by medium plus drugs replenishment every 3 to 4 days for 14 days relative to control2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID614133Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for HBsAg antigen secretion in HBV infected in human HepG2(2.2.15) cells2011Journal of natural products, Aug-26, Volume: 74, Issue:8
Swerilactones L-O, secoiridoids with C₁₂ and C₁₃ skeletons from Swertia mileensis.
AID86850Compound concentration required to inhibit the viral cell proliferation by 50% against HBV1998Bioorganic & medicinal chemistry letters, Jul-07, Volume: 8, Issue:13
Synthesis and biological evaluation of a series of 2'-fluorinated-2',3'-dideoxy-2',3'-didehydro-(L)-nucleosides.
AID407141Selectivity index, ratio of CC50 for human Hep G2.2.15 cells to IC50 for HBV surface antigen secretion2008Bioorganic & medicinal chemistry letters, Jul-01, Volume: 18, Issue:13
Synthesis and in vitro anti-hepatitis B virus activities of 4-aryl-6-chloro-quinolin-2-one and 5-aryl-7-chloro-1,4-benzodiazepine derivatives.
AID1565098Antiviral activity against drug resistant HIV-1 harboring reverse transcriptase Y181C mutant infected in human MT4 cells assessed as reduction in virus-induced cytopathic effect incubated for 5 days by MTT assay
AID1199055Selectivity index, ratio of CC50 for human MT4 cells to IC50 for Human immunodeficiency virus type 2 ROD infected in human MT4 cells2014Journal of natural products, Jun-27, Volume: 77, Issue:6
Jatrophane diterpenes as inhibitors of chikungunya virus replication: structure-activity relationship and discovery of a potent lead.
AID341760Antiviral activity against HIV1 with reverse transcriptase M184V mutation in human phytohemagglutininin-activated PBMC assessed as inhibition of viral replication2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
In vitro interactions between apricitabine and other deoxycytidine analogues.
AID358073Antiviral activity against HBV in human HepW10 cells assessed as inhibition of viral 2.4/2.1RNA replication2007Proceedings of the National Academy of Sciences of the United States of America, May-15, Volume: 104, Issue:20
Unique antiviral mechanism discovered in anti-hepatitis B virus research with a natural product analogue.
AID563940Antiviral activity against HIV1 pNL4-3 harboring Reverse transcriptase P119S/T165A mutant gene infected in TZM-bl cells after 72 hrs by luciferase assay2009Antimicrobial agents and chemotherapy, Nov, Volume: 53, Issue:11
Impact of novel human immunodeficiency virus type 1 reverse transcriptase mutations P119S and T165A on 4'-ethynylthymidine analog resistance profile.
AID1165077Cytotoxicity against mock-infected human MT4 cells after 5 days by MTT assay2014European journal of medicinal chemistry, Nov-24, Volume: 87Design, synthesis and anti-HIV evaluation of novel diarylnicotinamide derivatives (DANAs) targeting the entrance channel of the NNRTI binding pocket through structure-guided molecular hybridization.
AID323416Reduction in [3H]dexelvucitabine triphosphate in human CEM cells at 1 uM2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
Antiviral and cellular metabolism interactions between Dexelvucitabine and lamivudine.
AID354455Antiviral activity against HIV1 3B infected in human HOG.R5 cells after 4 days2004Journal of natural products, Jun, Volume: 67, Issue:6
New 3-O-acyl betulinic acids from Strychnos vanprukii Craib.
AID572998Mitochondrial toxicity in human HepG2 cells assessed as percent inhibition of beta-actin DNA at 100 uM after 14 days by real-time PCR2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Anti-human immunodeficiency virus activity, cross-resistance, cytotoxicity, and intracellular pharmacology of the 3'-azido-2',3'-dideoxypurine nucleosides.
AID1815388Resistance fold, ratio of EC50 for HIV1 harboring reverse transcriptase K103N mutant infected MV4 cells to EC50 for wild type HIV1 infected MV4 cells2021European journal of medicinal chemistry, Dec-15, Volume: 226Design of the naphthyl-diarylpyrimidines as potent non-nucleoside reverse transcriptase inhibitors (NNRTIs) via structure-based extension into the entrance channel.
AID340700Cmax in healthy human at 300 mg, po once daily coadministered with 600 mg, po apricitabine twice daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID1687685Antiviral activity against HIV-2 ROD strain infected in human MT4 cells assessed as reduction in virus-induced cytopathogenicity by MTT assay2020European journal of medicinal chemistry, Jan-15, Volume: 186Indazolyl-substituted piperidin-4-yl-aminopyrimidines as HIV-1 NNRTIs: Design, synthesis and biological activities.
AID519892Selectivity ratio of EC50 for 0.05 MOI HIV1 NL4-3 infected in human MT2 cells by MTS assay to EC50 for 0.05 MOI HIV1 NL4-3 infected in human MT2 cells by RT assay2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID322832Fold resistance, ratio of EC50 for lamivudine-resistant HBV with reverse transcriptase L180M/M204V mutant to EC50 for wild-type HBV2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID675190Therapeutic index, ratio of TC50 for human CEM-SS cells to EC50 for HIV-1 subtype 3B infected in CEM-SS cells2012Bioorganic & medicinal chemistry letters, Sep-01, Volume: 22, Issue:17
Synthesis and anti-HIV activities of symmetrical dicarboxylate esters of dinucleoside reverse transcriptase inhibitors.
AID1363966Antiviral activity against lamivudine-resistant wild type hepatitis B virus infected in human Huh7 cells assessed as reduction in secreted DNA levels measured on day 7 by real-time PCR analysis2017Bioorganic & medicinal chemistry, 02-01, Volume: 25, Issue:3
Discovery of hepatitis B virus capsid assembly inhibitors leading to a heteroaryldihydropyrimidine based clinical candidate (GLS4).
AID576247Apparent oral clearance in HIV-1 infected children aged 2.1 to 12.8 years at 4 mg/kg, po every 12 hrs coadministered with 8 mg/kg abacavir by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID1197833Resistance index, ratio of EC50 for HIV1 RES056 expressing reverse transcriptase K103N + Y181C double mutant to EC50 for wild type HIV1 3B2015European journal of medicinal chemistry, Mar-06, Volume: 92Fused heterocycles bearing bridgehead nitrogen as potent HIV-1 NNRTIs. Part 3: optimization of [1,2,4]triazolo[1,5-a]pyrimidine core via structure-based and physicochemical property-driven approaches.
AID1431325Selectivity index, ratio of TC50 for human HuH7 cells to IC50 for Hepatitis B virus subtype adw2 infected in human HuH7 cells assessed as inhibition of viral DNA replication2016Journal of natural products, Dec-23, Volume: 79, Issue:12
Synthesis of C-4-Substituted Steviol Derivatives and Their Inhibitory Effects against Hepatitis B Virus.
AID548586Antiviral activity against HIV1 isolate 166 harboring reverse transcriptase L74V mutant gene obtained as site-directed mutant of NL4-3 by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID582403Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral antigen level in serum at 15 mg/kg, po qd for 48 weeks measured on 60th week (Rvb = 3.3 +/- 1.6 log10 ng/ml)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID541151Selectivity ratio of EC50 for antiviral activity against 3TC-resistant HIV1 selected after 8 passages to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID740212Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for Hepatitis B virus-infected human HepG2(2.2.15) cells assessed as inhibition of HBeAg secretion2013Bioorganic & medicinal chemistry letters, Apr-01, Volume: 23, Issue:7
Anti-HBV active constituents from Piper longum.
AID1226103Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBsAg secretion at 75 uM after 9 days by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID523465Antiviral activity against Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as decrease in intracellular viral DNA level at 13 uM after 72 hrs by RT-PCR analysis2010Antimicrobial agents and chemotherapy, May, Volume: 54, Issue:5
Heat stress cognate 70 host protein as a potential drug target against drug resistance in hepatitis B virus.
AID556527Antiviral activity against Human immunodeficiency virus 1 clone 14682 harboring 122E, 135V, Q145V, 200A mutation in reverse transcriptase by phenosense assay relative to wild type2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Human immunodeficiency virus type 1 isolates with the reverse transcriptase (RT) mutation Q145M retain nucleoside and nonnucleoside RT inhibitor susceptibility.
AID582402Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral antigen level in serum at 15 mg/kg, po qd for 48 weeks (Rvb = 3.8 +/- 1.3 log10 ng/ml)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID1197453Selectivity index, ratio of TC50 for human HepG2(2.2.15) cells to IC50 for HBV infected in human HepG2(2.2.15) cells assessed as inhibition of viral DNA replication2015Bioorganic & medicinal chemistry, Feb-15, Volume: 23, Issue:4
Synthesis and anti-hepatitis B virus activity of C4 amide-substituted isosteviol derivatives.
AID738971Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for Hepatitis B virus infected in human HepG2.2.15 cells by HBsAg secretion inhibition assay2013Bioorganic & medicinal chemistry letters, Apr-01, Volume: 23, Issue:7
Anti-hepatitis B virus lignans from the root of Streblus asper.
AID89027Antiviral activity against drug-resistant HIV-1 virus (M184v) in Human peripheral blood mononuclear (PBM) cells2004Journal of medicinal chemistry, Mar-25, Volume: 47, Issue:7
Synthesis, structure-activity relationships, and mechanism of drug resistance of D- and L-beta-3'-fluoro-2',3'-unsaturated-4'-thionucleosides as anti-HIV agents.
AID540218Clearance in monkey after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID392501Antiviral activity against Human adenovirus 22009Bioorganic & medicinal chemistry, Jan-15, Volume: 17, Issue:2
Unified QSAR approach to antimicrobials. 4. Multi-target QSAR modeling and comparative multi-distance study of the giant components of antiviral drug-drug complex networks.
AID625997Fold resistance, ratio of EC90 for lamivudine-resistant Hepatitis B virus harboring reverse transcriptase L180M mutant to EC90 for wild type Hepatitis B virus2011Bioorganic & medicinal chemistry letters, Nov-01, Volume: 21, Issue:21
Antiviral activity of novel 2'-fluoro-6'-methylene-carbocyclic adenosine against wild-type and drug-resistant hepatitis B virus mutants.
AID548825Antiviral activity against HIV1 isolate 166 harboring reverse transcriptase L74V mutant gene obtained as site-directed mutant of NL4-3 by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID517837Antiviral activity against drug resistant HBV infected in M204I cells assessed as inhibition of viral DNA replication2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Antiviral activity of various 1-(2'-deoxy-β-D-lyxofuranosyl), 1-(2'-fluoro-β-D-xylofuranosyl), 1-(3'-fluoro-β-D-arabinofuranosyl), and 2'-fluoro-2',3'-didehydro-2',3'-dideoxyribose pyrimidine nucleoside analogues against duck hepatitis B virus (DHBV) and
AID519888Antiviral activity against 0.05 MOI wild type HIV1 NL4-3 infected in 2 hr-pretreated human MT2 cells measured after 5 days by MTS assay2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID417258Cmax in HIV-infected human assessed as Lamivudine monophosphate level in PBMC at 300 mg QD for 7 days measured per 10'6 cells in presence of zidovudine2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Intracellular pharmacokinetics of once versus twice daily zidovudine and lamivudine in adolescents.
AID574187Cytotoxicity against human skeletal muscle Myoblast assessed as increase in mitochondrial DNA on day 5 by RT-PCR relative to untreated control2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Impact of nucleoside reverse transcriptase inhibitors on mitochondrial DNA and RNA in human skeletal muscle cells.
AID1203824Mitochondrial toxicity in human HepG2 cells assessed as induction of lactic acid levels at 1 uM incubated for 14 days2015Journal of medicinal chemistry, Apr-23, Volume: 58, Issue:8
β-D-2'-C-Methyl-2,6-diaminopurine Ribonucleoside Phosphoramidates are Potent and Selective Inhibitors of Hepatitis C Virus (HCV) and Are Bioconverted Intracellularly to Bioactive 2,6-Diaminopurine and Guanosine 5'-Triphosphate Forms.
AID1226108Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as cell survival at 37.5 uM after 9 days (Rvb = 100%)2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID732671Immunoregulatory activity in Hepatitis B virus infected transgenic mouse assessed as increase in CD3+ population in peripheral blood at 100 mg/kg qd for 1 month by flow cytometry (Rvb = 30.1 +/-2.9%)2013Bioorganic & medicinal chemistry letters, Mar-01, Volume: 23, Issue:5
Synthesis and biological evaluation of nucleoside analogues than contain silatrane on the basis of the structure of acyclovir (ACV) as novel inhibitors of hepatitis B virus (HBV).
AID548799Antiviral activity against HIV1 isolate 188 harboring reverse transcriptase T215Y/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID53757In vitro antiviral activity against Hepatitis B virus in primary duck hepatocyte (DHBV) cultures and expressed as percent inhibition of viral DNA at 10 ug/mL2002Journal of medicinal chemistry, May-09, Volume: 45, Issue:10
Design and synthesis of novel 5-substituted acyclic pyrimidine nucleosides as potent and selective inhibitors of hepatitis B virus.
AID548571Antiviral activity against HIV1 isolate 056 expressing wild type reverse transcriptase gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1156486Antiviral activity against HIV2 ROD infected in human MT4 cells assessed as inhibition of virus-induced cytopathogenicity after 5 days by MTT assay2014European journal of medicinal chemistry, Jul-23, Volume: 82Design and synthesis of a new series of modified CH-diarylpyrimidines as drug-resistant HIV non-nucleoside reverse transcriptase inhibitors.
AID153103In vitro concentration required to cause death of uninfected PBMCs cell (peripheral blood mononuclear cells)2003Bioorganic & medicinal chemistry letters, Aug-04, Volume: 13, Issue:15
Are 5'-O-carbamate-2',3'-dideoxythiacytidine new anti-HIV and anti-HBV nucleoside drugs or prodrugs?
AID322848Fold resistance, ratio of Lamivudine -adenofir-resistant with HBV reverse transcriptase V173L/L180M/A181V/M204V mutant to wildtype HBV genotype E2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID582424Toxicity in Woodchuck hepatitis virus infected woodchuck assessed as effect on hematological parameters at 15 mg/kg, po qd for 48 weeks measured up to 60 weeks2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID246406In vitro effective concentration against Lamivudine resistant wild type HIV-1 in human peripheral blood mononuclear cells2005Journal of medicinal chemistry, Jun-02, Volume: 48, Issue:11
Synthesis, antiviral activity, and mechanism of drug resistance of D- and L-2',3'-didehydro-2',3'-dideoxy-2'-fluorocarbocyclic nucleosides.
AID328843Inhibition of human MRP3 expressed in MDCK2 cells assessed as increase in intracellular CMF fluorescence by CMFDA assay2007Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 35, Issue:3
Inhibition of MRP1/ABCC1, MRP2/ABCC2, and MRP3/ABCC3 by nucleoside, nucleotide, and non-nucleoside reverse transcriptase inhibitors.
AID1862268Antiviral activity against HIV2 ROD infected in human MT4 cells assessed as protection against virus-induced cytopathic effect incubated for 5 days by MTT assay2022European journal of medicinal chemistry, Oct-05, Volume: 240Design, synthesis, and biological evaluation of novel double-winged galloyl derivatives as HIV-1 RNase H inhibitors.
AID548585Antiviral activity against HIV1 isolate 162 harboring reverse transcriptase A62V/V75I/F77L/Y115F/F116Y/Q151M/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1203822Mitochondrial toxicity in human HepG2 cells assessed as effect on mitochondrial cytochrome c oxidase subunit 2 DNA level incubated for 14 days by real-time PCR method2015Journal of medicinal chemistry, Apr-23, Volume: 58, Issue:8
β-D-2'-C-Methyl-2,6-diaminopurine Ribonucleoside Phosphoramidates are Potent and Selective Inhibitors of Hepatitis C Virus (HCV) and Are Bioconverted Intracellularly to Bioactive 2,6-Diaminopurine and Guanosine 5'-Triphosphate Forms.
AID576237Cmax in HIV-1 infected children aged 2.5 to 4.8 years at 4 mg/kg, po every 12 hrs by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID1351355Antiviral activity against HBV infected in human HepG2(2.2.15) cells assessed as inhibition of viral DNA replication after 6 days by RT-PCR method2018European journal of medicinal chemistry, Jan-20, Volume: 144Design, synthesis and evaluation of novel phenyl propionamide derivatives as non-nucleoside hepatitis B virus inhibitors.
AID417060Drug metabolism in HIV-infected human PBMC assessed as zidovudine parent-drug level at 300 mg administered in two courses, first BID for 7 to 14 days followed by QD for 7 days and second course the subjects were switched to the other regimen measured per 2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Intracellular pharmacokinetics of once versus twice daily zidovudine and lamivudine in adolescents.
AID548802Antiviral activity against HIV1 isolate 200 harboring reverse transcriptase M41L/L210W/T215Y mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID340704Renal clearance in healthy human at 300 mg, po once daily coadministered with 600 mg, po apricitabine twice daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID323413Reduction in dexelvucitabine diphosphate choline level in human CEM cells at 1 uM2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
Antiviral and cellular metabolism interactions between Dexelvucitabine and lamivudine.
AID218505Concentration required to inhibit plaque formation by HSV-1 strain KOS (TK+) in monolayers of vero cells; ND means Not determined2001Bioorganic & medicinal chemistry letters, Nov-19, Volume: 11, Issue:22
Novel 5-vinyl pyrimidine nucleosides with potent anti-hepatitis B virus activity.
AID1815379Cytotoxicity against human MT4 cells assessed as reduction in cell viability incubated for 5 days by MTT assay2021European journal of medicinal chemistry, Dec-15, Volume: 226Design of the naphthyl-diarylpyrimidines as potent non-nucleoside reverse transcriptase inhibitors (NNRTIs) via structure-based extension into the entrance channel.
AID1599880Antiviral activity against HBV infected in pekin duck assessed as reduction in serum viral DNA level at 0.4 mmol/kg, po once daily for 14 days and measured on days 7, 14 post treatment and on day 3 after treatment cessation by qRT-PCR analysis2019ACS medicinal chemistry letters, Jun-13, Volume: 10, Issue:6
Design, Synthesis, and Anti-HBV Activity of New Bis(l-amino acid) Ester Tenofovir Prodrugs.
AID1869622Anti-HIV activity against wild type HIV-1 IIIB infected in human MT4 cells assessed as inhibition of HIV-induced cytopathic effect measured after 5 days by MTT assay2022Journal of medicinal chemistry, 07-14, Volume: 65, Issue:13
Reshaping an Acyclic Nucleoside Phosphonate into a Selective Anti-hepatitis B Virus Compound.
AID598075Antiviral activity against HIV1 infected in human PBMC assessed as inhibition of viral replication at 10 nM by p24 HIV antigen capture assay relative to control2011Bioorganic & medicinal chemistry letters, Jun-01, Volume: 21, Issue:11
Synthesis of 5-thiodidehydropyranylcytosine derivatives as potential anti-HIV agents.
AID328842Inhibition of human MRP2 expressed in MDCK2 cells assessed as increase in intracellular CMF fluorescence by CMFDA assay2007Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 35, Issue:3
Inhibition of MRP1/ABCC1, MRP2/ABCC2, and MRP3/ABCC3 by nucleoside, nucleotide, and non-nucleoside reverse transcriptase inhibitors.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1888702Resistance index, ratio of EC50 for antiviral activity against HIV1 with RT Y188L mutant infected in human MT4 cells to EC50 for antiviral activity against wild type HIV1 infected in human MT4 cells
AID404985Antiviral activity against HBeAg-deficient HBV genotype D with precore G1896A mutation in human Huh7 cells assessed as inhibition of viral replication after 5 days2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID548818Antiviral activity against HIV1 isolate 069 harboring reverse transcriptase D67E/T69SSG/V75M/M184V/L210W/T215Y mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548824Antiviral activity against HIV1 isolate 162 harboring reverse transcriptase A62V/V75I/F77L/Y115F/F116Y/Q151M/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID582407Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral RNA level per ug of total cell DNA at 15 mg/kg, po qd measured on 36th week on 48 weeks study (Rvb = 33 +/- 21 pg)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID1771356Inhibition of capsid protein in HBV infected in human HepDES19 cells assessed as inhibition of viral replication incubated for 3 days by strand preferential qPCR analysis2021European journal of medicinal chemistry, Dec-05, Volume: 225Design, synthesis and evaluation of heteroaryldihydropyrimidine analogues bearing spiro ring as hepatitis B virus capsid protein inhibitors.
AID675191Cytotoxicity against human PBMC2012Bioorganic & medicinal chemistry letters, Sep-01, Volume: 22, Issue:17
Synthesis and anti-HIV activities of symmetrical dicarboxylate esters of dinucleoside reverse transcriptase inhibitors.
AID1377840Cytotoxicity against human CEM cells by CellTiter 96 non-radioactive cell proliferation colorimetric assay2017European journal of medicinal chemistry, Sep-29, Volume: 138Synthesis of sulfamoylbenzamide derivatives as HBV capsid assembly effector.
AID91036Cytotoxic concentration of compound required for 50% extinction of HuH-6 cells2002Journal of medicinal chemistry, Jul-04, Volume: 45, Issue:14
2-Amino-6-arylthio-9-[2-(phosphonomethoxy)ethyl]purine bis(2,2,2-trifluoroethyl) esters as novel HBV-specific antiviral reagents.
AID519891Selectivity ratio of EC50 for 0.02 MOI HIV1 NL4-3 infected in human MT2 cells by MTS assay to EC50 for 0.02 MOI HIV1 NL4-3 infected in human MT2 cells by RT assay2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID1729157Antiviral activity against HIV1 harboring K103N mutant infected in human MT4 cells assessed as reduction in virus-induced cytopathic effect by MTT assay2021European journal of medicinal chemistry, Mar-05, Volume: 213Exploiting the tolerant region I of the non-nucleoside reverse transcriptase inhibitor (NNRTI) binding pocket. Part 2: Discovery of diarylpyrimidine derivatives as potent HIV-1 NNRTIs with high Fsp
AID517937Antiviral activity against HIV1 subtype B isolate 3 infected in HEK293 cells assessed as inhibition of virus replication after 72 hrs2010Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6
Telbivudine exhibits no inhibitory activity against HIV-1 clinical isolates in vitro.
AID1729153Selectivity index, ratio of CC50 for human MT4 cells to EC50 for antiviral activity against HIV HIV1 RES056 harboring K103N/Y181C double mutant infected in human MT4 cells2021European journal of medicinal chemistry, Mar-05, Volume: 213Exploiting the tolerant region I of the non-nucleoside reverse transcriptase inhibitor (NNRTI) binding pocket. Part 2: Discovery of diarylpyrimidine derivatives as potent HIV-1 NNRTIs with high Fsp
AID1741373Cytotoxicity against human HepG2.2.15 cells assessed as reduction in cell viability incubated for 4 days prior to compound washout followed by compound addition and measured after 4 days by CCK8 assay2020European journal of medicinal chemistry, Sep-15, Volume: 202Design, diversity-oriented synthesis and biological evaluation of novel heterocycle derivatives as non-nucleoside HBV capsid protein inhibitors.
AID417246Tmax in HIV-infected human assessed as Lamivudine monophosphate level in PBMC at 300 mg QD for 7 days in presence of zidovudine2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Intracellular pharmacokinetics of once versus twice daily zidovudine and lamivudine in adolescents.
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID154955Activity against Lamivudine-resistant virus (HIV-1XXBRU) in human PBM cells, expressed as EC502003Journal of medicinal chemistry, Jul-17, Volume: 46, Issue:15
l-2',3'-Didehydro-2',3'-dideoxy-3'-fluoronucleosides: synthesis, anti-HIV activity, chemical and enzymatic stability, and mechanism of resistance.
AID557021Antiviral activity against HIV1 CRF02_AG harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID1544320Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of extracellular HBV DNA replication at 20 uM supplemented with fresh medium containing compound every 3 days for 6 days measured post-last dose by FQ-P2019Bioorganic & medicinal chemistry letters, 06-01, Volume: 29, Issue:11
Design, synthesis, and biological evaluation of novel 2'-deoxy-2'-fluoro-2'-C-methyl 8-azanebularine derivatives as potent anti-HBV agents.
AID1771359Cytotoxicity against human HepDES19 cells assessed as reduction in cell viability measured after 3 days by by MTS assay2021European journal of medicinal chemistry, Dec-05, Volume: 225Design, synthesis and evaluation of heteroaryldihydropyrimidine analogues bearing spiro ring as hepatitis B virus capsid protein inhibitors.
AID1191298Selectivity index, ratio of TC50 for human HepG2(2.2.15) cells to IC50 for decrease in HBV viral DNA replication in human HepG2(2.2.15) cells2015European journal of medicinal chemistry, Jan-27, Volume: 90Design, synthesis, and bioevaluation of paeonol derivatives as potential anti-HBV agents.
AID358074Antiviral activity against HBV in human HepD2 cells assessed as inhibition of viral 2.4/2.1RNA replication2007Proceedings of the National Academy of Sciences of the United States of America, May-15, Volume: 104, Issue:20
Unique antiviral mechanism discovered in anti-hepatitis B virus research with a natural product analogue.
AID1649770Antiviral activity against HBV infected in human HepAD38 cells assessed as reduction in viral DNA levels incubated for 6 days by PCR analysis2020Journal of medicinal chemistry, 06-11, Volume: 63, Issue:11
Discovery of (1
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID557020Antiviral activity against HIV1 clade B harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID1614322Mitochondrial toxicity in human HepG2 cells assessed as inhibition of cytochrome c oxidase subunit 2 DNA level followed by medium plus drugs replenishment every 3 to 4 days for 14 days relative to control2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID548815Antiviral activity against HIV1 isolate 063 harboring reverse transcriptase M41L/D67N/K70R/M184V/L210W/T215Y/K219E mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1535523Antiviral activity against HIV1 RES056 containing reverse transcriptase K103N + Y181C mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 5 days by MTT assay2019Bioorganic & medicinal chemistry, 02-01, Volume: 27, Issue:3
Design, synthesis and biological evaluation of novel acetamide-substituted doravirine and its prodrugs as potent HIV-1 NNRTIs.
AID1165075Antiviral activity against HIV2 ROD infected in human MT4 cells assessed as inhibition of virus-induced syncytium formation after 5 days by MTT assay2014European journal of medicinal chemistry, Nov-24, Volume: 87Design, synthesis and anti-HIV evaluation of novel diarylnicotinamide derivatives (DANAs) targeting the entrance channel of the NNRTI binding pocket through structure-guided molecular hybridization.
AID586314Antiviral activity against Human T-cell leukemia/lymphoma virus type 1 infected in human PBMC assessed as inhibition of tax/rex gene expression at 22.93 ug/ml after 3 weeks post infection by quantitative real time RT-PCR2011Bioorganic & medicinal chemistry, Mar-15, Volume: 19, Issue:6
Antiviral activity of seed extract from Citrus bergamia towards human retroviruses.
AID570169Antiviral activity against wild type HBV infected in human Huh7.5 cells assessed as reduction of viral replication at 0.16 ug/ml after 36 hrs2011Journal of medicinal chemistry, Feb-10, Volume: 54, Issue:3
Design and synthesis of oxymatrine analogues overcoming drug resistance in hepatitis B virus through targeting host heat stress cognate 70.
AID732678Antiviral activity against Hepatitis B virus infected in transgenic mouse assessed as decrease in viral DNA level in liver at 100 mg/kg qd for 1 month by qPCR analysis2013Bioorganic & medicinal chemistry letters, Mar-01, Volume: 23, Issue:5
Synthesis and biological evaluation of nucleoside analogues than contain silatrane on the basis of the structure of acyclovir (ACV) as novel inhibitors of hepatitis B virus (HBV).
AID557052Antiviral activity against NRTI-resistant HIV1 harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID517936Antiviral activity against HIV1 subtype A isolate 2 infected in HEK293 cells assessed as inhibition of virus replication after 72 hrs2010Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6
Telbivudine exhibits no inhibitory activity against HIV-1 clinical isolates in vitro.
AID1248145Antiviral activity against HBV infected in human HepG2(2.2.15) cells2015Bioorganic & medicinal chemistry, Oct-15, Volume: 23, Issue:20
Synthesis and antiviral activity of maleopimaric and quinopimaric acids' derivatives.
AID1401774Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of intracellular HBV DNA level at 20 uM measured on day 9 by FQ-PCR analysis2018European journal of medicinal chemistry, Jan-01, Volume: 143Design, synthesis, and biological evaluation of new 1,2,3-triazolo-2'-deoxy-2'-fluoro- 4'-azido nucleoside derivatives as potent anti-HBV agents.
AID417059Drug metabolism in HIV-infected human PBMC assessed as zidovudine parent-drug level at 300 mg administered in two courses, first QD for 7 days followed by BID for 7 to 14 days and second course the subjects were switched to the other regimen measured per 2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Intracellular pharmacokinetics of once versus twice daily zidovudine and lamivudine in adolescents.
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID340702AUC (0 to 24 hrs) in healthy human at 300 mg, po once daily coadministered with 600 mg, po apricitabine twice daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID574186Cytotoxicity against human skeletal muscle Myoblast assessed as increase in mitochondrial DNA on day 2 by RT-PCR relative to untreated control2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Impact of nucleoside reverse transcriptase inhibitors on mitochondrial DNA and RNA in human skeletal muscle cells.
AID1226124Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBV DNA copies per uL at 37.5 uM after 3 days by real-time fluorescence quantitative PCR analysis2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID1555317Inhibition of capsid protein in lamivudine/entecavir-resistant Hepatitis B virus harboring rtL180M/rtM204V/rt184L mutant infected in human HepG2.2.15 cells assessed as reduction in viral DNA level at 100 uM measured after 72 hrs by PCR analysis relative t2019European journal of medicinal chemistry, Aug-15, Volume: 176Assessment of quinazolinone derivatives as novel non-nucleoside hepatitis B virus inhibitors.
AID1226097Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBsAg secretion at 300 uM after 6 days by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID322844Fold resistance, ratio of lamivudine-resistant HBV with reverse transcriptase L180M/M204V mutant to wild-type HBV genotype E2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID1197449Cytotoxicity against human HepG2(2.2.15) cells2015Bioorganic & medicinal chemistry, Feb-15, Volume: 23, Issue:4
Synthesis and anti-hepatitis B virus activity of C4 amide-substituted isosteviol derivatives.
AID1743639Resistance index, ratio of EC50 for antiviral activity against HIV1 expressing RT F227L/V106A mutant infected in human MT4 cells to EC50 for antiviral activity against HIV1 3B infected in human MT4 cells2020European journal of medicinal chemistry, Nov-15, Volume: 206Targeting dual tolerant regions of binding pocket: Discovery of novel morpholine-substituted diarylpyrimidines as potent HIV-1 NNRTIs with significantly improved water solubility.
AID580183Antiviral activity against Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as reduction in viral DNA by Southern blotting2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Antiviral agents 3. Discovery of a novel small molecule non-nucleoside inhibitor of hepatitis B virus (HBV).
AID358082Effect on virus RNA stability on doxycyclin-induced HBV pre genomic RNA production in Met-On-TRE HBV cells treated with 3 uM drug after doxycycline removal2007Proceedings of the National Academy of Sciences of the United States of America, May-15, Volume: 104, Issue:20
Unique antiviral mechanism discovered in anti-hepatitis B virus research with a natural product analogue.
AID1661360AUC (0 to 24 hrs) in monkey PBMC assessed as 3TC-TP level at 20 mg/kg, po administered as single dose by LC-MS/MS analysis2020Journal of medicinal chemistry, 08-13, Volume: 63, Issue:15
Mechanistic Insight into Antiretroviral Potency of 2'-Deoxy-2'-β-fluoro-4'-azidocytidine (FNC) with a Long-Lasting Effect on HIV-1 Prevention.
AID325077Drug level in human RBC assessed as concentration of Lamivudine triphosphate per 10^6 cells2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
Evidence and possible consequences of the phosphorylation of nucleoside reverse transcriptase inhibitors in human red blood cells.
AID322845Fold resistance, ratio of lamivudine-resistant HBV with reverse transcriptase L180M/A181V mutant to wild-type HBV genotype E2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID1565091Antiviral activity against drug resistant HIV-1 RES056 harboring reverse transcriptase K103N/Y181C double mutant infected in human MT4 cells assessed as reduction in virus-induced cytopathic effect incubated for 5 days by MTT assay
AID1320783Selectivity ratio of CC50 for human HepG2(2.2.15) cells to EC50 for reduction in HBV ayw1 extracellular DNA copy number2016Journal of medicinal chemistry, Oct-27, Volume: 59, Issue:20
Amidate Prodrugs of Deoxythreosyl Nucleoside Phosphonates as Dual Inhibitors of HIV and HBV Replication.
AID548805Antiviral activity against HIV1 isolate 204 harboring reverse transcriptase M41L/L210W/T215Y/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1226094Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBsAg secretion at 150 uM after 3 days by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID548588Antiviral activity against HIV1 isolate 180 harboring reverse transcriptase K65R mutant gene obtained as site-directed mutant of NL4-3 by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID246455Effective concentration to inhibit 50 % of hepatitis B virus replication in a cell culture model;ND=Not determined2005Journal of medicinal chemistry, Jan-27, Volume: 48, Issue:2
Synthesis and antiviral activity of helioxanthin analogues.
AID519890Selectivity ratio of EC50 for 0.01 MOI HIV1 NL4-3 infected in human MT2 cells by MTS assay to EC50 for 0.01 MOI HIV1 NL4-3 infected in human MT2 cells by RT assay2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID1742095Cytotoxicity against human HepG2 2.2.15 cells assessed as reduction in cell viability measured after 72 hrs by MTT assay2020European journal of medicinal chemistry, Nov-01, Volume: 205Discovery of novel quinazolinone derivatives as potential anti-HBV and anti-HCC agents.
AID1888696Antiviral activity against HIV1 with RT Y181C mutant infected in human MT4 cells cells assessed as protection against viral-induced cytopathogenecity by MTT assay
AID244625Selectivity index of virion as the ratio of CC50 and EC902005Journal of medicinal chemistry, Jul-28, Volume: 48, Issue:15
5'-Homoneplanocin A inhibits hepatitis B and hepatitis C.
AID1535527Selectivity index, ratio of CC50 for mock-infected human MT4 cells to EC50 for HIV1 RES056 RES056 containing reverse transcriptase K103N + Y181C mutant infected in human MT4 cells2019Bioorganic & medicinal chemistry, 02-01, Volume: 27, Issue:3
Design, synthesis and biological evaluation of novel acetamide-substituted doravirine and its prodrugs as potent HIV-1 NNRTIs.
AID1226095Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBsAg secretion at 75 uM after 3 days by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID404981Antiviral activity against HBV genotype D with reverse transcriptase M204I mutation in human Huh7 cells assessed as inhibition of viral replication after 5 days2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID1661365Cmax in monkey plasma at 20 mg/kg, po administered as single dose measured after 72 hrs by LC-MS/MS analysis2020Journal of medicinal chemistry, 08-13, Volume: 63, Issue:15
Mechanistic Insight into Antiretroviral Potency of 2'-Deoxy-2'-β-fluoro-4'-azidocytidine (FNC) with a Long-Lasting Effect on HIV-1 Prevention.
AID1661374Cytotoxicity against human Hut/CCR5 cells assessed as reduction in cell viability at 1000 to 10000 nM measured after 120 hrs by MTT assay2020Journal of medicinal chemistry, 08-13, Volume: 63, Issue:15
Mechanistic Insight into Antiretroviral Potency of 2'-Deoxy-2'-β-fluoro-4'-azidocytidine (FNC) with a Long-Lasting Effect on HIV-1 Prevention.
AID1535526Selectivity index, ratio of CC50 for mock-infected human MT4 cells to EC50 for wild type HIV1 3B infected in human MT4 cells2019Bioorganic & medicinal chemistry, 02-01, Volume: 27, Issue:3
Design, synthesis and biological evaluation of novel acetamide-substituted doravirine and its prodrugs as potent HIV-1 NNRTIs.
AID235453Selectivity (CC50/EC50) for death of uninfected PBMCs to that of inhibition of cytopathicity of HIV-1 LA1 on PBMCs (peripheral blood mononuclear cells)2003Bioorganic & medicinal chemistry letters, Aug-04, Volume: 13, Issue:15
Are 5'-O-carbamate-2',3'-dideoxythiacytidine new anti-HIV and anti-HBV nucleoside drugs or prodrugs?
AID572996Mitochondrial toxicity in human HepG2 cells assessed as percent lactic acid production at 100 uM after 14 days by real-time PCR relative to beta-actin DNA2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Anti-human immunodeficiency virus activity, cross-resistance, cytotoxicity, and intracellular pharmacology of the 3'-azido-2',3'-dideoxypurine nucleosides.
AID322833Fold resistance, ratio of EC50 for lamivudine-adefovir-resistant HBV with reverse transcriptase L180M/M204V/N236T mutant to EC50 for wild-type HBV2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID405005Effect on replication efficiency of HBV genotype D with reverse transcriptase L80I/L180M/M204I mutation in human Huh7 cells assessed as decrease in viral replication yield at 1 uM after 5 days relative to control2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID1771358Inhibition of capsid protein in HBV infected in human HepDES19 cells assessed as inhibition of viral replication by measuring plus polarity DNA level at 5 uM incubated for 3 days by strand preferential qPCR analysis relative to control2021European journal of medicinal chemistry, Dec-05, Volume: 225Design, synthesis and evaluation of heteroaryldihydropyrimidine analogues bearing spiro ring as hepatitis B virus capsid protein inhibitors.
AID519964Antiviral activity against 0.005 MOI HIV1 NL4-3 harboring wild type RT infected in human MT2 cells2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID414789Cytotoxicity against human HepG2(2.2.15) cells treated for 9 days measured after 24 hrs of last treatment by neutral red uptake assay2009Bioorganic & medicinal chemistry, Apr-15, Volume: 17, Issue:8
Synthesis and anti-hepatitis B virus activities of Matijing-Su derivatives.
AID358071Antiviral activity against HBV in HBV-Met cells assessed as inhibition of viral pre genomic RNA replication2007Proceedings of the National Academy of Sciences of the United States of America, May-15, Volume: 104, Issue:20
Unique antiviral mechanism discovered in anti-hepatitis B virus research with a natural product analogue.
AID1380569Antiviral activity against HIV1 virions containing reverse transcriptase K103N mutant derived from HIV/VSG-G or HIV/HA virions infected 293T cells using human A549 cells as target cells assessed as inhibition of viral replication using compound pre-mixed 2018Bioorganic & medicinal chemistry letters, 06-01, Volume: 28, Issue:10
Design, synthesis and biological evaluation of substituted (+)-SG-1 derivatives as novel anti-HIV agents.
AID341761Antiviral activity against HIV1 with reverse transcriptase M184V mutation in human phytohemagglutininin-activated PBMC assessed as inhibition of viral replication at 60 uM2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
In vitro interactions between apricitabine and other deoxycytidine analogues.
AID1869633Selectivity index, ratio of CC50 cytotoxicity against human HepG2.2.15 cells assessed as reduction in cell viability to EC50 for antiviral activity against wild type HBV infected in human HepG2 2.2.15 cells assessed as reduction in viral replication by DN2022Journal of medicinal chemistry, 07-14, Volume: 65, Issue:13
Reshaping an Acyclic Nucleoside Phosphonate into a Selective Anti-hepatitis B Virus Compound.
AID437967Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for HBV early antigen secretion2009Bioorganic & medicinal chemistry letters, Dec-01, Volume: 19, Issue:23
Anti-HBV agents. Part 3: preliminary structure-activity relationships of tetra-acylalisol A derivatives as potent hepatitis B virus inhibitors.
AID1565099Antiviral activity against drug resistant HIV-1 harboring reverse transcriptase Y188L mutant infected in human MT4 cells assessed as reduction in virus-induced cytopathic effect incubated for 5 days by MTT assay
AID1661350Tmax in monkey plasma at 20 mg/kg, po administered as single dose by LC-MS/MS analysis2020Journal of medicinal chemistry, 08-13, Volume: 63, Issue:15
Mechanistic Insight into Antiretroviral Potency of 2'-Deoxy-2'-β-fluoro-4'-azidocytidine (FNC) with a Long-Lasting Effect on HIV-1 Prevention.
AID1226116Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBeAg secretion at 37.5 uM after 6 days by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID1228539Oral bioavailability in Sprague-Dawley rat at 32 mg/kg2015Journal of medicinal chemistry, May-14, Volume: 58, Issue:9
Synthesis and biological evaluation of 4-substituted fluoronucleoside analogs for the treatment of hepatitis B virus infection.
AID154954Activity against Lamivudine-resistant virus (HIV-1M184V) in human PBM cells, expressed as EC502003Journal of medicinal chemistry, Jul-17, Volume: 46, Issue:15
l-2',3'-Didehydro-2',3'-dideoxy-3'-fluoronucleosides: synthesis, anti-HIV activity, chemical and enzymatic stability, and mechanism of resistance.
AID560908Antiviral activity against HBV harboring RNA polymerase N236T mutant gene infected in human HuH7 cells assessed as decrease in viral transient transfection after 24 hrs2009Antimicrobial agents and chemotherapy, Jul, Volume: 53, Issue:7
Alkoxyalkyl esters of 9-(s)-(3-hydroxy-2-phosphonomethoxypropyl) adenine are potent and selective inhibitors of hepatitis B virus (HBV) replication in vitro and in HBV transgenic mice in vivo.
AID582409Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral RNA level per ug of total cell DNA at 15 mg/kg, po qd for 48 weeks measured on 60th week (Rvb = 27 pg)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID464068Antiviral activity against 3TC-resistant HBV with polymerase L180M mutation infected in HepG2.2.15 cells assessed as nucleic acid and protein levels dosed daily for 9 days and measured 24 hrs after last treatment by Southern blot hybridization2010Bioorganic & medicinal chemistry letters, Mar-01, Volume: 20, Issue:5
Orally bioavailable anti-HBV dinucleotide acyloxyalkyl prodrugs.
AID548810Antiviral activity against HIV1 isolate 217 harboring reverse transcriptase D67N/K70E/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1165078Selectivity index, ratio of CC50 for mock-infected human MT4 cells to EC50 for HIV1 3B infected in human MT4 cells2014European journal of medicinal chemistry, Nov-24, Volume: 87Design, synthesis and anti-HIV evaluation of novel diarylnicotinamide derivatives (DANAs) targeting the entrance channel of the NNRTI binding pocket through structure-guided molecular hybridization.
AID1687686Cytotoxicity against human MT4 cells assessed as inhibition of cell viability by measuring reduction in absorbance at OD540 by MTT assay2020European journal of medicinal chemistry, Jan-15, Volume: 186Indazolyl-substituted piperidin-4-yl-aminopyrimidines as HIV-1 NNRTIs: Design, synthesis and biological activities.
AID540214Clearance in rat after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID614131Antiviral activity against HBV infected in human HepG2(2.2.15) cells assessed as reduction in HBeAg antigen secretion after 72 hrs by ELISA2011Journal of natural products, Aug-26, Volume: 74, Issue:8
Swerilactones L-O, secoiridoids with C₁₂ and C₁₃ skeletons from Swertia mileensis.
AID297672Antimycobacterial activity against Mycobacterium tuberculosis H37Ra at 100 uM by microplate alamar blue assay2007Journal of medicinal chemistry, Sep-20, Volume: 50, Issue:19
Inhibition of Mycobacterium tuberculosis, Mycobacterium bovis, and Mycobacterium avium by novel dideoxy nucleosides.
AID1228734Cytotoxicity against human MT4 cells assessed as inhibition of cell metabolism after 72 hrs by MTS assay2015Journal of natural products, May-22, Volume: 78, Issue:5
Antiviral Activity of Flexibilane and Tigliane Diterpenoids from Stillingia lineata.
AID1303215Cytotoxicity against human MT4 cells infected with HIV1 3B assessed as cell growth inhibition after 5 days by MTT assay2016European journal of medicinal chemistry, Jul-19, Volume: 117Design, synthesis and anti-HIV activity of novel quinoxaline derivatives.
AID1197832Antiviral activity against HIV1 RES056 expressing reverse transcriptase K103N + Y181C double mutant infected in human MT4 cells assessed as reduction in virus-induced cytopathic effect after 5 days by MTT assay2015European journal of medicinal chemistry, Mar-06, Volume: 92Fused heterocycles bearing bridgehead nitrogen as potent HIV-1 NNRTIs. Part 3: optimization of [1,2,4]triazolo[1,5-a]pyrimidine core via structure-based and physicochemical property-driven approaches.
AID200002In vitro antiviral activity against HIV-1 Reverse transcriptase wild type2003Bioorganic & medicinal chemistry letters, Jun-16, Volume: 13, Issue:12
The role of 2',3'-unsaturation on the antiviral activity of anti-HIV nucleosides against 3TC-resistant mutant (M184V).
AID341762Antiviral activity against HIV1 with reverse transcriptase M184V mutation in human phytohemagglutininin-activated PBMC assessed as inhibition of viral replication at 200 uM2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
In vitro interactions between apricitabine and other deoxycytidine analogues.
AID1888693Resistance index, ratio of EC50 for antiviral activity against HIV1 with RT L100I mutant infected in human MT4 cells to EC50 for antiviral activity against wild type HIV1 infected in human MT4 cells
AID354464Antiviral activity against HIV1 3B infected in human CEM-SS cells assessed as inhibition of virus-induced cytopathic effect after 6 days by MTS assay2004Journal of natural products, Jun, Volume: 67, Issue:6
New 3-O-acyl betulinic acids from Strychnos vanprukii Craib.
AID1377839Inhibition of capsid in HBV infected in human HepAD38 cells assessed as reduction in cccDNA formation by measuring reduction in HBe antigen secretion at 10 uM after 14 days by ELISA relative to control2017European journal of medicinal chemistry, Sep-29, Volume: 138Synthesis of sulfamoylbenzamide derivatives as HBV capsid assembly effector.
AID450973Lipophilicity, log P of the compound2009Bioorganic & medicinal chemistry, Sep-01, Volume: 17, Issue:17
Synthesis and anti-HIV activity of novel 2',3'-dideoxy-3'-thiacytidine prodrugs.
AID1507016Cytotoxicity against human HepG2.2.15 cells assessed as reduction in cell viability after 8 days by CCK-8 assay2017European journal of medicinal chemistry, Aug-18, Volume: 136Design, synthesis and primary biological evaluation of the novel 2-pyridone derivatives as potent non-nucleoside HBV inhibitors.
AID397590Antiviral activity against HIV1 RF in human H9 cells assessed as inhibition of virus-induced cytopathic effect by formazan-based conventional colorimetric technique2001Journal of natural products, Feb, Volume: 64, Issue:2
Natural product-based anti-HIV drug discovery and development facilitated by the NCI developmental therapeutics program.
AID1431324Antiviral activity against Hepatitis B virus subtype adw2 infected in human HuH7 cells assessed as inhibition of viral DNA replication by RT-PCR method2016Journal of natural products, Dec-23, Volume: 79, Issue:12
Synthesis of C-4-Substituted Steviol Derivatives and Their Inhibitory Effects against Hepatitis B Virus.
AID519872Antiviral activity against 0.02 MOI wild type HIV1 NL4-3 infected in human MT2 cells measured after 5 days by RT SPA2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID1661361Tmax in monkey PBMC assessed as 3TC-TP level at 20 mg/kg, po administered as single dose by LC-MS/MS analysis2020Journal of medicinal chemistry, 08-13, Volume: 63, Issue:15
Mechanistic Insight into Antiretroviral Potency of 2'-Deoxy-2'-β-fluoro-4'-azidocytidine (FNC) with a Long-Lasting Effect on HIV-1 Prevention.
AID574197Cytotoxicity against human skeletal muscle Myoblast assessed as change in Tfam mitochondrial RNA level on day 5 by RT-PCR relative to untreated control2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Impact of nucleoside reverse transcriptase inhibitors on mitochondrial DNA and RNA in human skeletal muscle cells.
AID691386Antiviral activity against Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as inhibition of viral replication2012Bioorganic & medicinal chemistry letters, Oct-15, Volume: 22, Issue:20
A new class of pyrimidine nucleosides: inhibitors of hepatitis B and C viruses.
AID1487263Selectivity index, ratio of CC50 for human MT4 cells to EC50 for wild type HIV1 3B infected in human MT4 cells2017Bioorganic & medicinal chemistry, 08-15, Volume: 25, Issue:16
Discovery of novel DAPY-IAS hybrid derivatives as potential HIV-1 inhibitors using molecular hybridization based on crystallographic overlays.
AID1815383Antiviral activity against HIV1 harboring reverse transcriptase Y188L mutant infected in human MT4 cells assessed as protection against virus-induced cytopathic effect incubated for 5 days by MTT assay2021European journal of medicinal chemistry, Dec-15, Volume: 226Design of the naphthyl-diarylpyrimidines as potent non-nucleoside reverse transcriptase inhibitors (NNRTIs) via structure-based extension into the entrance channel.
AID358072Antiviral activity against HBV in human HepG2(2.2.15) cells assessed as inhibition of viral 2.4/2.1RNA replication2007Proceedings of the National Academy of Sciences of the United States of America, May-15, Volume: 104, Issue:20
Unique antiviral mechanism discovered in anti-hepatitis B virus research with a natural product analogue.
AID253330Cytotoxic concentration against HBV replication in 2.2.15 cell culture2005Journal of medicinal chemistry, Jul-28, Volume: 48, Issue:15
5'-Homoneplanocin A inhibits hepatitis B and hepatitis C.
AID1434729Cytotoxicity against African green monkey Vero cells assessed as growth inhibition by CellTiter 96 non-radioactive cell proliferation colorimetric assay2017Bioorganic & medicinal chemistry letters, 02-15, Volume: 27, Issue:4
Synthesis and antiviral evaluation of novel heteroarylpyrimidines analogs as HBV capsid effectors.
AID410751Antiviral activity against lamivudine-resistant HBV reverse transcriptase LM/reverse transcriptase MV double mutant in human Huh7 cells after 4 days by intracellular HBV DNA replication assay2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Synthesis and anti-hepatitis B virus and anti-hepatitis C virus activities of 7-deazaneplanocin A analogues in vitro.
AID1694159Cytotoxicity against human CEM cells assessed as reduction in cell viability by MTT assay2021Bioorganic & medicinal chemistry, 02-01, Volume: 31Discovery and structure activity relationship of glyoxamide derivatives as anti-hepatitis B virus agents.
AID557051Antiviral activity against PI-resistant HIV1 harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID548841Antiviral activity against HIV1 isolate 220 harboring reverse transcriptase K70E/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID79629Antiviral activity against Hepatitis B virus (HBV) in 2.2.15 cells2000Journal of medicinal chemistry, Oct-19, Volume: 43, Issue:21
Synthesis and antiviral activity of oxaselenolane nucleosides.
AID1228525Antiviral activity against duck Hepatitis B virus infected in duck assessed as inhibition of viral DNA replication in liver at 20 mg/kg/day, po treatment initiated at day 5 after infection relative to control2015Journal of medicinal chemistry, May-14, Volume: 58, Issue:9
Synthesis and biological evaluation of 4-substituted fluoronucleoside analogs for the treatment of hepatitis B virus infection.
AID406541Cytotoxicity against human HepG2.2.15 cells after 9 days by MTT assay2008Bioorganic & medicinal chemistry, Jul-01, Volume: 16, Issue:13
Synthesis and anti-hepatitis B virus evaluation of novel ethyl 6-hydroxyquinoline-3-carboxylates in vitro.
AID322847Fold resistance, ratio of Lamivudine -adenofir-resistant HBV with reverse transcriptase V173L/L180M/A181V mutant to wildtype HBV genotype E2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID541153Selectivity ratio of EC50 for antiviral activity against EFV-resistant HIV1 selected after 7 passages to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID682487Cytotoxicity against human HeLa P4/R5 cells incubated for 2 hrs followed by compound-wash out measured after 46 hrs by MTS assay2012Journal of medicinal chemistry, May-24, Volume: 55, Issue:10
Synthesis and biological evaluation of fatty acyl ester derivatives of (-)-2',3'-dideoxy-3'-thiacytidine.
AID246358Effective concentrations at which 2-fold depression of extracellular virion DNA (HBV) was observed in 2.2.15 Cells2005Journal of medicinal chemistry, Jul-28, Volume: 48, Issue:15
5'-Homoneplanocin A inhibits hepatitis B and hepatitis C.
AID1572522Selectivity index, ratio of CC50 for human MT4 cells to EC50 for HIV1 RES056 harboring reverse transcriptase K103N/Y181C double mutant infected in human MT4 cells
AID1902000Cytotoxicity against human HepG2 2.2.15 cells infected with Hepatitis B virus assessed as inhibition of cell growth at 0.4 uM incubated for 6 days by RT PCR analysis relative to control2022European journal of medicinal chemistry, Mar-05, Volume: 231Design and synthesis of novel quinazolinone derivatives as anti-HBV agents with TLR8 agonist effect.
AID358064Antiviral activity against HBV in ayw wild type HepG2(2.2.15) cells assessed as inhibition of viral DNA replication2007Proceedings of the National Academy of Sciences of the United States of America, May-15, Volume: 104, Issue:20
Unique antiviral mechanism discovered in anti-hepatitis B virus research with a natural product analogue.
AID266285Antiviral activity against wild type HBV in human hepatoma 2.2.15 cells2006Journal of medicinal chemistry, Jun-15, Volume: 49, Issue:12
Effect of various pyrimidines possessing the 1-[(2-hydroxy-1-(hydroxymethyl)ethoxy)methyl] moiety, able to mimic natural 2'-deoxyribose, on wild-type and mutant hepatitis B virus replication.
AID557022Antiviral activity against HIV1 CRF01_AE harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID257337Cytotoxicity against human hepatoblastoma 2.2.15 cells2005Bioorganic & medicinal chemistry letters, Dec-15, Volume: 15, Issue:24
Synthesis and in vitro anti-hepatitis B and C virus activities of ring-expanded ('fat') nucleobase analogues containing the imidazo[4,5-e][1,3]diazepine-4,8-dione ring system.
AID323414Reduction in dexelvucitabine diphosphate choline level in human PBMC at 1 uM2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
Antiviral and cellular metabolism interactions between Dexelvucitabine and lamivudine.
AID1434726Cytotoxicity against human HepG2 cells assessed as growth inhibition by CellTiter 96 non-radioactive cell proliferation colorimetric assay2017Bioorganic & medicinal chemistry letters, 02-15, Volume: 27, Issue:4
Synthesis and antiviral evaluation of novel heteroarylpyrimidines analogs as HBV capsid effectors.
AID527721Antiviral activity against HBV infected in human HepG2(2.2.15) cells assessed as inhibition of viral replication after 2 days2010Bioorganic & medicinal chemistry, Nov-01, Volume: 18, Issue:21
Synthesis and in vitro antiviral activities of 3'-fluoro (or chloro) and 2',3'-difluoro 2',3'-dideoxynucleoside analogs against hepatitis B and C viruses.
AID261860Inhibition of HBV L180M/ M204V mutant transfected in D88 cell line at 10 ug/mL2006Journal of medicinal chemistry, Mar-23, Volume: 49, Issue:6
Inhibition of hepatitis B virus (HBV) replication by pyrimidines bearing an acyclic moiety: effect on wild-type and mutant HBV.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID404982Antiviral activity against HBV genotype D with reverse transcriptase L80I/M204I mutation in human Huh7 cells assessed as inhibition of viral replication after 5 days2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID625941Antiviral activity against lamivudine-resistant Hepatitis B virus harboring reverse transcriptase L180M mutant infected in human HepG2(2.2.15) cells assessed as inhibition of virus replication treated daily for 9 days by quantitative blot hybridization me2011Bioorganic & medicinal chemistry letters, Nov-01, Volume: 21, Issue:21
Antiviral activity of novel 2'-fluoro-6'-methylene-carbocyclic adenosine against wild-type and drug-resistant hepatitis B virus mutants.
AID582423Toxicity in Woodchuck hepatitis virus infected woodchuck assessed as change in body weight at 15 mg/kg, po qd for 48 weeks measured up to 60 weeks2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID1815384Antiviral activity against HIV1 harboring reverse transcriptase E138K mutant infected in human MT4 cells assessed as protection against virus-induced cytopathic effect incubated for 5 days by MTT assay2021European journal of medicinal chemistry, Dec-15, Volume: 226Design of the naphthyl-diarylpyrimidines as potent non-nucleoside reverse transcriptase inhibitors (NNRTIs) via structure-based extension into the entrance channel.
AID407138Antiviral activity against hepatitis B virus infected Hep G2.2.15 cells assessed as inhibition of HBeAg secretion2008Bioorganic & medicinal chemistry letters, Jul-01, Volume: 18, Issue:13
Synthesis and in vitro anti-hepatitis B virus activities of 4-aryl-6-chloro-quinolin-2-one and 5-aryl-7-chloro-1,4-benzodiazepine derivatives.
AID586320Antiviral activity against HIV1 infected in human PBMC assessed as inhibition of gag gene expression after 5 days post infection by quantitative real time RT-PCR2011Bioorganic & medicinal chemistry, Mar-15, Volume: 19, Issue:6
Antiviral activity of seed extract from Citrus bergamia towards human retroviruses.
AID266286Antiviral activity against HBV L180M/M204V mutant transfected in D88 cell line at 10 ug/mL2006Journal of medicinal chemistry, Jun-15, Volume: 49, Issue:12
Effect of various pyrimidines possessing the 1-[(2-hydroxy-1-(hydroxymethyl)ethoxy)methyl] moiety, able to mimic natural 2'-deoxyribose, on wild-type and mutant hepatitis B virus replication.
AID353552Antiviral activity against HBV assessed as inhibition of viral early antigen secretion2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Anti-HBV agents. Part 2: synthesis and in vitro anti-hepatitis B virus activities of alisol A derivatives.
AID517830Antiviral activity against DHBV infected in duck hepatocytes assessed as inhibition of viral DNA replication2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Antiviral activity of various 1-(2'-deoxy-β-D-lyxofuranosyl), 1-(2'-fluoro-β-D-xylofuranosyl), 1-(3'-fluoro-β-D-arabinofuranosyl), and 2'-fluoro-2',3'-didehydro-2',3'-dideoxyribose pyrimidine nucleoside analogues against duck hepatitis B virus (DHBV) and
AID681387TP_TRANSPORTER: uptake in Xenopus laevis oocytes2000The Journal of pharmacology and experimental therapeutics, Sep, Volume: 294, Issue:3
Rat multispecific organic anion transporter 1 (rOAT1) transports zidovudine, acyclovir, and other antiviral nucleoside analogs.
AID548817Antiviral activity against HIV1 isolate 067 harboring reverse transcriptase A62V/D67G/T69SVG/V75I/T215I mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID422693Antiviral activity against HIV1 with reverse transcriptase K70E M184V and K70G M184V mutation by antivirogram biological cutoffs assay relative to wild type HIV12007Antimicrobial agents and chemotherapy, Dec, Volume: 51, Issue:12
Novel drug resistance pattern associated with the mutations K70G and M184V in human immunodeficiency virus type 1 reverse transcriptase.
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID89635Concentration required to reduce the proliferation of PHA stimulated human peripheral blood T lymphocytes to 50% of untreated PHA stimulated control2002Journal of medicinal chemistry, May-09, Volume: 45, Issue:10
Design and synthesis of novel 5-substituted acyclic pyrimidine nucleosides as potent and selective inhibitors of hepatitis B virus.
AID548804Antiviral activity against HIV1 isolate 203 harboring reverse transcriptase M41L/L210W/T215Y/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1200843Antiviral activity against HIV1 3B infected in human MT4 cells assessed as reduction in virus-induced cytopathic effect after 5 days by MTT assay2015European journal of medicinal chemistry, Mar-26, Volume: 93Fused heterocycles bearing bridgehead nitrogen as potent HIV-1 NNRTIs. Part 4: design, synthesis and biological evaluation of novel imidazo[1,2-a]pyrazines.
AID519876Antiviral activity against 0.02 MOI wild type HIV1 NL4-3 infected in 2 hr-pretreated human MT2 cells measured after 5 days by RT SPA2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID450972Selectivity index, ratio of CCID50 for human PBMC to IC50 for HIV1 infected in human PBMC2009Bioorganic & medicinal chemistry, Sep-01, Volume: 17, Issue:17
Synthesis and anti-HIV activity of novel 2',3'-dideoxy-3'-thiacytidine prodrugs.
AID81557In vitro concentration required to inhibit HBV DNA secretion by HepG2.2.15 transfected by HBV2003Bioorganic & medicinal chemistry letters, Aug-04, Volume: 13, Issue:15
Are 5'-O-carbamate-2',3'-dideoxythiacytidine new anti-HIV and anti-HBV nucleoside drugs or prodrugs?
AID1693337Antiviral activity against lamivudine/entecavir-resistant HBV rtL180M/rtM204V/rtT184L mutant infected in human HepG2 2.2.15 cells assessed as inhibition of viral DNA replication measured after incubation of 72 hrs by RT-PCR analysis2021Bioorganic & medicinal chemistry, 01-01, Volume: 29Synthesis and evaluation of new phenyl acrylamide derivatives as potent non-nucleoside anti-HBV agents.
AID1191973Cytotoxicity against mock-infected human HeLa cells by MTT assay2015Bioorganic & medicinal chemistry letters, Mar-15, Volume: 25, Issue:6
Design, synthesis of new β-carboline derivatives and their selective anti-HIV-2 activity.
AID322841Antiviral activity against Lamivudine -adenofir-resistant HBV with reverse transcriptase V173L/L180M/A181V/M204V/N236T mutant2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID688917Antiviral activity against Hepatitis B virus infected in HepG2(2.2.15) cells assessed as reduction in HBsAg level at 20 uM after 9 days by ELISA2012Bioorganic & medicinal chemistry, Oct-01, Volume: 20, Issue:19
Synthesis and biological evaluation of novel homochiral carbocyclic nucleosides from 1-amino-2-indanols.
AID325078Drug level in human RBC assessed as concentration of Lamivudine triphosphate per 10^6 cells after 0.3 hrs2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
Evidence and possible consequences of the phosphorylation of nucleoside reverse transcriptase inhibitors in human red blood cells.
AID427244Antiviral activity against HBV infected in human HepG2(2.2.15) cells assessed as inhibition of HBV surface antigen at < TC502009Bioorganic & medicinal chemistry, Jul-01, Volume: 17, Issue:13
Synthesis and in vitro anti-hepatitis B virus activity of 6H-[1]benzothiopyrano[4,3-b]quinolin-9-ols.
AID550166Cytotoxicity against human HepG2(2.2.15) cells2011Bioorganic & medicinal chemistry, Jan-01, Volume: 19, Issue:1
Synthesis and in vitro anti-hepatitis B virus activity of six-membered azanucleoside analogues.
AID598200Cytotoxicity against human HepG2(2.2.15) cells after 8 days by MTT assay2011Bioorganic & medicinal chemistry, May-15, Volume: 19, Issue:10
Tryptamine derivatives as novel non-nucleosidic inhibitors against hepatitis B virus.
AID548839Antiviral activity against HIV1 isolate 215 harboring reverse transcriptase D67N/K70E mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1152371Antiviral activity against HIV2 ROD infected in human MT4 cells assessed as inhibition of virus-induced cytopathicity measured 5 days post viral infection by MTT assay2014Bioorganic & medicinal chemistry, Jun-15, Volume: 22, Issue:12
Synthesis and biological evaluation of CHX-DAPYs as HIV-1 non-nucleoside reverse transcriptase inhibitors.
AID423158Antiviral activity against wild type HIV2 ROD produced from full length pROD9 infected in human MAGIC-5A cells assessed as inhibition of Lac+ foci expression after 40 hrs2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Human immunodeficiency virus types 1 and 2 exhibit comparable sensitivities to Zidovudine and other nucleoside analog inhibitors in vitro.
AID340718Half life in healthy human PBMC assessed as intracellular apricitabine triphosphate level per 10'6 cells at 300 mg, po once daily coadministered with 600 mg, po apricitabine twice daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID384983Antiviral activity against HBV assessed as inhibition of viral surface antigen secretion in HepG2.2.15 cells by ELISA2008Journal of natural products, May, Volume: 71, Issue:5
Periglaucines A-D, anti-HBV and -HIV-1 alkaloids from Pericampylus glaucus.
AID1431337Antiviral activity against Hepatitis B virus subtype adw2 infected in human HuH7 cells assessed as reduction in HBx level at 5 ug/ml after 2 days by immunoblot method relative to control2016Journal of natural products, Dec-23, Volume: 79, Issue:12
Synthesis of C-4-Substituted Steviol Derivatives and Their Inhibitory Effects against Hepatitis B Virus.
AID682490Antiviral activity against HIV1 94US3393IN clade B clinical isolate infected in PHA-stimulated human PBMC assessed as inhibition of viral replication incubated for 6 hrs followed by compound-wash out measured after 6 days by liquid scintillation counting2012Journal of medicinal chemistry, May-24, Volume: 55, Issue:10
Synthesis and biological evaluation of fatty acyl ester derivatives of (-)-2',3'-dideoxy-3'-thiacytidine.
AID540216Clearance in dog after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID572781Ratio of IC50 for HIV1 harboring reverse transcriptase Q151M mutant infected in human HeLa P4/R5 cells to wild type HIV1 infected in human HeLa P4/R5 cells2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Anti-human immunodeficiency virus activity, cross-resistance, cytotoxicity, and intracellular pharmacology of the 3'-azido-2',3'-dideoxypurine nucleosides.
AID548580Antiviral activity against HIV1 isolate 070 harboring reverse transcriptase 65R/S68G mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1226088Selectivity index, ratio of CC50 for human HepG2.2.15 cells to IC50 for Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBsAg secretion2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID1815389Antiviral activity against HIV1 harboring reverse transcriptase K103N/Y181C double mutant infected in human MT4 cells assessed as protection against virus-induced cytopathic effect incubated for 5 days by MTT assay2021European journal of medicinal chemistry, Dec-15, Volume: 226Design of the naphthyl-diarylpyrimidines as potent non-nucleoside reverse transcriptase inhibitors (NNRTIs) via structure-based extension into the entrance channel.
AID1627278Cytotoxicity against human HepG2.2.15.7 cells assessed as reduction in cell viability after 9 days by tetrazolium dye based method2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Synthesis and anti-HBV activity of α-stereoisomer of aristeromycin based analogs.
AID519871Antiviral activity against 0.01 MOI wild type HIV1 NL4-3 infected in human MT2 cells measured after 5 days by RT SPA2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID588210Human drug-induced liver injury (DILI) modelling dataset from Ekins et al2010Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 38, Issue:12
A predictive ligand-based Bayesian model for human drug-induced liver injury.
AID322836Antiviral activity against lamivudine-resistant HBV with reverse transcriptase L180M/M204V mutant2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID1771363Inhibition of capsid protein in HBV infected in human HepDES19 cells assessed as inhibition of viral replication by measuring minus polarity DNA level at 20 uM incubated for 3 days by strand preferential qPCR analysis relative to control2021European journal of medicinal chemistry, Dec-05, Volume: 225Design, synthesis and evaluation of heteroaryldihydropyrimidine analogues bearing spiro ring as hepatitis B virus capsid protein inhibitors.
AID1320868Solubility of the compound2016European journal of medicinal chemistry, Oct-04, Volume: 121Structural optimization of pyridine-type DAPY derivatives to exploit the tolerant regions of the NNRTI binding pocket.
AID625936Antiviral activity against lamivudine-resistant Hepatitis B virus harboring reverse transcriptase M204V mutant infected in human HepG2(2.2.15) cells assessed as reduction of infectious virus titer treated daily for 9 days by quantitative Southern blot hyb2011Bioorganic & medicinal chemistry letters, Nov-01, Volume: 21, Issue:21
Antiviral activity of novel 2'-fluoro-6'-methylene-carbocyclic adenosine against wild-type and drug-resistant hepatitis B virus mutants.
AID211486Toxic activity against VERO cells.1997Journal of medicinal chemistry, Sep-12, Volume: 40, Issue:19
Synthesis, anti-human immunodeficiency virus and anti-hepatitis B virus activities of novel oxaselenolane nucleosides.
AID1191288Cytotoxicity against human HepG2(2.2.15) cells assessed as decrease in cell viability after 72 hrs by MTS assay2015European journal of medicinal chemistry, Jan-27, Volume: 90Design, synthesis, and bioevaluation of paeonol derivatives as potential anti-HBV agents.
AID517943Antiviral activity against HIV1 expressing reverse transcriptase D67N/K70R/T215F/K219E/M184V mutant infected in HEK293 cells assessed as inhibition of virus replication after 72 hrs2010Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6
Telbivudine exhibits no inhibitory activity against HIV-1 clinical isolates in vitro.
AID1599857Selectivity index, ratio of CC50 for human HepG2.2.15 cells to IC50 for HBV infected in human HepG2.2.15 cells2019ACS medicinal chemistry letters, Jun-13, Volume: 10, Issue:6
Design, Synthesis, and Anti-HBV Activity of New Bis(l-amino acid) Ester Tenofovir Prodrugs.
AID679629TP_TRANSPORTER: Anti-HIV-1 activity in MT-4 and MT-4/DOX5002003Molecular pharmacology, Jan, Volume: 63, Issue:1
Breast cancer resistance protein (BCRP/ABCG2) induces cellular resistance to HIV-1 nucleoside reverse transcriptase inhibitors.
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID557046Antiviral activity against HIV1 clade C harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID261856Inhibition of wild type HBV transfected in human hepatoblastoma 2.2.15 cells at 10 ug/mL2006Journal of medicinal chemistry, Mar-23, Volume: 49, Issue:6
Inhibition of hepatitis B virus (HBV) replication by pyrimidines bearing an acyclic moiety: effect on wild-type and mutant HBV.
AID1742098Selectivity index, ratio of CC50 for human HepG2 2.2.15 cells to IC50 for antiviral activity against HBV infected in human HepG2.2.15 cells assessed as inhibition of DNA replication2020European journal of medicinal chemistry, Nov-01, Volume: 205Discovery of novel quinazolinone derivatives as potential anti-HBV and anti-HCC agents.
AID519885Antiviral activity against 0.005 MOI wild type HIV1 NL4-3 infected in 2 hr-pretreated human MT2 cells measured after 5 days by MTS assay2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID328841Inhibition of human MRP1 expressed in MDCK2 cells assessed as increase in intracellular CMF fluorescence by CMFDA assay2007Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 35, Issue:3
Inhibition of MRP1/ABCC1, MRP2/ABCC2, and MRP3/ABCC3 by nucleoside, nucleotide, and non-nucleoside reverse transcriptase inhibitors.
AID738973Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBsAg secretion after 12 days by ELISA2013Bioorganic & medicinal chemistry letters, Apr-01, Volume: 23, Issue:7
Anti-hepatitis B virus lignans from the root of Streblus asper.
AID548812Antiviral activity against HIV1 isolate 058 harboring reverse transcriptase M41L/D67N/K70R/L210W/T215F/K219Q mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID582427Toxicity in Woodchuck hepatitis virus infected woodchuck assessed as increase of liver sorbitol dehydrogenase activity at 15 mg/kg, po qd measured on 28 to 48 weeks on 48 week study2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID1693336Selectivity index, ratio of CC50 for human HepG2 2.2.15 to IC50 of antiviral activity against HBV infected in human HepG2 2.2.15 cells assessed as decrease in extracellular viral DNA level measured after incubation of 6 days by RT-PCR analysis2021Bioorganic & medicinal chemistry, 01-01, Volume: 29Synthesis and evaluation of new phenyl acrylamide derivatives as potent non-nucleoside anti-HBV agents.
AID404908Cytotoxicity against human HL60 cells after 3 days by MTT assay2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
Strong and selective inhibitors of hepatitis B virus replication among novel N4-hydroxy- and 5-methyl-beta-L-deoxycytidine analogues.
AID423280Antiviral activity against multinucleoside-resistant HIV1 NL4-3 harboring A62V, V75I, F77L, F116Y, Q151M mutation in viral reverse transcriptase infected in human MAGIC-5A cells assessed as inhibition of Lac+ foci expression after 40 hrs2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Human immunodeficiency virus types 1 and 2 exhibit comparable sensitivities to Zidovudine and other nucleoside analog inhibitors in vitro.
AID261855Inhibition of duck HBV transfected in primary duck hepatocytes2006Journal of medicinal chemistry, Mar-23, Volume: 49, Issue:6
Inhibition of hepatitis B virus (HBV) replication by pyrimidines bearing an acyclic moiety: effect on wild-type and mutant HBV.
AID79635Concentration required to inhibit 50% of cytoplasmic HBV-DNA synthesis2002Journal of medicinal chemistry, Jul-04, Volume: 45, Issue:14
2-Amino-6-arylthio-9-[2-(phosphonomethoxy)ethyl]purine bis(2,2,2-trifluoroethyl) esters as novel HBV-specific antiviral reagents.
AID422692Ratio of IC50 for HIV1 with reverse transcriptase K70G/M184V mutation to IC50 for wild type HIV12007Antimicrobial agents and chemotherapy, Dec, Volume: 51, Issue:12
Novel drug resistance pattern associated with the mutations K70G and M184V in human immunodeficiency virus type 1 reverse transcriptase.
AID1226129Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBV DNA copies per uL at 300 uM after 9 days by real-time fluorescence quantitative PCR analysis2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID1815381Antiviral activity against HIV1 harboring reverse transcriptase K103N mutant infected in human MT4 cells assessed as protection against virus-induced cytopathic effect incubated for 5 days by MTT assay2021European journal of medicinal chemistry, Dec-15, Volume: 226Design of the naphthyl-diarylpyrimidines as potent non-nucleoside reverse transcriptase inhibitors (NNRTIs) via structure-based extension into the entrance channel.
AID246491Effective concentration to inhibit 50% of cytomegalovirus (CMV) replication in a cell culture model;ND=Not determined2005Journal of medicinal chemistry, Jan-27, Volume: 48, Issue:2
Synthesis and antiviral activity of helioxanthin analogues.
AID1614367Mitochondrial toxicity in human HepG2 cells assessed as inhibition of cytochrome c oxidase subunit 2 DNA level at 10 uM followed by medium plus drugs replenishment every 3 to 4 days for 14 days relative to control2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1771357Inhibition of capsid protein in HBV infected in human HepDES19 cells assessed as inhibition of viral replication by measuring plus polarity DNA level at 20 uM incubated for 3 days by strand preferential qPCR analysis relative to control2021European journal of medicinal chemistry, Dec-05, Volume: 225Design, synthesis and evaluation of heteroaryldihydropyrimidine analogues bearing spiro ring as hepatitis B virus capsid protein inhibitors.
AID358070Antiviral activity against HBV in human HepD2 cells assessed as inhibition of viral pre genomic RNA replication2007Proceedings of the National Academy of Sciences of the United States of America, May-15, Volume: 104, Issue:20
Unique antiviral mechanism discovered in anti-hepatitis B virus research with a natural product analogue.
AID519973Antiviral activity against HIV1 NL4-3 harboring M184V mutant RT at 2.5 uM after 6 days2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID246341Effective concentration to inhibit 50 % of Epstein Barr virus replication in a cell culture model2005Journal of medicinal chemistry, Jan-27, Volume: 48, Issue:2
Synthesis and antiviral activity of helioxanthin analogues.
AID520606Selectivity index, ratio of CC50 for human WI38 cells to EC50 for BK polyomavirus ATCC VR8372008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
Anti-BK virus activity of nucleoside analogs.
AID1377845Cytotoxicity against human HepG2 cells by CellTiter 96 non-radioactive cell proliferation colorimetric assay2017European journal of medicinal chemistry, Sep-29, Volume: 138Synthesis of sulfamoylbenzamide derivatives as HBV capsid assembly effector.
AID548800Antiviral activity against HIV1 isolate 192 harboring reverse transcriptase M41L/T215Y mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID572768Antiviral activity against HIV1 infected in human MT2 cells assessed as inhibition of viral replication2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Anti-human immunodeficiency virus activity, cross-resistance, cytotoxicity, and intracellular pharmacology of the 3'-azido-2',3'-dideoxypurine nucleosides.
AID1854347Antiviral activity against HIV-12022European journal of medicinal chemistry, Oct-05, Volume: 240HIV nucleoside reverse transcriptase inhibitors.
AID492270Cytotoxicity against human HepG2(2.2.15) cells after 8 days by MTT assay2010Bioorganic & medicinal chemistry, Jul-15, Volume: 18, Issue:14
Design and synthesis of novel benzimidazole derivatives as inhibitors of hepatitis B virus.
AID1473740Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID576242AUC (0 to tau) in HIV-1 infected children aged 8.5 to 12.3 years at 4 mg/kg, po every 12 hrs by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID519862Antiviral activity against HIV1 subtype B-LAI infected in 1 hr-pretreated human MT2 cells assessed as inhibition of multicycle replication measured on day 5 postinfection by RT SPA2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID1888692Selectivity index, ratio of CC50 for toxicity in mock-infected human MT4 cells assessed as reduction in cell viability by MTT assay to EC50 for antiviral activity against HIV1 3B infected in human MT4 cells cells assessed as protection against viral-induc
AID517939Antiviral activity against HIV1 subtype BF isolate 5 infected in HEK293 cells assessed as inhibition of virus replication after 72 hrs2010Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6
Telbivudine exhibits no inhibitory activity against HIV-1 clinical isolates in vitro.
AID563942Antiviral activity against HIV1 pNL4-3 harboring Reverse transcriptase T165A/M184V mutant gene infected in TZM-bl cells after 72 hrs by luciferase assay2009Antimicrobial agents and chemotherapy, Nov, Volume: 53, Issue:11
Impact of novel human immunodeficiency virus type 1 reverse transcriptase mutations P119S and T165A on 4'-ethynylthymidine analog resistance profile.
AID738967Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for Hepatitis B virus infected human HepG2.2.15 cells by DNA replication assay2013Bioorganic & medicinal chemistry letters, Apr-01, Volume: 23, Issue:7
Anti-hepatitis B virus lignans from the root of Streblus asper.
AID1544329Antiviral activity against lamivudine-resistant Hepatitis B virus harboring L180M/M204V mutant infected in human HepG2.2.15 cells assessed as inhibition of intracellular HBV DNA replication at 20 uM measured on day 3 by FQ-PCR analysis relative to control2019Bioorganic & medicinal chemistry letters, 06-01, Volume: 29, Issue:11
Design, synthesis, and biological evaluation of novel 2'-deoxy-2'-fluoro-2'-C-methyl 8-azanebularine derivatives as potent anti-HBV agents.
AID405004Effect on replication efficiency of HBV genotype D with reverse transcriptase L80I/M204I mutation in human Huh7 cells assessed as increase in viral replication yield at 1 uM after 5 days relative to control2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID1572520Cytotoxicity against human MT4 cells assessed as reduction in cell viability after 5 days by MTT assay
AID1743635Resistance index, ratio of EC50 for antiviral activity against HIV1 expressing RT K103N mutant infected in human MT4 cells to EC50 for antiviral activity against HIV1 3B infected in human MT4 cells2020European journal of medicinal chemistry, Nov-15, Volume: 206Targeting dual tolerant regions of binding pocket: Discovery of novel morpholine-substituted diarylpyrimidines as potent HIV-1 NNRTIs with significantly improved water solubility.
AID404980Antiviral activity against HBV genotype D with reverse transcriptase L80I mutation in human Huh7 cells assessed as inhibition of viral replication after 5 days2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID1869742Antiviral activity against Hepatitis B virus infected in duck assessed as inhibition of viral DNA replication in serum at 25 mg/kg, IG administered once daily for 28 days and measured on day 21
AID548826Antiviral activity against HIV1 isolate 174 harboring reverse transcriptase M184V mutant gene obtained as site-directed mutant of NL4-3 by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID322838Antiviral activity against lamivudine-resistant HBV with reverse transcriptase V173L/L180/M204V mutant2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID246559Effective concentration to inhibit 50 % of Human immunodeficiency virus replication in a cell culture model;ND=Not determined2005Journal of medicinal chemistry, Jan-27, Volume: 48, Issue:2
Synthesis and antiviral activity of helioxanthin analogues.
AID519893Selectivity ratio of EC50 for 0.005 MOI HIV1 NL4-3 infected in 2 hrs pretreated human MT2 cells by MTS assay to EC50 for 0.005 MOI HIV1 NL4-3 infected in 2 hrs pretreated human MT2 cells by RT assay2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID1401783Antiviral activity against Hepatitis B virus harboring rtV173L/L180M/M204V mutant infected in HepGRL1 cells assessed as inhibition of intracellular HBV DNA level at 20 uM measured on day 6 by FQ-PCR analysis relative to control2018European journal of medicinal chemistry, Jan-01, Volume: 143Design, synthesis, and biological evaluation of new 1,2,3-triazolo-2'-deoxy-2'-fluoro- 4'-azido nucleoside derivatives as potent anti-HBV agents.
AID1543318Antiviral activity against HIV1 3B infected in human C8166 cells assessed as inhibition of syncytial cell formation incubated for 72 hrs2019Journal of natural products, 07-26, Volume: 82, Issue:7
Dimeric Pyranonaphthoquinone Glycosides with Anti-HIV and Cytotoxic Activities from a Soil-Derived
AID576255AUC in HIV-1 infected children with body weight >17 kg at 8 mg/kg, po every 24 hrs coadministered with 240 mg/m2 of didanosine and efavirenz by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID675192Therapeutic index, ratio of TC50 for human PBMC to EC50 for HIV-1 subtype B US/92/727 infected in PBMC2012Bioorganic & medicinal chemistry letters, Sep-01, Volume: 22, Issue:17
Synthesis and anti-HIV activities of symmetrical dicarboxylate esters of dinucleoside reverse transcriptase inhibitors.
AID86872Effective concentration against Hepatitis B virus in human hepatoblastoma cell line1998Journal of medicinal chemistry, Jun-04, Volume: 41, Issue:12
Does the anti-hepatitis B virus activity of (+)-5'-noraristeromycin exist in its 4'-epimer and 4'-deoxygenated derivatives?
AID560904Antiviral activity against HBV harboring RNA polymerase L180M mutant gene infected in human HuH7 cells assessed as decrease in viral transient transfection after 24 hrs2009Antimicrobial agents and chemotherapy, Jul, Volume: 53, Issue:7
Alkoxyalkyl esters of 9-(s)-(3-hydroxy-2-phosphonomethoxypropyl) adenine are potent and selective inhibitors of hepatitis B virus (HBV) replication in vitro and in HBV transgenic mice in vivo.
AID1226089Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBeAg secretion by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID1661372Antiviral activity against JRFL pseudotyped HIV1 infected in human Hut/CCR5 cells assessed as time needed to reach 50% reduction of virus infection at 10000 nM incubated with cells for 4 hrs prior to compound washout followed by viral infection and measur2020Journal of medicinal chemistry, 08-13, Volume: 63, Issue:15
Mechanistic Insight into Antiretroviral Potency of 2'-Deoxy-2'-β-fluoro-4'-azidocytidine (FNC) with a Long-Lasting Effect on HIV-1 Prevention.
AID1226121Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBV DNA copies per uL at 300 uM after 3 days by real-time fluorescence quantitative PCR analysis2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID1380571Antiviral activity against HIV1 virions containing reverse transcriptase Y181C mutant derived from HIV/VSG-G or HIV/HA virions infected 293T cells using human A549 cells as target cells assessed as inhibition of viral replication using compound pre-mixed 2018Bioorganic & medicinal chemistry letters, 06-01, Volume: 28, Issue:10
Design, synthesis and biological evaluation of substituted (+)-SG-1 derivatives as novel anti-HIV agents.
AID1228534Half life in Sprague-Dawley rat at 2.5 mg/kg, iv2015Journal of medicinal chemistry, May-14, Volume: 58, Issue:9
Synthesis and biological evaluation of 4-substituted fluoronucleoside analogs for the treatment of hepatitis B virus infection.
AID614562Antiviral activity against HBV infected in human HepG2(2.2.15) cells assessed as inhibition of viral DNA replication by measuring HBsAg and HBeAg production after 9 days by EIA2011Bioorganic & medicinal chemistry, Sep-15, Volume: 19, Issue:18
Synthesis and biological evaluation of Matijing-Su derivatives as potent anti-HBV agents.
AID1507017Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBsAg secretion after 8 days by ELISA2017European journal of medicinal chemistry, Aug-18, Volume: 136Design, synthesis and primary biological evaluation of the novel 2-pyridone derivatives as potent non-nucleoside HBV inhibitors.
AID1226090Selectivity index, ratio of CC50 for human HepG2.2.15 cells to IC50 for Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBeAg secretion2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID572775Antiviral activity against HIV1 harboring reverse transcriptase L74V mutant infected in human HeLa P4/R5 cells assessed as inhibition of viral replication2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Anti-human immunodeficiency virus activity, cross-resistance, cytotoxicity, and intracellular pharmacology of the 3'-azido-2',3'-dideoxypurine nucleosides.
AID1316333Cytotoxicity against human mock-infected MT4 cells assessed as reduction in cell viability after 5 days by MTT assay2016Journal of medicinal chemistry, 09-08, Volume: 59, Issue:17
Design, Synthesis, and Evaluation of Thiophene[3,2-d]pyrimidine Derivatives as HIV-1 Non-nucleoside Reverse Transcriptase Inhibitors with Significantly Improved Drug Resistance Profiles.
AID732676Immunoregulatory activity in Hepatitis B virus infected transgenic mouse assessed as increase in cytokine IL-2 mRNA level in liver at 100 mg/kg qd for 1 month by qPCR analysis2013Bioorganic & medicinal chemistry letters, Mar-01, Volume: 23, Issue:5
Synthesis and biological evaluation of nucleoside analogues than contain silatrane on the basis of the structure of acyclovir (ACV) as novel inhibitors of hepatitis B virus (HBV).
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1694161Cytotoxicity against human HepG2 cells assessed as reduction in cell viability by MTT assay2021Bioorganic & medicinal chemistry, 02-01, Volume: 31Discovery and structure activity relationship of glyoxamide derivatives as anti-hepatitis B virus agents.
AID1614323Mitochondrial toxicity in human HepG2 cells assessed as inhibition of nuclear ribosomal-DNA level followed by medium plus drugs replenishment every 3 to 4 days for 14 days relative to control2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1815382Antiviral activity against HIV1 harboring reverse transcriptase Y181C mutant infected in human MT4 cells assessed as protection against virus-induced cytopathic effect incubated for 5 days by MTT assay2021European journal of medicinal chemistry, Dec-15, Volume: 226Design of the naphthyl-diarylpyrimidines as potent non-nucleoside reverse transcriptase inhibitors (NNRTIs) via structure-based extension into the entrance channel.
AID625999Antiviral activity against lamivudine-resistant Hepatitis B virus harboring reverse transcriptase L180M/M204V double mutant infected in human HepG2(2.2.15) cells assessed as reduction of infectious virus titer treated daily for 9 days by quantitative Sout2011Bioorganic & medicinal chemistry letters, Nov-01, Volume: 21, Issue:21
Antiviral activity of novel 2'-fluoro-6'-methylene-carbocyclic adenosine against wild-type and drug-resistant hepatitis B virus mutants.
AID444055Fraction absorbed in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID625940Fold resistance, ratio of EC90 for lamivudine-resistant Hepatitis B virus harboring reverse transcriptase M204I mutant to EC90 for wild type Hepatitis B virus2011Bioorganic & medicinal chemistry letters, Nov-01, Volume: 21, Issue:21
Antiviral activity of novel 2'-fluoro-6'-methylene-carbocyclic adenosine against wild-type and drug-resistant hepatitis B virus mutants.
AID517935Antiviral activity against HIV1 subtype A isolate 1 infected in HEK293 cells assessed as inhibition of virus replication after 72 hrs2010Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6
Telbivudine exhibits no inhibitory activity against HIV-1 clinical isolates in vitro.
AID1197831Selectivity index, ratio of CC50 for mock-infected human MT4 cells to EC50 for HIV1 3B infected in human MT4 cells2015European journal of medicinal chemistry, Mar-06, Volume: 92Fused heterocycles bearing bridgehead nitrogen as potent HIV-1 NNRTIs. Part 3: optimization of [1,2,4]triazolo[1,5-a]pyrimidine core via structure-based and physicochemical property-driven approaches.
AID1197830Cytotoxicity against mock-infected human MT4 cells assessed as reduction in cell viability after 4 days by MTT assay2015European journal of medicinal chemistry, Mar-06, Volume: 92Fused heterocycles bearing bridgehead nitrogen as potent HIV-1 NNRTIs. Part 3: optimization of [1,2,4]triazolo[1,5-a]pyrimidine core via structure-based and physicochemical property-driven approaches.
AID405003Effect on replication efficiency of HBV genotype D with reverse transcriptase L80I mutation in human Huh7 cells assessed as decrease in viral replication yield at 1 uM after 5 days relative to control2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID427242Antiviral activity against HBV infected in human HepG2(2.2.15) cells assessed as inhibition of HBV DNA replication2009Bioorganic & medicinal chemistry, Jul-01, Volume: 17, Issue:13
Synthesis and in vitro anti-hepatitis B virus activity of 6H-[1]benzothiopyrano[4,3-b]quinolin-9-ols.
AID732673Immunoregulatory activity in Hepatitis B virus infected transgenic mouse assessed as increase in cytokine IFN gamma level in serum at 100 mg/kg qd for 1 month by ELISA2013Bioorganic & medicinal chemistry letters, Mar-01, Volume: 23, Issue:5
Synthesis and biological evaluation of nucleoside analogues than contain silatrane on the basis of the structure of acyclovir (ACV) as novel inhibitors of hepatitis B virus (HBV).
AID404995Antiviral activity against HBV genotype D with reverse transcriptase L180M/M204I mutation in human Huh7 cells assessed as viral replication yield at 1 uM after 5 days relative to control2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID541152Selectivity ratio of EC50 for antiviral activity against EFV-resistant HIV1 selected after 3 passages to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID732669Immunoregulatory activity in Hepatitis B virus infected transgenic mouse assessed as increase in CD8+ population in peripheral blood at 100 mg/kg qd for 1 month by flow cytometry (Rvb = 14.1 +/-1.4%)2013Bioorganic & medicinal chemistry letters, Mar-01, Volume: 23, Issue:5
Synthesis and biological evaluation of nucleoside analogues than contain silatrane on the basis of the structure of acyclovir (ACV) as novel inhibitors of hepatitis B virus (HBV).
AID1226113Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBeAg secretion at 300 uM after 6 days by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID582413Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral antigen positive hepatocytes at 15 mg/kg, po qd for 48 weeks measured on 60th week (Rvb = 26 %)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID340847Apparent terminal half life in healthy human at 300 mg, po once daily coadministered with 600 mg, po apricitabine twice daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID450970Antiviral activity against HIV1 infected in human PBMC assessed as inhibition of viral p24 antigen production after 7 days by ELISA2009Bioorganic & medicinal chemistry, Sep-01, Volume: 17, Issue:17
Synthesis and anti-HIV activity of novel 2',3'-dideoxy-3'-thiacytidine prodrugs.
AID1226130Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBV DNA copies per uL at 150 uM after 9 days by real-time fluorescence quantitative PCR analysis2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID1729161Antiviral activity against HIV1 harboring F227L/V106A mutant infected in human MT4 cells assessed as reduction in virus-induced cytopathic effect by MTT assay2021European journal of medicinal chemistry, Mar-05, Volume: 213Exploiting the tolerant region I of the non-nucleoside reverse transcriptase inhibitor (NNRTI) binding pocket. Part 2: Discovery of diarylpyrimidine derivatives as potent HIV-1 NNRTIs with high Fsp
AID1693341Antiviral activity against lamivudine/entecavir-resistant HBV rtL180M/rtM204V/rtT184L mutant infected in human HepG2 2.2.15 cells assessed as inhibition of viral DNA replication at 100 uM measured after incubation of 72 hrs by RT-PCR analysis relative to 2021Bioorganic & medicinal chemistry, 01-01, Volume: 29Synthesis and evaluation of new phenyl acrylamide derivatives as potent non-nucleoside anti-HBV agents.
AID732677Immunoregulatory activity in Hepatitis B virus infected transgenic mouse assessed as increase in cytokine IFN gamma mRNA level in liver at 100 mg/kg qd for 1 month by qPCR analysis2013Bioorganic & medicinal chemistry letters, Mar-01, Volume: 23, Issue:5
Synthesis and biological evaluation of nucleoside analogues than contain silatrane on the basis of the structure of acyclovir (ACV) as novel inhibitors of hepatitis B virus (HBV).
AID519877Antiviral activity against 0.05 MOI wild type HIV1 NL4-3 infected in 2 hr-pretreated human MT2 cells measured after 5 days by RT SPA2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID273057Cytotoxicity against 2.2.15 cells2006Journal of medicinal chemistry, Oct-05, Volume: 49, Issue:20
9-{[3-fluoro-2-(hydroxymethyl)cyclopropylidene]methyl}adenines and -guanines. Synthesis and antiviral activity of all stereoisomers1.
AID218359Compound was evaluated for cytotoxicity against stationary Vero cells using MTT assay2001Bioorganic & medicinal chemistry letters, Nov-19, Volume: 11, Issue:22
Novel 5-vinyl pyrimidine nucleosides with potent anti-hepatitis B virus activity.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID353549Cytotoxicity against human HepG2(2.2.15) cells2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Anti-HBV agents. Part 2: synthesis and in vitro anti-hepatitis B virus activities of alisol A derivatives.
AID1316330Antiviral activity against wild type HIV1 3B harboring reverse transcriptase infected in human MT4 cells assessed as protection against virus induced cytotoxicity after 5 days by MTT assay2016Journal of medicinal chemistry, 09-08, Volume: 59, Issue:17
Design, Synthesis, and Evaluation of Thiophene[3,2-d]pyrimidine Derivatives as HIV-1 Non-nucleoside Reverse Transcriptase Inhibitors with Significantly Improved Drug Resistance Profiles.
AID727269Cytotoxicity against human HuH7 cells2013Bioorganic & medicinal chemistry letters, Jan-15, Volume: 23, Issue:2
2'-Fluoro-6'-methylene-carbocyclic adenosine phosphoramidate (FMCAP) prodrug: in vitro anti-HBV activity against the lamivudine-entecavir resistant triple mutant and its mechanism of action.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1320867Selectivity index, ratio of CC50 for mock-infected human MT4 cells to EC50 for HIV1 RES056 expressing reverse transcriptase K103N/Y181C double mutant2016European journal of medicinal chemistry, Oct-04, Volume: 121Structural optimization of pyridine-type DAPY derivatives to exploit the tolerant regions of the NNRTI binding pocket.
AID404994Antiviral activity against HBV genotype D with reverse transcriptase L80I/M204I mutation in human Huh7 cells assessed as viral replication yield at 1 uM after 5 days relative to control2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID576229Cmin in HIV-1 infected children aged 2.5 to 14 years at 8 mg/kg, po every 24 hrs coadministered with 240 mg/m2 of didanosine and efavirenz by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID540215Volume of distribution at steady state in rat after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID1226099Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBsAg secretion at 75 uM after 6 days by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID358075Antiviral activity against HBV in mouse HBV-Met cells assessed as inhibition of viral 2.4/2.1RNA replication2007Proceedings of the National Academy of Sciences of the United States of America, May-15, Volume: 104, Issue:20
Unique antiviral mechanism discovered in anti-hepatitis B virus research with a natural product analogue.
AID404998Antiviral activity against HBeAg-deficient HBV genotype D with precore G1896A mutation and reverse transcriptase L80I mutation in human Huh7 cells assessed as viral replication yield at 1 uM after 5 days relative to control2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID1694160Cytotoxicity against African green monkey Vero cells assessed as reduction in cell viability by MTT assay2021Bioorganic & medicinal chemistry, 02-01, Volume: 31Discovery and structure activity relationship of glyoxamide derivatives as anti-hepatitis B virus agents.
AID519865Antiviral activity against HIV1 subtype B-NL4-3 infected in 3 hrs pretreated human MT2 cells assessed as inhibition of multicycle replication measured on day 5 postinfection by RT SPA2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID625932Antiviral activity against wild type Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as inhibition of virus replication treated daily for 9 days by quantitative blot hybridization method2011Bioorganic & medicinal chemistry letters, Nov-01, Volume: 21, Issue:21
Antiviral activity of novel 2'-fluoro-6'-methylene-carbocyclic adenosine against wild-type and drug-resistant hepatitis B virus mutants.
AID1387650Antiviral activity against HIV1 infected in human PBMC incubated for 24 hrs in presence of 10% NHS by GFP based single cycle HIV replication assay2018Journal of medicinal chemistry, 10-25, Volume: 61, Issue:20
Synthesis and Antiviral Evaluation of Carbocyclic Nucleoside Analogs of Nucleoside Reverse Transcriptase Translocation Inhibitor MK-8591 (4'-Ethynyl-2-fluoro-2'-deoxyadenosine).
AID1565090Antiviral activity against HIV-1 3B infected in human MT4 cells assessed as reduction in virus-induced cytopathic effect incubated for 5 days by MTT assay
AID1055516Cytostatic activity against human HeLa cells assessed as growth inhibition after 3 days by particle counting analysis2013European journal of medicinal chemistry, , Volume: 70Design, synthesis and biological evaluation of phosphorodiamidate prodrugs of antiviral and anticancer nucleosides.
AID1228529Antiviral activity against duck Hepatitis B virus infected in duck assessed as inhibition of viral DNA replication in liver at 20 mg/kg/day, po treatment initiated at day 10 after infection relative to control2015Journal of medicinal chemistry, May-14, Volume: 58, Issue:9
Synthesis and biological evaluation of 4-substituted fluoronucleoside analogs for the treatment of hepatitis B virus infection.
AID519882Antiviral activity against 0.01 MOI wild type HIV1 NL4-3 infected in human MT2 cells measured after 5 days by MTS assay2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID576250AUC (0 to tau) in HIV-1 infected children aged 2.1 to 12.8 years at 4 mg/kg, po every 24 hrs coadministered with 8 mg/kg abacavir by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID328846Inhibition of human MRP1 expressed in MDCK2 cells assessed as increase in intracellular CMF fluorescence at 10 uM by CMFDA assay2007Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 35, Issue:3
Inhibition of MRP1/ABCC1, MRP2/ABCC2, and MRP3/ABCC3 by nucleoside, nucleotide, and non-nucleoside reverse transcriptase inhibitors.
AID422695Ratio of IC50 for HIV1 with reverse transcriptase K70G mutation to IC50 for wild type HIV12007Antimicrobial agents and chemotherapy, Dec, Volume: 51, Issue:12
Novel drug resistance pattern associated with the mutations K70G and M184V in human immunodeficiency virus type 1 reverse transcriptase.
AID618858Cytotoxicity against phytohemagglutininin-stimulated human PBMC after 6 days by trypan blue exclusion assay2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Synthesis, antiviral activity, cytotoxicity and cellular pharmacology of l-3'-azido-2',3'-dideoxypurine nucleosides.
AID1226092Selectivity index, ratio of CC50 for human HepG2.2.15 cells to IC50 for Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBV DNA replication2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID273056Inhibition of HBV replication in 2.2.15 cells by DNA hybridization assay2006Journal of medicinal chemistry, Oct-05, Volume: 49, Issue:20
9-{[3-fluoro-2-(hydroxymethyl)cyclopropylidene]methyl}adenines and -guanines. Synthesis and antiviral activity of all stereoisomers1.
AID548823Antiviral activity against HIV1 isolate 160 harboring reverse transcriptase S68G/V75(I/T)/F77L/Y115F/F116Y /Q151M mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID340707Tmax in healthy human PBMC assessed as intracellular apricitabine triphosphate level at 300 mg, po administered once daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID1743631Antiviral activity against HIV1 harboring RT F227L/V106Amutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect incubated for 5 days by MTT assay2020European journal of medicinal chemistry, Nov-15, Volume: 206Targeting dual tolerant regions of binding pocket: Discovery of novel morpholine-substituted diarylpyrimidines as potent HIV-1 NNRTIs with significantly improved water solubility.
AID422694Antiviral activity against HIV1 with reverse transcriptase K70E M184V and K70G M184V mutation by vircotype clinical cutoffs assay relative to wild type HIV12007Antimicrobial agents and chemotherapy, Dec, Volume: 51, Issue:12
Novel drug resistance pattern associated with the mutations K70G and M184V in human immunodeficiency virus type 1 reverse transcriptase.
AID576243Apparent oral clearance in HIV-1 infected children aged 8.5 to 12.3 years at 4 mg/kg, po every 12 hrs by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID369218Antiviral activity against woodchuck hepatitis virus infected woodchucks assessed as log reduction of serum viral DNA per ml of serum after 4 weeks2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
Antiviral effect of orally administered (-)-beta-D-2-aminopurine dioxolane in woodchucks with chronic woodchuck hepatitis virus infection.
AID563943Antiviral activity against HIV1 pNL4-3 harboring Reverse transcriptase P119S/T165A/M184V mutant gene infected in TZM-bl cells after 72 hrs by luciferase assay2009Antimicrobial agents and chemotherapy, Nov, Volume: 53, Issue:11
Impact of novel human immunodeficiency virus type 1 reverse transcriptase mutations P119S and T165A on 4'-ethynylthymidine analog resistance profile.
AID340715Cmin in healthy human PBMC assessed as intracellular apricitabine triphosphate level per 10'6 cells at 300 mg, po once daily coadministered with 600 mg, po apricitabine twice daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID218018Cytotoxic concentration required to reduce the viability of Vero cells as determined by MTT assay2002Journal of medicinal chemistry, May-09, Volume: 45, Issue:10
Design and synthesis of novel 5-substituted acyclic pyrimidine nucleosides as potent and selective inhibitors of hepatitis B virus.
AID1507015Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of viral DNA replication at 20 uM after 8 days by real time fluorescent PCR method relative to control2017European journal of medicinal chemistry, Aug-18, Volume: 136Design, synthesis and primary biological evaluation of the novel 2-pyridone derivatives as potent non-nucleoside HBV inhibitors.
AID740214Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for Hepatitis B virus-infected human HepG2(2.2.15) cells assessed as inhibition of HBsAg secretion2013Bioorganic & medicinal chemistry letters, Apr-01, Volume: 23, Issue:7
Anti-HBV active constituents from Piper longum.
AID614132Cytotoxicity in human HepG2(2.2.15) cells after 72 hrs by MTT assay2011Journal of natural products, Aug-26, Volume: 74, Issue:8
Swerilactones L-O, secoiridoids with C₁₂ and C₁₃ skeletons from Swertia mileensis.
AID1729156Antiviral activity against HIV1 harboring L100I mutant infected in human MT4 cells assessed as reduction in virus-induced cytopathic effect by MTT assay2021European journal of medicinal chemistry, Mar-05, Volume: 213Exploiting the tolerant region I of the non-nucleoside reverse transcriptase inhibitor (NNRTI) binding pocket. Part 2: Discovery of diarylpyrimidine derivatives as potent HIV-1 NNRTIs with high Fsp
AID1449527Mitochondrial toxicity in human HepG2 cells assessed as inhibition of cytochrome c oxidase subunit 2 DNA levels measured on day 14 by RT-PCR method2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID410755Antiviral activity against adefovir-resistant wild type HBV in human Huh7 cells after 4 days by intracellular HBV DNA replication assay2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Synthesis and anti-hepatitis B virus and anti-hepatitis C virus activities of 7-deazaneplanocin A analogues in vitro.
AID626004Antiviral activity against lamivudine/entecavir-resistant Hepatitis B virus harboring reverse transcriptase L180M/M204V/S202G infected in human HepG2(2.2.15) cells assessed as inhibition of virus replication treated daily for 9 days by quantitative blot h2011Bioorganic & medicinal chemistry letters, Nov-01, Volume: 21, Issue:21
Antiviral activity of novel 2'-fluoro-6'-methylene-carbocyclic adenosine against wild-type and drug-resistant hepatitis B virus mutants.
AID341755Drug level in human phytohemagglutininin-activated PBMC assessed as Lamivudine monophosphate level at 2.6 uM after 24 hrs2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
In vitro interactions between apricitabine and other deoxycytidine analogues.
AID582406Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral RNA level per ug of total cell DNA at 15 mg/kg, po qd measured on 12th week on 48 weeks study (Rvb = 46 +/- 25 pg)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID519875Antiviral activity against 0.01 MOI wild type HIV1 NL4-3 infected in 2 hr-pretreated human MT2 cells measured after 5 days by RT SPA2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID576246AUC (0 to tau) in HIV-1 infected children aged 2.1 to 12.8 years at 4 mg/kg, po every 12 hrs coadministered with 8 mg/kg abacavir by HPLC2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?
AID384985Antiviral activity against HBV assessed as inhibition of viral e-antigen secretion in HepG2.2.15 cells by ELISA2008Journal of natural products, May, Volume: 71, Issue:5
Periglaucines A-D, anti-HBV and -HIV-1 alkaloids from Pericampylus glaucus.
AID358078Cytotoxicity against HBV transfected human adriamycin-resistant HepD2 cells with RTM20V and RTV180M mutation by MTT assay2007Proceedings of the National Academy of Sciences of the United States of America, May-15, Volume: 104, Issue:20
Unique antiviral mechanism discovered in anti-hepatitis B virus research with a natural product analogue.
AID404989Antiviral activity against HBeAg-deficient HBV genotype D with precore G1896A mutation and reverse transcriptase L180M/M204I mutation in human Huh7 cells assessed as inhibition of viral replication after 5 days2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID322843Antiviral activity against entecavir-resistant HBV with reverse transcriptase L180M/S202G/M204V mutant2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID519962Selectivity ratio of EC50 for 0.05 MOI HIV1 NL4-3 infected in 2 hrs pretreated human MT2 cells by MTS assay to EC50 for 0.05 MOI HIV1 NL4-3 infected in 2 hrs pretreated human MT2 cells by RT assay2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID1815392Resistance fold, ratio of EC50 for HIV1 harboring reverse transcriptase Y188L mutant infected MV4 cells to EC50 for wild type HIV1 infected MV4 cells2021European journal of medicinal chemistry, Dec-15, Volume: 226Design of the naphthyl-diarylpyrimidines as potent non-nucleoside reverse transcriptase inhibitors (NNRTIs) via structure-based extension into the entrance channel.
AID417237Drug metabolism in HIV-infected human PBMC assessed as zidovudine triphosphate level at 300 mg administered in two courses, first BID for 7 to 14 days followed by QD for 7 days and second course the subjects were switched to the other regimen measured per2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Intracellular pharmacokinetics of once versus twice daily zidovudine and lamivudine in adolescents.
AID1544344Antiviral activity against lamivudine-resistant Hepatitis B virus harboring L180M/M204V mutant infected in human HepG2.2.15 cells assessed as inhibition of extracellular HBV DNA replication at 20 uM supplemented with fresh medium containing compound every2019Bioorganic & medicinal chemistry letters, 06-01, Volume: 29, Issue:11
Design, synthesis, and biological evaluation of novel 2'-deoxy-2'-fluoro-2'-C-methyl 8-azanebularine derivatives as potent anti-HBV agents.
AID557053Antiviral activity against NRTI-, PI-resistant HIV1 harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID268269Selectivity index, CC50 for HepG2.2.15 cells/IC50 for HBV2006Journal of medicinal chemistry, Jul-27, Volume: 49, Issue:15
Synthesis and anti-hepatitis B virus activity of novel benzimidazole derivatives.
AID1742099Antiviral activity against HBV infected in human HepG2.2.15 cells assessed as inhibition of HBsAg production supplemented with fresh medium containing compound every 3 days for 6 days by EIA relative to control2020European journal of medicinal chemistry, Nov-01, Volume: 205Discovery of novel quinazolinone derivatives as potential anti-HBV and anti-HCC agents.
AID550165Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of viral DNA replication by semi-quantitative EIA2011Bioorganic & medicinal chemistry, Jan-01, Volume: 19, Issue:1
Synthesis and in vitro anti-hepatitis B virus activity of six-membered azanucleoside analogues.
AID1544309Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of intracellular HBV DNA replication at 20 uM supplemented with fresh medium containing compound every 3 days for 6 days measured post-last dose by FQ-P2019Bioorganic & medicinal chemistry letters, 06-01, Volume: 29, Issue:11
Design, synthesis, and biological evaluation of novel 2'-deoxy-2'-fluoro-2'-C-methyl 8-azanebularine derivatives as potent anti-HBV agents.
AID1572519Antiviral activity against HIV1 RES056 harboring reverse transcriptase K103N/Y181C double mutant infected in human MT4 cells assessed as inhibition of virus-induced cytotoxicity after 5 days by MTT assay
AID1226132Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBV DNA copies per uL at 37.5 uM after 9 days by real-time fluorescence quantitative PCR analysis2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID235451Selectivity (CC50/EC50) for death of uninfected MT4 cell to that of inhibition of cytopathicity of HIV-1 IIIB on MT-4 cell2003Bioorganic & medicinal chemistry letters, Aug-04, Volume: 13, Issue:15
Are 5'-O-carbamate-2',3'-dideoxythiacytidine new anti-HIV and anti-HBV nucleoside drugs or prodrugs?
AID519869Antiviral activity against HIV1 subtype B-ASM 044 infected in 1 hr-pretreated PBMC cells assessed as inhibition of p24 antigen production measured on day 5 postinfection by ELISA2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID405008Effect on replication efficiency of HBeAg-deficient HBV genotype D with precore G1896A mutation and reverse transcriptase L80I/L180M/M204I mutation in human Huh7 cells assessed as increase in viral replication yield at 1 uM after 5 days relative to contro2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID1815386Resistance fold, ratio of EC50 for HIV1 harboring reverse transcriptase Y181C mutant infected MV4 cells to EC50 for wild type HIV1 infected MV4 cells2021European journal of medicinal chemistry, Dec-15, Volume: 226Design of the naphthyl-diarylpyrimidines as potent non-nucleoside reverse transcriptase inhibitors (NNRTIs) via structure-based extension into the entrance channel.
AID23457Partition coefficient (logP)2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Potent nonclassical nucleoside antiviral drugs based on the N,N-diarylformamidine concept.
AID618794Antiviral activity against Hepatitis B virus infected in human HepAD38 assessed as reduction of viral DNA level on day 7 by quantitative-PCR assay analysis2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Synthesis, antiviral activity, cytotoxicity and cellular pharmacology of l-3'-azido-2',3'-dideoxypurine nucleosides.
AID340693Cmax in healthy human at 300 mg, po administered once daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID1226127Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBV DNA copies per uL at 75 uM after 6 days by real-time fluorescence quantitative PCR analysis2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID1815393Resistance fold, ratio of EC50 for HIV1 harboring reverse transcriptase E138K mutant infected MV4 cells to EC50 for wild type HIV1 infected MV4 cells2021European journal of medicinal chemistry, Dec-15, Volume: 226Design of the naphthyl-diarylpyrimidines as potent non-nucleoside reverse transcriptase inhibitors (NNRTIs) via structure-based extension into the entrance channel.
AID1487261Antiviral activity against wild type HIV1 3B infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 5 days by MTT assay2017Bioorganic & medicinal chemistry, 08-15, Volume: 25, Issue:16
Discovery of novel DAPY-IAS hybrid derivatives as potential HIV-1 inhibitors using molecular hybridization based on crystallographic overlays.
AID1869624Cytotoxicity against human MT4 cells assessed as reduction in cell viability by MTT assay2022Journal of medicinal chemistry, 07-14, Volume: 65, Issue:13
Reshaping an Acyclic Nucleoside Phosphonate into a Selective Anti-hepatitis B Virus Compound.
AID444054Oral bioavailability in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1071715Antiviral activity against Hepatitis B virus assessed as inhibition of viral infection by DNA virion assay2014European journal of medicinal chemistry, Mar-03, Volume: 74Synthesis and biological evaluation of 2-oxonicotinonitriles and 2-oxonicotinonitrile based nucleoside analogues.
AID1869623Anti-HIV activity against wild type HIV-2 ROD infected in human MT4 cells assessed as inhibition of HIV-induced cytopathic effect measured after 5 days by MTT assay2022Journal of medicinal chemistry, 07-14, Volume: 65, Issue:13
Reshaping an Acyclic Nucleoside Phosphonate into a Selective Anti-hepatitis B Virus Compound.
AID1743628Antiviral activity against HIV1 harboring RT Y181C mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect incubated for 5 days by MTT assay2020European journal of medicinal chemistry, Nov-15, Volume: 206Targeting dual tolerant regions of binding pocket: Discovery of novel morpholine-substituted diarylpyrimidines as potent HIV-1 NNRTIs with significantly improved water solubility.
AID325080Drug level in human PBMC assessed as concentration of Lamivudine triphosphate per 10^6 cells after 0.3 hrs2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
Evidence and possible consequences of the phosphorylation of nucleoside reverse transcriptase inhibitors in human red blood cells.
AID47456Compound concentration required to inhibit cell growth by 50% against CEM cells1998Bioorganic & medicinal chemistry letters, Jul-07, Volume: 8, Issue:13
Synthesis and biological evaluation of a series of 2'-fluorinated-2',3'-dideoxy-2',3'-didehydro-(L)-nucleosides.
AID404990Antiviral activity against HBeAg-deficient HBV genotype D with precore G1896A mutation and reverse transcriptase L80I/L180M/M204I mutation in human Huh7 cells assessed as inhibition of viral replication after 5 days2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID88983Compound concentration required to inhibit the viral cell proliferation by 50% against HIV; Range = 2-31998Bioorganic & medicinal chemistry letters, Jul-07, Volume: 8, Issue:13
Synthesis and biological evaluation of a series of 2'-fluorinated-2',3'-dideoxy-2',3'-didehydro-(L)-nucleosides.
AID580184Cytotoxicity against human HepG2(2.2.15) cells by neutral red dye uptake assay2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Antiviral agents 3. Discovery of a novel small molecule non-nucleoside inhibitor of hepatitis B virus (HBV).
AID1743626Antiviral activity against HIV1 harboring RT L100I mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect incubated for 5 days by MTT assay2020European journal of medicinal chemistry, Nov-15, Volume: 206Targeting dual tolerant regions of binding pocket: Discovery of novel morpholine-substituted diarylpyrimidines as potent HIV-1 NNRTIs with significantly improved water solubility.
AID268268Cytotoxicity against HepG2.2.15 cells2006Journal of medicinal chemistry, Jul-27, Volume: 49, Issue:15
Synthesis and anti-hepatitis B virus activity of novel benzimidazole derivatives.
AID1687687Selectivity index, ratio of CC50 for cytotoxicity against human MT4 cells reduction in cell viability by MTT assay to EC50 for antiviral activity against wild type HIV-1 strain IIIB infected in human MT4 cells assessed as reduction in virus-induced cytopa2020European journal of medicinal chemistry, Jan-15, Volume: 186Indazolyl-substituted piperidin-4-yl-aminopyrimidines as HIV-1 NNRTIs: Design, synthesis and biological activities.
AID1741376Antiviral activity against HBV infected in human HepG2.2.15 cells assessed as reduction in HBsAg secretion incubated for 4 days prior to compound washout followed by compound addition and measured after 4 days by ELISA2020European journal of medicinal chemistry, Sep-15, Volume: 202Design, diversity-oriented synthesis and biological evaluation of novel heterocycle derivatives as non-nucleoside HBV capsid protein inhibitors.
AID261859Inhibition of HBV M204I mutant transfected in B1 cell line2006Journal of medicinal chemistry, Mar-23, Volume: 49, Issue:6
Inhibition of hepatitis B virus (HBV) replication by pyrimidines bearing an acyclic moiety: effect on wild-type and mutant HBV.
AID1226114Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBeAg secretion at 150 uM after 6 days by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID323412Reduction in dexelvucitabine diphosphate choline level in human PBMC at 100 uM2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
Antiviral and cellular metabolism interactions between Dexelvucitabine and lamivudine.
AID1902001Antiviral activity against Hepatitis B virus infected in human HepG2 2.2.15 cells assessed as inhibition of DNA replication2022European journal of medicinal chemistry, Mar-05, Volume: 231Design and synthesis of novel quinazolinone derivatives as anti-HBV agents with TLR8 agonist effect.
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID1226123Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBV DNA copies per uL at 75 uM after 3 days by real-time fluorescence quantitative PCR analysis2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID1191401Antiviral activity against wild type HIV-2 ROD infected in human MT4 cells assessed as reduction of virus-induced cytopathic effect after 5 days by MTT assay2015Bioorganic & medicinal chemistry, Feb-01, Volume: 23, Issue:3
Synthesis and biological evaluation of DAPY-DPEs hybrids as non-nucleoside inhibitors of HIV-1 reverse transcriptase.
AID519870Antiviral activity against 0.005 MOI wild type HIV1 NL4-3 infected in human MT2 cells measured after 5 days by RT SPA2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID1888705Resistance index, ratio of EC50 for antiviral activity against HIV1 with RT RES056 mutant infected in human MT4 cells to EC50 for antiviral activity against wild type HIV1 infected in human MT4 cells
AID557049Antiviral activity against HIV1 clade G harboring mutant reverse transcriptase relative to HIV1 CNDO with wild type reverse transcriptase2009Antimicrobial agents and chemotherapy, Jun, Volume: 53, Issue:6
Antiviral activity of MK-4965, a novel nonnucleoside reverse transcriptase inhibitor.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID582428Toxicity in Woodchuck hepatitis virus infected woodchuck assessed as increase of serum gamma-glutamyltransferase activity at 15 mg/kg, po qd for 48 weeks2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID1687682Antiviral activity against HIV-1 Y181C mutant strain infected in human MT4 cells assessed as reduction in virus-induced cytopathogenicity by MTT assay2020European journal of medicinal chemistry, Jan-15, Volume: 186Indazolyl-substituted piperidin-4-yl-aminopyrimidines as HIV-1 NNRTIs: Design, synthesis and biological activities.
AID307875Inhibition of cytoplasmic HBV DNA synthesis in HepG2.2.15 cells after 8 days
AID106426Effective concentration to inhibit HIV-1 IIIB cytopathicity in MT-4 cells was determined in vitro2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Potent nonclassical nucleoside antiviral drugs based on the N,N-diarylformamidine concept.
AID1387651Cytotoxicity in human MT4 cells expressing GFP assessed as reduction in cell viability incubated for 48 hrs by cell-titer-Glo luminescent cell viability assay2018Journal of medicinal chemistry, 10-25, Volume: 61, Issue:20
Synthesis and Antiviral Evaluation of Carbocyclic Nucleoside Analogs of Nucleoside Reverse Transcriptase Translocation Inhibitor MK-8591 (4'-Ethynyl-2-fluoro-2'-deoxyadenosine).
AID405582Cytotoxicity against human 293T cells assessed as inhibition of cell proliferation by tetrazolium dye method2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
Selective inhibition of porcine endogenous retrovirus replication in human cells by acyclic nucleoside phosphonates.
AID478523Antiviral activity against HBV infected in HepG2(2.2.15) cells assessed as inhibition of viral surface antigen secretion after 8 days by radio immunoassay2010European journal of medicinal chemistry, May, Volume: 45, Issue:5
Synthesis and antiviral activity of new acrylamide derivatives containing 1,2,3-thiadiazole as inhibitors of hepatitis B virus replication.
AID548835Antiviral activity against HIV1 isolate 204 harboring reverse transcriptase M41L/L210W/T215Y/M184V mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID565983Selectivity index, ratio of CC50 for human HepG2(2.2.15) cells to IC50 for Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as inhibition of viral e antigen secretion2011European journal of medicinal chemistry, Jan, Volume: 46, Issue:1
Structure-activity relationships study of 6-chloro-4-(2-chlorophenyl)-3-(2-hydroxyethyl) quinolin-2(1H)-one derivatives as novel non-nucleoside anti-hepatitis B virus agents.
AID63717Percent inhibition of viral DNA in the presence of 10 mg/mL compound compared to untreated infected controls in duck hepatocytes2001Bioorganic & medicinal chemistry letters, Nov-19, Volume: 11, Issue:22
Novel 5-vinyl pyrimidine nucleosides with potent anti-hepatitis B virus activity.
AID738972Cytotoxicity against human HepG2(2.2.15) cells after 12 days by MTT assay2013Bioorganic & medicinal chemistry letters, Apr-01, Volume: 23, Issue:7
Anti-hepatitis B virus lignans from the root of Streblus asper.
AID519864Antiviral activity against HIV1 subtype B-NL4-3 infected in 2 hrs pretreated human MT2 cells assessed as inhibition of multicycle replication measured on day 5 postinfection by RT SPA2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID580185Antiviral activity against Hepatitis B virus infected in human Huh7 cells assessed as reduction in viral DNA after 1 day by Southern blotting2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Antiviral agents 3. Discovery of a novel small molecule non-nucleoside inhibitor of hepatitis B virus (HBV).
AID582395Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as reduction of viral DNA replicative intermediate level per ug of total cell DNA at 15 mg/kg, po qd measured on 36th week on 48 weeks study (Rvb = 1132 +/- 738 pg)2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID200144Ratio for inhibition of HIV-1 RT to that of type and HIV-1 RT M184V mutant was determined2003Bioorganic & medicinal chemistry letters, Jun-16, Volume: 13, Issue:12
The role of 2',3'-unsaturation on the antiviral activity of anti-HIV nucleosides against 3TC-resistant mutant (M184V).
AID625933Antiviral activity against wild type Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as reduction of infectious virus titer treated daily for 9 days by quantitative Southern blot hybridization assay2011Bioorganic & medicinal chemistry letters, Nov-01, Volume: 21, Issue:21
Antiviral activity of novel 2'-fluoro-6'-methylene-carbocyclic adenosine against wild-type and drug-resistant hepatitis B virus mutants.
AID625935Antiviral activity against lamivudine-resistant Hepatitis B virus harboring reverse transcriptase M204V mutant infected in human HepG2(2.2.15) cells assessed as inhibition of virus replication treated daily for 9 days by quantitative blot hybridization me2011Bioorganic & medicinal chemistry letters, Nov-01, Volume: 21, Issue:21
Antiviral activity of novel 2'-fluoro-6'-methylene-carbocyclic adenosine against wild-type and drug-resistant hepatitis B virus mutants.
AID328844Inhibition of human MRP2 expressed in MDCK2 cells assessed as increase in intracellular CMF fluorescence at 10 uM by CMFDA assay2007Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 35, Issue:3
Inhibition of MRP1/ABCC1, MRP2/ABCC2, and MRP3/ABCC3 by nucleoside, nucleotide, and non-nucleoside reverse transcriptase inhibitors.
AID548578Antiviral activity against HIV1 isolate 067 harboring reverse transcriptase A62V/D67G/T69SVG/V75I/T215I mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID1544312Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of intracellular HBV DNA replication at 20 uM supplemented with fresh medium containing compound every 3 days for 9 days measured post-last dose by FQ-P2019Bioorganic & medicinal chemistry letters, 06-01, Volume: 29, Issue:11
Design, synthesis, and biological evaluation of novel 2'-deoxy-2'-fluoro-2'-C-methyl 8-azanebularine derivatives as potent anti-HBV agents.
AID527561Antiviral activity against DHBV infected in duck hepatocytes assessed as inhibition of viral DNA replication at 0.5 to 1 ug/ml after 2 days relative to control2010Bioorganic & medicinal chemistry, Nov-01, Volume: 18, Issue:21
Synthesis and in vitro antiviral activities of 3'-fluoro (or chloro) and 2',3'-difluoro 2',3'-dideoxynucleoside analogs against hepatitis B and C viruses.
AID556524Antiviral activity against Human immunodeficiency virus 1 clone pNL4-3-Q145M harboring K102Q, Q145M, S162C, K277R, I293V mutation in reverse transcriptase by phenosense assay relative to wild type2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Human immunodeficiency virus type 1 isolates with the reverse transcriptase (RT) mutation Q145M retain nucleoside and nonnucleoside RT inhibitor susceptibility.
AID405207Effect on replication efficiency of HBeAg-deficient HBV genotype D with precore G1896A mutation and reverse transcriptase L80I mutation in human Huh7 cells assessed as decrease viral replication yield at 1 uM after 5 days relative to control2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID727268Antiviral activity against entecavir-resistant Hepatitis B virus harboring L180M/M204V/S202G triple mutant infected in human HuH7 cells2013Bioorganic & medicinal chemistry letters, Jan-15, Volume: 23, Issue:2
2'-Fluoro-6'-methylene-carbocyclic adenosine phosphoramidate (FMCAP) prodrug: in vitro anti-HBV activity against the lamivudine-entecavir resistant triple mutant and its mechanism of action.
AID1226107Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as cell survival at 75 uM after 9 days (Rvb = 100%)2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID444050Fraction unbound in human plasma2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1572518Antiviral activity against HIV1 3B infected in human MT4 cells assessed as inhibition of virus-induced cytotoxicity after 5 days by MTT assay
AID582419Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as absent of lesion in lobular hepatitis at 15 mg/kg, po qd measured on 12th week on 48 weeks study2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID467612Fraction unbound in human plasma2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Prediction of volume of distribution values in human using immobilized artificial membrane partitioning coefficients, the fraction of compound ionized and plasma protein binding data.
AID1431320Cytotoxicity against human HuH7 cells assessed as reduction in cell viability after 3 days by MTS assay2016Journal of natural products, Dec-23, Volume: 79, Issue:12
Synthesis of C-4-Substituted Steviol Derivatives and Their Inhibitory Effects against Hepatitis B Virus.
AID257342Selectivity index (CC50/EC50) for inhibition of HBV replicative intermediate synthesis in human hepatoblastoma 2.2.15 cells2005Bioorganic & medicinal chemistry letters, Dec-15, Volume: 15, Issue:24
Synthesis and in vitro anti-hepatitis B and C virus activities of ring-expanded ('fat') nucleobase analogues containing the imidazo[4,5-e][1,3]diazepine-4,8-dione ring system.
AID519966Antiviral activity against 0.005 MOI HIV1 NL4-3 harboring wild type RT infected in human MT2 cells by phenosense assay2008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Entecavir exhibits inhibitory activity against human immunodeficiency virus under conditions of reduced viral challenge.
AID1200847Selectivity index, ratio of CC50 for mock-infected human MT4 cells to EC50 for HIV1 RES056 expressing reverse transcriptase K103N/Y181C double mutant2015European journal of medicinal chemistry, Mar-26, Volume: 93Fused heterocycles bearing bridgehead nitrogen as potent HIV-1 NNRTIs. Part 4: design, synthesis and biological evaluation of novel imidazo[1,2-a]pyrazines.
AID550167Selectivity index, ratio of TC50 for human HepG2(2.2.15) cells to IC50 for Hepatitis B virus2011Bioorganic & medicinal chemistry, Jan-01, Volume: 19, Issue:1
Synthesis and in vitro anti-hepatitis B virus activity of six-membered azanucleoside analogues.
AID1888697Antiviral activity against HIV1 with RT Y188L mutant infected in human MT4 cells cells assessed as protection against viral-induced cytopathogenecity by MTT assay
AID63719Concentration required to reduce the viral DNA in infected cells to 50% of untreated infected controls.2001Bioorganic & medicinal chemistry letters, Nov-19, Volume: 11, Issue:22
Novel 5-vinyl pyrimidine nucleosides with potent anti-hepatitis B virus activity.
AID1320866Selectivity index, ratio of CC50 for mock-infected human MT4 cells to EC50 for HIV1 3B expressing wild type reverse transcriptase2016European journal of medicinal chemistry, Oct-04, Volume: 121Structural optimization of pyridine-type DAPY derivatives to exploit the tolerant regions of the NNRTI binding pocket.
AID417239AUC in HIV-infected human assessed as Lamivudine diphosphate level in PBMC at 300 mg QD for 7 days in presence of zidovudine2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Intracellular pharmacokinetics of once versus twice daily zidovudine and lamivudine in adolescents.
AID1888703Resistance index, ratio of EC50 for antiviral activity against HIV1 with RT E138K mutant infected in human MT4 cells to EC50 for antiviral activity against wild type HIV1 infected in human MT4 cells
AID152627Antiviral activity against (HIV-1M184V) mutant strain in human PBM cells2002Journal of medicinal chemistry, Oct-24, Volume: 45, Issue:22
Stereoselective synthesis and antiviral activity of D-2',3'-didehydro-2',3'-dideoxy-2'-fluoro-4'-thionucleosides.
AID556525Antiviral activity against Human immunodeficiency virus 1 clone 38086 harboring K49R, V60I, I135V, Q145M, Q174H, G196E, Q207E, R211K, V245K mutation in reverse transcriptase by phenosense assay relative to wild type2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Human immunodeficiency virus type 1 isolates with the reverse transcriptase (RT) mutation Q145M retain nucleoside and nonnucleoside RT inhibitor susceptibility.
AID1565096Antiviral activity against drug resistant HIV-1 harboring reverse transcriptase L100I mutant infected in human MT4 cells assessed as reduction in virus-induced cytopathic effect incubated for 5 days by MTT assay
AID427243Selectivity index, ratio of TC50 for human HepG2(2.2.15) cells to IC50 for inhibition of HBV DNA replication2009Bioorganic & medicinal chemistry, Jul-01, Volume: 17, Issue:13
Synthesis and in vitro anti-hepatitis B virus activity of 6H-[1]benzothiopyrano[4,3-b]quinolin-9-ols.
AID246789Effective concentrations at which 10-fold depression of intracellular intermediates of HBV DNA was observed in 2.2.15 Cells2005Journal of medicinal chemistry, Jul-28, Volume: 48, Issue:15
5'-Homoneplanocin A inhibits hepatitis B and hepatitis C.
AID325082Ratio of drug level in human RBC to human PBMC assessed as concentration of Lamivudine triphosphate after 0.3 hrs2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
Evidence and possible consequences of the phosphorylation of nucleoside reverse transcriptase inhibitors in human red blood cells.
AID1203826Mitochondrial toxicity in human HepG2 cells assessed as induction of lactic acid levels at 50 uM incubated for 14 days2015Journal of medicinal chemistry, Apr-23, Volume: 58, Issue:8
β-D-2'-C-Methyl-2,6-diaminopurine Ribonucleoside Phosphoramidates are Potent and Selective Inhibitors of Hepatitis C Virus (HCV) and Are Bioconverted Intracellularly to Bioactive 2,6-Diaminopurine and Guanosine 5'-Triphosphate Forms.
AID1815395Resistance fold, ratio of EC50 for HIV1 harboring reverse transcriptase K103N/Y181C double mutant infected MV4 cells to EC50 for wild type HIV1 infected MV4 cells2021European journal of medicinal chemistry, Dec-15, Volume: 226Design of the naphthyl-diarylpyrimidines as potent non-nucleoside reverse transcriptase inhibitors (NNRTIs) via structure-based extension into the entrance channel.
AID1207746Inhibition of Cav1.2 current measured using QPatch automatic path clamp system in CHO cells expressing Cav1.2, beta-2 and alpha-2/delta-1 subunits2013Scientific reports, , Volume: 3MICE models: superior to the HERG model in predicting Torsade de Pointes.
AID1869625Selectivity index, ratio of CC50 for cytotoxicity against human MT4 cells assessed as reduction in cell viability by MTT assay to EC50 for anti-HIV activity against wild type HIV-1 IIIB infected in human MT4 cells assessed as inhibition of HIV-induced cyt2022Journal of medicinal chemistry, 07-14, Volume: 65, Issue:13
Reshaping an Acyclic Nucleoside Phosphonate into a Selective Anti-hepatitis B Virus Compound.
AID404988Antiviral activity against HBeAg-deficient HBV genotype D with precore G1896A mutation and reverse transcriptase L80I/M204I mutation in human Huh7 cells assessed as inhibition of viral replication after 5 days2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID1197829Antiviral activity against HIV1 3B infected in human MT4 cells assessed as reduction in virus-induced cytopathic effect after 5 days by MTT assay2015European journal of medicinal chemistry, Mar-06, Volume: 92Fused heterocycles bearing bridgehead nitrogen as potent HIV-1 NNRTIs. Part 3: optimization of [1,2,4]triazolo[1,5-a]pyrimidine core via structure-based and physicochemical property-driven approaches.
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID1543317Toxicity in human C8166 cells assessed as reduction in cell viability incubated for 72 hrs by MTT assay2019Journal of natural products, 07-26, Volume: 82, Issue:7
Dimeric Pyranonaphthoquinone Glycosides with Anti-HIV and Cytotoxic Activities from a Soil-Derived
AID1721279Antiviral activity against HBV infected in human HepAD38 cells assessed as inhibition of viral DNA at 10 uM incubated for 4 days by SYBR green dye based RT-PCR analysis relative to control2020Bioorganic & medicinal chemistry, 08-15, Volume: 28, Issue:16
Junceellolide B, a novel inhibitor of Hepatitis B virus.
AID1241034Cytotoxicity against human HepG2(2.2.1) cells2015Bioorganic & medicinal chemistry, Sep-01, Volume: 23, Issue:17
2- and 3-Fluoro-3-deazaneplanocins, 2-fluoro-3-deazaaristeromycins, and 3-methyl-3-deazaneplanocin: Synthesis and antiviral properties.
AID1449531Mitochondrial toxicity in human HepG2 cells assessed as lactic acid production at 10 uM measured on day 14 by spectrophotometric method relative to control2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID563937Antiviral activity against HIV1 pNL4-3 harboring Reverse transcriptase P119S mutant gene infected in TZM-bl cells after 72 hrs by luciferase assay2009Antimicrobial agents and chemotherapy, Nov, Volume: 53, Issue:11
Impact of novel human immunodeficiency virus type 1 reverse transcriptase mutations P119S and T165A on 4'-ethynylthymidine analog resistance profile.
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID1565100Antiviral activity against drug resistant HIV-1 harboring reverse transcriptase F227L/V106A double mutant infected in human MT4 cells assessed as reduction in virus-induced cytopathic effect incubated for 5 days by MTT assay
AID548828Antiviral activity against HIV1 isolate 185 harboring reverse transcriptase T215Y mutant gene by phenosense assay relative to wild type2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID548809Antiviral activity against HIV1 isolate 215 harboring reverse transcriptase D67N/K70E mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID492271Antiviral activity against Hepatitis B virus infected in human HepG2(2.2.15) cells assessed as inhibition of viral cytoplasmic DNA synthesis after 8 days by RT-PCR analysis2010Bioorganic & medicinal chemistry, Jul-15, Volume: 18, Issue:14
Design and synthesis of novel benzimidazole derivatives as inhibitors of hepatitis B virus.
AID582399Antiviral activity against Woodchuck hepatitis virus infected in woodchuck assessed as absent of lesion in portal hepatitis at 15 mg/kg, po qd measured on 12th week on 48 weeks study2008Antimicrobial agents and chemotherapy, Oct, Volume: 52, Issue:10
Antiviral effects of lamivudine, emtricitabine, adefovir dipivoxil, and tenofovir disoproxil fumarate administered orally alone and in combination to woodchucks with chronic woodchuck hepatitis virus infection.
AID340701Tmax in healthy human at 300 mg, po once daily coadministered with 600 mg, po apricitabine twice daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID1507024Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of viral DNA replication after 8 days by real time fluorescent PCR method2017European journal of medicinal chemistry, Aug-18, Volume: 136Design, synthesis and primary biological evaluation of the novel 2-pyridone derivatives as potent non-nucleoside HBV inhibitors.
AID1363963Antiviral activity against lamivudine-resistant wild type hepatitis B virus infected in human Huh7 cells assessed as reduction in intracellular DNA levels measured on day 7 by real-time PCR analysis2017Bioorganic & medicinal chemistry, 02-01, Volume: 25, Issue:3
Discovery of hepatitis B virus capsid assembly inhibitors leading to a heteroaryldihydropyrimidine based clinical candidate (GLS4).
AID104417Compound was tested for anti-HIV activity in MT-2/ IIIB cells and the ratio of the drug concentration (ID50) required to inhibit cell growth was reported.1998Bioorganic & medicinal chemistry letters, Jul-07, Volume: 8, Issue:13
Synthesis and biological evaluation of a series of 2'-fluorinated-2',3'-dideoxy-2',3'-didehydro-(L)-nucleosides.
AID1457763Selectivity index, ratio of CC50 for HepG2.2.15 cells to EC50 for HBV ayw1 infected in human HepG2(2.2.15) cells assessed as reduction in viral replication by measuring extracellular viral DNA copy2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Expanding the Antiviral Spectrum of 3-Fluoro-2-(phosphonomethoxy)propyl Acyclic Nucleoside Phosphonates: Diamyl Aspartate Amidate Prodrugs.
AID322837Antiviral activity against lamivudine-resistant HBV with reverse transcriptase L180M/A181V mutant2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID572994Mitochondrial toxicity in human HepG2 cells assessed as percent mitochondrial DNA production at 100 uM after 14 days by real-time PCR relative to control2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Anti-human immunodeficiency virus activity, cross-resistance, cytotoxicity, and intracellular pharmacology of the 3'-azido-2',3'-dideoxypurine nucleosides.
AID541155Selectivity ratio of EC50 for antiviral activity against APV-resistant HIV1 selected after 4 passages to EC50 for antiviral activity against wild-type HIV1 3B2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Preclinical evaluation of GS-9160, a novel inhibitor of human immunodeficiency virus type 1 integrase.
AID404992Antiviral activity against HBV genotype D with reverse transcriptase L80I mutation in human Huh7 cells assessed as viral replication yield at 1 uM after 5 days relative to control2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID266279Antiviral activity against wild type HBV in human hepatoma 2.2.15 cells at 10 ug/mL2006Journal of medicinal chemistry, Jun-15, Volume: 49, Issue:12
Effect of various pyrimidines possessing the 1-[(2-hydroxy-1-(hydroxymethyl)ethoxy)methyl] moiety, able to mimic natural 2'-deoxyribose, on wild-type and mutant hepatitis B virus replication.
AID410600Antiviral activity against HBV in human HepG2(2.2.15) cells assessed as extracellular HBV virion DNA level after 24 hrs2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Synthesis and anti-hepatitis B virus and anti-hepatitis C virus activities of 7-deazaneplanocin A analogues in vitro.
AID1072521Selectivity index, ratio of cytotoxicity towards human HepG2.2.15 cells to IC50 for HBV DNA production2014European journal of medicinal chemistry, Mar-21, Volume: 75A review of non-nucleoside anti-hepatitis B virus agents.
AID1434725Antiviral activity against HBV infected in human HepAD38 cells assessed as inhibition of DNA replication after 5 days by RT-PCR method2017Bioorganic & medicinal chemistry letters, 02-15, Volume: 27, Issue:4
Synthesis and antiviral evaluation of novel heteroarylpyrimidines analogs as HBV capsid effectors.
AID596753Cytotoxicity against human HepG2(2.2.15) cells after 8 days by MTT assay2011Journal of natural products, Apr-25, Volume: 74, Issue:4
Homoflavonoid glucosides from Ophioglossum pedunculosum and their anti-HBV activity.
AID404997Antiviral activity against HBeAg-deficient HBV genotype D with precore G1896A mutation in human Huh7 cells assessed as viral replication yield at 1 uM after 5 days relative to control2007Antimicrobial agents and chemotherapy, Jul, Volume: 51, Issue:7
The L80I substitution in the reverse transcriptase domain of the hepatitis B virus polymerase is associated with lamivudine resistance and enhanced viral replication in vitro.
AID1191972Antiviral activity against HIV2 ROD infected in human MT4 cells assessed as protection against virus-induced cytotoxicity after 5 days by MTT assay2015Bioorganic & medicinal chemistry letters, Mar-15, Volume: 25, Issue:6
Design, synthesis of new β-carboline derivatives and their selective anti-HIV-2 activity.
AID1226102Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBsAg secretion at 150 uM after 9 days by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID437966Antiviral activity against HBV assessed as inhibition of viral early antigen secretion2009Bioorganic & medicinal chemistry letters, Dec-01, Volume: 19, Issue:23
Anti-HBV agents. Part 3: preliminary structure-activity relationships of tetra-acylalisol A derivatives as potent hepatitis B virus inhibitors.
AID340699Apparent terminal half life in healthy human at 300 mg, po administered once daily for 4 days2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
Effect of Lamivudine on the plasma and intracellular pharmacokinetics of apricitabine, a novel nucleoside reverse transcriptase inhibitor, in healthy volunteers.
AID1693339Antiviral activity against wild type HBV infected in human HepG2 2.2.15 cells assessed as inhibition of viral DNA replication at 100 uM measured after incubation of 72 hrs by RT-PCR analysis relative to control2021Bioorganic & medicinal chemistry, 01-01, Volume: 29Synthesis and evaluation of new phenyl acrylamide derivatives as potent non-nucleoside anti-HBV agents.
AID682488Antiviral activity against HIV1 by cell-based assay2012Journal of medicinal chemistry, May-24, Volume: 55, Issue:10
Synthesis and biological evaluation of fatty acyl ester derivatives of (-)-2',3'-dideoxy-3'-thiacytidine.
AID322849Fold resistance, ratio of lamivudine -adenofir-resistant with HBV reverse transcriptase V173L/L180M/A181V/M204V/N236T mutant to wild-type HBV genotype E2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
In vitro activity of 2,4-diamino-6-[2-(phosphonomethoxy)ethoxy]-pyrimidine against multidrug-resistant hepatitis B virus mutants.
AID1544332Antiviral activity against lamivudine-resistant Hepatitis B virus harboring L180M/M204V mutant infected in human HepG2.2.15 cells assessed as inhibition of intracellular HBV DNA replication at 20 uM supplemented with fresh medium containing compound every2019Bioorganic & medicinal chemistry letters, 06-01, Volume: 29, Issue:11
Design, synthesis, and biological evaluation of novel 2'-deoxy-2'-fluoro-2'-C-methyl 8-azanebularine derivatives as potent anti-HBV agents.
AID410753Antiviral activity against lamivudine-resistant HBV reverse transcriptase M204V mutant in human Huh7 cells after 4 days by intracellular HBV DNA replication assay2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Synthesis and anti-hepatitis B virus and anti-hepatitis C virus activities of 7-deazaneplanocin A analogues in vitro.
AID517838Antiviral activity against drug resistant HBV infected in M204I cells assessed as inhibition of viral DNA replication at 10 ug/mL2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Antiviral activity of various 1-(2'-deoxy-β-D-lyxofuranosyl), 1-(2'-fluoro-β-D-xylofuranosyl), 1-(3'-fluoro-β-D-arabinofuranosyl), and 2'-fluoro-2',3'-didehydro-2',3'-dideoxyribose pyrimidine nucleoside analogues against duck hepatitis B virus (DHBV) and
AID572991Mitochondrial toxicity in human HepG2 cells assessed as percent inhibition of mitochondrial DNA at 10 uM after 14 days by real-time PCR2009Antimicrobial agents and chemotherapy, Sep, Volume: 53, Issue:9
Anti-human immunodeficiency virus activity, cross-resistance, cytotoxicity, and intracellular pharmacology of the 3'-azido-2',3'-dideoxypurine nucleosides.
AID1226120Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBeAg secretion at 37.5 uM after 9 days by ELISA2015European journal of medicinal chemistry, May-05, Volume: 95Design, synthesis, biological evaluation and molecular docking studies of phenylpropanoid derivatives as potent anti-hepatitis B virus agents.
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID1888700Resistance index, ratio of EC50 for antiviral activity against HIV1 with RT K103N mutant infected in human MT4 cells to EC50 for antiviral activity against wild type HIV1 infected in human MT4 cells
AID341750Drug level in human resting PBMC assessed as Lamivudine diphosphate level at 2.6 uM after 24 hrs2007Antimicrobial agents and chemotherapy, Aug, Volume: 51, Issue:8
In vitro interactions between apricitabine and other deoxycytidine analogues.
AID548798Antiviral activity against HIV1 isolate 185 harboring reverse transcriptase T215Y mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID282656Cytotoxicity against CEM cells2004Journal of medicinal chemistry, Dec-30, Volume: 47, Issue:27
(Z)- and (E)-[2-Fluoro-2-(hydroxymethyl)cyclopropylidene]methylpurines and -pyrimidines, a new class of methylenecyclopropane analogues of nucleosides: synthesis and antiviral activity.
AID691383Antiviral activity against Duck hepatitis B virus infected in pekin duck primary hepatocytes assessed as inhibition of viral replication2012Bioorganic & medicinal chemistry letters, Oct-15, Volume: 22, Issue:20
A new class of pyrimidine nucleosides: inhibitors of hepatitis B and C viruses.
AID565981Cytotoxicity against human HepG2(2.2.15) cells2011European journal of medicinal chemistry, Jan, Volume: 46, Issue:1
Structure-activity relationships study of 6-chloro-4-(2-chlorophenyl)-3-(2-hydroxyethyl) quinolin-2(1H)-one derivatives as novel non-nucleoside anti-hepatitis B virus agents.
AID21031Partition coefficient was measured in the solution of 1-octanol with a phosphate buffer (0.2) at pH 7.41994Journal of medicinal chemistry, Jul-08, Volume: 37, Issue:14
Inhibition of human immunodeficiency virus type 1 replication by phosphonoformate- and phosphonoacetate-2',3'-dideoxy-3'-thiacytidine conjugates.
AID548807Antiviral activity against HIV1 isolate 211 harboring reverse transcriptase D67N/K70R/T215F/K219E/M184V mutant gene by phenosense assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Development of hexadecyloxypropyl tenofovir (CMX157) for treatment of infection caused by wild-type and nucleoside/nucleotide-resistant HIV.
AID307876Cytotoxicity against HepG2.2.15 cells after 6 hrs by MTT assay
AID325081Ratio of drug level in human RBC to human PBMC assessed as concentration of Lamivudine triphosphate2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
Evidence and possible consequences of the phosphorylation of nucleoside reverse transcriptase inhibitors in human red blood cells.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID1729150Antiviral activity against HIV1 RES056 harboring K103N/Y181C double mutant infected in human MT4 cells assessed as reduction in virus-induced cytopathic effect by MTT assay2021European journal of medicinal chemistry, Mar-05, Volume: 213Exploiting the tolerant region I of the non-nucleoside reverse transcriptase inhibitor (NNRTI) binding pocket. Part 2: Discovery of diarylpyrimidine derivatives as potent HIV-1 NNRTIs with high Fsp
AID1347411qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID504810Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID504812Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
AID1745855NCATS anti-infectives library activity on the primary C. elegans qHTS viability assay2023Disease models & mechanisms, 03-01, Volume: 16, Issue:3
In vivo quantitative high-throughput screening for drug discovery and comparative toxicology.
AID1745854NCATS anti-infectives library activity on HEK293 viability as a counter-qHTS vs the C. elegans viability qHTS2023Disease models & mechanisms, 03-01, Volume: 16, Issue:3
In vivo quantitative high-throughput screening for drug discovery and comparative toxicology.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID504812Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID504810Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1391719Selectivity index, ratio of CC50 for human HepG2.215 cells to IC50 for Hepatitis B virus infected in human HepG2.215 cells assessed as inhibition of HBsAg secretion2018Bioorganic & medicinal chemistry letters, 05-15, Volume: 28, Issue:9
Design, synthesis and biological evaluation of seco-A-pentacyclic triterpenoids-3,4-lactone as potent non-nucleoside HBV inhibitors.
AID1754645Antiviral activity against HIV1 harboring RT E138K mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect incubated for 5 days by MTT assay2021Bioorganic & medicinal chemistry, 07-15, Volume: 42Exploiting the hydrophobic channel of the NNIBP: Discovery of novel diarylpyrimidines as HIV-1 NNRTIs against wild-type and K103N mutant viruses.
AID1391717Antiviral activity against Hepatitis B virus infected in human HepG2.215 cells assessed as inhibition of HBeAg secretion after 3 days by ELISA2018Bioorganic & medicinal chemistry letters, 05-15, Volume: 28, Issue:9
Design, synthesis and biological evaluation of seco-A-pentacyclic triterpenoids-3,4-lactone as potent non-nucleoside HBV inhibitors.
AID1506330Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBeAg secretion at 3.13 ug/ml after 8 days by ELISA relative to control2017MedChemComm, Jan-01, Volume: 8, Issue:1
Synthesis and biological activity evaluation of novel peroxo-bridged derivatives as potential anti-hepatitis B virus agents.
AID1391724Antiviral activity against Hepatitis B virus infected in human HepG2.215 cells assessed as reduction in cellular viral DNA level at 25 uM after 9 days by real time QF-PCR analysis relative to control2018Bioorganic & medicinal chemistry letters, 05-15, Volume: 28, Issue:9
Design, synthesis and biological evaluation of seco-A-pentacyclic triterpenoids-3,4-lactone as potent non-nucleoside HBV inhibitors.
AID1292008Selectivity index, ratio of CC50 for mock infected human MT4 cells to EC50 for HIV2 ROD infected in human MT4 cells2016European journal of medicinal chemistry, Jun-10, Volume: 115Design, synthesis and evaluation of novel HIV-1 NNRTIs with dual structural conformations targeting the entrance channel of the NNRTI binding pocket.
AID1389502Selectivity index, ratio of CC50 for human HepG2.2.15 cells to EC50 for HBV infected in human HepG2.2.15 cells2018Bioorganic & medicinal chemistry, 05-01, Volume: 26, Issue:8
2-Arylthio-5-iodo pyrimidine derivatives as non-nucleoside HBV polymerase inhibitors.
AID1754647Antiviral activity against HIV1 harboring RT RES056 mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect incubated for 5 days by MTT assay2021Bioorganic & medicinal chemistry, 07-15, Volume: 42Exploiting the hydrophobic channel of the NNIBP: Discovery of novel diarylpyrimidines as HIV-1 NNRTIs against wild-type and K103N mutant viruses.
AID1754638Cytotoxicity against mock-infected human MT4 cells incubated for 5 days by MTT assay2021Bioorganic & medicinal chemistry, 07-15, Volume: 42Exploiting the hydrophobic channel of the NNIBP: Discovery of novel diarylpyrimidines as HIV-1 NNRTIs against wild-type and K103N mutant viruses.
AID1292012Selectivity index, ratio of CC50 for mock infected human MT4 cells to EC50 for HIV1 3B infected in human MT4 cells2016European journal of medicinal chemistry, Jun-10, Volume: 115Design, synthesis and evaluation of novel HIV-1 NNRTIs with dual structural conformations targeting the entrance channel of the NNRTI binding pocket.
AID1754641Antiviral activity against HIV1 harboring RT L100I mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect incubated for 5 days by MTT assay2021Bioorganic & medicinal chemistry, 07-15, Volume: 42Exploiting the hydrophobic channel of the NNIBP: Discovery of novel diarylpyrimidines as HIV-1 NNRTIs against wild-type and K103N mutant viruses.
AID1754640Antiviral activity against wild type HIV-2 ROD infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect measured after 5 days by MTT assay2021Bioorganic & medicinal chemistry, 07-15, Volume: 42Exploiting the hydrophobic channel of the NNIBP: Discovery of novel diarylpyrimidines as HIV-1 NNRTIs against wild-type and K103N mutant viruses.
AID1298247Inhibition of HIV1 wild type reverse transcriptase p66/p51 using poly(rA) template and measured after 40 mins by picogreen based spectrofluorometry2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
1,6-Bis[(benzyloxy)methyl]uracil derivatives-Novel antivirals with activity against HIV-1 and influenza H1N1 virus.
AID1754644Antiviral activity against HIV1 harboring RT Y188L mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect incubated for 5 days by MTT assay2021Bioorganic & medicinal chemistry, 07-15, Volume: 42Exploiting the hydrophobic channel of the NNIBP: Discovery of novel diarylpyrimidines as HIV-1 NNRTIs against wild-type and K103N mutant viruses.
AID1754642Antiviral activity against HIV1 harboring K103N mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect incubated for 5 days by MTT assay2021Bioorganic & medicinal chemistry, 07-15, Volume: 42Exploiting the hydrophobic channel of the NNIBP: Discovery of novel diarylpyrimidines as HIV-1 NNRTIs against wild-type and K103N mutant viruses.
AID1391725Selectivity index, ratio of CC50 for human HepG2.215 cells to IC50 for Hepatitis B virus infected in human HepG2.215 cells assessed as reduction in covalently closed circular DNA level2018Bioorganic & medicinal chemistry letters, 05-15, Volume: 28, Issue:9
Design, synthesis and biological evaluation of seco-A-pentacyclic triterpenoids-3,4-lactone as potent non-nucleoside HBV inhibitors.
AID1292007Antiviral activity against HIV2 ROD infected in human MT4 cells assessed as cell viability after 4 days by MTT assay2016European journal of medicinal chemistry, Jun-10, Volume: 115Design, synthesis and evaluation of novel HIV-1 NNRTIs with dual structural conformations targeting the entrance channel of the NNRTI binding pocket.
AID1754646Antiviral activity against HIV1 harboring RT F227L/V106A mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect incubated for 5 days by MTT assay2021Bioorganic & medicinal chemistry, 07-15, Volume: 42Exploiting the hydrophobic channel of the NNIBP: Discovery of novel diarylpyrimidines as HIV-1 NNRTIs against wild-type and K103N mutant viruses.
AID1389500Antiviral activity against HBV infected in human HepG2.2.15 cells assessed as inhibition of viral DNA levels after 72 hrs by qRT-PCR analysis2018Bioorganic & medicinal chemistry, 05-01, Volume: 26, Issue:8
2-Arylthio-5-iodo pyrimidine derivatives as non-nucleoside HBV polymerase inhibitors.
AID1391726Antiviral activity against Hepatitis B virus infected in human HepG2.215 cells assessed as reduction in covalently closed circular DNA level after 9 days by real time QF-PCR analysis2018Bioorganic & medicinal chemistry letters, 05-15, Volume: 28, Issue:9
Design, synthesis and biological evaluation of seco-A-pentacyclic triterpenoids-3,4-lactone as potent non-nucleoside HBV inhibitors.
AID1391718Cytotoxicity against human HepG2.215 cells assessed as reduction in cell viability after 3 days by MTT assay2018Bioorganic & medicinal chemistry letters, 05-15, Volume: 28, Issue:9
Design, synthesis and biological evaluation of seco-A-pentacyclic triterpenoids-3,4-lactone as potent non-nucleoside HBV inhibitors.
AID1292011Cytotoxicity against mock infected human MT4 cells after 4 days by MTT assay2016European journal of medicinal chemistry, Jun-10, Volume: 115Design, synthesis and evaluation of novel HIV-1 NNRTIs with dual structural conformations targeting the entrance channel of the NNRTI binding pocket.
AID1506329Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBsAg secretion at 3.13 ug/ml after 8 days by ELISA relative to control2017MedChemComm, Jan-01, Volume: 8, Issue:1
Synthesis and biological activity evaluation of novel peroxo-bridged derivatives as potential anti-hepatitis B virus agents.
AID1298246Selectivity index, ratio of CC50 for human MT4 cells to EC50 for HIV-1 3B infected in human MT4 cells2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
1,6-Bis[(benzyloxy)methyl]uracil derivatives-Novel antivirals with activity against HIV-1 and influenza H1N1 virus.
AID1754643Antiviral activity against HIV1 harboring RT Y181C mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect incubated for 5 days by MTT assay2021Bioorganic & medicinal chemistry, 07-15, Volume: 42Exploiting the hydrophobic channel of the NNIBP: Discovery of novel diarylpyrimidines as HIV-1 NNRTIs against wild-type and K103N mutant viruses.
AID1298245Cytotoxicity against human MT4 cells after 5 days MTT assay2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
1,6-Bis[(benzyloxy)methyl]uracil derivatives-Novel antivirals with activity against HIV-1 and influenza H1N1 virus.
AID1391716Antiviral activity against Hepatitis B virus infected in human HepG2.215 cells assessed as inhibition of HBsAg secretion after 3 days by ELISA2018Bioorganic & medicinal chemistry letters, 05-15, Volume: 28, Issue:9
Design, synthesis and biological evaluation of seco-A-pentacyclic triterpenoids-3,4-lactone as potent non-nucleoside HBV inhibitors.
AID1506328Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBeAg secretion at 3.13 ug/ml after 4 days by ELISA relative to control2017MedChemComm, Jan-01, Volume: 8, Issue:1
Synthesis and biological activity evaluation of novel peroxo-bridged derivatives as potential anti-hepatitis B virus agents.
AID1298243Antiviral activity against HIV-1 3B infected in human MT4 cells assessed as reduction of virus-induced cytopathic effect after 5 days by MTT assay2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
1,6-Bis[(benzyloxy)methyl]uracil derivatives-Novel antivirals with activity against HIV-1 and influenza H1N1 virus.
AID1506327Antiviral activity against Hepatitis B virus infected in human HepG2.2.15 cells assessed as inhibition of HBsAg secretion at 3.13 ug/ml after 4 days by ELISA relative to control2017MedChemComm, Jan-01, Volume: 8, Issue:1
Synthesis and biological activity evaluation of novel peroxo-bridged derivatives as potential anti-hepatitis B virus agents.
AID1391720Selectivity index, ratio of CC50 for human HepG2.215 cells to IC50 for Hepatitis B virus infected in human HepG2.215 cells assessed as inhibition of HBeAg secretion2018Bioorganic & medicinal chemistry letters, 05-15, Volume: 28, Issue:9
Design, synthesis and biological evaluation of seco-A-pentacyclic triterpenoids-3,4-lactone as potent non-nucleoside HBV inhibitors.
AID1292009Antiviral activity against wild type HIV1 3B infected in human MT4 cells assessed as cell viability after 4 days by MTT assay2016European journal of medicinal chemistry, Jun-10, Volume: 115Design, synthesis and evaluation of novel HIV-1 NNRTIs with dual structural conformations targeting the entrance channel of the NNRTI binding pocket.
AID1754637Antiviral activity against wild type HIV-1 IIIB infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect measured after 5 days by MTT assay2021Bioorganic & medicinal chemistry, 07-15, Volume: 42Exploiting the hydrophobic channel of the NNIBP: Discovery of novel diarylpyrimidines as HIV-1 NNRTIs against wild-type and K103N mutant viruses.
AID1754639Selectivity index, ratio of CC50 for human MT4 cells to EC50 for Antiviral activity against HIV-1 IIIB infected in human MT4 cells2021Bioorganic & medicinal chemistry, 07-15, Volume: 42Exploiting the hydrophobic channel of the NNIBP: Discovery of novel diarylpyrimidines as HIV-1 NNRTIs against wild-type and K103N mutant viruses.
AID1389499Cytotoxicity against human HepG2.2.15 cells after 72 hrs by MTT assay2018Bioorganic & medicinal chemistry, 05-01, Volume: 26, Issue:8
2-Arylthio-5-iodo pyrimidine derivatives as non-nucleoside HBV polymerase inhibitors.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (6,630)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's794 (11.98)18.2507
2000's3355 (50.60)29.6817
2010's2052 (30.95)24.3611
2020's429 (6.47)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 91.24

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index91.24 (24.57)
Research Supply Index9.04 (2.92)
Research Growth Index4.76 (4.65)
Search Engine Demand Index169.92 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (91.24)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials1,425 (20.28%)5.53%
Trials0 (0.00%)5.53%
Reviews755 (10.75%)6.00%
Reviews0 (0.00%)6.00%
Case Studies753 (10.72%)4.05%
Case Studies0 (0.00%)4.05%
Observational77 (1.10%)0.25%
Observational0 (0.00%)0.25%
Other4,015 (57.15%)84.16%
Other13 (100.00%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (489)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Efficacy and Safety of an Initial Regimen Raltegravir (RAL) + Lamivudine/Abacavir Fixed-Dose Combination (3TC/ABC FDC) for 48 Weeks in ART-naïve, HIV/TB Co-Infected Adult Subjects Receiving Rifabutin-containing, 1-line Anti-TB Therapy [NCT01059422]Phase 410 participants (Anticipated)Interventional2010-10-31Recruiting
Randomized Phase 3 Trial to Evaluate Two Simplified Antiretroviral Treatment Strategies in HIV Infected Children, Treated by Antiretroviral Triple Therapy Before One Year of Age, in Virological Success in Africa (Burkina Faso, Côte d'Ivoire, Rwanda) [NCT01127204]Phase 2/Phase 3161 participants (Actual)Interventional2011-06-30Completed
Phase II, Parallel, Randomized, Clinical Trials Comparing the Responses to Initiation of NNRTI-Based Versus PI-Based Antiretroviral Therapy in HIV Infected Infants Who Have and Have Not Previously Received Single Dose Nevirapine for Prevention of Mother-t [NCT00307151]Phase 2452 participants (Actual)Interventional2005-12-31Completed
Clinical Trial of CNS Penetrating ART to Prevent NeuroAIDS in China [NCT01340950]Phase 4250 participants (Actual)Interventional2010-07-31Completed
A Randomized, Pilot Estimation Study to Compare the Safety and Efficacy of Raltegravir+TDF+3TC Versus TDF+3TC+EFV in HBV/HIV Co-infected Patients [NCT01318096]60 participants (Anticipated)Interventional2011-03-31Not yet recruiting
UNCPM 22314 - Evaluating the Safety of Pregnancy, Infant and Maternal Health Outcomes Among PrEP Users in Malawi [NCT06158126]621 participants (Anticipated)Observational [Patient Registry]2024-01-01Not yet recruiting
Maternal Tenofovir-containing Combination Drug Regimen During the Second and Third Trimesters of Pregnancy for Prevention of Mother-to-child Transmission of HIV and HBV in HIV-HBV Co-infected Mothers [NCT01125696]Phase 245 participants (Actual)Interventional2012-05-31Completed
Open-Label, Fixed-Sequence, Crossover Study To Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects [NCT01220232]Phase 114 participants (Actual)Interventional2010-11-30Completed
Phase 2 Comparison of Low-Dose Naltrexone vs ARV Effectiveness in HIV+ Progression [NCT01174914]Phase 2171 participants (Actual)Interventional2008-03-31Completed
An Open-label, Randomized, Single Dose, Crossover, Pivotal Bioequivalence Study of Fixed-dose Combination Tablets of Dolutegravir and Lamivudine Versus Dolutegravir and Lamivudine Single Entities and Food Effect Assessment in Healthy Volunteers [NCT03078556]Phase 1154 participants (Actual)Interventional2017-03-27Completed
A Single Arm, Phase 3 Study, Exploring the Safety of Doravirine-based First-line Antiretroviral Therapy for Women of Reproductive Potential Living With HIV, a Pilot Switch Study Strategy in South Africa [NCT04433780]Phase 3133 participants (Actual)Interventional2021-01-04Completed
Incidence of HBV Reactivation in HBsAg Negative/HBcAb Positive Diffuse Large B Cell Lymphoma or High Grade Follicular Lymphoma Patients: A Prospective Study [NCT01210287]Phase 2/Phase 3110 participants (Anticipated)Interventional2010-10-31Active, not recruiting
Pre-exposure Prophylaxis of HIV Infection Among Men Who Have Sex With Men (MSM) and Transgender Women (TG) in Suburban Yangon, Myanmar [NCT04781426]200 participants (Actual)Observational2020-10-28Completed
Investigation of Efficacy of Tenofovir Monotherapy in Comparison With Lamivudine Plus Adefovir in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir Combination Therapy - Multicenter Randomiz [NCT03236584]Phase 376 participants (Actual)Interventional2015-09-01Active, not recruiting
NEVIRAPINE Plus LAMIVUDINE (3TC) for HIV Maintenance Therapy - A Single Center Pilot Study [NCT03223402]20 participants (Actual)Interventional2016-12-23Completed
Special Drug Use Investigation for ZEFIX (Lamivudine) Tablet (HBV Cirrhosis) [NCT01376154]342 participants (Actual)Observational2006-06-30Completed
The Effects of Maraviroc Versus Efavirenz in Combination With Zidovudine/Abacavir on the CD4/CD8 Ratio in Treatment-naïve HIV-infected Individuals [NCT03178084]Phase 3721 participants (Actual)Interventional2014-10-15Completed
A Phase IIb, Randomized, Double-blind, Parallel-group Study to Assess the Efficacy, Safety, Tolerability, and Resistance Profile of GSK3640254 in Combination With Dolutegravir Compared to Dolutegravir Plus Lamivudine in HIV-1 Infected, Treatment-naïve Adu [NCT04900038]Phase 285 participants (Actual)Interventional2021-08-18Terminated(stopped due to Company decision to stop compound development. The decision was not based on any safety or efficacy concerns. It reflected the company strategy for portfolio progression.)
A Pilot Clinical Trial of Reverse Transcriptase Inhibitors in Children With Aicardi-Goutières Syndrome (AGS) [NCT02363452]Phase 211 participants (Actual)Interventional2015-09-10Completed
A Randomized, Open-Label, Single-Dose, 3-Period, Crossover Evaluation of the Relative Bioavailability of Two Experimental Fixed-Dose Combination Tablet Formulations of Dolutegravir 50 mg/Abacavir 600 mg/Lamivudine 300 mg Compared to Co-Administered Dolute [NCT01366547]Phase 118 participants (Actual)Interventional2011-06-30Completed
Body Composition Sub-study of the D2EFT Trial [NCT03675815]Phase 4155 participants (Actual)Interventional2019-12-05Active, not recruiting
"Safeguard the Household - A Study of HIV Antiretroviral Therapy Treatment Strategies Appropriate for a Resource Poor Country" [NCT00255840]812 participants (Actual)Interventional2006-07-31Completed
A Pilot Trial Evaluating Maintenance Therapy With Lamivudine(Epivir®) and Dolutegravir(Tivicay®) in Human Immunodeficiency Virus 1 (HIV-1) Infected Patients Virologically Suppressed With Triple HAART - ANRS 167 Lamidol [NCT02527096]Phase 2110 participants (Actual)Interventional2015-09-17Completed
Impact of DOlutegravir+Lamivudine Simplification on TIssue and Blood Latent Replication-competent HIV-1 Reservoirs (IDOLTIB Study) [NCT04034862]Phase 336 participants (Actual)Interventional2019-10-01Active, not recruiting
Efficacy of Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy in Patients With Viral Suppression. Randomized, Open-label 96 Weeks Non-inferiority Trial [NCT01307488]Phase 4286 participants (Actual)Interventional2011-09-30Completed
A Phase IIIB, Randomized Trial of Open-Label Efavirenz or Atazanavir With Ritonavir in Combination With Double-Blind Comparison of Emtricitabine/Tenofovir or Abacavir/Lamivudine in Antiretroviral-Naive Subjects [NCT00118898]Phase 31,864 participants (Actual)Interventional2005-09-30Completed
Maintaining Options for Mothers Study (MOMS): A Phase II Randomized Comparison of Three Antiretroviral Strategies Administered for 7 or 21 Days to Reduce the Emergence of Nevirapine Resistant HIV-1 Following a Single Intrapartum Dose of Nevirapine [NCT00099632]Phase 2484 participants (Actual)Interventional2006-03-31Completed
A Phase 3, Randomized, Multicenter Study of the Treatment of Antiretroviral-Naive HIV-1 Infected Subjects Comparing Tenofovir Disoproxil Fumarate and Emtricitabine in Combination With Efavirenz vs Combivir (Lamivudine/Zidovudine) and Efavirenz [NCT00112047]Phase 3517 participants (Actual)Interventional2003-07-31Completed
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents (Age 2 to Less Than 18) With Chronic Hepatitis B [NCT00095121]Phase 3173 participants (Actual)Interventional2004-06-30Completed
A Randomized, Double-Blind Study of the Safety and Efficacy of GSK1349572 Plus Abacavir/Lamivudine Fixed-Dose Combination Therapy Administered Once Daily Compared to Atripla Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects [NCT01263015]Phase 3844 participants (Actual)Interventional2011-02-01Completed
An Evaluation of the Uptake and Safety of, and Adherence to Antiretroviral Treatment Among Individuals With CD4 ≥ 250 Cells/mm3 and HIV Virus Load ≥ 50,000 cp/mL [NCT01583439]11 participants (Actual)Interventional2012-09-30Terminated(stopped due to Low Accrual.)
DOR/TDF/3TC Maintenance Therapy Among Patients Harboring M184V/I Mutation: a Pilot Open-label Study [NCT06034938]Phase 232 participants (Anticipated)Interventional2023-12-01Not yet recruiting
A Prospective Randomised Open Label Clinical Trial to Determine the Efficacy of Nevirapine, Compared With a Combination of ZDV + 3TC, in Decreasing the Peripartum Mother to Child Transmission of HIV. Women, Who Present After 38 Weeks Gestation or in Labou [NCT02181933]Phase 32,648 participants (Actual)Interventional1999-04-30Completed
Randomized Clinical Trial to Evaluate the Efficacy of a Dolutegravir Monotherapy (Tivicay®) Versus the Maintenance of a Successful Triple Therapy Using Abacavir + Lamivudine + Dolutegravir (Triumeq®) in HIV-1- Infected Patients [NCT02596334]Phase 3158 participants (Actual)Interventional2015-12-23Terminated(stopped due to 5 patients on tivicay had virological failure)
Multicenter Study of Options for Second-Line Effective Combination Therapy (SELECT) [NCT01352715]Phase 3515 participants (Actual)Interventional2012-03-13Completed
Pilot 24week Clinical Trial to Assess the Safety, Tolerability and Efficacy of Dual Therapy With Raltegravir/Lamivudine Combination, Replacing Standard Combination Therapy in HIV-infected Pts With Prolonged Virological Suppression. [NCT02284035]Phase 375 participants (Anticipated)Interventional2015-01-31Recruiting
Daily Antiretroviral Therapy (DART 1): An Open-Label, Single-Arm, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Didanosine Enteric Coated (Ddl-EC) in Combination With Lamivudine (3TC) and Efavirenz (EFV) Once Daily in Anti [NCT00116415]65 participants Interventional2002-03-31Completed
A Phase 3 Study Switching HIV-1 Infected Subjects With an Undetectable Viral Load From a HAART Regimen Dosed Twice Daily or More Frequently to a Once-Daily HAART Regimen [NCT00135369]Phase 3300 participants Interventional2002-09-30Completed
Bioequivalence Study of CRushed TriUMeq With or Without Drip Feed Compared to the Whole Tablet (SCRUM) [NCT02569346]Phase 122 participants (Actual)Interventional2016-03-31Completed
Is Dual Therapy as Effective as Triple Therapy Regarding CD4+/CD8+ Ratio Recovery and Improvement of Immune Activation and Inflammation in HIV-infected Patients With Consistent Plasma Viral Load Suppression (Tridual) [NCT03447873]Phase 4153 participants (Actual)Interventional2017-06-01Completed
A Randomised Non-inferiority Trial With Nested PK to Assess DTG/3TC Fixed Dose Formulations for the Maintenance of Virological Suppression in Children With HIV Infection Aged 2 to <15 Years Old [NCT04337450]Phase 2/Phase 3370 participants (Anticipated)Interventional2022-04-22Recruiting
A Phase IIb Randomized, Controlled, Partially Blinded Clinical Trial to Investigate Safety, Efficacy and Dose-response of BMS-986001 in Treatment-naive HIV-1-infected Subjects, Followed by an Open-label Period on the Recommended Dose [NCT01489046]Phase 2297 participants (Actual)Interventional2011-02-28Terminated
Efficacy of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus Tenofovir/Emtricitabine in HIV-1-infected Treatment-naïve Adults Without Baseline Genotyping Test (D2ARLING Study) [NCT04549467]Phase 4244 participants (Actual)Interventional2020-11-17Active, not recruiting
The Safety and Antiviral Efficacy of Stavudine Extended Release Formulation as Compared to Stavudine Immediate Release Formulation, Each as Part of Potent Antiretroviral Combination Therapy [NCT00005918]Phase 3730 participants Interventional2000-06-30Completed
Evaluating Inflammatory and Immunological Changes of HIV-positive Patients Switching to DTG Dual Regimen Compared to Those Switching to a Triple Drugs Regimen (B/F/TAF) [NCT04054089]Phase 466 participants (Anticipated)Interventional2019-09-30Not yet recruiting
A Phase Iv Single-Arm Open-Label Non-Randomized Study To Evaluate The Safety And Pharmacokinetics Of Nelfinavir (Viracept, A430) 1250mg Twice Daily (250mg Or 625mg Forms) With Lamivudine/Zidovudine (Combivir) Background Therapy In Hiv/Hepatitis C Virus (H [NCT00141284]Phase 412 participants (Actual)Interventional2005-10-31Completed
Elimination of Paediatric HIV-1 Infection: Evaluation of the Prevention Programme and Rescue Intervention Based on the Expanded Programme on Immunization (EPI). ANRS 12388 PREVENIR-PEV Study. [NCT03869944]Phase 297 participants (Actual)Interventional2019-12-04Active, not recruiting
The Effect of Anti-viral Drugs Used in Late Pregnancy in Mothers With Hepatitis B Virus Infection on Long-term Development of Children [NCT02301650]400 participants (Anticipated)Observational2014-10-31Enrolling by invitation
A Phase III, Randomized, Open-Label Trial to Evaluate Strategies for Providing Antiretroviral Therapy to Infants Shortly After Primary Infection in a Resource Poor Setting [NCT00102960]Phase 3377 participants (Actual)Interventional2005-07-31Completed
A Randomized, Open-label, Single-dose, Two-period, Crossover Study to Demonstrate the Bioequivalence of the Fixed Dose Combination (FDC) of Lamivudine and Adefovir Dipivoxil (100mg/10mg) to Heptodin® (100mg ) and Hepsera® (10mg) [NCT01353742]Phase 140 participants (Actual)Interventional2011-02-21Completed
A Phase III, Randomised, Double-blind, Multicentre, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus Tenofovir/Emtricitabine in HIV-1-infected Treatment-n [NCT02831764]Phase 3722 participants (Actual)Interventional2016-07-18Completed
A Phase IIa Multicenter, Open-Label Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A in Treatment-Naïve HIV-1 Infected Subjects With Selected Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Transmitted Resistance Mutations [NCT02629822]Phase 210 participants (Actual)Interventional2016-01-14Completed
A Phase III, Randomised, Double Blind, Multicentre, Parallel Group, Non Inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus Tenofovir/Emtricitabine in Human Immunodeficiency Vir [NCT02831673]Phase 3719 participants (Actual)Interventional2016-07-21Completed
A Prosp., Multic., Randomized, Open-label Trial to Assess the Safety, Tolerability and Efficacy of Dual Therapy With Boosted Darunavir + Dolutegravir When Switching From SOC ART in HIV-patients With Sustained Virological Suppr. [NCT02486133]Phase 3269 participants (Actual)Interventional2015-07-31Completed
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral Treatment-Naive Adults [NCT02607930]Phase 3631 participants (Actual)Interventional2015-11-13Completed
HIV Drug Resistance Profiles Among Individuals Failing Tenofovir/Lamivudine and Dolutegravir First Line Regimen in Brazil [NCT04453436]2,500 participants (Anticipated)Observational [Patient Registry]2020-09-01Not yet recruiting
A Study to Compare Long-Term Safety and Tolerability of Stavudine (d4T) Extended Release (ER) Versus Conventional (Immediate Release, IR) Formulations, Each In Combination With Lamivudine (3TC) and Efavirenz (EFV) in Subjects Who Have Completed BMS Studie [NCT00116298]Phase 3900 participants Interventional2001-01-31Completed
Implementation and Evaluation of an HIV-2 Viral Load and ARV Resistance Informed Algorithm for 2nd-line ART in HIV-2 Infected Patients in the Initiative Sénégalaise d'Accès Aux Antirétroviraux (ISAARV) Program [NCT03394196]152 participants (Actual)Interventional2018-07-04Terminated(stopped due to COVID-19 and Funding)
Phase I/II Study of the Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age [NCT03760458]Phase 1/Phase 257 participants (Actual)Interventional2020-09-09Completed
Multicenter, Double-Blind, Randomized, Dose Ranging Study to Compare the Safety and Activity of MK0518 Plus Tenofovir and Lamivudine (3TC) Versus Efavirenz Plus Tenofovir and Lamivudine (3TC) in ART-Naive, HIV-Infected Patients [NCT00100048]Phase 2206 participants (Actual)Interventional2005-01-31Completed
Phase III Randomized Trial of the Safety and Efficacy of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV-1 Transmission [NCT00099359]Phase 31,735 participants (Actual)Interventional2004-02-29Completed
A Prospective, Randomised, Open-label, Multi-centre Study to Compare Three Chronic Hepatitis B (CHB) Treatment Strategies Over a 2year Period in Chinese HBeAg Positive CHB Patients [NCT01088009]Phase 4366 participants (Actual)Interventional2010-03-31Completed
A Phase I/II Comparative Pharmacokinetic Study of the Fixed-Dose Combination (FDC) of Zidovudine (ZDV), Lamivudine (3TC), and Nevirapine (NVP) as GPO-Vir Z30 Pediatric Tablets Versus the Individual Liquid Formulations in HIV-Infected Children Greater Than [NCT00672412]Phase 1/Phase 242 participants (Actual)Interventional2008-10-31Completed
A Phase III, Randomized, 2x2 Factorial Trial to Assess the Efficacy of Antiviral Therapy in Women and Infants in Reducing Vertical Transmission of Hepatitis B in Africa [NCT04704024]Phase 3450 participants (Anticipated)Interventional2021-09-03Recruiting
Daily Antiretroviral Therapy (DART-II): An Open-Label, Single-Arm, Prospective, Multicenter Clinical Trial To Evaluate the Efficacy and Safety fo Stavudine Extended Release (d4T XR) in Combination With Lamivudine (3TC) and Efavirenz (EFV) Once Daily in An [NCT00116116]Phase 470 participants Interventional2002-03-31Completed
'COMBINE-2': Real-world Evidence for Effectiveness of Two Drug Regimen, Antiretroviral Therapy With Integrase Inhibitors Plus a Reverse Transcriptase Inhibitor [NCT04019873]1 participants (Actual)Observational2019-11-18Completed
Open-label Access to Dolutegravir for HIV-1 Infected Children and Adolescents Completing IMPAACT Studies P1093 and P2019 [NCT03016533]Phase 3300 participants (Anticipated)Interventional2017-06-07Recruiting
Dolutegravir-Lamivudine for naïve HIV-Infected Patients With ≤200 CD4/mm3 [NCT04880395]Phase 4230 participants (Anticipated)Interventional2021-05-20Recruiting
A Phase 2B, Randomized, Double-Blind, Active-Comparator-Controlled, Dose-Ranging Clinical Trial to Evaluate the Safety, Tolerability, Antiretroviral Activity, and Pharmacokinetics of MK-8591 Given in Combination With Doravirine (DOR) and Lamivudine (3TC) [NCT03272347]Phase 2123 participants (Actual)Interventional2017-11-27Completed
[NCT01139203]300 participants (Anticipated)Interventional2009-08-31Recruiting
Defining the Potency of DTG/3TC for Suppressed HIV Patients in Real-life: the DUALING Study. [NCT04707326]480 participants (Anticipated)Observational [Patient Registry]2019-11-01Recruiting
The Effect of Telbivudine on Renal Function in Chronic Hepatitis B Patients With Mild to Moderate Renal Impairment [NCT03778567]Phase 431 participants (Actual)Interventional2013-08-01Completed
Pilot Single-Arm Clinical Trial to Evaluate the Efficacy, PK Interactions and Safety of Dolutegravir Plus 2 NRTIs in HIV-1-Infected Solid Organ Transplant Patients [NCT03360682]Phase 420 participants (Anticipated)Interventional2018-04-12Active, not recruiting
The Time to Protection and Adherence Requirements of Raltegravir With or Without Lamivudine in Protection From HIV Infection [NCT03205566]Phase 438 participants (Actual)Interventional2017-09-19Completed
Pharmacokinetics of EFV 400mg Once Daily During Pregnancy in HIV+ Women [NCT02499874]Phase 126 participants (Actual)Interventional2015-08-31Completed
A Randomized, Open Label Study Evaluating the Efficacy and Safety of Glucocorticoids in Patients With Pre-ACLF-HBV [NCT01344174]200 participants (Anticipated)Interventional2011-05-31Recruiting
Research on the Antiretroviral Therapy and Immune Reconstitution on Chinese HIV/AIDS Patients [NCT00872417]Phase 4750 participants (Anticipated)Interventional2009-03-31Not yet recruiting
Continuation of Lamivudine Plus Adefovir Versus Switching to Entecavir Plus Adefovir in Adults With Chronic Hepatitis B Who Have Resistant Mutants to Lamivudine and Show Suboptimal Response to Combination of Lamivudine Plus Adefovir [NCT01023217]Phase 490 participants (Actual)Interventional2009-11-30Completed
Randomized, Open-Labeled Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Continuing Lamivudine Therapy or Switching to Entecavir in Subjects With Chronic Hepatitis B Who Achieved Undetectable HBV DNA [NCT00637663]Phase 472 participants (Actual)Interventional2008-02-29Completed
Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women [NCT00993031]Phase 3389 participants (Actual)Interventional2009-12-15Completed
A Randomised Controlled Trial Comparing the Efficacy of Infant Peri-exposure Prophylaxis With Lopinavir/Ritonavir (LPV/r) Versus Lamivudine to Prevent HIV-1 Transmission by Breastfeeding [NCT00640263]Phase 31,500 participants (Anticipated)Interventional2009-12-31Completed
Efficacy of Antiviral Therapy With Lamivudine or Entecavir After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma [NCT00768157]Phase 4200 participants (Anticipated)Interventional2007-04-30Recruiting
A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe [NCT00834457]Phase 2/Phase 349 participants (Actual)Interventional2007-06-30Completed
A Randomized, Open-label Trial to Compare the Efficacy and Safety of Early Initiation of cART With or Without Autologous HIV-1 Specific Cytotoxic T Lymphocyte (CTL) Infusion in Treatment-Naïve Acute HIV-1 Infected Adults [NCT02231281]Phase 365 participants (Anticipated)Interventional2014-08-31Active, not recruiting
A Randomized, Non-comparative, Phase IIb, Unblinded Trial, Evaluating the Efficacy and Safety of Tenofovir-emtricitabine or Lamivudine Plus Zidovudine, Lopinavir/Ritonavir, or Raltegravir, Among ARV-naïve HIV-2 Infected Adult Patients, in West Africa [NCT02150993]Phase 2/Phase 3210 participants (Actual)Interventional2016-01-26Completed
Evaluation of 3TC or FTC Mono-therapy Compared to Continuing HAART as a Bridging Antiretroviral Strategy in Persistently Non-adherent Children, Adolescents, and Young Adults Who Are Failing HAART and Have the M184V Resistance Mutation. [NCT01338025]Phase 433 participants (Actual)Interventional2011-03-31Terminated(stopped due to Study was halted for lack of accrual)
Evaluation of the Capacity of a Weekly Strategy of 4 Consecutive Days on Treatment Followed by 3 Days Off Treatment, in HIV-1 Infected Patients With Undetectable Viral Load for at Least 12 Months, to Maintain a Virological Success With This Intermittent M [NCT02157311]Phase 3100 participants (Actual)Interventional2014-07-31Completed
A Phase I/II Comparative Pharmacokinetic Study of the Fixed-Dose Combination (FDC) of Stavudine (d4T), Lamivudine (3TC), and Nevirapine (NVP) as GPO-VIR Pediatric Chewable Tablets Versus the Individual Liquid Formulations in HIV Infected Children 6 Months [NCT00312091]Phase 1/Phase 244 participants (Actual)Interventional2006-12-31Completed
Cellular Pharmacology and Platelet Effects of Abacavir and Lamivudine Anabolites [NCT04301661]25 participants (Actual)Observational2020-03-06Completed
A Randomized Double-Blind Study of Safety, Virologic and Immunological Effects of Stavudine Plus Lamivudine (3TC) Versus Zidovudine Plus Lamivudine in HIV-Infected Subjects Following At Least Six Months of Zidovudine Therapy [NCT00002371]Phase 380 participants Interventional1996-06-30Completed
Phase IIb, Double-Blinded, Multicenter, Randomized Study to Assess the Effect on Central Nervous System (CNS) Toxicity of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppre [NCT02652260]Phase 286 participants (Actual)Interventional2016-03-04Active, not recruiting
Efficacy and Safety of Dolutegravir + Lamivudine in Antiretroviral Treatment-naive Adults With HIV-1 Infection in a Multicenter Real-life Cohort Study [NCT04638686]185 participants (Actual)Observational2020-06-15Completed
A Prospective Randomized Double-Blind Trial of Three Maintenance Regimens for HIV-Infected Subjects Receiving Induction Therapy With Zidovudine, Lamivudine and Indinavir [NCT00001084]Phase 2500 participants InterventionalCompleted
Efficacy and Safety of Early Switching to Dolutegravir/Lamivudine (DTG/3TC) From INSTI-based Three-drug Regimens in HIV-1-infected Adults Previously naïve Who Achieve Virological Suppression [NCT04979468]Phase 3440 participants (Anticipated)Interventional2021-03-23Recruiting
Phase 2 Multicentric Open-label Study of Switch From Abacavir/Lamivudine Fixed Dose Combination Plus Nevirapine to Abacavir/Lamivudine/Dolutegravir in Virologically Suppressed HIV-1 Infected Adults [NCT02067767]Phase 253 participants (Actual)Interventional2014-02-28Completed
An Open Label Randomized Clinical Trial, to Evaluate the Treatment With Darunavir/Ritonavir + Lamivudine Once Daily Versus Continuing With Darunavir/Ritonavir Once Daily + Tenofovir/Emtricitabine or Abacavir/Lamivudine in HIV Infected Subject With Suppres [NCT02159599]Phase 4249 participants (Actual)Interventional2014-07-31Completed
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologica [NCT02603120]Phase 3567 participants (Actual)Interventional2015-11-11Completed
Effect of Reducing Nucleotide Exposure on Bone Health (ReNew) [NCT03549689]Phase 20 participants (Actual)Interventional2019-08-01Withdrawn(stopped due to Withdrawn by drug manufacturer)
A Study to Evaluate Dolutegravir Plus Lamivudine Dual Therapy for the Treatment of Naïve HIV-1-infected Participants [NCT02582684]Phase 2122 participants (Actual)Interventional2015-12-08Completed
ProSpective, MultI-Center, Observational PrograM to Assess the Effectiveness of Dual TheraPy (Lopinavir/Ritonavir + LamivudinE) in Treatment-Experienced HIV Infected Patients in the Routine Clinical Settings of the Russian Federation (SIMPLE) [NCT02581202]216 participants (Actual)Observational2015-12-21Completed
Study of Once-Daily Abacavir/Lamivudine Versus Tenofovir/Emtricitabine, Administered With Efavirenz in Antiretroviral-Naive, HIV-1 Infected Adult Subjects [NCT00549198]Phase 4392 participants (Actual)Interventional2007-06-30Completed
Phase IIb Pilot Study for the Evaluation of the Safety and the Feasibility of Treatment Simplification to Tenofovir+Emtricitabine+Raltegravir or to Lamivudine+Abacavir+Raltegravir in Patients With Optimal Virological Control and Toxicity to the Current Co [NCT00958100]Phase 240 participants (Actual)Interventional2009-08-31Completed
A Comparative Study of Entecavir vs Adefovir Plus Lamivudine vs Combination Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Chinese Subjects [NCT00986778]Phase 40 participants (Actual)Interventional2009-12-31Withdrawn(stopped due to Business Objectives Changed)
Virologic Outcomes of Lamivudine/Dolutegravir in Virologically Suppressed Subjects With Expected or Confirmed Resistance to Lamivudine. [NCT04880785]Phase 2121 participants (Actual)Interventional2021-07-28Active, not recruiting
Doravirine for Persons With Excessive Weight Gain on Integrase Inhibitors and Tenofovir Alafenamide (The Do IT Study) [NCT04636437]Phase 4222 participants (Anticipated)Interventional2021-05-20Recruiting
A Multicenter, Randomized, Double-Blind, Comparative Trial Of A Novel CCR5 Antagonist, UK-427,857, In Combination With Zidovudine/Lamivudine Versus Efavirenz In Combination With Zidovudine/Lamivudine For The Treatment Of Antiretroviral-Naive HIV-1 Infecte [NCT00098293]Phase 3916 participants (Actual)Interventional2004-11-30Completed
"A Prospective, Randomized, Multicenter, Open-label, Exploratory Study of Utilizing of Response-Guided-Therapy (RGT) Strategy on Optimal Nucleoside Analogue (NUC)-Experienced Patients" [NCT02560649]Phase 4324 participants (Anticipated)Interventional2015-05-31Active, not recruiting
A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care Versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples [NCT00074581]Phase 33,526 participants (Actual)Interventional2005-02-28Completed
The Effect of Rifampicin on the Pharmacokinetics of Intracellular Tenofovir-diphosphate and Tenofovir When Coadministered With Tenofovir Alafenamide Fumarate During the Maintenance Phase of Tuberculosis Treatment in TB/HIV-1 Coinfected Participants [NCT04424264]Phase 118 participants (Actual)Interventional2019-12-05Completed
A Phase IV Study of the Antiviral Activity and Safety of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection Who Are Negative for Hepatitis B e Antigen in Korea [NCT00393484]Phase 4122 participants (Actual)Interventional2007-02-28Completed
ADORE: A Single-arm, Phase 3, Pilot Study Investigating the Efficacy of Doravirine in Adults Living With HIV Experiencing Virological Failure on First-line Efavirenz-based Antiretroviral Therapy With Non-nucleoside Reverse Transcriptase Inhibitor Resistan [NCT04429152]Phase 325 participants (Anticipated)Interventional2021-02-09Recruiting
Randomized, Double-Blind Trial of Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis [NCT00076336]Phase 3232 participants (Actual)Interventional2003-12-31Completed
A Randomized, Open-label Study Evaluating the Efficacy and Safety of Peginterferon Alfa-2a (40KD) (PEGASYS®) or Adefovir Dipivoxil (ADV) in Patients With Lamivudine-resistant HBeAg Positive Chronic Hepatitis B [NCT02598063]Phase 4255 participants (Actual)Interventional2005-10-31Completed
A Phase 4, Randomized, Open Label, Controlled Study of Boosted Darunavir and Lamivudine Versus Boosted Darunavir and Emtricitabine/Tenofovir or Lamivudine/Tenofovir in Naïve HIV-1 Infected Subjects [NCT02770508]Phase 4145 participants (Actual)Interventional2015-11-30Completed
A Prospective, Single Arm, Open-label 96 Week Observational Trial of the Tolerability, Adherence and Efficacy of a Dolutegravir/Abacavir/Lamivudine Single Tablet Regimen in HIV-1 Antibody Positive People Living With HIV With a History of Injection Drug Us [NCT02659761]Phase 450 participants (Anticipated)Interventional2016-11-30Recruiting
A Randomized, Open-Label, Third-Party Blinded Study for the Prophylaxis and Treatment of Nelfinavir-associated Diarrhea [NCT00650637]Phase 317 participants (Actual)Interventional2003-01-31Terminated(stopped due to The study was prematurely discontinued due to administrative reasons on August 18, 2003. There were no safety concerns that led to the decision to terminate.)
APT-POCT-01: An Open Label, Pharmacokinetic Study of Plasma/Urine/Salivary Drug Concentrations Over Fourteen Days Following Drug Intake Cessation, In HIV-Uninfected Healthy Volunteers Dosing to Steady-state to Further Development of Point of Care Diagnost [NCT04302896]Early Phase 130 participants (Actual)Interventional2020-08-31Completed
[NCT00618176]Phase 4198 participants (Actual)Interventional2005-01-31Completed
Vitamin D and Calcium Supplement Attenuate Bone Loss Among HIV- Infected Patients Receiving Tenofovir Disoproxil Fumarate, Lamivudine or Emtricitabine and Efavirenz: An Open-label, Randomized Controlled Trial [NCT02827643]48 participants (Anticipated)Interventional2016-06-30Recruiting
P1060 Substudy Comparing Differences in Malaria Parasitemia by Real Time Quantitative PCR in HIV-Infected Infants and Children on PI-Based HAART Versus NNRTI-Based HAART [NCT00719602]Early Phase 1105 participants (Actual)Interventional2009-08-31Completed
A Randomized Study of Lamivudine Prophylaxis or Treatment Against Hepatitis B Reactivation in Non-Hodgkin's Lymphoma Patients Carrying Hepatitis B Surface Antigen [NCT00201318]Phase 250 participants Interventional2001-09-30Completed
A Randomized, Controlled, Open-label, Dose-exploration Study to Assess the Effectiveness and Safety of Lipovirtide Combined With Nucleoside Drugs in HIV-infected Patients Who Have Not Received Antiviral Treatment Before. [NCT06061536]Phase 264 participants (Anticipated)Interventional2023-11-02Recruiting
A Phase II, Stratified, Randomized, Double-Blind, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil (ADF) at Two Dose Levels in Triple Combination Therapies With Protease Inhibitors (PI) and Nucleoside Reverse Transcriptase Inhibitors (R [NCT00002184]Phase 2120 participants InterventionalCompleted
Real Life Study of Dolutegravir Plus Lamivudine in HIV-1-Infected Treatment-Naive Patients [NCT04002323]139 participants (Anticipated)Observational [Patient Registry]2019-05-07Recruiting
Antiretroviral Treatment Guided by Proviral Genotype: Pilot Trial of Proof of Concept. [NCT03539224]Phase 241 participants (Actual)Interventional2017-11-02Active, not recruiting
Initiation of a Once Daily Regimen of Tenofovir, Lamivudine and Efavirenz After 4 Weeks Versus 12 Weeks of Tuberculosis Treatment in HIV-1 Infected Patients (Time Study) [NCT01014481]Phase 4156 participants (Actual)Interventional2009-10-31Terminated(stopped due to this study was ended prematurely by ethical committees with a reason of the final outcome was achieved with no longer recruitment was needed.)
A Randomised, Double-Blinded, Placebo-Controlled Trial of Lamivudine Treatment in HBeAg Negative Chronic Hepatitis B Patients (in Asia) [NCT00338780]Phase 40 participants Interventional2000-11-30Completed
The Optimization of HAART for Chinese--a RCT Study [NCT02945163]Phase 4184 participants (Actual)Interventional2018-03-05Completed
A Pilot Study Of Open-Label Fixed Dose Combination Zidovudine/Lamivudine/Abacavir In HIV-Infected Persons With Tuberculosis In Moshi, Tanzania; Tuberculosis And HIV Immune Reconstitution Syndrome Trial (THIRST) [NCT00851630]Phase 470 participants (Actual)Interventional2004-06-30Completed
Evaluating Responses to Antiretroviral Drugs in Cells and Tissues (The ERADICATE Study): Comprehensive Comparisons of Viral and Cellular Dynamics Among Previously-Untreated Subjects With Acute HIV Infection (Seroconversion Syndrome) or Recently Acquired H [NCT00006443]24 participants InterventionalCompleted
A Multicenter, Randomized, Controlled Tial of Combination Therapy for Lamivudine-resistant Chronic Hepatitis B Patient: Comparing Clevudine Plus Adefovir With Lamivudine Plus Adefovir [NCT00798460]Phase 430 participants (Actual)Interventional2008-12-31Terminated(stopped due to could not enroll patients)
Pharmacokinetics, Safety and Efficacy of Atazanavir /Dolutegravir/Lamivudine Regimen as Maintenance Regimen in Patients With Intolerance and/or Resistance to NRTIs, NNRTIs and RTV: A Pilot Study [NCT02566707]Phase 29 participants (Actual)Interventional2015-08-31Terminated(stopped due to due to introduction of another integrase inhibitor, recruitement was not feasible anymore.)
See Detailed Description [NCT00440947]Phase 3515 participants (Actual)Interventional2007-03-31Completed
Randomized, Open-Label, Phase IV Trial in Nucleus(t)id-Naive Patients With Chronic Hepatitis B to Examine the Effect of Telbivudine Compared to Lamivudine on the Early Dynamics and Kinetics of Viral Suppression (Early-Viral-Dynamics Study) [NCT00710216]Phase 440 participants (Anticipated)InterventionalWithdrawn(stopped due to Sponsor withdraw)
Randomized, Open-Labelled Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Continuing Lamivudine Therapy or Switching to Entecavir in Subjects With Chronic Hepatitis B With Detectable HBV DNA [NCT00625560]Phase 472 participants (Actual)Interventional2008-02-29Completed
Simplification From Tenofovir Plus Lamivudine or Emtricitabine Plus Ritonavir-Boosted-Protease Inhibitor to Ritonavir-Boosted-Atazanavir Plus Lamivudine in Virologically-Suppressed-HIVInfected Adults With Osteopenia [NCT02652793]45 participants (Anticipated)Interventional2015-07-31Recruiting
CID 0708 - Sex, Aging and Antiretroviral Pharmacokinetics [NCT00666055]11 participants (Actual)Observational2008-03-31Completed
[NCT00669487]Phase 3150 participants (Actual)Interventional2008-04-30Completed
Steady-state Pharmacokinetics of Efavirenz (Sustiva/Stocrin) 400 mg Once Daily in the Presence of Rifampicin and Isoniazid (Rifinah or the Local Generics) [NCT02832778]Phase 135 participants (Anticipated)Interventional2016-11-21Recruiting
A Phase 2b/3, Randomized, Double Blind, Dose Confirming Study of the Safety, Efficacy and Tolerability of Apricitabine Versus Lamivudine in Treatment-experienced HIV-1 Infected Patients With the M184V/I Mutation in Reverse Transcriptase [NCT00612898]Phase 2/Phase 3239 participants (Actual)Interventional2008-02-29Terminated(stopped due to Sponsor decision)
Dolutegravir-Lamivudine as Dual Therapy in naïve HIV-Infected Patients With Documented M184V Mutation:A Pilot Study [NCT05295394]Phase 40 participants (Actual)Interventional2019-05-22Withdrawn(stopped due to Low recruitment, We did not find participants with the M184V mutation , inclusion criteria , throughout 230 resistance tests carried out)
Pharmacokinetic and Safety Pilotstudy of RAltegravir and Atazanavir in a Once DAily Dose Regimen in HIV-1 Infected Patients (PRADA) [NCT00943540]Phase 220 participants (Anticipated)Interventional2009-07-31Completed
Acceptability and Feasibility of Injectable Cabotegravir Pre-exposure Prophylaxis (PrEP) Versus Oral PrEP in Routine Care up to 15 Months in Private Pharmacies in South Africa [NCT06138600]Phase 3200 participants (Anticipated)Interventional2023-11-01Active, not recruiting
Phase 3, Single Center, Controlled, Investigator-blinded, Randomized Matched Pair Design Study of CD4 Cell Recovery in HIV-1 Patients With Sustained Virologic Response Comparing Protease Inhibitor and Non-nucleoside Reverse Transcriptase Inhibitor Based T [NCT00966160]Phase 3215 participants (Actual)Interventional1999-01-31Completed
Pilot Phase IV, Multicenter, Randomized, Open-label and Controlled Study to Assess the Evolution of Peripheral Body Fat Distribution After Switching From Zidovudine Containing Backbone to Truvada in HIV-1-infected Patients on HAART (RECOMB Study). [NCT00324649]Phase 480 participants (Actual)Interventional2006-05-31Completed
Intra-ocular Penetration of Oral Lamivudine and Measurement of Systemic Inflammatory Markers in Patients Undergoing Rhegmatogenous Retinal Detachment Surgery [NCT06056596]Early Phase 120 participants (Anticipated)Interventional2024-01-31Recruiting
A Phase I, Relative Oral Bioavailability Study of Different Fixed Dose Combinations of Dolutegravir and Lamivudine in Healthy Subjects [NCT02738931]Phase 130 participants (Actual)Interventional2016-05-31Completed
A Phase III Randomized, Open Label Trial to Evaluate Dolutegravir Versus Efavirenz 400 mg, Both Combined With Tenofovir Disoproxil Fumarate + Lamivudine for the Initial Management of HIV Infected Adults in Resource-limited Settings [NCT02777229]Phase 3616 participants (Actual)Interventional2016-07-31Completed
A Prospective, Randomized, Open Label Phase IV Study to Evaluate the Rationale of Switching From Fixed Dose Abacavir (ABC)/Lamivudine (3TC) to Fixed Dose Tenofovir DF (TDF)/Emtricitabine (FTC) in Virologically Suppressed, HIV-1 Infected Patients Maintaine [NCT00724711]Phase 4312 participants (Actual)Interventional2008-07-31Completed
Bioequivalence Study Between Lamivudine Formulations in the Form of Coated Tablet 150 mg (Test) and EPIVIR of Glaxosmithkline in Healthy Volunteers of Both Genders in Fasting Condition [NCT02604004]Phase 128 participants (Actual)Interventional2013-04-30Completed
Randomized Control Trial of Early vs Delayed ART in the Treatment of Cryptococcal Meningitis. [NCT00830856]54 participants (Actual)Interventional2006-10-31Completed
Multicenter, International, Prospective, Phase III, Randomized, Superiority Trial Comparing Two Maintenance Strategies With Mono or Bi-therapy of Protease Inhibitors With or Without Lamivudine in Virologically Suppressed HIV Patients on Second Line Antire [NCT01905059]Phase 3265 participants (Actual)Interventional2014-02-28Completed
A Single Center, Randomized Open Label Study of Initial Interleukin-2 Compared to Delayed Interleukin-2 When Added to Zidovudine, 3TC and Nelfinavir In Order to Modulate Immune Function and to Sustain Suppression of HIV-1 Replication Among Those Persons W [NCT00006441]398 participants (Actual)Interventional2003-02-28Completed
A Phase III, Randomised, Multicenter, Parallel, Open-Label Study to Compare the Efficacy, Safety, and Tolerability of GW433908 (1400 Mg Bid) and Nelfinavir (1250 Mg Bid) Over 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Adults [NCT00008554]Phase 3210 participants Interventional2000-11-30Active, not recruiting
Study of Protease Inhibitor and/or Non-Nucleoside Reverse Transcriptase Inhibitor With Dual Nucleosides in Initial Therapy of HIV Infection [NCT00000919]900 participants InterventionalCompleted
A Randomized, Open-Label Study of the Long-Term Effectiveness of Three Initial Highly Active Antiretroviral Therapy (HAART) Strategies in HAART-Niave, HIV-Infected Persons [NCT00000922]1,710 participants InterventionalCompleted
A Randomized Comparative Study of Combined Zidovudine-Lamivudine (3TC) vs. the Better of ddI Monotherapy vs. Zidovudine Plus Ddl in Symptomatic HIV-1 Infected Children [NCT00001066]Phase 2740 participants InterventionalCompleted
A Pilot Study to Evaluate the Immunologic Consequences of a Highly Active Antiretroviral Therapy Regimen (HAART) Consisting of Ritonavir (ABT-538), Zidovudine (AZT), and Lamivudine (3TC) in Moderately Advanced HIV-1 Disease [NCT00001075]55 participants InterventionalCompleted
A Phase 3b Multi-center, Open Label, Single Arm, 52-week Study, Evaluating the Feasibility, Efficacy and Safety of Rapid Test and Treat Intervention in Newly Diagnosed HIV-1 Infected Adults Using a Fixed Dose Combination of Dolutegravir Plus Lamivudine (D [NCT03945981]Phase 3131 participants (Actual)Interventional2019-07-02Completed
Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy [NCT00000831]Phase 2280 participants InterventionalCompleted
A Phase II Study of Intermittent Recombinant Human Interleukin-2 (rhIL-2) by Intravenous or Subcutaneous Administration in Subjects With HIV Infection on Highly Active Antiretroviral Therapy (HAART) Compared to HAART Alone [NCT00000870]Phase 2200 participants InterventionalCompleted
A Phase I Trial of the Safety, Tolerance, and Pharmacokinetics of Oral Ritonavir Co-Administered With Lamivudine (3TC) and Zidovudine (ZDV) in HIV-1-Infected Pregnant Women and Their Infants [NCT00000888]Phase 114 participants InterventionalCompleted
A Phase I Pharmacokinetic Study of Once Versus Twice Daily Dosing With Zidovudine and Lamivudine [NCT00014014]Phase 120 participants InterventionalCompleted
Use of Combination Antiviral Therapy to Delineate the Identity and Longevity of Persistent Reservoirs of HIV-1 Infection and Replication [NCT00001644]Phase 142 participants (Actual)Interventional1997-03-03Completed
A Randomized, Double-Blind, Adjuvant-Controlled, Multicenter Study to Compare the Virologic and Immunologic Effect of Highly Active Antiretroviral Therapy (HAART) Plus Remune Versus HAART Plus Incomplete Freund's Adjuvant (IFA) in Antiretroviral-Naive Pat [NCT00005002]Phase 3688 participants InterventionalActive, not recruiting
Efficacy and Safety of Continuing Lamivudine Plus Adefovir or Adefovir Versus Switching to Entecavir Plus Adefovir in Patients With Chronic Hepatitis B Who Have Resistant Mutants to Lamivudine and Show Suboptimal Response to Combination of Lamivudine Plus [NCT02482272]Phase 490 participants (Anticipated)Interventional2015-05-31Recruiting
Pharmacokinetics of Plasma Lamivudine (3TC), and Its Active Intracellular Anabolite 3TC-Triphosphate Over a 24 Hour Dosing Interval Following Administration of 3TC 300 mg and 150 mg Once Daily to HIV-Negative Healthy Volunteers [NCT00985647]Phase 1/Phase 224 participants (Actual)Interventional2009-12-31Completed
Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With Chronic HBV Infection. [NCT00810524]Phase 4600 participants (Anticipated)Interventional2007-01-31Recruiting
HIV Infection and Breastfeeding: Interventions for Maternal and Infant Health [NCT00164736]Phase 32,369 participants (Actual)Interventional2004-03-31Completed
Optimization of Antiretroviral Therapy [NCT02935075]Phase 4184 participants (Actual)Interventional2018-03-05Completed
Multicentric Randomised Controlled Trial Assessing the Efficacy of Two Strategies of Structured Treatment Interruption of Highly Active Antiretroviral Therapy (HAART) Compared With a Continuous HAART in HIV- Infected Adults in Abidjan [NCT00158405]Phase 3840 participants (Actual)Interventional2002-12-31Completed
A Randomized, Open Label, Phase IV, Multicenter Study for Efficacy and Safety of Lamivudine Versus Entecarvir Therapy in HBV-related Advanced Liver Disease Patients With High Viral Load and Normal or Slightly Elevated Transaminase [NCT00823550]Phase 4462 participants (Anticipated)Interventional2009-01-31Active, not recruiting
Phase III Study of Adefovir Dipivoxil Tablets in Patients With Compensated Chronic Hepatitis B -Comparative Study Against Lamivudine- [NCT00316719]Phase 3105 participants (Actual)Interventional2006-01-31Completed
A Comparative Study of Entecavir vs. Adefovir Plus Lamivudine vs Combination Entecavir Plus Adefovir in Lamivudine-resistant Chronic Hepatitis B Subjects: The DEFINE Study [NCT00410202]Phase 3629 participants (Actual)Interventional2008-03-31Completed
A Multicenter, Open-Label, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate/d4T/3TC Versus Indinavir Sulfate/Nelfinavir Mesylate/d4T/3TC in HIV-Infected Individuals [NCT00002430]220 participants InterventionalCompleted
Nucleosides And Darunavir/Dolutegravir In Africa (NADIA): a Randomised Controlled Trial of Darunavir Versus Dolutegravir and Tenofovir Versus Zidovudine in Second-line Antiretroviral Therapy Regimens for the Public Health Approach in Sub-Saharan Africa [NCT03988452]Phase 3465 participants (Actual)Interventional2019-07-30Active, not recruiting
Randomized, Open-Label Evaluation of Efficacy of Once-Daily Protease Inhibitor and Once-Daily Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Therapy Combinations for Initial Treatment of HIV-1 Infected Persons From Resource-Limited Settings (PE [NCT00084136]Phase 41,571 participants (Actual)Interventional2005-05-31Completed
[NCT02202473]Phase 4192 participants (Actual)InterventionalCompleted
Chemoembolization With or Without Antiviral Therapy for Unresectable HBV-related Hepatocellular Carcinoma With Low HBV DNA Replication: Effectiveness and Safety. A Prospective and Randomized Clinical Trial [NCT01894269]Phase 4200 participants (Anticipated)Interventional2013-07-31Recruiting
A Prospective, Open-label Trial of Two Abacavir/Lamivudine Based Regimen (ABC/3TC + Darunavir/Ritonavir or ABC/3TC + Raltegravir) in Late Presenter naïve Patients (With CD4 Count <200 Cells/µL - Advanced HIV Disease) [NCT01900106]Phase 347 participants (Actual)Interventional2013-11-30Completed
Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Virus Reactivation in Patients With Non-Hodgkin Lymphoma on CHOP/R-CHOP: a Randomized Phase II Study [NCT01914744]Phase 282 participants (Anticipated)Interventional2013-02-28Recruiting
Liver Cancer Institiute ,Fudan University [NCT01936233]Phase 3112 participants (Anticipated)Interventional2013-08-31Recruiting
A Single-Center, Open-Label Study to Evaluate the Renal Function Improvement in Lamivudine Long Term Used HBsAg Positive Kidney Transplantation Patients After Switch to Telbivudine Treatment. [NCT02894554]Phase 419 participants (Actual)Interventional2014-07-31Terminated(stopped due to clinical myalgia)
Pharmacokinetic Study of Twice Daily vs Once Daily Lamivudine and Abacavir as Part of Combination Antiretroviral Therapy in Children With HIV Infection [NCT01982396]Phase 119 participants (Actual)Interventional2003-01-31Completed
A Prospective, Randomized, Three-period Crossover, Interaction Study to Evaluate the Pharmacokinetics of Doravirine and Tenofovir Disoproxil Fumarate Co-administered With Cross-sex Hormonal Therapy in Adult HIV-negative Transgender Women [NCT04283656]Phase 17 participants (Actual)Interventional2022-02-14Completed
The Study of Mechanisms of Lipodystrophy in HIV-Infected Patients [NCT00006190]Phase 40 participants Interventional2000-11-30Completed
A Phase II Trial to Evaluate the Safety and Efficacy of Induction Treatment With Lamivudine Plus Stavudine Plus Abacavir Plus Amprenavir/Ritonavir Followed by Supervised Treatment Interruption in Subjects With Acute HIV Infection or Recent Seroconversion [NCT00000940]Phase 2121 participants (Actual)Interventional1999-05-31Completed
A Phase I/II Study of Ritonavir Therapy in HIV-1 Infected Infants and Children [NCT00000952]Phase 160 participants InterventionalCompleted
Comparison of the Virologic Efficacy of Nelfinavir and/or DMP 266 (Efavirenz, EFV) in Combination With One or Two New Nucleoside Analogs in Nucleoside Experienced Subjects: A Roll-Over Study to ACTG 302/303 [NCT00001087]Phase 2300 participants InterventionalCompleted
Immunologic and Virologic Consequences of Long-Term Highly Active Antiretroviral Therapy (HAART) in Subjects With Moderately Advanced HIV-1 Disease: A Follow-Up Study to ACTG 315 [NCT00000891]Phase 234 participants InterventionalCompleted
A Phase III Randomized, Controlled Trial of Efavirenz (EFV) or Nelfinavir (NFV) in Combination With Fixed-Dose Combination Lamivudine/Zidovudine (3TC/ZDV) and Indinavir (IDV) in HIV-Infected Subjects With Less Than or Equal to 200 CD4 Cells/mm3 or Greater [NCT00000903]Phase 3444 participants InterventionalCompleted
Treatment Outcome of Children With HIV Infection [NCT00476606]1,000 participants (Anticipated)Observational2003-03-31Active, not recruiting
Randomized, Open-Labeled Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Continuing Lamivudine Therapy or Switching to Entecavir in Subjects With Chronic Hepatitis B Who Achieved Undetectable HBV DNA [NCT00625339]Phase 472 participants (Actual)Interventional2008-02-29Completed
Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir of Chinese HIV/AIDS Patients In Acute HIV-1 Infection [NCT02219672]Phase 318 participants (Anticipated)Interventional2014-07-31Recruiting
Transgender Men and HIV in Uganda: PrEP Uptake and Persistence [NCT04867798]75 participants (Actual)Observational2021-09-16Completed
A Randomized, Open Labeled, Multicenter Study Comparing Entecavir Versus Lamivudine as Antiviral Prophylaxis for Patients With Hepatitis B Infection Undergoing Cytotoxic Chemotherapy for Malignant Tumors [NCT01580202]Phase 3180 participants (Actual)Interventional2012-04-30Completed
A Phase I, Single Dose, Five-period Crossover Relative Bioavailability Study of a Fixed-dose Combination Dolutegravir/Abacavir/Lamivudine Dispersible Tablet as Compared to a Co-dose of TIVICAY and EPZICOM in Healthy Subjects [NCT02893488]Phase 120 participants (Actual)Interventional2016-09-01Completed
Phase III Open-label Randomized Multicenter Trial to Assess the Non-inferiority of Raltegravir Compared With EFavirenz, Both in Combination With LAmivudine and TEnofovir, in ART-naïve HIV-1-infected Patients Receiving Rifampin for Active TuBerculosis [NCT02273765]Phase 3460 participants (Actual)Interventional2015-09-11Completed
Nucleoside Switch Pilot for Virologically Controlled HIV Subjects With Decreasing CD4 Cells Who Have Received TDF-based ARV Therapy [NCT01608269]Phase 430 participants (Anticipated)Interventional2010-11-30Completed
A Multicenter, Randomized, Controlled Study Comparing the Efficacy and Safety of 48 Weeks of 40kD Branched Pegylated Interferon Alfa-2a (PEG-IFN, RO 25-8310) Versus 96 Weeks of PEG-IFN, Alone or in Combination With 100 mg Lamivudine for 48 Weeks in Patien [NCT01095835]Phase 3131 participants (Actual)Interventional2005-02-28Completed
A Pilot Study of Highly Active Antiretroviral Therapy Using Isentress (Raltegravir) and Epzicom (Abacavir/Lamivudine) in Antiretroviral Naive HIV-Infected Subjects [NCT00740064]Phase 430 participants (Anticipated)Interventional2008-05-31Active, not recruiting
Safety and Efficacy of the Universal Use of EFV-TDF-FTC and AZT-3TC-LPV/r Combinations in Pregnant and Breastfeeding Women to Prevent mother-to Child Transmission of HIV-1 o, Resource-limited Settings: A Multicentre Randomized Phase 3 Clinical Trial [NCT00936195]Phase 30 participants (Actual)Interventional2010-01-31Withdrawn(stopped due to faillure to obtain insurance because of refusal from insurance companies)
A Randomized Open Label Study Evaluating the Efficacy of Continuous Telbivudine Versus Lamivudine in Patients With HBeAg-negative Chronic Hepatitis B Who Had Previously Achieved an Undetectable Viral Load During 24 Weeks of Telbivudine Therapy [NCT01005238]Phase 427 participants (Actual)Interventional2009-09-30Terminated(stopped due to unsufficient patient recruitment)
Phase I Three-way Crossover Bioequivalence Study of Pediatric Formulations of Lamivudine/Zidovudine/Nevirapine Using Healthy Adult Volunteers [NCT01469520]Phase 124 participants (Actual)Interventional2010-10-31Active, not recruiting
The Effects of Switching From Dolutegravir/Lamivudine/Abacavir (d/l/a) to Bictegravir/Emtricitabine/Tenofovir Alafenamide (b/f/Taf) in Patients With Suppressed Viral Load on Neuropsychiatric Side Effects and Neurocognitive Function [NCT04155554]Phase 3100 participants (Anticipated)Interventional2020-01-29Recruiting
Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis [NCT05630872]Phase 230 participants (Anticipated)Interventional2024-01-02Not yet recruiting
Phase 2a Open Label Study, Safety and Tolerability of Combination Antiretroviral Therapy (Triumeq) in Participants With Amyotrophic Lateral Sclerosis (ALS) - The Lighthouse Project. [NCT02868580]Phase 243 participants (Actual)Interventional2016-10-31Completed
Adjunctive Therapy With Telmisartan Instituted With ART During Acute HIV Infection to Reduce the Establishment of CNS Reservoirs of HIV and Lymph Node Fibrosis [NCT02750059]Phase 221 participants (Actual)Interventional2015-01-31Completed
Trial for the Optimal Timing of HIV Therapy After Cryptococcal Meningitis [NCT01075152]Phase 4177 participants (Actual)Interventional2010-11-30Completed
Virologic and Immunologic Activity of Continued Lamivudine (3TC) vs Delavirdine (DLV) in Combination With Indinavir (IDV) and Zidovudine (ZDV) or Stavudine (d4T) in 3TC-Experienced Subjects [NCT00000882]Phase 2300 participants InterventionalCompleted
ART Drug Dosage Adjustment Using FSCII in Chinese HIV-infected Population [NCT02632474]Phase 410 participants (Actual)Interventional2015-04-30Completed
Prevention of Mother-to-child Transmission of HIV-1: Programme Evaluation and Innovative Responsive Intervention Integrated in the Expanded Programme of Immunization. PROMISE-EPI Study [NCT03870438]Phase 31,506 participants (Actual)Interventional2019-12-14Completed
Breastfeeding Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere) [NCT01061151]Phase 33,747 participants (Actual)Interventional2011-03-01Completed
Determination of Plasma and Intracellular Levels of Nucleoside Reverse Transcriptase Inhibitors (NRTI) and of Nucleotide Analog Tenofovir Disoproxil Fumarate (TDF) in Patients Treated With Abacavir and/or Lamivudine Given With or Without TDF. [NCT00335192]Phase 432 participants (Actual)Interventional2005-01-31Completed
A Randomized, Prospective Study of the Efficacy, Safety and Tolerability of Two Doses of GW433908Ritonavir Given With Abacavir/Lamivudine Fixed Dose Combination [NCT00335270]Phase 4100 participants Interventional2006-03-31Completed
A 3 Arm, Prospective Study to Compare the Effect of 6 Weeks Exposure to the Combination of Lopinavir (LPVr)/Combivir® (AZT/3TC) Versus Lopinavir Alone or Combivir® Alone in HIV-negative Healthy Subjects on the Development of Abnormalities of Lipid and Glu [NCT00192621]Phase 450 participants (Actual)Interventional2004-11-30Completed
Analysis of Lipodystrophy in HIV-Infected Individuals A Prospective, Non-randomised, 48 Week Study of the Effect of PI Containing and Non-PI Containing Antiretroviral Regimens on the Expression of Adipocyte Specific Genes, Protein Levels and Cellular Stru [NCT00192660]Phase 480 participants (Actual)Interventional2003-02-28Completed
A Phase III Randomized Trial of the Safety and Antiretroviral Effects of Zidovudine/Lamivudine/Abacavir Versus Zidovudine/Lamivudine/Lopinavir/Ritonavir in the Prevention of Perinatal Transmission of HIV [NCT00086359]Phase 319 participants (Actual)Interventional2004-07-31Completed
Implementing Anti-Retroviral Therapy in Resource-Constrained Settings: A Randomized Controlled Trial to Assess the Effect of Integrated Tuberculosis and HIV Care on the Incidence of AIDS-Defining Conditions or Mortality in Subjects Co-Infected With Tuberc [NCT00091936]592 participants (Anticipated)Interventional2009-08-31Completed
A Phase II, Open Label, Single Arm Trial to Evaluate the Pharmacokinetics,Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Antiretroviral Naive HIV-1 Infected Adolescents and Children Aged >= 6 to <18 Years [NCT00799864]Phase 254 participants (Actual)Interventional2011-01-07Completed
The Adult Antiretroviral Treatment and Resistance Study (Tshepo) [NCT00197613]Phase 3650 participants Interventional2002-12-31Completed
Lamivudine Therapy in Patients With Prior Entecavir Treatment and Undetectable Viral Load [NCT01013272]50 participants (Actual)Interventional2007-06-30Completed
Effect of Cytoreductive Chemotherapy Combined With Highly Active Antiretroviral Therapy on Lymph Node HIV DNA in HIV-Infected Subjects [NCT00000899]Phase 110 participants InterventionalCompleted
A Randomized, Double-blind, Double-simulated, Active-controlled,Phase III Clinical Study Evaluating the Efficacy and Safety of Azvudine Combined With Tenofovir Fumarate and Efavirenz in Hiv-infected Treatment Naive Patients [NCT04303598]Phase 3720 participants (Anticipated)Interventional2020-04-01Not yet recruiting
A Real-world Study of Lamivudine and Dotiravir Sodium Tablets in the Treatment-naïve HIV-1 Infected Patients [NCT05332470]200 participants (Anticipated)Observational2022-05-01Not yet recruiting
Bioavailability Study of a New Pediatric Formulation of Zidovudine/Lamivudine in Adult Volunteers [NCT00470041]Phase 112 participants (Anticipated)Interventional2007-06-30Completed
Pilot Study to Investigate the Safety and Feasibility of AntiRetroviral Therapy for Alzheimer's Disease (ART-AD) [NCT04552795]Phase 1/Phase 212 participants (Actual)Interventional2021-02-15Active, not recruiting
Efficacy, Safety and Tolerability of Switching to Dolutegravir/Lamivudine in Virologically-suppressed Adults Living With HIV on Bictegravir/Tenofovir Alafenamide/emtricitabine-the DYAD Study [NCT04585737]Phase 4222 participants (Actual)Interventional2020-09-22Completed
Tenofovir Versus Lamivudine for Patients of Chronic Hepatitis B With Severe Acute Exacerbation [NCT01848743]Phase 3120 participants (Anticipated)Interventional2013-04-30Recruiting
A Study on the Viral Kinetics of Different Regimens of Pegylated Interferon and Lamivudine Combination Therapy in HBeAg Positive Chronic Hepatitis B [NCT00226447]Phase 230 participants Interventional2002-12-31Completed
A Phase I Trial of the Safety, Tolerance, and Pharmacokinetics of Oral Nelfinavir (Viracept) Co-Administered With Zidovudine (ZDV) and Lamivudine (3TC) in HIV Infected Pregnant Women and Their Infants [NCT00000887]Phase 124 participants InterventionalCompleted
Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND) [NCT04826562]Phase 440 participants (Actual)Interventional2021-09-26Active, not recruiting
A Phase II, Randomized, Open-Label Comparative Trial of Salvage Antiretroviral Therapies for HIV-Infected Individuals With Virological Evidence of Nelfinavir Treatment Failure as Reflected by Plasma HIV RNA Concentration of >= 1,000 Copies/ml [NCT00000918]Phase 2300 participants InterventionalCompleted
Influence of Risk Status for Disease Progression on the Response to Antiretroviral Interventions: A Follow-up Study to ACTG 175 [NCT00001068]Phase 2210 participants InterventionalCompleted
An Open-Label Randomized Study of Delavirdine Mesylate (Rescriptor) in Combination With Zidovudine (Retrovir) and Two Doses of Indinavir (Crixivan) Versus Zidovudine, Lamivudine (Epivir), and Indinavir in HIV-1-Infected Individuals [NCT00002400]45 participants InterventionalCompleted
A Phase II, Open-Label, Randomized Study of the Efficacy and Safety of Epivir 150 Mg BID Versus Epivir 300 Mg Once-Daily When Administered for 24 Weeks in Combination With FDA-Approved Dosage Regimens of Zerit and Either Crixivan or Viracept in Subjects W [NCT00002442]Phase 20 participants Interventional1999-06-30Completed
A Phase II, Open-Label Study of AG1549 in Combination With Other Antiretroviral Agents in Treatment-Naive HIV-Infected Patients [NCT00004998]Phase 230 participants Interventional1999-11-30Suspended
Randomized Trial of Switch to Tenofovir Versus Continue Lamivudine/Adefovir Treatment in Lamivudine-resistance Chronic Hepatitis B Patients Who Have Undergone Lamivudine/Adefovir Add-on Treatment [NCT01491295]Phase 4160 participants (Anticipated)Interventional2012-09-30Recruiting
Post-Marketing Clinical Study of EPZICOM Tablet (Lamivudine / Abacavir Sulfate) - Pharmacokinetic Study in HIV-Infected Patients - [NCT00337922]Phase 48 participants Interventional2006-07-31Completed
Study of Changes in CD4 Lymphocyte Count in Patients With a HAART Regimen Including DDI + Tenofovir and With Viral Suppression Following the Replacement of Tenofovir With Abacavir Once Daily or Following the Double Replacement of DDI + Tenofovir With Abac [NCT00338390]Phase 375 participants (Actual)Interventional2005-04-30Completed
A Randomization Trial of Adjuvant Lamivudine/ Adefovir Dipivoxil Against Recurrence in Post-operative HBV-related Hepatocellular Carcinoma [NCT00455091]117 participants (Actual)Observational2007-05-31Terminated(stopped due to No cases enrollment)
Comparison of the Steady State Pharmacokinetics of Nevirapine, Stavudine Plus Lamivudine in HIV Positive Ugandan Patients Taking Triomune 40 With the Pharmacokinetics of the Originator Products. [NCT00455585]Phase 418 participants Interventional2007-01-31Completed
Prospective Randomized Study for the Comparison of Adding Adefovir Dipivoxil and Switching to Entecavir in Patients With Lamivudine-resistant Chronic Hepatitis B [NCT00531167]Phase 4219 participants (Actual)Interventional2007-04-30Completed
Randomized, Non-inferiority Trial Comparing a Dual Maintenance Therapy Strategy With Dolutegravir + Lamivudine (DTG/3TC) or Atazanavir/Ritonavir + Lamivudine (ATV/r+3TC) Versus the Standard WHO First Line Triple Therapy Tenofovir + Lamivudine + Efavirenz [NCT04022967]Phase 3480 participants (Actual)Interventional2020-09-21Active, not recruiting
Multicentre, Open Label, Prospective, Randomised Clinical Trial of an Antiretroviral Simplification Treatment With Efavirenz + Abacavir + 3TC Once Daily [NCT00314626]Phase 399 participants (Actual)Interventional2004-11-30Completed
Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-term Observational Study [NCT00537966]2,017 participants (Anticipated)Interventional2002-01-31Recruiting
A Randomized, Open Label, Multicenter Study Comparing the Safety and Efficacy of Once Daily Regimen Containing Epzicom or Truvada Combined With Ritonavir Boosted Atazanavir as Initial Therapy for HIV-1 Infection (ET Study) [NCT00544128]Phase 4109 participants (Actual)Interventional2007-10-31Completed
An Evaluation of the Bioequivalence of a Combined Formulated Tablet (50mg/600mg/300mg Dolutegravir/Abacavir/Lamivudine) Compared to One Dolutegravir 50mg Tablet and One EPZICOM† (600mg/300mg Abacavir/Lamivudine) Tablet Administered Concurrently and the Ef [NCT01622790]Phase 166 participants (Actual)Interventional2012-06-30Completed
Phase IV Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients [NCT00084253]Phase 4200 participants (Anticipated)Interventional2004-06-30Completed
An International, Double Blind, Randomized, Phase III Study to Evaluate the Tolerance, Safety, and Effectiveness of Viramune (Nevirapine) in Preventing Clinical AIDS Progression Events or Death When Used in Combination With Lamivudine (3TC) and Stable (>= [NCT00002368]Phase 32,000 participants InterventionalCompleted
A Phase I Study of Methotrexate for HIV Infection [NCT00000834]Phase 130 participants InterventionalCompleted
Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals [NCT00001080]0 participants (Actual)InterventionalWithdrawn(stopped due to as of 4/23/97)
A Pilot Study of Once-Daily Therapy With Amprenavir, Ritonavir, Lamivudine and Abacavir in HIV-Infected, Antiretroviral-Naive Patients [NCT00001968]Phase 125 participants Interventional2000-01-31Completed
A Double-Blind, Randomized, Dose Response Study of Three Doses of Delavirdine Mesylate (U-90152S) in Combination With Zidovudine (ZDV) Versus ZDV Alone in HIV-1 Infected Individuals With CD4 Counts of 200-500mm3 [NCT00002124]Phase 31,250 participants InterventionalCompleted
A Phase II Open-Label Exploratory Study of Saquinavir + Zidovudine + Lamivudine in HIV Infected Patients [NCT00002190]Phase 230 participants InterventionalCompleted
A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TC [NCT00002208]Phase 3400 participants InterventionalCompleted
A Randomized Controlled Clinical Study to Determine If the Addition of HIV RNA Viral Load Is an Effective Tool in Determining Treatment Regimens for HIV-Infected Patients [NCT00002376]Phase 4540 participants InterventionalCompleted
A Multicenter, Double-Blind, Randomized Pilot Study to Compare the Safety and Activity of L-756423/Indinavir, 1600/800 Mg Qd or 800/400 Mg Bid Versus Indinavir, 800 Mg q8h, All in Combination With Stavudine and Lamivudine [NCT00002424]Phase 2186 participants InterventionalSuspended
A Randomized Lamivudine (3TC)/Dideoxycytidine (ddC) Double-Blind Multicenter Trial (With Open-Label AZT) to Evaluate the Safety and Efficacy of Low Dose 3TC Administered Concurrently With AZT Versus High Dose 3TC Administered Concurrently With AZT Versus [NCT00002436]Phase 3325 participants InterventionalCompleted
Phase I/II Study of ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naive HIV-Infected Patients [NCT00004578]Phase 1/Phase 2100 participants (Actual)Interventional1997-11-30Completed
A 96-Week, Randomized, Open-Label, Multicenter Trial to Evaluate the Safety and Tolerability of the Antiretroviral Activity of Stavudine (40mg BID) Plus Lamivudine (150mg BID) Plus Nelfinavir (1250mg BID) Versus Abacavir (300mg BID) Plus Combivir (3TC 150 [NCT00005106]Phase 4230 participants Interventional1999-09-30Completed
Tipranavir (PNU-140690): A Fourteen Day Dose-response Study Using a Prototype Self-emulsifying Drug Delivery System (SEDDS) Formulation in Treatment-naive HIV-1 Infected Patients. Report on the Post-study Option, a 46-week Treatment Period of Triple Thera [NCT02249130]Phase 218 participants (Actual)Interventional1999-03-31Completed
A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A Once-Daily Versus ATRIPLA™ Once-Daily in Treatment-Naïve HIV-1 Infected Subjects [NCT02403674]Phase 3734 participants (Actual)Interventional2015-06-05Completed
An Open Label, Randomized Study to Compare Antiretroviral Therapy (ART) Initiation When CD4 is Between 15% to 24% to ART Initiation When CD4 Falls Below 15% in Children With HIV Infection and Moderate Immune Suppression [NCT00234091]Phase 3300 participants (Actual)Interventional2006-04-30Completed
An Open-Label, Randomized Study to Determine the Impact of Antiretroviral Treatment in HCV/HIV-Coinfected Subjects With High CD4+ Cell Count on the Efficacy of Hepatitis C Treatment With Pegylated Interferon Alfa-2A and Ribavirin [NCT00100581]2 participants (Actual)InterventionalCompleted
A Multicenter, Randomized, Open Label, Clinical Trial Comparing a QD Regimen of Didanosine, Lamivudine and Efavirenz With a Standard BID Regimen of Zidovudine, Lamivudine and Efavirenz in the Starting Treatment of Human Immunodeficiency Virus Infection (G [NCT00256828]Phase 4360 participants Interventional2004-06-30Completed
A Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety and Efficacy of the Combination of 1592U89/Zidovudine (ZDV)/Lamivudine (3TC) Versus the Combination of Zidovudine (ZDV)/Lamivudine (3TC) in HIV-1 Therapy-Experienced Pediatric Patients. [NCT00002391]Phase 30 participants InterventionalCompleted
Safeguard the Household: A Study of HIV Antiretroviral Therapy Treatment Strategies Appropriate for a Resource Poor Country [NCT00080522]813 participants Interventional2005-02-28Completed
A Multicenter, Open-Label, 24-Week Pilot Study to Evaluate the Safety and Activity of Indinavir Sulfate 1200 Mg q.d. and Ritonavir 200 Mg q.d. in Combination With Stavudine and Lamivudine in Treatment Naive HIV-1 Infected Patients [NCT00002451]Phase 28 participants InterventionalActive, not recruiting
Long-Term Lamivudine Therapy for Chronic Hepatitis B [NCT00120354]Phase 450 participants Interventional2005-07-11Completed
A Randomized Clinical Trial to Determine the Efficacy of Early Versus Standard Antiretroviral Therapy in HIV Infected Adults With CD4+ T Cell Counts Between 200 and 350 Cells/mm3 [NCT00120510]816 participants (Actual)Interventional2007-07-31Completed
Abacavir Pharmacokinetics During Chronic Therapy in HIV-1 Infected Adolescents and Young Adults [NCT00087945]30 participants Interventional2004-07-31Completed
Efficacy and Tolerability of an Antiretroviral bi-Therapy in HIV-1 Infected Patients With Multidrug Resistant HIV ANRS 109 Vista Trial. [NCT00120783]Phase 240 participants Interventional2002-02-28Terminated
MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS) [NCT00122226]Phase 450 participants Interventional2003-01-31Active, not recruiting
HAART Regimen Comprising 3TC + ddI + EFV in Once-daily Administration in HIV-1 Infected Children in Burkina Faso [NCT00122538]Phase 252 participants (Actual)Interventional2006-02-28Completed
See Detailed Description [NCT00085943]Phase 3866 participants Interventional2004-05-31Completed
AN OPEN STUDY OF LAMIVUDINE TREATMENT IN ADULT HBeAg NEGATIVE (Presumed Pre-core Mutant) CHRONIC HEPATITIS B PATIENTS IN IRAN. [NCT00354653]Phase 4100 participants Interventional2002-02-09Completed
Difference in Efficacy Between Umbilical Cord Mesenchyma Stem Cell Transplantation and Classical Therapy in Liver Cirrhosis Patients [NCT01718587]Phase 1/Phase 260 participants (Anticipated)Interventional2012-11-30Not yet recruiting
Clinical Trial: Backup With Combivir (AZT/3TC) or Single Dose (sd) Truvada (FTC/TDF) in Order to Avoid NNRTI Resistance After sd Nevirapine for the Prevention of Mother-to-child Transmission (MTCT) [NCT00346567]566 participants (Actual)Interventional2006-06-30Completed
See Detailed Description [NCT00094367]Phase 3900 participants Interventional2004-07-31Completed
A Phase III Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B [NCT00131742]Phase 30 participants Interventional2004-07-31Completed
A Pilot Study of Safety, Effectiveness, and Adherence of Lamivudine/Zidovudine and Efavirenz (3TC/ZDV + EFV) to Treat HIV-1 Infection in Senegal [NCT00100568]44 participants (Actual)Interventional2006-07-31Completed
A Prospective, Multicenter, Open, Randomized Phase 2a Trial to Confirm a Sustained Virological Suppression Defined as HIV-RNA <50 Copies/ml of 3 Different Doses of Fozivudine in Context to a Standard Zidovudine Based Antiretroviral Therapy Regimen After 2 [NCT01714414]Phase 2120 participants (Actual)Interventional2012-12-31Completed
A Randomized Clinical Trial Assessing Continuous HAART Versus Interrupted HAART in a Resource Poor Clinic [NCT00100646]30 participants (Actual)Interventional2007-03-31Completed
Combivir, 1592U89, 141W94 Triple Antiretroviral, Experienced Patient Trial [NCT00002217]0 participants InterventionalCompleted
A Phase II, Randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Two Antiretroviral Therapeutic Strategies: A Dual PI-Based HAART Regimen Versus a Multi-NRTI ART Regimen, in ART-Experienced Children and Youth Who Have Experienced Virol [NCT00102206]Phase 26 participants (Actual)InterventionalCompleted
A Randomized Study Comparing Lamivudine Versus Adefovir Dipivoxil for Prevention of zHBV Reactivation in HBsAg Seropositive Patients Undergoing Cytotoxic Chemotherapy [NCT00489151]70 participants (Anticipated)Interventional2005-06-30Recruiting
A Randomized, Double-Blind Multicenter Trial to Compare the Safety and Efficacy of Lamivudine (3TC; GR109714X) Monotherapy Versus Zidovudine (AZT) Monotherapy Versus 3TC Administered With AZT in the Treatment of HIV-1 Infected Patients Who Are AZT Naive ( [NCT00002320]Phase 3320 participants InterventionalCompleted
A Phase 3b, Multi-center, Randomized, Parallel-group, Open-label, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Oral Dolutegravir/Lamivudine Once-daily as a First-line Regimen Compared to Oral Bictegravir/Emtricitabine/Tenofov [NCT05979311]Phase 3412 participants (Anticipated)Interventional2023-12-29Not yet recruiting
A Phase II Trial of Lamivudine in Combination With Chemoimmunotherapy in Patients With Extensive Stage SCLC [NCT04696575]Phase 228 participants (Anticipated)Interventional2021-07-02Recruiting
A Randomized, Parallel Arm, Comparative, Open Label, Multicenter Study of the Activity and Safety of Two Formulations of Saquinavir in Combination With Other Antiretroviral Drugs [NCT00002162]Phase 2140 participants InterventionalCompleted
A Phase I Safety and Pharmacokinetic Study of 1592U89 Alone and In Combination With Other Antiretroviral Agents in Infants and Children With HIV Infection [NCT00000865]Phase 132 participants InterventionalCompleted
Viral and Immune Dynamics in HIV-Infected Patients With Tuberculosis [NCT00004736]Phase 144 participants InterventionalCompleted
Treatment Rollover for Subjects Formerly on ACTG 328 With Subcutaneous Interleukin-2 (IL-2) in Combination With Highly Active Antiretroviral Therapy (HAART) [NCT00000923]110 participants InterventionalCompleted
Contribution of the Integrase Inhibitor Dolutegravir to Obesity and Cardiovascular Disease in Persons Living With HIV [NCT04340388]Phase 410 participants (Actual)Interventional2020-09-17Completed
A Phase II Rolling Arm Master Protocol (PRAM) of Novel Antiretroviral Therapy in Stable Experienced HIV- Infected Children; PRAM-1: ZDV+3TC vs. d4T+Ritonavir vs. ZDV+3TC+Ritonavir; PRAM-1, Step 2: d4T+Nevirapine+Ritonavir; PRAM-1, Step 3: d4T+Indinavir vs [NCT00001083]Phase 2240 participants InterventionalCompleted
A Study of the Effects of Combination Antiretroviral Therapy in Acute HIV-1 Infection With an Emphasis on Immunological Responses [NCT00001119]288 participants Interventional1999-10-31Completed
A Randomized, Open-Label, Two Arm Trial to Compare the Safety and Antiviral Efficacy of GW433908/Ritonavir QD to Nelfinavir BID When Used in Combination With Abacavir and Lamivudine for 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Subjects [NCT00009061]Phase 3624 participants Interventional2000-11-30Active, not recruiting
Randomized Trial of Protease Inhibitor-Including vs. Protease Inhibitor-Sparing Regimens for Women Who Initiate Therapy of HIV Infection During Pregnancy [NCT00017719]Phase 3440 participants Interventional2002-05-31Completed
Nucleoid as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma [NCT00555334]Phase 4200 participants (Anticipated)Interventional2007-11-30Recruiting
A Phase IIb Extension Study of LdT (Telbivudine), Lamivudine or LdT Plus Lamivudine in Patients With Chronic Hepatitis B Who Have Completed Study NV-02B-003 [NCT00124241]Phase 20 participants InterventionalCompleted
Evaluation of Safety and Efficacy of Two Different Once Daily Anti Retroviral Treatment Regimens Along With Anti-tuberculosis Treatment in Patients With HIV-1 and Tuberculosis [NCT00332306]Phase 3180 participants (Anticipated)Interventional2006-06-30Active, not recruiting
A Randomized Controlled Study Comparing the Impact of Prophylactic Versus Deferred Lamivudine on the Delivery of Cytotoxic Chemotherapy in Hepatitis B Surface-antigen Positive Patients With Malignant Solid Tumor [NCT00516945]110 participants (Anticipated)Interventional2004-09-30Completed
A Randomized Controlled Trial to Compare the Efficacy of a Four Drug Antiretroviral Regimen Alone or in Combination With GM-CSF or IL-12 Administered to HIV-1 Infected Subjects as Measured by the Characteristics of Viral Decay [NCT00000896]24 participants InterventionalCompleted
A Phase I/II Study of Safety and Efficacy of Lamivudine (EPIVIR®) and Tenofovir Disoproxil Fumarate (VIREAD®) Used to Lower the Plasma Level of Viral RNA of HERV-K(HML2) in Patients With Lymphoma [NCT01528865]Phase 1/Phase 20 participants (Actual)Interventional2015-12-31Withdrawn(stopped due to Funding was removed.)
ART Pharmacokinetics, Mitochondrial Integrity, and Antioxidant Capacity in Severely Malnourished HIV-infected Malawian Children [NCT01529125]42 participants (Actual)Observational2011-07-31Completed
Efficacy of Adefovir and Lamivudine Combination Therapy in Patients With Entecavir Resistance [NCT01546116]Phase 420 participants (Actual)Interventional2010-02-28Completed
A Feasibility Study of Lamivudine/Zidovudine (3TC/ZDV) Plus Efavirenz (EFV) as Initial Therapy of HIV-1 Infected Patients in a Rural Area of China [NCT00100594]100 participants (Anticipated)Interventional2005-05-31Completed
Evaluation of the Relationship Between Immunologic Recovery After Highly Active Antiretroviral Therapy and the Ability to Mobilize CD34+ Stem Cells Following G-CSF Administration [NCT00006578]0 participants (Actual)InterventionalWithdrawn
An Open-Label, Single Center Trial to Evaluate the Efficacy and Safety of Quadruple Chemotherapy (Zidovudine, EPIVIR, 1592U89, and 141W94) in Subjects Infected With HIV-1 (GW QUAD) [NCT00006617]25 participants InterventionalCompleted
Lamivudine and Therapeutic Vaccine Evaluation in Senegalese Patients With Chronic Hepatitis B Infection [NCT00120796]Phase 38 participants (Actual)Interventional2005-08-31Terminated(stopped due to poor patient recrutment)
Phase II, Randomized, Open-Label Study of Switching to Protease Inhibitor-Sparing Regimens for Improvement of Metabolic Abnormalities [NCT00021463]Phase 2342 participants InterventionalCompleted
A Phase IV Multicenter Study of the Efficacy and Safety of 48-Week Induction Treatment With TRIZIVIR (Abacavir 300 Mg/Lamivudine 150 Mg/Zidovudine 300 Mg Combination Tablet BID) With Efavirenz (600 Mg QD) Followed by 48-Week Randomized, Open-Label, Mainte [NCT00011895]Phase 4400 participants Interventional2001-02-28Active, not recruiting
Randomized Study to Evaluate Immediate Potent Antiretroviral Therapy for HIV-Infected Subjects With CD4 Cell Counts Less Than 350 Cells/mm3 Admitted to Intensive Care Areas With an AIDS-Defining Illness, Pneumonia, or Sepsis [NCT00028327]Phase 3250 participants InterventionalCompleted
A Randomized, Controlled Trial of Two Potent, Simplified Regimens Utilizing A Protease Inhibitor-Sparing Regimen Versus A Nucleoside-Sparing Regimen for HIV-Infected Subjects Who Participated in ACTG 388 or Who Responded to A First Potent Combination Regi [NCT00014937]240 participants InterventionalCompleted
A Randomized, Double-Blind, Phase II Study of 141W94 (VX-478) Monotherapy vs. 141W94 (VX-478) Plus ZDV Plus 3TC in HIV Infected Individuals [NCT00001085]Phase 294 participants InterventionalCompleted
A Phase IV, Open-label, Multicenter Study of Treatment With TRIZIVIR (Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg) Twice Daily and Tenofovir 300mg Once-daily for 48 Weeks in HIV-infected Subjects Experiencing Early Virologic Failure (ZIAGEN Intensifi [NCT00038506]Phase 4100 participants Interventional2002-03-31Completed
Lamivudine for Chronic Hepatitis B [NCT00001457]Phase 260 participants Interventional1995-09-30Completed
A Phase III, Randomized, Open-label, Multicenter Study of the Safety and Efficacy of Efavirenz Versus Tenofovir When Administered in Combination With the Abacavir/Lamivudine Fixed-dose Combination Tablet as a Once-daily Regimen in Antiretroviral-naive HIV [NCT00053638]Phase 3345 participants Interventional2003-02-28Completed
A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B [NCT00057265]Phase 30 participants Interventional2003-02-28Completed
Delaying HIV Disease Progression With Punctuated Antiretroviral Therapy in HIV-Associated Tuberculosis [NCT00078247]Phase 3350 participants (Anticipated)Interventional2004-10-31Completed
A Randomised Trial of Lamivudine Plus Interferon Versus Lamivudine for the Treatment of HBeAg Positive Chronic Hepatitis B Virus (HBV) [NCT00140725]Phase 3160 participants Interventional2000-04-30Completed
A Pilot Study of a Nucleoside Analogue Reverse Transcriptase Inhibitor Sparing Regimen in Antiretroviral-Naïve, HIV-infected Patients [NCT00143689]Phase 413 participants (Actual)Interventional2002-04-30Completed
A Randomized Study to Evaluate Virologic Response Following Discontinuation vs. no Discontinuation of 3TC in Patients Who Are Infected With HIV With Previously Documented Reduced Susceptibility to 3TC and Who Have Adequate Virologic Suppression on Combina [NCT00143728]Phase 4152 participants (Anticipated)Interventional2004-01-31Suspended(stopped due to Enrollment.)
Phase III, Randomized, Double-Blind Comparison of Three Protease Inhibitor-Sparing Regimens for the Initial Treatment of HIV Infection [NCT00013520]Phase 31,125 participants InterventionalCompleted
A Randomized, Double-Blind Trial of Telbivudine (LdT) Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis. [NCT00275652]Phase 36 participants Interventional2004-06-30Completed
Immunologic Consequences of Antiretroviral Therapy Intensification in Subjects With Moderately Advanced HIV-1 Disease: A Follow-Up Study to ACTG 315/375 [NCT00034086]22 participants InterventionalCompleted
A Double-Blind, Randomized Trial of Antiviral Activity and Safety of 12 Weeks Oral Treatment With ACH-126,443 (Beta-L-Fd4C) in Treatment-Naive HBV-Infected Adults [NCT00034359]Phase 279 participants (Actual)Interventional2002-02-28Completed
A Phase I/II, Open Label Study to Evaluate the Ability of Combination Therapy With ABT-378/Ritonavir (Kaletra), Lamivudine (Epivir), Efavirenz (Sustiva)and Tenofovir DF to Completely Suppress Viral Replication in Subjects Infected With HIV-1 [NCT00038220]Phase 240 participants Interventional2000-07-31Completed
A Phase III, Randomized, Open-Label Comparison of Lopinavir/Ritonavir Plus Efavirenz Versus Lopinavir/Ritonavir Plus 2 NRTIs Versus Efavirenz Plus 2 NRTIs as Initial Therapy for HIV-1 Infection [NCT00050895]Phase 3775 participants InterventionalCompleted
Multicenter, Pilot Study of Telbivudine (LdT) Anti-HBV Treatment Prior to the Initiation of Highly Active Antiretroviral Therapy Containing Lamivudine in Subjects Coinfected With HBV and HIV [NCT00051090]0 participants (Actual)InterventionalWithdrawn
Augmenting the Magnitude of HAART-Induced Immune Restoration With the Use of Cyclosporine [NCT00031070]Phase 240 participants InterventionalCompleted
Glaxo Wellcome Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects (TARHEEL) [NCT00005764]Phase 4100 participants Interventional2000-05-31Completed
Phase II Trial Of Induction Therapy With EPOCH Chemotherapy And Maintenance Therapy With Combivir/Interferon ALPHA-2a For HTLV-1 Associated T-Cell Non-Hodgkin's Lymphoma [NCT00041327]Phase 219 participants (Actual)Interventional2002-10-31Completed
A Phase II, Randomised, Double-blind, Dose-ranging Study of AVX754 Versus Lamivudine in Treatment-experienced HIV-1 Infected Patients With the M184V Mutation in Reverse Transcriptase [NCT00126880]Phase 252 participants (Actual)Interventional2005-07-31Completed
A Retrospective Study to Compare the 3-Year Antiviral Efficacy of Nevirapine and Efavirenz in Combination With D4t and 3tc in 2NN Patients and of Trizivir Versus Trizivir Plus Nevirapine in CHARM Patients [NCT00127972]Phase 4763 participants (Actual)Interventional2004-02-29Completed
A Randomized, Open-Label Study Exploring a Simplified Kaletra® (Lopinavir/Ritonavir)-Based Therapy Versus a Sustiva® (Efavirenz)-Based Standard of Care in Previously Non-Treated HIV-Infected Subjects [NCT00075231]Phase 2150 participants Interventional2003-12-31Completed
A Randomized Trial of Switching Antiviral Therapy From Lamivudine to Telbivudine (LdT) vs. Continued Lamivudine Treatment in Adults With Chronic Hepatitis B [NCT00132652]Phase 3240 participants Interventional2005-02-28Completed
A Phase II Open Label Clinical Trial of Maternal Zidovudine/Lamivudine and Either Nevirapine or Nelfinavir for Maximal Reduction of Mother-to-child HIV Transmission in Resource-limited Settings Among Breastfeeding Populations [NCT00146380]Phase 2520 participants (Anticipated)Interventional2003-07-31Active, not recruiting
Free Study: a Randomised, Open Label, Multicentre Strategic Study to Evaluate the Efficacy and Toxicity of an Early Switch From a PI-containing Regimen to Trizivir ® on Guidance of Viral Load in HIV-1 Infected , Antiretroviral naïve Adults [NCT00405925]Phase 3207 participants (Actual)Interventional2003-03-31Completed
A Phase II Study of Lopinavir/Ritonavir in Combination With Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-Infected Subjects [NCT00043953]Phase 230 participants (Actual)Interventional2002-08-31Completed
Feasibility Study of a Once Daily Antiretroviral Regimen for HIV-Infected Patients With CD4 Below 200/mm3, in Hô Chi Minh City, Vietnam [NCT00158470]Phase 3100 participants (Actual)Interventional2003-09-30Completed
A Phase 3, Randomized, Double-Blind, Multicenter Study of the Treatment of Antiretroviral-naive, HIV-1-Infected Patients Comparing Tenofovir Disoproxil Fumarate Administered in Combination With Lamivudine and Efavirenz vs. Stavudine, Lamivudine and Efavir [NCT00158821]Phase 3180 participants (Anticipated)Interventional2000-03-31Completed
See Detailed Description [NCT00044577]Phase 3166 participants Interventional2002-07-16Completed
Boosted PI VS. NNRTI Based Therapy as Initial Treatment for HIV-1 Infected Patients With Advanced Disease [NCT00162643]Phase 4300 participants Interventional2004-12-31Recruiting
A Phase III Study Comparing the Antiviral Efficacy and Safety of BMS-232632 With Efavirenz; Each in Combination With Fixed Dose Zidovudine-Lamivudine [NCT00013897]Phase 30 participants Interventional2001-02-28Completed
A Phase III, 48-Week, Open-Label, Randomized, Multicenter Study of the Safety and Efficacy of the Abacavir/Lamivudine Fixed-Dose Combination Tablet Administered QD Versus Abacavir + Lamivudine Administered BID in Combination With a PI or NNRTI in Antiretr [NCT00046176]Phase 3240 participants Interventional2002-08-26Completed
Virological and Clinical Anti-HBV Efficacy of Tenofovir in Antiretroviral naïve Patients With HIV/HBV Co-infection [NCT00192595]Phase 436 participants (Actual)Interventional2004-01-31Completed
A Randomised, Open-label Trial to Assess the Safety and Efficacy of Switching to Tenofovir-emtricitabine or Abacavir-lamivudine: The STEAL Study. [NCT00192634]Phase 4357 participants (Actual)Interventional2005-12-31Completed
Randomized, Open-Label 2x2 Factorial Study to Compare the Safety and Efficacy of Different Combination Antiretroviral Therapy Regimens in Treatment Naive Patients With Advanced HIV Disease and/or CD4+ Cell Counts Less Than 200 Cells/MicroL [NCT00342355]Phase 41,771 participants (Actual)Interventional2004-01-31Completed
A Randomized, Double-Blind, Placebo-Controlled Study of AG1549 in Combination With Viracept (Nelfinavir Mesylate) and Combivir (Zidovudine + Lamivudine) in Treatment-Naive HIV-Infected Patients [NCT00004999]Phase 2350 participants Interventional1999-08-31Suspended
Optimizing Pediatric HIV-1 Treatment in Infants With Prophylactic Exposure to Nevirapine, Nairobi, Kenya (6-12 Month RCT) [NCT00427297]Phase 334 participants (Actual)Interventional2007-09-30Terminated(stopped due to There is no longer equipoise. DSMB recommended termination.)
Open Label Randomized Controlled Trial to Assess the Impact of Prophylactic Exposure to Tenofovir Gel on the Efficacy of Subsequent Tenofovir-containing Antiretroviral Therapy on Viral Suppression [NCT01387022]59 participants (Actual)Interventional2011-06-30Completed
Entecavir Intensification for Persistent Hepatitis B Virus (HBV) Viremia in HIV-HBV Infection [NCT00662545]Phase 410 participants (Actual)Interventional2008-04-30Completed
A Phase II, Open-Label Trial, to Evaluate Pharmacokinetics, Safety, Tolerability and Antiviral Activity of Drv/Rtv Once Daily in Treatment-Naive HIV-1 Infected Adolescents Aged Between 12 and < 18 Years [NCT00915655]Phase 212 participants (Actual)Interventional2009-07-31Completed
A Pilot, Open-Label, Randomized, Comparative Study of the Antiviral Efficacy of Lopinavir/Ritonavir Single-Drug Regimen Versus Lopinavir/Ritonavir in Combination With Lamivudine/Zidovudine in Antiretroviral Naïve Patients [NCT00234923]Phase 3138 participants (Actual)Interventional2003-08-31Completed
A Randomised Open Label Multi-centre Trial to Evaluate the Pharmacokinetic, Efficacy and Safety Parameters of Nevirapine 150mg/m2 and Nevirapine 4 or 7 mg/kg When Administered in Combination With AZT and 3TC for 48 Weeks in Antiretroviral naïve Paediatric [NCT00273975]Phase 2123 participants Interventional2002-01-31Completed
Prevention of HIV1 Mother to Child Transmission Without Nucleoside Analogue Reverse Transcriptase Inhibitors in the Pre-partum Phase. A Multicenter Randomised Phase II/III Open Label Study With a Group of 100 Pregnant Women Receiving Lopinavir/Ritonavir a [NCT00424814]Phase 2/Phase 3105 participants (Actual)Interventional2007-03-31Completed
Molecular, Biochemical and Clinical Differences Between Stavudine and Tenofovir, Each Combined With Lamivudine and Efavirenz in South African HIV-infected Patients [NCT01601899]Phase 460 participants (Actual)Interventional2008-10-31Terminated(stopped due to DSMB decision to begin closeout process in view of April 2010 SA HAART guideline)
Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial [NCT00272480]Phase 2/Phase 316 participants (Actual)Interventional1999-11-08Completed
A Phase IIIb, Randomized, Open-label Study of the Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine Once Daily Compared to Atazanavir and Ritonavir Plus Tenofovir/Emtricitabine Once Daily in HIV-1 Infected Antiretroviral Therapy Naïve Women [NCT01910402]Phase 3499 participants (Actual)Interventional2013-08-22Completed
A Phase 3, Open Label, Randomised, Parallel Group Study to Compare the Effect on Prevention and Resolution of Treatment Related Adverse Events of a Simplified, Once Daily Regimen of a Fixed Dose Combination Tablet of Emtricitabine and Tenofovir DF Versus [NCT00323544]Phase 3220 participants Interventional2004-10-31Completed
Efficacy of Adefovir Dipivoxil Versus Adefovir Dipivoxil Plus Lamivudine for the Treatment of Chronic Hepatitis B in Patients With Normal Baseline ALT [NCT00230477]Phase 419 participants (Actual)Interventional2003-04-30Completed
Viral Decay Kinetics During Induction Therapy With or Without the Use of Enfuvirtide in HAART-naÃ-ve Patients With Advanced HIV [NCT00344760]Phase 42 participants (Anticipated)Interventional2005-01-31Completed
PHPT-5 Second Phase: Perinatal Antiretroviral Intensification for the Prevention of Mother-to-child Transmission of HIV in Thai Women Having Received Less Than 8 Weeks of HAART During Pregnancy [NCT01511237]Phase 3379 participants (Actual)Interventional2011-12-31Completed
A 48-Week, Randomized, Open-Label Phase 3B Study Comparing the Antiviral Efficacy and Safety of ATV/RTV 3TC With ATV/RTV Plus TDF/FTC In HIV-1-Infected, Treatment-Naïve Subjects, Followed By a 48-Week Period on ATV/RTV Plus 3TC [NCT01620944]Phase 33 participants (Actual)Interventional2012-07-31Terminated(stopped due to Business objectives have changed)
Comparison Between Lamivudine and Entecavir Treatment in Patients With Spontaneous Severe Acute Exacerbation of Chronic Hepatitis B. [NCT01627223]Phase 417 participants (Actual)Interventional2012-07-31Terminated(stopped due to Slow progress in recruiting study patients)
Maraviroc Switch Central Nervous System (CNS) Substudy: a Substudy of MARCH, a Randomised, Open-label Study to Evaluate the Efficacy and Safety of Maraviroc (MVC) as a Switch for Either Nucleoside or Nucleotide Analogue Reverse Transcriptase Inhibitors (N [NCT01637233]28 participants (Actual)Observational2012-06-30Completed
Maraviroc Switch Collaborative Study Renal Substudy [NCT01637259]Phase 476 participants (Actual)Interventional2012-06-30Completed
[NCT01693679]Phase 4120 participants (Anticipated)Interventional2012-09-30Active, not recruiting
Single-Dose Fasting and Fed Pilot BE Study in Healthy Males and Females Not of Childbearing Potential [NCT05030025]Early Phase 143 participants (Actual)Interventional2021-08-01Completed
Open-Label Study With Rilpivirine in Treatment-naïve Indian Subjects With HIV-1 Infection to Determine Safety and Efficacy [NCT03563742]Phase 358 participants (Actual)Interventional2018-09-24Terminated(stopped due to High SF rate (less treatment-naïve subjects & subjects with viral load <100000). Reevaluation in scientific position in India after internal discussion.)
Randomized Trial of Tenofovir Versus Lamivudine Plus Adefovir in Lamivudine Plus Adefovir Treated Lamivudine-resistant Chronic Hepatitis B Patients With Undetectable Hepatitis B Virus DNA. [NCT01732367]Phase 4171 participants (Actual)Interventional2012-11-30Completed
The Efficacy and Safety of Telbivudine and Lamivudine Use in Highly Viremic Mothers to Prevent Hepatitis B Transmission [NCT01743079]Phase 4700 participants (Actual)Interventional2009-01-31Completed
Nevirapine vs Ritonavir-boosted Lopinavir in ART HIV-infected Adults in a Resource-limited Setting; a Randomized, Multicenter, Parallel Group Study [NCT01772940]Phase 4425 participants (Actual)Interventional2008-12-31Completed
Nucleoside Analogue in Late Preganancy to Prevent Vertical Transmission of Hepatitis B Virus [NCT01788371]Phase 4700 participants (Actual)Interventional2009-03-31Completed
Comparison of Telbivudine Plus Adefovir With Lamivudine Plus Adefovir for the Treatment of Lamivudine-resistant Chronic Hepatitis B at 52 Weeks: A Pilot Study [NCT01804387]Phase 460 participants (Anticipated)Interventional2011-05-31Recruiting
The Incidence of Lactic Acidosis During Entecavir Treatment in Chronic Hepatitis B Patients With Severe Cirrhosis or Hepatic Failure [NCT01354652]Phase 45 participants (Actual)Interventional2011-05-31Terminated(stopped due to Tenofovir has become available in Korea.)
A Phase III Multicenter, Open-Label, Randomized Study to Evaluate a Switch to MK-1439A in HIV-1-Infected Subjects Virologically Suppressed on a Regimen of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) [NCT02397096]Phase 3673 participants (Actual)Interventional2015-06-09Completed
A Phase II Study of the Prolongation of Virologic Success (ACTG 372A) and Options for Virologic Failure (ACTG B/C/D) in HIV-Infected Subjects Receiving Indinavir in Combination With Nucleoside Analogs: A Rollover Study for ACTG 320 [NCT00000885]Phase 2440 participants InterventionalCompleted
A Phase II Study of 1) Amprenavir (141W94/VX478) Plus 3TC Plus ZDV (or d4T) or 2) IDV Plus NVP Plus 3TC Plus d4T in Subjects Previously Treated With Amprenavir and 3) Other Treatment Regimens (Observational ARM) in Subjects Previously Treated With Amprena [NCT00001095]Phase 294 participants InterventionalCompleted
An Open-Label, Non-Comparative Study of Saquinavir-SGC in Combination With Zidovudine (AZT) and Lamivudine (3TC) in the Treatment of HIV-1 Infected Patients With No Previous Anti-Retroviral Drug Therapy [NCT00002367]Phase 340 participants InterventionalCompleted
A Phase II, Stratified, Randomized, Open-Label, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil and Indinavir in Combination With Zidovudine, Lamivudine, or Stavudine for the Treatment of Therapy Naive HIV-Infected Patients With CD4 Ce [NCT00002379]Phase 2100 participants InterventionalCompleted
A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects. [NCT00002199]Phase 3550 participants InterventionalCompleted
An Exploratory Study of Fortovase (Saquinavir) Soft Gelatin Capsules (SGC) Plus d4T and 3TC or Fortovase (Saquinavir) SGC Plus Nelfinavir and d4T in Patients With HIV-1 Associated Nephropathy [NCT00002397]Phase 324 participants InterventionalCompleted
A Phase IIIB, Open-Label, Randomized Study of the Effect of an Education Intervention on Virological Outcomes, Adherence, Immunological Outcome, and Health Outcomes in HIV-Infected Subjects From Under-Represented Populations Treated With Triple Nucleoside [NCT00002409]Phase 3200 participants InterventionalCompleted
A Multicenter, Open-Label, 24-Week Pilot Study to Evaluate the Safety and Efficacy of Indinavir Sulfate 800 Mg b.i.d. in Combination With Ritonavir 100 Mg/d4T/3TC b.i.d. in HIV-Infected Individuals [NCT00002241]Phase 280 participants InterventionalActive, not recruiting
Randomised Double-Blind Placebo-Controlled Phase 3 Trial of Triumeq in Amyotrophic Lateral Sclerosis [NCT05193994]Phase 3390 participants (Anticipated)Interventional2022-02-24Recruiting
Long Term Follow-up of Patients Experiencing Structured Treatment Interruption (STI) With or Without Low Doses of Interleukin-2 During Primary HIV Infection (PHI) [NCT02300623]Phase 412 participants (Actual)Interventional2000-03-31Completed
A Phase II, Randomized Study of the Antiviral Activity and Resistance Interactions of Lamivudine (3TC) in Combination With Zidovudine (AZT), Stavudine (d4T), or Didanosine (ddI) Versus Monotherapy With ddI or d4T in HIV-Infected Individuals With 200 - 600 [NCT00000838]Phase 2256 participants InterventionalCompleted
A Phase II, Randomized Study of the Safety and Efficacy of Hydroxyurea in Subjects on Potent Antiretroviral Therapy With Less Than 200 Copies/ml of HIV RNA in the Plasma [NCT00000916]Phase 2399 participants InterventionalCompleted
Multi-Drug Antiretroviral Therapy for Heavily Pretreated Pediatric AIDS Patients: A Phase I Proof of Concept Trial [NCT00001108]Phase 16 participants InterventionalCompleted
[NCT00380614]Phase 40 participants Interventional2002-01-31Completed
A Prospective Randomized Trial Comparing the Response of HIV Kaposi's Sarcoma (KS) to HAART Versus the Combination of HAART and Chemotherapy (CXT) [NCT00380770]Phase 4112 participants (Actual)Interventional2003-01-31Completed
A Multiclinic, Open Pilot Study to Investigate the Effect of Combination Antiretroviral Therapy Including Indinavir Sulfate on Coagulation Factors, on Platelet Aggregation, and on Factor VIII/IX Half-Life in HIV-1 Seropositive Patients With Hemophilia A o [NCT00002386]Phase 455 participants InterventionalCompleted
A Phase III, Multicenter, Randomized, Open-Label Study to Compare Antiretroviral Activity and Tolerability of Three Different Combination Regimens (DMP 266 + Indinavir, DMP 266 + Zidovudine + Lamivudine, Indinavir + Zidovudine + Lamivudine) in HIV-Infecte [NCT00002410]Phase 30 participants InterventionalCompleted
A Randomized, Open-Label Equivalence Study of FTC Versus Lamivudine in Patients on a Stable Triple Antiretroviral Therapy Regimen Containing Lamivudine, Stavudine or Zidovudine, and a Protease Inhibitor or Non-Nucleoside Reverse Transcriptase Inhibitor [NCT00002416]Phase 3390 participants InterventionalCompleted
A Phase II/III 48-Week, Randomized, Double-Blind, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lamivudine 300mg Once Daily Vs. Lamivudine 150mg BID in Combination With Zidovudine 300mg BID and Efavirenz 600mg Once Daily in Antiretr [NCT00004852]Phase 20 participants Interventional1999-09-30Completed
Evaluation of HIV RNA Suppression Produced by a Triple Combination Regimen Containing an Enteric Coated Formulation of Didanosine (ddI EC) Administered Once Daily Compared to a Reference Combination Regimen [NCT00002429]Phase 3500 participants Interventional1999-07-31Completed
Changes in Weight and Body Composition After Switch to Dolutegravir/Lamivudine Compared to Continued Dolutegravir/Abacavir/Lamivudine for Virologically Suppressed HIV Infection: A Randomized Open-label Superiority Trial: AVERTAS-1 [NCT04904406]Phase 495 participants (Anticipated)Interventional2020-10-22Recruiting
Phase 3b, Single Arm, Single Site Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) [NCT03311945]Phase 349 participants (Anticipated)Interventional2018-05-03Recruiting
Combination of Lamivudine and Adefovir Dipivoxil for Treatment of Chronic Hepatitis B [NCT00023309]Phase 241 participants (Actual)Interventional2001-08-31Completed
A Randomized Phase II Study of the Safety, Immunologic, and Virologic Effects of Cyclosporine A in Conjunction With Trizivir(R) and Kaletra(R) Versus Trizivir(R) and Kaletra(R) Alone During Primary HIV-1 Infection [NCT00084149]Phase 254 participants (Actual)Interventional2004-02-29Completed
A Preliminary Assessment of Safety and Antiviral Activity of Open-label Entecavir in Subjects With Chronic Hepatitis B Following Monotherapy in Other Entecavir Trials [NCT01438424]Phase 21,053 participants (Actual)Interventional2001-01-31Completed
A Comparison of a Four-Drug Regimen Comprised of 141W94, 1592U89, and Combivir With a Three-Drug Regimen Comprised of Nelfinavir and Combivir in Antiretroviral-Naive HIV-Infected Patients. [NCT00002216]0 participants InterventionalCompleted
A Phase 2b Study to Evaluate the Efficacy, Safety and PK of a Combination of Bictegravir, Emtricitabine, and Tenofovir Alafenamide Fumarate for Treatment of HIV-1 Infection in Patients With Drug-susceptible Tuberculosis on a Rifampicin-based Regimen [NCT04734652]Phase 2120 participants (Anticipated)Interventional2022-02-18Recruiting
A Phase 1, Drug-Drug Interaction Study to Evaluate the Safety, Tolerability, and the Induction Potential of TBAJ-876 on CYP3A4 and P-glycoprotein and the Inhibition Potential of TBAJ-876 on P-glycoprotein in Healthy Adult Subjects [NCT05526911]Phase 128 participants (Actual)Interventional2022-07-20Completed
An Open Label Study to Investigate the Safety and Efficacy of Abacavir/Lamivudine/Dolutegravir and the Pharmacokinetic Profile of Dolutegravir in HIV-infected Patients of 60 Years of Age and Older [NCT02509195]Phase 440 participants (Anticipated)Interventional2015-08-04Completed
A Randomized, Multicenter, Prospective Study to Compare Antiviral Efficacy and Safety of Switching to ETV Plus TDF Versus Maintaining LAM/LDT Plus ADF Combination in CHC With PVR to LAM/LDF Plus ADF Combination Rescue Therapy for YMDD Mutation [NCT01597934]Phase 4104 participants (Anticipated)Interventional2012-08-31Active, not recruiting
Safety and Efficacy of Switching a Stable Combined Antiretroviral Therapeutic Regimen to Atazanavir With Ritonavir Plus Lamivudine in Treatment Experienced HIV Positive Patients With Full and Stable Virological Suppression [NCT01599364]Phase 4266 participants (Actual)Interventional2014-04-30Completed
Pharmacokinetic, Safety and Acceptability Study of the Abacavir/Lamivudine/Lopinavir/Ritonavir/-30/15/ 40/10mg vs. Lopinavir/Ritonavir 40/10mg Pellets Plus Dual Abacavir/Lamivudine-60/30mg Tablets in HIV Infected Children [NCT03836833]Phase 1/Phase 250 participants (Anticipated)Interventional2019-06-04Recruiting
Early Intensive Antiretroviral Combination Therapy in HIV-1 Infected Infants and Children [NCT00000872]Phase 255 participants (Anticipated)InterventionalCompleted
A Phase I/II, Open-Label Study to Evaluate the Safety, Tolerance and Pharmacokinetics of Stavudine (d4T) in Combination With Lamivudine (3TC) in HIV-Infected Pregnant Women and Their Infants [NCT00000878]Phase 126 participants InterventionalCompleted
RAD-1: A Phase I/II Antiretroviral Management Algorithm for Pediatric Subjects of Four-Drug Combination Therapies Based on Prior Antiretroviral Experience [NCT00000902]Phase 1217 participants InterventionalCompleted
A Phase I Trial of the Safety and Pharmacokinetics of Fortovase (Saquinavir-SGC) Co-Administered With Low Dose (Ritonavir) RTV, ZDV and 3TC in HIV Seropositive Pregnant Women During Gestation and Postpartum, and in Their Infant's Post-Maternal Dosing [NCT00000920]Phase 124 participants InterventionalCompleted
A Phase I Trial of the Safety, Tolerance, and Pharmacokinetics of Oral Indinavir Co-Administered With Lamivudine (3TC) and Zidovudine (ZDV) in HIV-1-Infected Pregnant Women During Gestation and Post Partum, and in Their Infants Post Maternal Dosing [NCT00000944]Phase 124 participants InterventionalCompleted
3TC (Lamivudine; GR109714X) Open-Label Program [NCT00002108]0 participants InterventionalCompleted
An Open Label, Randomized, Comparative Study of Zerit (d4T) + Videx (ddI) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700/mm3 and HIV RNA Baseline Copy Number of > [NCT00002168]200 participants InterventionalCompleted
A Phase II, 48 Week, Open-Label Study Designed to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of a Simplified Dosing Regimen of Preveon (Adefovir Dipivoxil; bis-POM PMEA), Videx (Didanosine; ddI), Sustiva (Efavirenz; DMP-266), and Ep [NCT00002234]Phase 225 participants InterventionalCompleted
A Randomized Phase IIIB Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) TID Regimen in Combination With Two NRTIs Versus Saquinavir Soft Gel Capsule (SGC) BID Regimen in Combination With Two NRTIs Versus Saquinavir Soft Gel Capsule (SGC) B [NCT00002378]Phase 3825 participants InterventionalCompleted
A Randomized, Double-Blind, Phase III Study of Indinavir Sulfate With Open-Label Zidovudine (AZT) and Lamivudine (3TC) in Subjects With HIV Infection With CD4 Cell Counts <= 200 Cells/mm3 and >= 6 Months of Prior AZT Experience [NCT00000841]Phase 31,750 participants InterventionalCompleted
A Multicenter, Open-Labeled, 96-Week Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Indinavir in Combination With Stavudine and Lamivudine in Pediatric Patients With HIV-1 Infection [NCT00000901]Phase 124 participants InterventionalCompleted
A Randomized, Double-Blind, Parallel-Group, Multicenter Trial to Evaluate the Safety and Efficacy of 1592U89 in Combination With Lamivudine (3TC) and Zidovudine (ZDV) Versus 3TC/ZDV in HIV-1-Infected, Antiretroviral Therapy-Naive Subjects With CD4+ Counts [NCT00002389]Phase 3210 participants InterventionalCompleted
A Randomized Open-Label Strategic Study to Evaluate the Safety and Efficacy of 3 Different Convergent and Divergent Drug Combination Therapies in Anti-Retroviral Naive HIV-1 Infected Patients With CD4+ Counts Above 200/mm3 [NCT00002407]0 participants InterventionalCompleted
A Randomized, Multicenter Study of Epivir 150 Mg Bid, Retrovir 200 Mg Tid and a Protease Inhibitor Vs 3TC 150 Mg/ZDV 300 Mg Fixed Dose Tablet Given Bid With a Protease Inhibitor in HIV-Infected Patients [NCT00002203]0 participants InterventionalCompleted
A Phase II, 48-Week, Uncontrolled, Open-Label Study Designed to Evaluate the Safety and Efficacy of Quadruple Antiretroviral Therapy (EPIVIR, Abacavir, Amprenavir, and Indinavir) in Subjects Acutely Infected With HIV-1 [NCT00002233]Phase 230 participants InterventionalCompleted
Effect of Amprenavir on Carbohydrate and Lipid Metabolism in Patients With HIV Infection [NCT00002245]Phase 30 participants Interventional1999-04-30Completed
A Randomized, Open-Label, Study of Nelfinavir or Efavirenz in HIV-1 Infected, Antiretroviral Naive Patients [NCT00005000]Phase 4200 participants Interventional1999-12-31Active, not recruiting
Dolutegravir-Lamivudine as Dual Therapy in Naive HIV-Infected Patients: A Pilot Study [NCT02211482]Phase 420 participants (Actual)Interventional2014-10-31Completed
A Randomized, Open-Label, Pilot Treatment Trial Evaluating Cellular Dynamics and Immune Restoration in Treatment-Naive HIV-Infected Subjects Receiving Either the Protease Inhibitor LPV/r or the Nucleoside Analogue Reverse Transcriptase Inhibitors d4T/3TC/ [NCT00004855]55 participants InterventionalCompleted
A Phase IIIB Randomized, Multicenter Study of the Efficacy and Safety of Combivir 1 Tablet Po Bid Plus Ziagen 300mg Po Bid Versus an Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg Combination Tablet Po Bid, Administered for 24 Weeks in Subjects With HIV [NCT00004981]Phase 3230 participants InterventionalActive, not recruiting
A Phase IV, Open-Label, Randomized Study to Compare the Efficacy and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) for 96 Weeks in the Treatment of HIV-1 Infe [NCT00005017]Phase 4300 participants InterventionalActive, not recruiting
A Phase IV, Open-Label, Multicenter Study of the Efficacy and Safety of Quadruple Combination Antiretroviral Therapy With Combivir (Lamivudine 150mg/Zidovudine 300mg) BID, Ziagen (Abacavir) 300mg BID, and Sustiva (Efavirenz) 600mg QD for 24 Weeks, Followe [NCT00004585]Phase 440 participants Interventional1999-10-31Completed
Comparison of 2 Alternative Antiretroviral Combinations in HIV Post-exposure Prophylaxis: AZT-3TC (Combivir®) + Lopinavir-ritonavir (Kaletra®) Versus AZT-3TC (Combivir®)+ Atazanavir (Reyataz®). Multicentre, Prospective, Randomized, Open Study [NCT00385645]Phase 4255 participants (Actual)Interventional2006-05-31Completed
Comparison of Antiretroviral Activity and Immunological Effect of Two Triple Treatments With and Without Protease Inhibitors in naïve HIV-1-infected Patients With CD4 < 100/mm3 [NCT00385957]Phase 470 participants InterventionalCompleted
Controlled Clinical Trial of Antiviral Cytotoxic T Lymphocyte (CTL) Infusion Following Combination Antiretroviral Drug Therapy for Asymptomatic HIV-1 Infection [NCT00000875]16 participants InterventionalTerminated
A Phase II Randomized Study of the Virologic and Immunologic Effects of Zidovudine Plus Lamivudine (3TC) Versus d4T Versus Zidovudine Plus d4T in HIV-Infected Patients With CD4 Cell Counts Between 300-600/mm3 and No Previous Nucleoside Experience [NCT00001067]Phase 2105 participants InterventionalCompleted
A Phase II Rolling Arm Master Protocol (PRAM) of Novel Antiretroviral Therapy in Stable Experienced HIV-Infected Children. PRAM-2: A Phase I/II Randomized, Multicenter Protocol Comparing Four Antiretroviral Regimens Containing Combinations of Protease Inh [NCT00001091]Phase 1200 participants InterventionalCompleted
An Open Label, Randomized, Comparative Study of Zerit (d4T) + Epivir (3TC) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700 Cells/mm3 and HIV RNA Baseline Copy Numb [NCT00002369]200 participants InterventionalCompleted
A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients With HIV Infection [NCT00002183]Phase 160 participants InterventionalCompleted
A Phase III Trial to Evaluate the Safety and Antiviral Efficacy of 141W94 in Combination With Retrovir and Epivir Compared to Retrovir and Epivir Alone in Patients With HIV Infection. [NCT00002195]Phase 3290 participants InterventionalCompleted
SWITCH OR ADD PEGYLATED-INTERFERON IN CHRONIC HEPATITIS B PATIENTS ON LONG TERM NUCLEOS(T)IDE THERAPY (SWAP TRIAL) [NCT01928511]Phase 4254 participants (Actual)Interventional2014-01-31Completed
Observational Retrospective Multicenter Study Aimed at Evaluating the Incidence of Hepatitis B Reactivation in Patients Affected by Chronic Lymphocytic Leukemia Treated With Ibrutinib [NCT03528941]109 participants (Actual)Observational2018-11-28Completed
A Phase IIb, Dose Ranging Study of Oral GSK1265744 in Combination With Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus -1 (HIV-1) Virologic Suppression Followed by an Evaluation of Maintenance of Virologic Suppres [NCT01641809]Phase 2244 participants (Actual)Interventional2012-08-06Completed
An Open-Label, 48-Week Extension Study of Elvucitabine Administered In Combination With Background Antiretroviral Agents in Participants Who Have Completed 14 Days of Treatment in Protocol ACH443-014A. [NCT00380159]Phase 24 participants (Actual)Interventional2006-09-30Completed
Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure (ASPIRE) Study [NCT02263326]Phase 389 participants (Actual)Interventional2014-12-31Completed
A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer [NCT03144804]Phase 236 participants (Actual)Interventional2017-10-31Completed
An Open-label Single-Center, 4-Period William's Cross-Over Design Drug Interaction Trial to Determine the Effects of Sorbitol-Containing Solutions on Lamivudine Exposure Following Administration of Lamivudine Oral Solution in Healthy Adult Subjects [NCT02634073]Phase 416 participants (Actual)Interventional2016-01-01Completed
Phase 3b, Single Arm, Simplification Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk [NCT03333083]Phase 350 participants (Anticipated)Interventional2018-05-03Recruiting
Investigating Influence of Pregnancy-induced Changes in Antiretroviral Pharmacokinetics, Together With Polymorphisms in Drug Disposition Genes, on Viral Decay Dynamics in HIV Positive Women Starting Therapy Late in Pregnancy and Postpartum [NCT03284645]194 participants (Actual)Observational2017-12-22Completed
A Phase 3b, Randomized, Open-Label Study to Evaluate Switching From a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppress [NCT02616783]Phase 3167 participants (Actual)Interventional2015-12-22Completed
Switching From Regimens Consisting of a RTV-Boosted Protease Inhibitor Plus TDF/FTC to a Combination of Raltegravir Plus Nevirapine and Lamivudine in HIV Patients With Suppressed Viremia and Impaired Renal Function (RANIA Study) (Pilot Study) Protocol MK- [NCT02116660]Phase 211 participants (Actual)Interventional2014-09-03Terminated(stopped due to This study was terminated early due to poor recruitment.)
A Multiclinic, Open Study to Evaluate the Ability of the Combination of Indinavir, Zidovudine and Lamivudine to Result in Sustained Suppression of HIV-1 in Asymptomatic HIV-1 Seropositive Patients [NCT00002179]Phase 4200 participants InterventionalCompleted
A Phase II, Open-Label, Multicenter Study to Characterize the Effectiveness and Safety of Efavirenz in Combination With Stavudine and Lamivudine in Antiretroviral Therapy-Naive HIV-Infected Patients [NCT00002227]Phase 260 participants InterventionalCompleted
A Phase II, Randomized, Controlled, Open-Label Trial of Combination Therapy With Nelfinavir (NFV) and Saquinavir (SQV)Sgc With Delavirdine (DLV) or 3TC/ZDV Versus Nelfinavir (NFV) and 3TC/ZDV in Subjects With HIV Infection and > 5,000 HIV RNA Copies/ML [NCT00001094]Phase 20 participants (Actual)InterventionalWithdrawn
An Open-Label Randomized Study of Delavirdine Mesylate (DLV, Rescriptor) in Triple and Quadruple Combinations With Zidovudine (ZDV), Indinavir (IDV), and Lamivudine (3TC) in HIV-1 Infected Individuals [NCT00002401]160 participants InterventionalCompleted
A Six-Month Safety and Antiviral Study in HIV-1 Seropositive, AZT-Experienced Patients With CD4 Counts Less Than or Equal to 50 Cells/mm3 to Evaluate MK-639 Alone Versus Zidovudine (AZT) and 3TC Versus the Combination of MK-639 With AZT/3TC [NCT00002155]600 participants InterventionalCompleted
A Study Evaluating the Efficacy and Tolerability of Dolutegravir Plus Lamivudine in HIV Infected Adults Who Are Virologically Suppressed and With Evidence of TDF Toxicity [NCT05493969]Phase 4100 participants (Anticipated)Interventional2022-08-31Not yet recruiting
Latency and Early Neonatal Provision of Antiretroviral Drugs Clinical Trial [NCT02431975]Phase 473 participants (Actual)Interventional2015-08-31Completed
Efficacy and Safety of Albuvirtide for Injection Combined With LPV/r for Treatment of HIV-1-Infected Patients Failed First-line Antiretroviral Therapy [NCT02369965]Phase 3418 participants (Actual)Interventional2014-02-19Completed
A Phase II, Open-Label Trial for Treatment of HIV Infection in Subjects Who Have Failed Initial Combination Therapy With Regimens Containing Indinavir or Nelfinavir: Combination Therapy With 3TC (150 Mg BID), Abacavir (300 Mg BID) and Amprenavir (1200 Mg [NCT00002423]Phase 2100 participants Interventional1999-03-31Completed
A Prospective, Open-label, Multicenter Study of Lamivudine Extending Therapy in Chronic Hepatitis B Patients After 3-year of Oral Antiviral Agents [NCT02337127]Phase 4500 participants (Anticipated)Interventional2011-06-30Recruiting
Inhibition of Reverse Transcription in Type I Interferon Mediated Neuropathology [NCT04731103]Phase 224 participants (Anticipated)Interventional2022-08-24Recruiting
Lopinavir/Ritonavir/Combivir vs. Abacavir/Zidovudine/Lamivudine for Virologic Efficacy and the Prevention of Mother-to-Child HIV Transmission Among Breastfeeding Women With CD4 Counts Greater Than or Equal to 200 Cells/mm3 in Botswana [NCT00270296]Phase 2730 participants (Actual)Interventional2006-06-30Completed
A 96-Week, Phase IV, Randomized, Double-Blind, Multicenter Study of the Safety and Efficacy of EPZICOM Versus TRUVADA Administered in Combination With KALETRA in Antiretroviral-Naive HIV-1 Infected Subjects [NCT00244712]Phase 4688 participants (Actual)Interventional2005-07-31Completed
Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis [NCT01720238]621 participants (Actual)Observational2012-03-31Active, not recruiting
A Phase 3b, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed on Regimens Containing ABC/3TC [NCT02469246]Phase 3567 participants (Actual)Interventional2015-06-29Completed
Safety and Pharmacokinetics of Dolutegravir in Pregnant HIV Mothers and Their Neonates: A Pilot Study [NCT02245022]Phase 2/Phase 360 participants (Actual)Interventional2017-03-14Completed
IGHID 11417 - The Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection: Impact on the Latent HIV Reservoir and Long-Term Immunologic Effect [NCT02384395]40 participants (Actual)Interventional2015-09-30Completed
A Randomized, Blinded, 12-week Comparison of Elvucitabine/Efavirenz/Tenofovir Versus Lamivudine/Efavirenz/Tenofovir in HIV-1 Infected Treatment-naive Participants. There is a 36 Week, Open-label, Extension Phase for Eligible Participants. [NCT00350272]Phase 276 participants (Actual)Interventional2006-05-31Completed
Effect of Substituting Truvada for Combivir or Trizivir vs Continuing Combivir or Trizivir on Physiologic Correlates of Mitochondrial Function in Subjects Infected With Human Immunodeficiency Virus on Highly Active Antiretroviral Therapy [NCT00960622]Phase 417 participants (Actual)Interventional2006-08-31Completed
Steady State Bioequivalence of Generic and Innovator Formulations of Stavudine, Lamivudine, and Nevirapine in HIV-infected Ugandan Adults [NCT01025830]Phase 420 participants (Actual)Interventional2006-02-28Completed
BHP Early Infant Treatment Study: A Clinical Treatment Trial of HIV+ Infants in Botswana [NCT02369406]Phase 2/Phase 367 participants (Actual)Interventional2015-05-04Active, not recruiting
Changes in Weight After Switch to Dolutegravir/Lamivudine or Doravirine/Tenofovir/Lamivudine Compared to Continued Treatment With Dolutegravir/Tenofovir/Lamivudine for Virologically Suppressed HIV Infection. AVERTAS-2 [NCT04903847]Phase 4126 participants (Anticipated)Interventional2021-02-02Recruiting
A Randomised Trial of Monitoring Practice and Induction Maintenance Drug Regimens in the Management of Antiretroviral Therapy in Children With HIV Infection in Africa [NCT02028676]Phase 41,206 participants (Actual)Interventional2007-03-31Completed
DTG/3TC vs. BIC/FTC/TAF Maintenance Therapy in People Living With HIV: an Open-label Randomized Clinical Trial [NCT04884139]Phase 4555 participants (Anticipated)Interventional2021-07-14Active, not recruiting
A Randomized, Double-Blind, Phase III Study of ABT-378/Ritonavir Plus Stavudine and Lamivudine vs Nelfinavir Plus Stavudine and Lamivudine in Antiretroviral Naive HIV-Infected Subjects [NCT00004583]Phase 3660 participants Interventional1999-03-31Completed
A Comparative Study of the Antiviral Efficacy and Safety of Entecavir Plus Tenofovir Versus Adefovir Added to Continuing Lamivudine in Adults With Lamivudine- Resistant Chronic Hepatitis B Virus Infection [NCT00605384]Phase 34 participants (Actual)Interventional2008-08-31Terminated(stopped due to Business Objectives Have Changed)
Sex and Disease Dependent Nucleoside Analog Toxicity [NCT01386970]Phase 443 participants (Actual)Interventional2005-05-31Completed
Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive. Randomized Clinical, Not Masked, Trial Comparing DRVr3TC, ABC3TC (Kivexa) RPV, or EVG COBI FTC TDF (Stribild) for 48 Weeks [NCT02470650]Phase 4150 participants (Anticipated)Interventional2015-06-30Recruiting
Antiretroviral Regime for Viral Eradication in Newborns After Intervention Failure of Mother-to-child Transmission of HIV [NCT02712801]Phase 4600 participants (Actual)Interventional2016-04-30Completed
IMPAACT 1092: Phase IV Evaluation Of The Steady State Pharmacokinetics Of Zidovudine, Lamivudine, and Lopinavir/Ritonavir in Severely Malnourished HIV-1-Infected Children [NCT01818258]Phase 452 participants (Actual)Interventional2015-10-26Completed
A Randomized Study of the Long-Term Suppression of Plasma HIV RNA Levels by Triple Combination Regimens in Treatment Naive Subjects [NCT00002411]0 participants Interventional1998-03-31Completed
A 14 Day Randomized, Double-blind, Study of Once Daily Elvucitabine Versus Lamivudine in Participants With a Documented M184V Mutation [NCT00312039]Phase 1/Phase 220 participants (Anticipated)Interventional2006-03-31Completed
A Phase IV Randomized Trial to Evaluate the Virologic Response and Pharmacokinetics of Two Different Potent Regimens in HIV Infected Women Initiating Triple Antiretroviral Regimens Between 20 and 36 Weeks of Pregnancy for the Prevention of Mother-to-Child [NCT01618305]Phase 4408 participants (Actual)Interventional2013-09-05Completed
Phase I/II Study of the Pharmacokinetics, Safety and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-Infected Children and Adolescents [NCT03332095]Phase 1/Phase 255 participants (Actual)Interventional2018-07-02Completed
Booster-free Antiretroviral Therapy for Persons Living With HIV and Multidrug Resistance: A Multicentre Multi-stage Randomized Trial [NCT06037564]Phase 4210 participants (Anticipated)Interventional2023-11-13Enrolling by invitation
A Pilot Study on the Efficacy of DTG Plus 3TC for Prophylaxis of Mother-to-child Transmission of HIV Infection in Pregnant Women Who Have Detectable Viral Load After 14 Weeks of Gestation [NCT04808973]Phase 320 participants (Actual)Interventional2021-07-01Completed
A Phase IIIb, Randomized, Open-Label Study of Pegylated Interferon Alfa-2A in Combination With Lamivudine or Entecavir Compared With Untreated Control Patients in Children With HBeAg Positive Chronic Hepatitis B in the Immune-Tolerant Phase [NCT02263079]Phase 362 participants (Actual)Interventional2014-06-16Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00023309 (5) [back to overview]Virological Response
NCT00023309 (5) [back to overview]Biological Response
NCT00023309 (5) [back to overview]Histological Response
NCT00023309 (5) [back to overview]HBeAg Loss at Week 196
NCT00023309 (5) [back to overview]Maintained Combined Response (Virological, Biochemical and Histological Response).
NCT00074581 (2) [back to overview]Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms
NCT00074581 (2) [back to overview]All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms
NCT00076336 (5) [back to overview]Number of Participants With Improvement, Stabilization, and Worsening in Child-Turcotte-Pugh (CTP) Score at Week 52 and Week 104
NCT00076336 (5) [back to overview]Number of Participants With Improvement, Stabilization, and Worsening in a Modified (3-component) CTP Score
NCT00076336 (5) [back to overview]Number of Participants With Clinical Response
NCT00076336 (5) [back to overview]Time to Initial Clinical Response
NCT00076336 (5) [back to overview]Duration of Initial Clinical Response
NCT00084136 (18) [back to overview]Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison)
NCT00084136 (18) [back to overview]Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)
NCT00084136 (18) [back to overview]Time to Treatment Failure (PI Comparison)
NCT00084136 (18) [back to overview]Time to Treatment Failure (NRTI Comparison)
NCT00084136 (18) [back to overview]Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison)
NCT00084136 (18) [back to overview]Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)
NCT00084136 (18) [back to overview]Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison)
NCT00084136 (18) [back to overview]Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison)
NCT00084136 (18) [back to overview]Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison)
NCT00084136 (18) [back to overview]Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison)
NCT00084136 (18) [back to overview]Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison)
NCT00084136 (18) [back to overview]Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison)
NCT00084136 (18) [back to overview]Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison)
NCT00084136 (18) [back to overview]Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison)
NCT00084136 (18) [back to overview]Time to Immunologic Failure (NRTI Comparison)
NCT00084136 (18) [back to overview]Time to Immunologic Failure (PI Comparison)
NCT00084136 (18) [back to overview]Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)
NCT00084136 (18) [back to overview]Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)
NCT00084149 (7) [back to overview]Number of Patients With Viral Load Less Than 50 Copies/ml
NCT00084149 (7) [back to overview]Proviral DNA (log10)
NCT00084149 (7) [back to overview]Levels of Proviral DNA in Peripheral Blood Mononuclear Cells (PBMC) (log10)
NCT00084149 (7) [back to overview]HIV-1 Viral Load Levels
NCT00084149 (7) [back to overview]Adverse Events Related to Study Medication
NCT00084149 (7) [back to overview]Proviral DNA Levels (log10)
NCT00084149 (7) [back to overview]CD4 T Cell Levels
NCT00095121 (22) [back to overview]Change From ADV Baseline to ADV Week 192 for ALT
NCT00095121 (22) [back to overview]Change From ADV Baseline to ADV Week 192 for Serum HBV DNA
NCT00095121 (22) [back to overview]Change From ADV Baseline to ADV Week 240 for Serum HBV DNA
NCT00095121 (22) [back to overview]Change From ADV Baseline to ADV Week 240 for ALT
NCT00095121 (22) [back to overview]Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Baseline)
NCT00095121 (22) [back to overview]Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < 1000 Copies/mL (Polymerase Chain Reaction [PCR]-Based Assay) and Normal Alanine Aminotransferase (ALT) at Week 48 (Missing = Failure)
NCT00095121 (22) [back to overview]Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss or Seroconversion by End of Blinded Treatment (Study Week 48; Randomized and Treated Analysis Set)
NCT00095121 (22) [back to overview]Percentage of Participants With HBeAg Loss or Seroconversion by ADV Week 240 (Open Label Analysis Set, Participants Who Were HBeAg Positive at ADV Baseline; Missing = Excluded)
NCT00095121 (22) [back to overview]Percentage of Participants With HBeAg Loss or Seroconversion by ADV Week 192 (Open Label Analysis Set, Participants Who Were HBeAg Positive at ADV Baseline; Missing = Excluded)
NCT00095121 (22) [back to overview]Cumulative Summary of Participants With HBV Genotypic Changes From Baseline (Resistance Surveillance) for Subjects Who Received Combination ADV + Lamivudine Therapy
NCT00095121 (22) [back to overview]Cumulative Summary of Participants With HBV Genotypic Changes From Baseline (Resistance Surveillance)
NCT00095121 (22) [back to overview]Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 240)
NCT00095121 (22) [back to overview]Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 192)
NCT00095121 (22) [back to overview]Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Baseline)
NCT00095121 (22) [back to overview]Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 240)
NCT00095121 (22) [back to overview]Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment - Missing = Failure) (ADV Week 192)
NCT00095121 (22) [back to overview]Percentage of Participants With Normal ALT at ADV Week 240 (Missing = Failure)
NCT00095121 (22) [back to overview]Percentage of Participants With Normal ALT at ADV Week 192 (Missing = Failure)
NCT00095121 (22) [back to overview]Percentage of Participants With Normal ALT at Adefovir Baseline (Missing = Failure)
NCT00095121 (22) [back to overview]Percentage of Participants With Durable HBeAg Seroconversion
NCT00095121 (22) [back to overview]Adefovir (ADV) Baseline Serum HBV DNA
NCT00095121 (22) [back to overview]ADV Baseline ALT
NCT00098293 (17) [back to overview]Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48
NCT00098293 (17) [back to overview]Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 48 and 96
NCT00098293 (17) [back to overview]Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 48 and 96
NCT00098293 (17) [back to overview]Change From Baseline in Log 10-transformed Plasma Viral Load (HIV-1 RNA) Levels at Week 48 and 96
NCT00098293 (17) [back to overview]Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population
NCT00098293 (17) [back to overview]Time-Averaged Difference (TAD) in log10-transformed HIV-1 RNA Levels
NCT00098293 (17) [back to overview]Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 for Enhanced Sensitivity Trofile Assay (ESTA) R5 Participants
NCT00098293 (17) [back to overview]Time to Virologic Failure
NCT00098293 (17) [back to overview]Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 96
NCT00098293 (17) [back to overview]Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 48 for Per Protocol (PP) Population
NCT00098293 (17) [back to overview]Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 for Enhanced Sensitivity Trofile Assay (ESTA) R5 Participants
NCT00098293 (17) [back to overview]Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 96
NCT00098293 (17) [back to overview]Number of Participants With Efavirenz Associated Mutations at Time of Treatment Failure Through Week 48 and 96
NCT00098293 (17) [back to overview]Number of Participants With NRTI Associated Mutations at Time of Treatment Failure Through Week 48 and 96
NCT00098293 (17) [back to overview]Number of Participants With Phenotypic Resistance at Time of Treatment Failure Through Week 48 and 96
NCT00098293 (17) [back to overview]Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 Analyzed Using Logistic Regression
NCT00098293 (17) [back to overview]Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 Analyzed Using Logistic Regression
NCT00099359 (7) [back to overview]Infant HIV Infection Status
NCT00099359 (7) [back to overview]Infant HIV-1 Infection Status
NCT00099359 (7) [back to overview]Participant Deaths
NCT00099359 (7) [back to overview]Participants With Serious Adverse Events
NCT00099359 (7) [back to overview]3TC and NFV Pharmacokinetics
NCT00099359 (7) [back to overview]NVP Pharmacokinetics
NCT00099359 (7) [back to overview]Risk Factors for Perinatal HIV-1 Transmission
NCT00099632 (5) [back to overview]Number of Participants With New PI-resistant Variants as Detected by Standard Composite (Bulk) Genotyping.
NCT00099632 (5) [back to overview]Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping.
NCT00099632 (5) [back to overview]Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping
NCT00099632 (5) [back to overview]Number of Participants Who Discontinued Study Treatment Prematurely
NCT00099632 (5) [back to overview]Severe (Grade 3) and Higher Adverse Events and Any Grade Adverse Event That Leads to a Treatment Change From First Day of Study Treatment to Week 12
NCT00100048 (26) [back to overview]Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II)
NCT00100048 (26) [back to overview]Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II)
NCT00100048 (26) [back to overview]Change From Baseline in CD4 Cell Count at Week 96
NCT00100048 (26) [back to overview]Change From Baseline in CD4 (T-helper) Cell Count at Week 240
NCT00100048 (26) [back to overview]Change From Baseline in Plasma HIV RNA at Week 96
NCT00100048 (26) [back to overview]Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II)
NCT00100048 (26) [back to overview]Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96
NCT00100048 (26) [back to overview]Number of Patients With Drug-related LAEs
NCT00100048 (26) [back to overview]Number of Patients With Drug-related CAEs
NCT00100048 (26) [back to overview]Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I)
NCT00100048 (26) [back to overview]Number of Patients With Clinical Adverse Experiences (CAEs)
NCT00100048 (26) [back to overview]Number of Patients That Discontinued With LAEs
NCT00100048 (26) [back to overview]Number of Patients That Discontinued With CAEs
NCT00100048 (26) [back to overview]Number of Patients With Laboratory Adverse Experiences (LAEs)
NCT00100048 (26) [back to overview]Number of Patients With Serious CAEs (Cohort I and II Combined)
NCT00100048 (26) [back to overview]Number of Patients With Serious CAEs and Non-serious CAEs at Week 144
NCT00100048 (26) [back to overview]Number of Patients With Serious Drug-related CAEs
NCT00100048 (26) [back to overview]Number of Patients With Serious Drug-related LAEs
NCT00100048 (26) [back to overview]Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs)
NCT00100048 (26) [back to overview]Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 48
NCT00100048 (26) [back to overview]Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240
NCT00100048 (26) [back to overview]Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II)
NCT00100048 (26) [back to overview]Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240
NCT00100048 (26) [back to overview]Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I)
NCT00100048 (26) [back to overview]Change From Baseline in Plasma HIV RNA at Week 240
NCT00100048 (26) [back to overview]Number of Patients With Serious LAEs
NCT00102960 (13) [back to overview]Number of Participants Who Experienced Regimen-limiting ART Drug Toxicity
NCT00102960 (13) [back to overview]Number of Participants Who Experienced Virological Failure Defined as Confirmed HIV-1 RNA Value of at Least 10,000 Copies Per/ml Recorded on Two Consecutive Separate Occasions After 24 Weeks of Treatment (Initial Therapy or Restart)
NCT00102960 (13) [back to overview]Number of Participants Who Experienced Clinical Failure (Defined as Development of Severe CDC Stage B or Stage C Disease.) on Therapy.
NCT00102960 (13) [back to overview]Total Occurrence of Grade 3 or 4 Laboratory Events
NCT00102960 (13) [back to overview]Time to Failure of First Line Therapy or Death
NCT00102960 (13) [back to overview]Time to First Hospitalization
NCT00102960 (13) [back to overview]Total Occurrence of Grade 3 or 4 Clinical Events
NCT00102960 (13) [back to overview]Time to Death Alone or Death Plus Life Threatening Stage C Events or HIV Events Associated With Permanent End-organ Damage.
NCT00102960 (13) [back to overview]Duration of Hospitalisation
NCT00102960 (13) [back to overview]Hospitalization Rates
NCT00102960 (13) [back to overview]Number of Children Experiencing Severe CDC Stage B or Stage C Disease or Death (Cumulative After 3.5 Years)
NCT00102960 (13) [back to overview]Number of Participants Who Experienced Immunological Failure Defined as Failure of CD4% to Reach 20% or CD4% Falls Below 20% on Two Occasions, Within 4 Weeks, at Any Time After the First 24 Weeks of Therapy (Initial Therapy or Restart)
NCT00102960 (13) [back to overview]Time From Randomization to Starting or Needing to Start Continuous Therapy
NCT00112047 (53) [back to overview]Change in Trunk Fat (kg) From Week 48 to Week 144
NCT00112047 (53) [back to overview]Change in Trunk Fat (kg) From Week 48 to Week 96
NCT00112047 (53) [back to overview]Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm
NCT00112047 (53) [back to overview]Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time-to-Loss-of Virologic Response [TLOVR] Algorithm
NCT00112047 (53) [back to overview]Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)
NCT00112047 (53) [back to overview]Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)
NCT00112047 (53) [back to overview]Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm
NCT00112047 (53) [back to overview]Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 48 (Defined by FDA TLOVR Algorithm)
NCT00112047 (53) [back to overview]Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)
NCT00112047 (53) [back to overview]Percentage of Participants With HIV-1 RNA < 50 c/mL at Week 48
NCT00112047 (53) [back to overview]Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 144
NCT00112047 (53) [back to overview]Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 48
NCT00112047 (53) [back to overview]Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 96
NCT00112047 (53) [back to overview]Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)
NCT00112047 (53) [back to overview]Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 144
NCT00112047 (53) [back to overview]Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 48
NCT00112047 (53) [back to overview]Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 96
NCT00112047 (53) [back to overview]Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)
NCT00112047 (53) [back to overview]Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 144
NCT00112047 (53) [back to overview]Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96)
NCT00112047 (53) [back to overview]Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 48.
NCT00112047 (53) [back to overview]Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 144
NCT00112047 (53) [back to overview]Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96)
NCT00112047 (53) [back to overview]Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 48
NCT00112047 (53) [back to overview]Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 96
NCT00112047 (53) [back to overview]Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 48
NCT00112047 (53) [back to overview]Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 96
NCT00112047 (53) [back to overview]Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) at Week 144
NCT00112047 (53) [back to overview]Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) Through Week 240 (Atripla Week 96)
NCT00112047 (53) [back to overview]Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) at Week 144
NCT00112047 (53) [back to overview]Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) Through Week 240 (Atripla Week 96)
NCT00112047 (53) [back to overview]Quality of Life (SF-12v2 Health Survey: Mental Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
NCT00112047 (53) [back to overview]Quality of Life (SF-12v2 Health Survey: Physical Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
NCT00112047 (53) [back to overview]Treatment Satisfaction Questionnaire (Bothered With the Side Effects of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
NCT00112047 (53) [back to overview]Treatment Satisfaction Questionnaire (General Satisfaction With Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
NCT00112047 (53) [back to overview]Treatment Satisfaction Questionnaire (Satisfaction With Convenience and Simplicity of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
NCT00112047 (53) [back to overview]Treatment Satisfaction Questionnaire (Satisfaction With Current Treatment Regimen to Control HIV): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
NCT00112047 (53) [back to overview]Treatment Satisfaction Questionnaire (Satisfaction With Tolerability of Current Treatment Regimen) Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
NCT00112047 (53) [back to overview]Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)
NCT00112047 (53) [back to overview]Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 240 (Atripla Week 96)
NCT00112047 (53) [back to overview]Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 144
NCT00112047 (53) [back to overview]Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 48
NCT00112047 (53) [back to overview]Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 96
NCT00112047 (53) [back to overview]Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 144
NCT00112047 (53) [back to overview]Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 48
NCT00112047 (53) [back to overview]Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 96
NCT00112047 (53) [back to overview]Change in Limb Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
NCT00112047 (53) [back to overview]Change in Limb Fat (kg) From Week 48 to Week 144
NCT00112047 (53) [back to overview]Change in Limb Fat (kg) From Week 48 to Week 96
NCT00112047 (53) [back to overview]Change in Total Body Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
NCT00112047 (53) [back to overview]Change in Total Body Fat (kg) From Week 48 to Week 144
NCT00112047 (53) [back to overview]Change in Total Body Fat (kg) From Week 48 to Week 96
NCT00112047 (53) [back to overview]Change in Trunk Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
NCT00118898 (22) [back to overview]Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline
NCT00118898 (22) [back to overview]Change in CD4 Count (Cells/mm3) From Baseline
NCT00118898 (22) [back to overview]Number of Participants With Virologic Failure and Emergence of Major Resistance
NCT00118898 (22) [back to overview]Number of Participants With Virologic Failure
NCT00118898 (22) [back to overview]Number of Participants With Treatment Modification
NCT00118898 (22) [back to overview]Number of Participants With Regimen Failure
NCT00118898 (22) [back to overview]Number of Participants With a Grade 3/4 Safety Event
NCT00118898 (22) [back to overview]Amount of Study Follow-up
NCT00118898 (22) [back to overview]Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline
NCT00118898 (22) [back to overview]Cumulative Probability of Not Experiencing Regimen Failure
NCT00118898 (22) [back to overview]The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL
NCT00118898 (22) [back to overview]Time From Treatment Dispensation to Treatment Modification
NCT00118898 (22) [back to overview]Cumulative Probability of Not Experiencing Treatment Modification
NCT00118898 (22) [back to overview]Cumulative Probability of Not Experiencing Virologic Failure
NCT00118898 (22) [back to overview]Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events.
NCT00118898 (22) [back to overview]Time From Randomization to Virologic Failure
NCT00118898 (22) [back to overview]Time From Treatment Dispensation to a Grade 3/4 Safety Event
NCT00118898 (22) [back to overview]Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)
NCT00118898 (22) [back to overview]Change in Fasting Total Cholesterol Level From Baseline
NCT00118898 (22) [back to overview]Change in Fasting Triglyceride Level From Baseline
NCT00118898 (22) [back to overview]Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event
NCT00118898 (22) [back to overview]Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL
NCT00244712 (14) [back to overview]Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks
NCT00244712 (14) [back to overview]Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96
NCT00244712 (14) [back to overview]Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction
NCT00244712 (14) [back to overview]Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96
NCT00244712 (14) [back to overview]Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
NCT00244712 (14) [back to overview]Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
NCT00244712 (14) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
NCT00244712 (14) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
NCT00244712 (14) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
NCT00244712 (14) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
NCT00244712 (14) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.
NCT00244712 (14) [back to overview]Median Change From Baseline in CD4+ Cells at Weeks 48 and 96
NCT00244712 (14) [back to overview]Median Change From Baseline in HIV-1 RNA at Week 48 and 96
NCT00244712 (14) [back to overview]Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility
NCT00255840 (1) [back to overview]Cumulative Treatment Failure Rate of Participants on First Line Antiretroviral Therapy Monitored by Primary Health Care Nurses (Investigative Arm)is Not Inferior to the Cumulative Treatment Failure Rate of Participants Monitored by Doctors (Control Arm).
NCT00270296 (2) [back to overview]Number of Participants With Virologic Suppression
NCT00270296 (2) [back to overview]Number of HIV+ Infants
NCT00307151 (9) [back to overview]Number of Participants Developing New NRTI, NNRTI or PI-resistant Virus
NCT00307151 (9) [back to overview]Change in CD4 Percent From Entry to Week 48
NCT00307151 (9) [back to overview]Time From Randomization to Treatment Failure, Defined as Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment
NCT00307151 (9) [back to overview]Time From Randomization to Virologic Failure
NCT00307151 (9) [back to overview]Time From Start of Study Treatment to First New Grade >=3 Lab Abnormality, Sign or Symptom Occurring on Study Treatment
NCT00307151 (9) [back to overview]Time From Randomization to HIV-related Disease Progression or Death
NCT00307151 (9) [back to overview]Time From Randomization to Death
NCT00307151 (9) [back to overview]Percent of Participants With Treatment Failure, Defined as a Confirmed Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment
NCT00307151 (9) [back to overview]Percent of Participants Experiencing Virologic Failure
NCT00316719 (10) [back to overview]Mean Alanine Aminotransferase (ALT) Level at Week 52
NCT00316719 (10) [back to overview]Time to Onset of ALT Normalization
NCT00316719 (10) [back to overview]Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 52
NCT00316719 (10) [back to overview]Percentage of Participants With HBV DNA Loss (<400 Copies/mL) at Week 52
NCT00316719 (10) [back to overview]Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 52
NCT00316719 (10) [back to overview]Percentage of Participants With Hepatitis B e Antigen/Antibody (HBeAg/Ab) Seroconversion at Week 52
NCT00316719 (10) [back to overview]Percentage of Participants With Hepatitis B s Antigen (HBsAg) Loss at Week 52
NCT00316719 (10) [back to overview]Mean Change From Baseline in Hepatitis B Virus (HBV) DNA at Week 52
NCT00316719 (10) [back to overview]Rate of Emergence of Resistant Virus at Week 52
NCT00316719 (10) [back to overview]Percentage of Participants With Hepatitis B s Antigen/ Antibody (HBsAg/Ab) Seroconversion at Week 52
NCT00324649 (18) [back to overview]Percentage of Participants With HIV-1 RNA > 50 and < 400 Copies/mL
NCT00324649 (18) [back to overview]Percentage of Participants With Any Adverse Event
NCT00324649 (18) [back to overview]Percentage of Participants Who Maintain Confirmed HIV-1 RNA < 50 Copies/mL
NCT00324649 (18) [back to overview]Percentage of Participants Who Discontinue the Study Prematurely (Before Week 48) Due to Adverse Events.
NCT00324649 (18) [back to overview]Percentage of Days for Which Participants Were Compliant With Study Drug
NCT00324649 (18) [back to overview]Percent Change From Baseline in Hematocrit
NCT00324649 (18) [back to overview]Change From Baseline in Waist Circumference/Hip Circumference Ratio
NCT00324649 (18) [back to overview]Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Oral Mucosa)
NCT00324649 (18) [back to overview]Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Lymphocytes)
NCT00324649 (18) [back to overview]Change From Baseline in Limb Fat at Week 48
NCT00324649 (18) [back to overview]Change From Baseline in Lactate Concentration
NCT00324649 (18) [back to overview]Change From Baseline in Hemoglobin
NCT00324649 (18) [back to overview]Change From Baseline in Fasting Serum Triglycerides
NCT00324649 (18) [back to overview]Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL)
NCT00324649 (18) [back to overview]Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL)
NCT00324649 (18) [back to overview]Change From Baseline in Cluster Determinant 4 (CD4) Cell Count
NCT00324649 (18) [back to overview]Change From Baseline in Fasting Total Cholesterol
NCT00324649 (18) [back to overview]Percentage of Participants With Virologic Failure
NCT00342355 (2) [back to overview]Serious Adverse Events
NCT00342355 (2) [back to overview]Progression to AIDS or Death in tx naïve Pts With Adv HIV dx in the Four Randomly Assigned Regimens.
NCT00350272 (2) [back to overview]The Proportion Of Participants With Virologic Response For 10 mg/Day Elvucitabine In HIV-1-Infected Participants By 12 Weeks Compared With The Proportion Of Participants With Lamivudine 300 mg/Day
NCT00350272 (2) [back to overview]The Safety Profile Of Elvucitabine.
NCT00393484 (14) [back to overview]Number of Participants With Clinically or Statistically Significant Changes in Vital Sign Measurements at Week 24
NCT00393484 (14) [back to overview]Number of Participants With Normalization of Serum Alanine Aminotransferase (ALT) Levels at Weeks 24, 48, and 96
NCT00393484 (14) [back to overview]Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 24
NCT00393484 (14) [back to overview]Percentage of Participants With a Virologic Response as Defined by Undetectable Hepatitis B Virus DNA at Weeks 48, 96, 144, 192, and 240
NCT00393484 (14) [back to overview]Mean Laboratory Test Values for Alanine Aminotransferase (ALT) at Week 24
NCT00393484 (14) [back to overview]Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 96
NCT00393484 (14) [back to overview]Number of Participants With Virologic Rebound at Week 24
NCT00393484 (14) [back to overview]Percentage of Participants Who Achieved a Virologic Response at Week 24
NCT00393484 (14) [back to overview]Mean Log10 Reduction From Baseline in Hepatitis B Virus (HBV) DNA at Weeks 24, 48, 96, 144, 192, and 240
NCT00393484 (14) [back to overview]Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Most Common AEs, and Grade 3/4 AEs at Week 24
NCT00393484 (14) [back to overview]Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Most Common AEs, and Grade 3/4 AEs at Week 240
NCT00393484 (14) [back to overview]Number of Participants With Elevations in Alanine Transaminase (ALT) and Aspartate Aminoaminase (AST) Levels, Elevations in ALT and AST Levels,Simultaneous Elevations in ALT and Total Bilirubin Levels, and ALT Flares at Week 24
NCT00393484 (14) [back to overview]Number of Participants With Viral Rebound and Drug-resistant Hepatitis B Virus (HBV) DNA Mutations at Week 96
NCT00393484 (14) [back to overview]Number of Participants With Hepatitis B Virus (HBV) DNA <10^3, <10^4, or < 10^5 Copies/mL by Polymerase Chain Reaction (PCR) Assy at Weeks 24, 48, and 96
NCT00410202 (25) [back to overview]Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at Week 96
NCT00410202 (25) [back to overview]Change in Mean log10 From Baseline in HBV DNA at Week 48
NCT00410202 (25) [back to overview]Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < 50 IU/mL (Approximately 300 Copies/mL) by Polymerase Chain Reaction (PCR) at Week 48
NCT00410202 (25) [back to overview]Percentage of Participants With HBsAg Seroconversion at Week 48
NCT00410202 (25) [back to overview]Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 96
NCT00410202 (25) [back to overview]Percentage of Participants With HBsAg Seroconversion at Week 96
NCT00410202 (25) [back to overview]Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48
NCT00410202 (25) [back to overview]Percentage of Participants With HBeAg Seroconversion at Week 96 (Treated HBeAg-positive Participants Only)
NCT00410202 (25) [back to overview]Percentage of Participants With HBeAg Seroconversion at Week 48 (Treated HBeAg-positive Participants Only)
NCT00410202 (25) [back to overview]Percentage of Participants With Confirmed HBeAg Loss at Week 96 (Treated HBeAg Positive Participants Only)
NCT00410202 (25) [back to overview]Percentage of Participants With Confirmed HBeAg Loss at Week 48 (Treated HBeAg Positive Participants Only)
NCT00410202 (25) [back to overview]Percentage of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieve ALT Normalization at Week 96
NCT00410202 (25) [back to overview]Percentage of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieve ALT Normalization at Week 48
NCT00410202 (25) [back to overview]Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 96
NCT00410202 (25) [back to overview]Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 96
NCT00410202 (25) [back to overview]Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 48
NCT00410202 (25) [back to overview]Change in Mean log10 From Baseline in HBV DNA at Week 96
NCT00410202 (25) [back to overview]Percentage of Participants With HBV DNA by PCR Category at Week 96
NCT00410202 (25) [back to overview]Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48
NCT00410202 (25) [back to overview]Percentage of Participants With HBV DNA by PCR Category at Week 48
NCT00410202 (25) [back to overview]Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to Adverse Events or Laboratory Abnormalities During Treatment
NCT00410202 (25) [back to overview]Number of Participants With Laboratory Abnormalities: Serum Chemistry
NCT00410202 (25) [back to overview]Number of Participants With Laboratory Abnormalities: Hematology
NCT00410202 (25) [back to overview]Cumulative Probability of Emergent Genotypic Resistance at Year 2
NCT00410202 (25) [back to overview]Cumulative Probability of Emergent Genotypic Resistance at Year 1
NCT00427297 (4) [back to overview]Incidence of Severe Adverse Events (Excluding Mortality)
NCT00427297 (4) [back to overview]Incidence of Mortality
NCT00427297 (4) [back to overview]Immunologic Failure
NCT00427297 (4) [back to overview]Viral Failure
NCT00440947 (26) [back to overview]Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c) /Milliliter (ml) at the Week 84 Visit
NCT00440947 (26) [back to overview]Change From Baseline in CD4+ Cell Count at Week 144
NCT00440947 (26) [back to overview]Change From Baseline in CD4+ Cell Count at Week 36
NCT00440947 (26) [back to overview]Change From Baseline in CD4+ Cell Count at Week 84
NCT00440947 (26) [back to overview]Change From Baseline in HIV-1 RNA at Week 144
NCT00440947 (26) [back to overview]Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
NCT00440947 (26) [back to overview]Mean Percent Compliance at Week 84
NCT00440947 (26) [back to overview]Mean Percent Compliance at Week 36
NCT00440947 (26) [back to overview]Mean Percent Compliance at Week 144
NCT00440947 (26) [back to overview]Mean Age at Baseline of Participants Randomized to Treatment for the 48-Week Randomized Phase
NCT00440947 (26) [back to overview]Change From Baseline in HIV-1 RNA at Week 84
NCT00440947 (26) [back to overview]Change From Baseline in HIV-1 RNA at Week 36
NCT00440947 (26) [back to overview]Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 84 Visit
NCT00440947 (26) [back to overview]Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit
NCT00440947 (26) [back to overview]Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit
NCT00440947 (26) [back to overview]Percentage of Participants Who Achieved Plasma HIV-1 RNA <400 c/ml at the Week 36 Visit
NCT00440947 (26) [back to overview]Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit
NCT00440947 (26) [back to overview]Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit
NCT00440947 (26) [back to overview]Number of Participants Who Met the Protocol-defined Virologic Failure (PDVF) Criteria at Week 36
NCT00440947 (26) [back to overview]Number of Participants Who Met the PDVF Criteria at Week 84
NCT00440947 (26) [back to overview]Number of Participants Who Met the PDVF Criteria at Week 144
NCT00440947 (26) [back to overview]Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144
NCT00440947 (26) [back to overview]Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84
NCT00440947 (26) [back to overview]Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36
NCT00440947 (26) [back to overview]Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
NCT00440947 (26) [back to overview]Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
NCT00549198 (58) [back to overview]Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96
NCT00549198 (58) [back to overview]Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24
NCT00549198 (58) [back to overview]Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48
NCT00549198 (58) [back to overview]Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96
NCT00549198 (58) [back to overview]Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24
NCT00549198 (58) [back to overview]Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48
NCT00549198 (58) [back to overview]Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48
NCT00549198 (58) [back to overview]Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96
NCT00549198 (58) [back to overview]Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24
NCT00549198 (58) [back to overview]Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48
NCT00549198 (58) [back to overview]Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96
NCT00549198 (58) [back to overview]Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96
NCT00549198 (58) [back to overview]Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24
NCT00549198 (58) [back to overview]Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48
NCT00549198 (58) [back to overview]Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96
NCT00549198 (58) [back to overview]Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24
NCT00549198 (58) [back to overview]Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48
NCT00549198 (58) [back to overview]Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96
NCT00549198 (58) [back to overview]Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24
NCT00549198 (58) [back to overview]Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48
NCT00549198 (58) [back to overview]Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96
NCT00549198 (58) [back to overview]Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24
NCT00549198 (58) [back to overview]Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48
NCT00549198 (58) [back to overview]Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96
NCT00549198 (58) [back to overview]"Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized"
NCT00549198 (58) [back to overview]Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96
NCT00549198 (58) [back to overview]Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24
NCT00549198 (58) [back to overview]Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48
NCT00549198 (58) [back to overview]Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96
NCT00549198 (58) [back to overview]Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24
NCT00549198 (58) [back to overview]Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48
NCT00549198 (58) [back to overview]Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96
NCT00549198 (58) [back to overview]Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24
NCT00549198 (58) [back to overview]Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48
NCT00549198 (58) [back to overview]Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96
NCT00549198 (58) [back to overview]Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24
NCT00549198 (58) [back to overview]Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48
NCT00605384 (1) [back to overview]Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs or Laboratory Abnormalities
NCT00662545 (5) [back to overview]Hepatitis B Virus (HBV) DNA
NCT00662545 (5) [back to overview]HIV RNA < 75 Copies/ml
NCT00662545 (5) [back to overview]Incidence of Permanent Discontinuation Due to Toxicity
NCT00662545 (5) [back to overview]Incidence of New Hepatic Decompensation( Ascites, Variceal Hemorrhage, Encephalopathy)
NCT00662545 (5) [back to overview]Incidence of ALT Flares
NCT00724711 (14) [back to overview]Change From Baseline Fasting Lipid Parameters at Week 48
NCT00724711 (14) [back to overview]Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48
NCT00724711 (14) [back to overview]Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48
NCT00724711 (14) [back to overview]Change From Baseline C-Reactive Protein at Week 48
NCT00724711 (14) [back to overview]Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48
NCT00724711 (14) [back to overview]Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48
NCT00724711 (14) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
NCT00724711 (14) [back to overview]Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48
NCT00724711 (14) [back to overview]Change From Baseline Fasting Glucose at Week 48
NCT00724711 (14) [back to overview]Change From Baseline Fibrinogen at Week 48
NCT00724711 (14) [back to overview]Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48
NCT00724711 (14) [back to overview]Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm
NCT00724711 (14) [back to overview]Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48
NCT00724711 (14) [back to overview]Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48
NCT00851630 (4) [back to overview]Tuberculosis-immune Reconstitution Inflammatory Syndrome Events
NCT00851630 (4) [back to overview]HIV RNA Level < 50 Copies/ml
NCT00851630 (4) [back to overview]Number of Serious Adverse Events (SAEs)
NCT00851630 (4) [back to overview]Plasma HIV Ribonucleic Acid (RNA) Level < 400 Copies/ml
NCT00915655 (2) [back to overview]Virological Response[Viral Load <50 Copies/mL, TLOVR]
NCT00915655 (2) [back to overview]Virological Response [Viral Load <50 Copies/mL, FDA-SNAPSHOT]
NCT00960622 (1) [back to overview]Change in Peak Oxygen Uptake.
NCT00993031 (14) [back to overview]Placental Malaria Defined as Positive Placental RDT
NCT00993031 (14) [back to overview]Prevalence of Composite Clinical Outcome Defined by LBW, Stillbirth(Intrauterine Fetal Demise >20wks GA), Late Spontaneous Abortion(Miscarriage 12-20wks GA), Preterm Delivery(<37wks Gestation), Neonatal Death(Death of Liveborn Infant Within First 28days)
NCT00993031 (14) [back to overview]Prevalence of Malaria Defined as Positive Placental Blood PCR
NCT00993031 (14) [back to overview]Prevalence of Malaria Defined as Positive Placental Blood Smear
NCT00993031 (14) [back to overview]Placental Malaria Defined Placental Histopathologic Analysis
NCT00993031 (14) [back to overview]Number of Participants With Severe Maternal Anemia Defined by Hemoglobin < 8g/dl at Any Point During the Trial in Each Treatment Group
NCT00993031 (14) [back to overview]Number of Participants With Maternal to Child Transmission of HIV, Measured by Infant HIV DNA PCR
NCT00993031 (14) [back to overview]Number of Participants With Maternal HIV RNA Suppression of <400 Copies/mL
NCT00993031 (14) [back to overview]Number of Participants With Grade 3 or 4 Toxicity in the Two Treatment Groups in Women
NCT00993031 (14) [back to overview]Maternal Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk After Pregnancy
NCT00993031 (14) [back to overview]Incidence of Pre-eclampsia Defined by Hypertension > 140/90 on Two Occasions Measured > 6 Hours Apart With ≥1+ Proteinuria on Clean Catch Urine Dipstick
NCT00993031 (14) [back to overview]Change in Maternal CD4 Cell Counts
NCT00993031 (14) [back to overview]ART Levels in Hair Samples at Delivery
NCT00993031 (14) [back to overview]Maternal Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk During Pregnancy
NCT01023217 (1) [back to overview]Complete Virologic Response (CVR, Serum HBV DNA Undetectable by PCR or Less Than 60 IU/mL)
NCT01025830 (2) [back to overview]Maximum Plasma Concentration of Drug
NCT01025830 (2) [back to overview]Area Under the Concentration-Time Curve(AUC)
NCT01061151 (28) [back to overview]Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events
NCT01061151 (28) [back to overview]Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies)
NCT01061151 (28) [back to overview]Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies)
NCT01061151 (28) [back to overview]Postpartum Component: Proportion of Mother-Infant Pairs With no Death or HIV Diagnosis Through 24 Months Post-delivery
NCT01061151 (28) [back to overview]Postpartum Component: Incidence of Grade 3 or Higher Adverse Events and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events
NCT01061151 (28) [back to overview]Postpartum Component: Incidence of Confirmed Infant HIV Infection
NCT01061151 (28) [back to overview]Maternal Health Component: Toxicity: Incidence of Grade 3 or Greater Laboratory Results or Signs and Symptoms and Selected Grade 2 Hematologic, Renal, and Hepatic Laboratory Results
NCT01061151 (28) [back to overview]Maternal Health Component: Other Targeted Medical Conditions
NCT01061151 (28) [back to overview]Maternal Health Component: Incidence Rate of Progression to AIDS-defining Illness, Death, or a Serious Non-AIDS Cardiovascular, Hepatic, or Renal Event
NCT01061151 (28) [back to overview]Maternal Health Component: Incidence Rate of Cardiovascular or Other Metabolic Events
NCT01061151 (28) [back to overview]Maternal Health Component: Incidence of Tuberculosis
NCT01061151 (28) [back to overview]Maternal Health Component: Incidence of Progression to AIDS-defining Illness or Death
NCT01061151 (28) [back to overview]Maternal Health Component: Incidence of HIV/AIDS-related Events
NCT01061151 (28) [back to overview]Maternal Health Component: Incidence of HIV/AIDS-related Event or World Health Organization (WHO) Clinical Stage 2 or 3 Events
NCT01061151 (28) [back to overview]Maternal Health Component: Incidence of HIV/AIDS-related Event or Death
NCT01061151 (28) [back to overview]Maternal Health Component: Incidence of Death
NCT01061151 (28) [back to overview]Maternal Health Component: Incidence of AIDS-defining Illness
NCT01061151 (28) [back to overview]Antepartum Component: Number of Infant HIV Infections
NCT01061151 (28) [back to overview]Maternal Health Component: Incidence Rate of Death or Any Condition of Particular Concern
NCT01061151 (28) [back to overview]Antepartum Component: Number of Confirmed Infant HIV Infections
NCT01061151 (28) [back to overview]Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures
NCT01061151 (28) [back to overview]Antepartum Component: Maternal HIV RNA Less Than 400 Copies/mL at Delivery
NCT01061151 (28) [back to overview]Postpartum Component: Proportion of Infants Alive Through 12 and 24 Months Post-delivery
NCT01061151 (28) [back to overview]Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component)
NCT01061151 (28) [back to overview]Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component)
NCT01061151 (28) [back to overview]Antepartum Component: Number of Mothers With Obstetrical Complications
NCT01061151 (28) [back to overview]Antepartum Component: Number of Mothers With Obstetrical Complications
NCT01061151 (28) [back to overview]Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events
NCT01075152 (10) [back to overview]HIV-1 Viral Suppression
NCT01075152 (10) [back to overview]Incidence of Cryptococcal-relapse
NCT01075152 (10) [back to overview]Percentage of Participants, Per CSF WBC Subgroup, Who Died by Week 26
NCT01075152 (10) [back to overview]Mortality
NCT01075152 (10) [back to overview]Karnofsky Functional Status
NCT01075152 (10) [back to overview]Microbiologic Clearance
NCT01075152 (10) [back to overview]Safety of ART Initiation
NCT01075152 (10) [back to overview]Incidence of Immune Reconstitution Inflammatory Syndrome
NCT01075152 (10) [back to overview]46-week Survival
NCT01075152 (10) [back to overview]Antiretroviral Therapy Tolerability
NCT01095835 (11) [back to overview]Percentage of Participants With Lamivudine Genotype Resistance During PEG-IFN+LAM96 Combined Therapy
NCT01095835 (11) [back to overview]Percentage of Participants With HBV-DNA Lowering to <3,400 IU/mL and to < 2,000 IU/mL
NCT01095835 (11) [back to overview]Percentage of Participants Achieving the Combined Response at the End of Treatment
NCT01095835 (11) [back to overview]Percentage of Participants With HBV-DNA Below Limit of Quantification
NCT01095835 (11) [back to overview]Percentage of Participants With ALT Normalization
NCT01095835 (11) [back to overview]Percentage of Participants Achieving Combined Response Using a Cut-Off for HBV-DNA Levels to 2,000 IU/mL
NCT01095835 (11) [back to overview]Change From Baseline of Quantitative Hepatitis B Surface Antigen (HbsAg) Level at the End of Treatment
NCT01095835 (11) [back to overview]Percentage of Participants Achieving Histological Response
NCT01095835 (11) [back to overview]Percentage of Participants Achieving the Combined Response at 24 Weeks of Follow-up
NCT01095835 (11) [back to overview]Percentage of Participants Achieving the Combined Response at the End of the Follow-up Period
NCT01095835 (11) [back to overview]Percentage of Participants With Loss of Hepatitis B Surface Antigen (HbsAg) and Hepatitis B Surface Antibodies (Anti-HBs) Seroconversion
NCT01263015 (11) [back to overview]Change From Baseline in Plasma HIV-1 RNA at Weeks 2, 4, 8, 12, 16, 24, 32, 40,48, 60, 72, 84, 96, 108, 120, 132 and 144
NCT01263015 (11) [back to overview]Number of Participants With a Confirmed Plasma HIV-1 RNA Level >=1000 c/mL at or After Week 16 and Before Week 24, or a Confirmed Plasma HIV-1 RNA Level >=200 c/mL at or After Week 24
NCT01263015 (11) [back to overview]Number of Participants With the Indicated Genotypic Resistance With Virological Failure (VF) Through 144
NCT01263015 (11) [back to overview]Number of Participants With the Indicated Post-baseline HIV-associated Conditions and Progression, Excluding Recurrences at Week 144
NCT01263015 (11) [back to overview]Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 96 and Week 144
NCT01263015 (11) [back to overview]Number of Participants With the Indicated Grade 1 to 4 Clinical and Hematology Toxicities at Week144
NCT01263015 (11) [back to overview]Proportion of Subjects Responding Based on Plasma HIV-1 RNA <50 c/mL at Week 48
NCT01263015 (11) [back to overview]Time to Viral Suppression (<50 c/mL)
NCT01263015 (11) [back to overview]Change From Baseline in CD4+ Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144
NCT01263015 (11) [back to overview]Change From Baseline in CD4+ Cell Counts at Week 144
NCT01263015 (11) [back to overview]Change From Baseline in the Symptom Bother Score (SBS) at Week 4 Through Week 48
NCT01338025 (4) [back to overview]Number of Participants Non-adherent as Measured by 3-day Recall
NCT01338025 (4) [back to overview]Change in HIV-1 RNA Levels
NCT01338025 (4) [back to overview]Change in CD4+ T Cell Count
NCT01338025 (4) [back to overview]Number of Participants With Immunologic Deterioration
NCT01352715 (9) [back to overview]Number of Participants With Grade 3 or Higher Adverse Event (AE) at Least One Grade Higher Than Baseline
NCT01352715 (9) [back to overview]Number of Participants With a Targeted Serious Non-AIDS-defining Event or Death
NCT01352715 (9) [back to overview]Number of Participants With a New AIDS-defining Events or Death
NCT01352715 (9) [back to overview]Number of Participants Discontinuing Randomized Treatment for Toxicity
NCT01352715 (9) [back to overview]Cumulative Probability of Virologic Failure by Week 48
NCT01352715 (9) [back to overview]Change in CD4+ Cell Count From Baseline to Week 48
NCT01352715 (9) [back to overview]Number of Participants With HIV-1 Drug Resistance Mutations in Protease, Reverse Transcriptase, and Integrase in Participants With Virologic Failure at Baseline and at Time of Virologic Failure
NCT01352715 (9) [back to overview]Changes in Fasting Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides, and Glucose From Baseline
NCT01352715 (9) [back to overview]Percentage of Time Spent in Hospital
NCT01354652 (2) [back to overview]Incidence of Elevated Venous Lactate Levels More Than 2 mmol/L of Any Etiology
NCT01354652 (2) [back to overview]Overall OLT-free Survival
NCT01386970 (2) [back to overview]3TC-TP Drug Levels Compared Between HIV Negative and HIV Infected Subject
NCT01386970 (2) [back to overview]ZDV-TP Drug Levels Compared Between HIV Negative and HIV Infected Subject
NCT01387022 (4) [back to overview]Change in CD4+ Cell Count From Randomisation to 12 Months Post-randomisation
NCT01387022 (4) [back to overview]Reported Adverse Events With Severity Grades 3 and 4 Based on the DAIDS Toxicity Grading Tables
NCT01387022 (4) [back to overview]Tenofovir Resistance, Defined as Presence of K65R, K70E or Any of the TAMS Mutations
NCT01387022 (4) [back to overview]The Antiretroviral Treatment Failure Rate at 12 Months.
NCT01438424 (26) [back to overview]Overall Study: Percentage of Participants With HBeAg Seroconversion
NCT01438424 (26) [back to overview]Overall Study: Percentage of Participants Who Achieved ALT Normalization
NCT01438424 (26) [back to overview]Overall Study: Percentage of Participants Who Achieved a Loss of Hepatitis B e Antigen (HBeAg)
NCT01438424 (26) [back to overview]Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay
NCT01438424 (26) [back to overview]Overall Study: Number of Participants With Normal Pancreatic Enzyme and Renal Function Values at Baseline and Abnormalities in Pancreatic Enzyme and Renal Function Laboratory Test Results at End of Dosing
NCT01438424 (26) [back to overview]Overall Study: Number of Participants With Normal Hematology Values at Baseline and Abnormalities in Hematology Laboratory Test Results Through Week 240
NCT01438424 (26) [back to overview]Overall Study: Number of Participants With Normal Electrolyte and Fasting Glucose Values at Baseline and Abnormalities in Electrolyte and Fasting Glucose Laboratory Test Results at End of Dosing
NCT01438424 (26) [back to overview]Overall Study: Number of Participants With Death As Outcome, Any Adverse Event (AE), Grade 3-4 AEs, Serious Adverse Events (SAEs), and Discontinuations Due to AEs
NCT01438424 (26) [back to overview]Overall Study: Mean Alanine Transaminase (ALT) Levels
NCT01438424 (26) [back to overview]Off-treatment Follow-up: Percentage of Participants With Sustained Hepatitis B Virus (HBV) DNA <10,000 Copies by Polymerase Chain Reaction (PCR) Assay (Amendment 11 Cohort)
NCT01438424 (26) [back to overview]Off-treatment Follow-up: Percentage of Participants With Sustained HBV DNA <1,000, <300, and <10,000 Copies/mL by PCR Assay and With ALT ≤1*ULN (Amendment 11 Cohort)
NCT01438424 (26) [back to overview]Off-treatment Follow-up: Mean Change in HBV DNA (Amendment 11 Cohort)
NCT01438424 (26) [back to overview]Overall Study: Percentage of Participants With a Confirmed ≥1 log10 Increase From Nadir in HBV DNA by PCR Assay
NCT01438424 (26) [back to overview]Overall Study: Mean HBV DNA Level by PCR Assay
NCT01438424 (26) [back to overview]Week 96: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay, Loss of HBeAg, HBeAg Seroconversion, and ALT ≤1.0*ULN (Lamivudine Continuous Switch Cohort)
NCT01438424 (26) [back to overview]Week 96: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Retreatment Switch Cohort)
NCT01438424 (26) [back to overview]Week 192: Percentage of Participants With Improvement in Fibrosis (Efficacy Evaluable Cohort)
NCT01438424 (26) [back to overview]Week 192: Percentage of Participants With Histologic Improvement (Efficacy Evaluable Cohort)
NCT01438424 (26) [back to overview]Week 192: Number of Participants With Death As Outcome, Any AE, Grade 3-4 AEs, SAEs, Discontinuations Due to AEs, and Abnormalities in Selected Laboratory Test Results
NCT01438424 (26) [back to overview]Week 144: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Retreatment Switch Cohort)
NCT01438424 (26) [back to overview]Week 144: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Continuous Switch Cohort)
NCT01438424 (26) [back to overview]Week 144: Number of Participants With Death As Outcome, Any AE, Grade 3-4 AEs, SAEs, Discontinuations Due to AEs, and Abnormalities in Selected Laboratory Test Results
NCT01438424 (26) [back to overview]Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay, Loss of HBeAG, Seroconversion, and ALT ≤1.0*Upper Limit of Normal (ULN) (Entecavir Continuous Treatment Cohort)
NCT01438424 (26) [back to overview]Percentage of Participants Who Achieved HBV DNA <300 and <10^4 Copies/mL by PCR Assay and ALT ≤1.0*Upper Limit of Normal (ULN) (Entecavir Retreatment Cohort)
NCT01438424 (26) [back to overview]Overall Study: Percentage of Participants With Sustained HBV DNA Level <300 Copies/mL by PCR Assay
NCT01438424 (26) [back to overview]Overall Study: Percentage of Participants With Sustained HBV DNA <10^4 Copies/mL by PCR Assay
NCT01618305 (17) [back to overview]Proportion of Women With HIV-1 Drug Resistance Mutations at Screening, 2-4 Weeks Postpartum in Women Who Stopped Antiretroviral Therapy, and at the Time of Inadequate Virologic Response Using Standard and Ultrasensitive Methods.
NCT01618305 (17) [back to overview]Proportion of HIV-infected Infants With Genotypic Resistance to Study Drugs
NCT01618305 (17) [back to overview]Log10 Change in Viral Load From Entry to Each Time Point Prior to Delivery
NCT01618305 (17) [back to overview]Proportion of Women With Plasma HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery
NCT01618305 (17) [back to overview]Proportion of Women With 1) Successful Viral Load (Plasma HIV-1 RNA VL) Decrease From Entry to Week 2 and VL Less Than 1,000 Copies/ml at All Time Points After 4 Weeks on Study Drugs, Until Delivery; and 2) Who Remain on the Assigned Study Regimen
NCT01618305 (17) [back to overview]Proportion of Women Who Experienced at Least One New Adverse Event of Greater Than or Equal to Grade 3 as Defined in the Division of AIDS (DAIDS) Toxicity Table
NCT01618305 (17) [back to overview]Proportion of Women Who Achieved HIV-1 RNA Virologic Suppression Below the Lower Limit of Quantification of the Assay at Delivery
NCT01618305 (17) [back to overview]Proportion of Participants Who Discontinued Randomized Study Drug Prior to Labor and Delivery.
NCT01618305 (17) [back to overview]Proportion of Infants Who Experienced at Least One Adverse Event of Greater Than or Equal to Grade 3.
NCT01618305 (17) [back to overview]Proportion of Deliveries With a Low Birth Weight (Less Than 2,500 Grams)
NCT01618305 (17) [back to overview]Proportion of Deliveries With an Extremely Low Birth Weight (<1,500 Grams).
NCT01618305 (17) [back to overview]Proportion of Women With HIV-1 RNA Vaginal Viral Load Less Than 1200 Copies/mL at Weeks 4 and 6 From Treatment Initiation
NCT01618305 (17) [back to overview]Proportion of Women With HIV-1 RNA Plasma Viral Load Less Than 200 Copies/mL at Weeks 4 and 6 From Treatment Initiation
NCT01618305 (17) [back to overview]Proportion of Women With HIV-1 Drug Resistance Mutations at Screening, 2-4 Weeks Postpartum in Women Who Stopped Antiretroviral Therapy, and at the Time of Inadequate Virologic Response Using Standard and Ultrasensitive Methods.
NCT01618305 (17) [back to overview]Proportion of Deliveries That Were Premature (Less Than 37 Weeks Gestation)
NCT01618305 (17) [back to overview]Proportion of Deliveries That Were Extremely Premature (Less Than 34 Weeks Gestation).
NCT01618305 (17) [back to overview]Proportion of Deliveries That Had an Outcome of a Stillbirth/Fetal Demise.
NCT01641809 (57) [back to overview]Change From Baseline in Hemoglobin Level Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Hemoglobin Level Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit
NCT01641809 (57) [back to overview]Number of Participants With Adherence to Study Treatment
NCT01641809 (57) [back to overview]Number of Participants With Adherence to Study Treatment
NCT01641809 (57) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase
NCT01641809 (57) [back to overview]Number of Participants With AEs and SAEs Over Time
NCT01641809 (57) [back to overview]Number of Participants With AEs and SAEs-Induction Phase
NCT01641809 (57) [back to overview]Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time
NCT01641809 (57) [back to overview]Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase
NCT01641809 (57) [back to overview]Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit
NCT01641809 (57) [back to overview]Maximum Observed Concentration (Cmax) for GSK1265744 at Week 2
NCT01641809 (57) [back to overview]Concentration at the End of a Dosing Interval (Ctau) for GSK1265744 at Week 2
NCT01641809 (57) [back to overview]Area Under the Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) for GSK1265744 at Week 2
NCT01641809 (57) [back to overview]Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
NCT01641809 (57) [back to overview]Number of Participants With Adherence to Study Treatment
NCT01641809 (57) [back to overview]Change From Baseline in ALT, AST and CK Over Time by Visit
NCT01641809 (57) [back to overview]Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit
NCT01641809 (57) [back to overview]Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit
NCT01641809 (57) [back to overview]Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time
NCT01641809 (57) [back to overview]Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase
NCT01641809 (57) [back to overview]Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase
NCT01641809 (57) [back to overview]Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease
NCT01641809 (57) [back to overview]Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance
NCT01641809 (57) [back to overview]Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96
NCT01641809 (57) [back to overview]Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm
NCT01641809 (57) [back to overview]Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase
NCT01641809 (57) [back to overview]Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Induction Phase
NCT01641809 (57) [back to overview]Percentage of Participants Who Discontinued Investigational Product Due to Adverse Events
NCT01641809 (57) [back to overview]Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase
NCT01641809 (57) [back to overview]Number of Participants With Treatment Emergent Phenotypic Resistance
NCT01641809 (57) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase
NCT01641809 (57) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase
NCT01641809 (57) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm
NCT01641809 (57) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis
NCT01641809 (57) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis
NCT01641809 (57) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis
NCT01641809 (57) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm
NCT01641809 (57) [back to overview]Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in CD4+ Cell Count Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in CD4+ Cell Count Over Time by Visit
NCT01641809 (57) [back to overview]Change From Baseline in ALT, AST and CK Over Time by Visit
NCT01641809 (57) [back to overview]Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
NCT01818258 (17) [back to overview]Plasma Clearance of Lamivudine
NCT01818258 (17) [back to overview]Minimum Trough Concentration (Ctrough) of Lopinavir
NCT01818258 (17) [back to overview]HIV Viral Load <400 Copies/mL
NCT01818258 (17) [back to overview]Free Fraction of LPV at Hour 2 Post Dose
NCT01818258 (17) [back to overview]Change in WHO Weight-for-height Z-score
NCT01818258 (17) [back to overview]Change in Mid-upper Arm Circumference
NCT01818258 (17) [back to overview]Change in HIV Viral Load From Baseline
NCT01818258 (17) [back to overview]Change in CD4 Percent
NCT01818258 (17) [back to overview]Grade 3 or Higher Adverse Events Through 24 Weeks
NCT01818258 (17) [back to overview]Grade 3 or Higher Adverse Events Related to Study Drugs Through Week 24
NCT01818258 (17) [back to overview]Plasma Clearance of Ritonavir
NCT01818258 (17) [back to overview]Steady-state Zidovudine Area Under the Curve
NCT01818258 (17) [back to overview]Steady-state Ritonavir Area Under the Curve
NCT01818258 (17) [back to overview]Steady-state Lopinavir Area Under the Curve
NCT01818258 (17) [back to overview]Steady-state Lamivudine Area Under the Curve
NCT01818258 (17) [back to overview]Plasma Clearance of Zidovudine
NCT01818258 (17) [back to overview]Plasma Clearance of Lopinavir
NCT01910402 (48) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups
NCT01910402 (48) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups
NCT01910402 (48) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase
NCT01910402 (48) [back to overview]Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase
NCT01910402 (48) [back to overview]Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints
NCT01910402 (48) [back to overview]Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints
NCT01910402 (48) [back to overview]Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points
NCT01910402 (48) [back to overview]Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48
NCT01910402 (48) [back to overview]HIVTSQs Total Score at Indicated Timepoints
NCT01910402 (48) [back to overview]Number of Participants With AEs by Maximum Toxicity-Randomized Phase
NCT01910402 (48) [back to overview]Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)-Randomized Phase
NCT01910402 (48) [back to overview]Number of Participants With Any AEs, and SAEs in Continuation Phase
NCT01910402 (48) [back to overview]Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase
NCT01910402 (48) [back to overview]Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase
NCT01910402 (48) [back to overview]Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase
NCT01910402 (48) [back to overview]Number of Participants With AEs by Maximum Toxicity-Continuation Phase
NCT01910402 (48) [back to overview]Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase
NCT01910402 (48) [back to overview]Number of Participants With Post-Baseline HIV-1 Disease Progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)
NCT01910402 (48) [back to overview]Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase
NCT01910402 (48) [back to overview]Number of Participants With Treatment Emergent Resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase)
NCT01910402 (48) [back to overview]Number of Participants With Treatment Emergent Resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)
NCT01910402 (48) [back to overview]Absolute Values in CD4+ Cell Count at Indicated Timepoints-Continuation Phase
NCT01910402 (48) [back to overview]Change From Baseline in TC/HDL Ratio at Week 48
NCT01910402 (48) [back to overview]Change From Baseline in Triglycerides at Week 48
NCT01910402 (48) [back to overview]Number of Participants Who Withdrew From Treatment Due to AEs-Continuation Phase
NCT01910402 (48) [back to overview]Number of Participants Who Withdrew From Treatment Due to AEs-Randomized Phase
NCT01910402 (48) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48
NCT01910402 (48) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 c/mL in Continuation Phase
NCT01910402 (48) [back to overview]Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase
NCT01910402 (48) [back to overview]Change From Baseline in Lipase at Indicated Timepoints
NCT01910402 (48) [back to overview]Change From Baseline in Hematocrit Count at Indicated Time Points
NCT01910402 (48) [back to overview]Change From Baseline in Erythrocytes at Indicated Time Points
NCT01910402 (48) [back to overview]Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points
NCT01910402 (48) [back to overview]Change From Baseline in Creatinine Clearance at Indicated Time Points
NCT01910402 (48) [back to overview]Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase
NCT01910402 (48) [back to overview]Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase
NCT01910402 (48) [back to overview]Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Continuation Phase
NCT01910402 (48) [back to overview]Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points
NCT01910402 (48) [back to overview]Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points
NCT01910402 (48) [back to overview]Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints
NCT01910402 (48) [back to overview]Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints
NCT01910402 (48) [back to overview]Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points
NCT01910402 (48) [back to overview]Change From Baseline in Albumin at Indicated Timepoints
NCT01910402 (48) [back to overview]Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points
NCT01910402 (48) [back to overview]Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS
NCT01910402 (48) [back to overview]Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline
NCT01910402 (48) [back to overview]Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase
NCT01910402 (48) [back to overview]Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase
NCT02028676 (58) [back to overview]Cotrimoxazole: Change From Baseline in CD4% to Week 72
NCT02028676 (58) [back to overview]Cotrimoxazole: Change From Baseline in Absolute CD4 to Week 72
NCT02028676 (58) [back to overview]Cotrimoxazole: Body Mass Index-for-age Z-score
NCT02028676 (58) [back to overview]Cotrimoxazole: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)
NCT02028676 (58) [back to overview]CDM vs LCM, Induction ART: Suppression of HIV RNA Viral Load 72 Weeks After Baseline
NCT02028676 (58) [back to overview]CDM vs LCM, Induction ART: Suppression of HIV RNA Viral Load 144 Weeks After Baseline
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 72
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: Height-for-age Z-score
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: New ART-modifying Adverse Event
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks) at 96 Weeks
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: New Grade 3 or 4 Adverse Event Definitely/Probably or Uncertainly Related to ART
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: New or Recurrent WHO Stage 3 or 4 Event or Death
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: New Serious Adverse Events Not Solely Related to HIV
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: New WHO Stage 3 or 4 Event or Death
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: Weight-for-age Z-score
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)
NCT02028676 (58) [back to overview]Cotrimoxazole: All-cause Mortality
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Suppressed HIV RNA Viral Load 48 Weeks After Randomisation
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Suppression of HIV RNA Viral Load 96 Weeks After Randomisation
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Weight-for-age Z-score
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: Cessation of First-line Regimen for Clinical/Immunological Failure
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: Body Mass Index-for-age Z-score
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: All-cause Mortality
NCT02028676 (58) [back to overview]LCM vs CDM: Change From Baseline in CD4% to Week 144
NCT02028676 (58) [back to overview]LCM vs CDM: Change From Baseline in CD4% to Week 72
NCT02028676 (58) [back to overview]LCM vs CDM: Disease Progression to a New WHO Stage 4 Event or Death
NCT02028676 (58) [back to overview]LCM vs CDM: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV
NCT02028676 (58) [back to overview]Induction ART: New WHO Stage 4 Event or Death
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks) at 48 Weeks
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: All-cause Mortality
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Body Mass Index-for-age Z-score
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 48
NCT02028676 (58) [back to overview]LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 144
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 72
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 96
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 48
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 72
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 96
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Height-for-age Z-score
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV, Judged Definitely/Probably or Uncertain Whether Related to Lamivudine or Abacavir
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: New Serious Adverse Events Not Solely Related to HIV
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 4 Event or Death
NCT02028676 (58) [back to overview]Induction ART: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV
NCT02028676 (58) [back to overview]Induction ART: Change From Baseline in CD4% to 144 Weeks From ART Initiation
NCT02028676 (58) [back to overview]Induction ART: Change From Baseline in CD4% 72 Weeks After ART Initiation
NCT02028676 (58) [back to overview]Cotrimoxazole: Weight-for-age Z-score
NCT02028676 (58) [back to overview]Cotrimoxazole: New WHO Stage 4 Event or Death
NCT02028676 (58) [back to overview]Cotrimoxazole: New WHO Stage 3 Severe Recurrent Pneumonia or Diarrhoea
NCT02028676 (58) [back to overview]Cotrimoxazole: New WHO Stage 3 or 4 Event or Death
NCT02028676 (58) [back to overview]Cotrimoxazole: New Severe Pneumonia
NCT02028676 (58) [back to overview]Cotrimoxazole: New Serious Adverse Events Not Solely Related to HIV
NCT02028676 (58) [back to overview]Cotrimoxazole: New Hospitalisation or Death
NCT02028676 (58) [back to overview]Cotrimoxazole: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV
NCT02028676 (58) [back to overview]Cotrimoxazole: New Clinical and Diagnostic Positive Malaria
NCT02028676 (58) [back to overview]Cotrimoxazole: Height-for-age Z-score
NCT02028676 (58) [back to overview]Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 3 or 4 Event or Death
NCT02116660 (1) [back to overview]Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
NCT02263079 (19) [back to overview]Percentage of Participants With Loss of Hepatitis B Virus Envelope Antigen (HBeAg)
NCT02263079 (19) [back to overview]Percentage of Participants With Seroconversion to Hepatitis B Surface Antibody (Anti-HBs), Defined as Loss of HBsAg and Presence of Anti-HBs
NCT02263079 (19) [back to overview]Percentage of Participants With Seroconversion to Hepatitis B Surface Antibody (Anti-HBs), Defined as Loss of HBsAg and Presence of Anti-HBs
NCT02263079 (19) [back to overview]Percentage of Participants With Seroconversion to Hepatitis B Envelope Antibody (Anti-HBe), Defined as Loss of HBeAg and Presence of Anti-HBe
NCT02263079 (19) [back to overview]Percentage of Participants With Seroconversion to Hepatitis B Envelope Antibody (Anti-HBe), Defined as Loss of HBeAg and Presence of Anti-HBe
NCT02263079 (19) [back to overview]Percentage of Participants With Loss of Hepatitis B Virus Envelope Antigen (HBeAg)
NCT02263079 (19) [back to overview]Percentage of Participants With Different Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels (Less Than [<] 20,000 International Units Per Milliliter [IU/mL], < 2000 IU/mL, or Undetectable HBV DNA)
NCT02263079 (19) [back to overview]Percentage of Participants With Different Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels (Less Than [<] 20,000 International Units Per Milliliter [IU/mL], < 2000 IU/mL, or Undetectable HBV DNA)
NCT02263079 (19) [back to overview]Percentage of Participants With Combined Response for HBeAg Seroconversion (Defined as Loss of HBeAg and Presence of Anti-HBe) and HBV DNA Levels <2000 IU/mL
NCT02263079 (19) [back to overview]Percentage of Participants With Combined Response for HBeAg Seroconversion (Defined as Loss of HBeAg and Presence of Anti-HBe) and HBV DNA Levels <2000 IU/mL
NCT02263079 (19) [back to overview]Percentage of Participants With Combined Response for HBeAg Seroconversion (Defined as Loss of HBeAg and Presence of Anti-HBe) and HBV DNA Levels <20,000 IU/mL
NCT02263079 (19) [back to overview]Percentage of Participants With Combined Response for HBeAg Seroconversion (Defined as Loss of HBeAg and Presence of Anti-HBe) and HBV DNA Levels <20,000 IU/mL
NCT02263079 (19) [back to overview]Percentage of Participants With Adverse Events (AEs)
NCT02263079 (19) [back to overview]Change From Baseline in HBV DNA Levels in the Untreated Control Participants
NCT02263079 (19) [back to overview]Change From Baseline in HBV DNA Levels in the Peg-INF-Alfa-2A (Treated) Arm
NCT02263079 (19) [back to overview]Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) at 24 Weeks Post-End of Treatment/End of Untreated Observation
NCT02263079 (19) [back to overview]Percentage of Participants With Loss of HBsAg
NCT02263079 (19) [back to overview]Percentage of Participants With AEs Leading to Dose Modification or Interruption
NCT02263079 (19) [back to overview]Serum Concentration of Peg-INF-Alfa-2A
NCT02263326 (8) [back to overview]Change in LDL Cholesterol From Baseline to Week 48
NCT02263326 (8) [back to overview]Change in Total Cholesterol From Baseline to Week 48
NCT02263326 (8) [back to overview]Drug Resistance Associated Mutations
NCT02263326 (8) [back to overview]Proportion of Participants With Virologic Success
NCT02263326 (8) [back to overview]Residual Viremia by HIV-1 Single-copy Assay
NCT02263326 (8) [back to overview]Proportion of Participants With Treatment Failure
NCT02263326 (8) [back to overview]Change in CD4 Count From Baseline to Week 48
NCT02263326 (8) [back to overview]Change in Creatinine Clearance From Baseline to Week 48
NCT02384395 (4) [back to overview]Number of Participants With Grade 3 or Higher Adverse Event (AE)
NCT02384395 (4) [back to overview]Median Change HIV-1 RNA Level Among Participants Completing Week 24 Visit
NCT02384395 (4) [back to overview]Number of Participants With Viral Load Measurement <200 Copies/mL at Week 24
NCT02384395 (4) [back to overview]Proportion of Treated Participants With HIV-1 RNA to <50 Copies/mL at Week 48
NCT02397096 (12) [back to overview]Percentage of Participants Maintaining HIV-1 RNA <50 Copies/mL
NCT02397096 (12) [back to overview]Percentage of Participants Maintaining Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
NCT02397096 (12) [back to overview]Percentage of Participants With HIV-1 RNA >=50 Copies/mL
NCT02397096 (12) [back to overview]Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts
NCT02397096 (12) [back to overview]Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts
NCT02397096 (12) [back to overview]Mean Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C)
NCT02397096 (12) [back to overview]Mean Change From Baseline in Fasting Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
NCT02397096 (12) [back to overview]Percentage of Participants Experiencing ≥1 Adverse Event (AE)
NCT02397096 (12) [back to overview]Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL
NCT02397096 (12) [back to overview]Percentage of Participants Discontinuing From Study Medication Due to an AE(s)
NCT02397096 (12) [back to overview]Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL
NCT02397096 (12) [back to overview]Percentage of Participants Experiencing ≥1 Serious Adverse Event (SAE)
NCT02403674 (14) [back to overview]Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48
NCT02403674 (14) [back to overview]Percentage of Participants Experiencing ≥1 AE
NCT02403674 (14) [back to overview]Percentage of Participants Discontinuing From Study Medication Due to an AE(s)
NCT02403674 (14) [back to overview]Change From Baseline in Fasting Triglycerides at Week 48
NCT02403674 (14) [back to overview]Change From Baseline in Fasting Non-HDL-C at Week 48
NCT02403674 (14) [back to overview]Change From Baseline in Fasting LDL-C at Week 48
NCT02403674 (14) [back to overview]Change From Baseline in Fasting HDL-C at Week 48
NCT02403674 (14) [back to overview]Change From Baseline in Fasting Cholesterol at Week 48
NCT02403674 (14) [back to overview]Percentage of Participants With HIV-1 RNA Below the Limit of Quantification (BLoQ) at Week 48
NCT02403674 (14) [back to overview]Percentage of Participants With Tier-2 Neuropsychiatric AEs
NCT02403674 (14) [back to overview]Plasma Concentration of Doravirine at Week 48
NCT02403674 (14) [back to overview]Percentage of Participants With Tier-1 Neuropsychiatric Adverse Events (AEs)
NCT02403674 (14) [back to overview]Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
NCT02403674 (14) [back to overview]Change From Baseline in CD4 Cell Counts at Week 48
NCT02469246 (12) [back to overview]Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm
NCT02469246 (12) [back to overview]Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
NCT02469246 (12) [back to overview]Percent Change From Baseline in Spine BMD at Week 48
NCT02469246 (12) [back to overview]Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm
NCT02469246 (12) [back to overview]Percent Change From Baseline in Spine BMD at Week 96
NCT02469246 (12) [back to overview]Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm
NCT02469246 (12) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm
NCT02469246 (12) [back to overview]Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm
NCT02469246 (12) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm
NCT02469246 (12) [back to overview]Percent Change From Baseline in Hip BMD at Week 96
NCT02469246 (12) [back to overview]Change From Baseline in CD4 Cell Count at Week 96
NCT02469246 (12) [back to overview]Change From Baseline in CD4 Cell Count at Week 48
NCT02581202 (36) [back to overview]Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 24
NCT02581202 (36) [back to overview]Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 48
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Base-10 Logarithm Transformed Data)
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Untransformed Data)
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 24
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 48
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 24
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 48
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Base-10 Logarithm Transformed Data)
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Untransformed Data)
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (U/L)
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (µmol/L)
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (U/L)
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (µmol/L)
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Glucose
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: HDL
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Insulin
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: LDL
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Serum Creatinine
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Total Cholesterol
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Triglycerides
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: LDL
NCT02581202 (36) [back to overview]Number of Participants Who Developed Resistance to Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs), and Protease Inhibitors (PIs)
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Serum Creatinine
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Total Cholesterol
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Triglycerides
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: HDL
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (U/L)
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (µmol/L)
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (U/L)
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48
NCT02581202 (36) [back to overview]Number of Participants With Adverse Events
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Glucose
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Insulin
NCT02581202 (36) [back to overview]Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (µmol/L)
NCT02582684 (12) [back to overview]Fasting Lipids and Glucose
NCT02582684 (12) [back to overview]Creatinine Clearance
NCT02582684 (12) [back to overview]Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- ITT Missing = Ignored
NCT02582684 (12) [back to overview]Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL - Missing = Ignored
NCT02582684 (12) [back to overview]Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL- As Treated
NCT02582684 (12) [back to overview]Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- As Treated
NCT02582684 (12) [back to overview]Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/mL - Missing = Failure
NCT02582684 (12) [back to overview]Number of Participants With Grade 3 of Higher Adverse Events
NCT02582684 (12) [back to overview]CD4+ Cell Count
NCT02582684 (12) [back to overview]Change in CD4+ Cell Count
NCT02582684 (12) [back to overview]Proportion of Participants With Plasma HIV-1 RNA < 200 Copies/mL - Missing = Failure
NCT02582684 (12) [back to overview]Number of HIV-1 Drug Resistance Mutation Occurrences in Participants
NCT02603120 (7) [back to overview]Hip Bone Mineral Density at Baseline
NCT02603120 (7) [back to overview]Percentage Change From Baseline in Hip BMD at Week 48
NCT02603120 (7) [back to overview]Percentage Change From Baseline in Spine BMD at Week 48
NCT02603120 (7) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Defined by the US FDA-defined Snapshot Algorithm
NCT02603120 (7) [back to overview]Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm
NCT02603120 (7) [back to overview]Spine Bone Mineral Density (BMD) at Baseline
NCT02603120 (7) [back to overview]Change From Baseline in CD4+ Cell Count at Week 48
NCT02607930 (24) [back to overview]Change From Baseline in log10 HIV-1 RNA at Week 144
NCT02607930 (24) [back to overview]Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm
NCT02607930 (24) [back to overview]Change From Baseline in log10 HIV-1 RNA at Week 48
NCT02607930 (24) [back to overview]Change From Baseline in log10 HIV-1 RNA at Week 96
NCT02607930 (24) [back to overview]Percentage Change From Baseline in Hip BMD at Week 144
NCT02607930 (24) [back to overview]Percentage Change From Baseline in Hip BMD at Week 48
NCT02607930 (24) [back to overview]Percentage Change From Baseline in Hip BMD at Week 96
NCT02607930 (24) [back to overview]Percentage Change From Baseline in Spine BMD at Week 144
NCT02607930 (24) [back to overview]Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
NCT02607930 (24) [back to overview]Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm
NCT02607930 (24) [back to overview]Change From Baseline in CD4+ Cell Count at Week 144
NCT02607930 (24) [back to overview]Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm
NCT02607930 (24) [back to overview]Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm
NCT02607930 (24) [back to overview]Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
NCT02607930 (24) [back to overview]Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
NCT02607930 (24) [back to overview]Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm
NCT02607930 (24) [back to overview]Percentage Change From Baseline in Spine BMD at Week 96
NCT02607930 (24) [back to overview]Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm
NCT02607930 (24) [back to overview]Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
NCT02607930 (24) [back to overview]Change From Baseline in CD4+ Cell Count at Week 48
NCT02607930 (24) [back to overview]Change From Baseline in CD4+ Cell Count at Week 48 Open-Label
NCT02607930 (24) [back to overview]Percentage Change From Baseline in Spine BMD at Week 48
NCT02607930 (24) [back to overview]Change From Baseline in CD4+ Cell Count at Week 96
NCT02607930 (24) [back to overview]Change From Baseline in CD4+ Cell Count at Week 96 Open-Label
NCT02616783 (8) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
NCT02616783 (8) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm
NCT02616783 (8) [back to overview]Percent Change From Baseline to Week 48 in Hip BMD
NCT02616783 (8) [back to overview]Percent Change From Baseline to Week 24 in Spine BMD
NCT02616783 (8) [back to overview]Percent Change From Baseline to Week 24 in Hip BMD
NCT02616783 (8) [back to overview]Change in Baseline in CD4+ Cell Count at Week 48
NCT02616783 (8) [back to overview]Change From Baseline in CD4+ Cell Count at Week 24
NCT02616783 (8) [back to overview]Percent Change From Baseline to Week 48 in Spine BMD
NCT02629822 (14) [back to overview]Change From Baseline in CD4 Cell Count at Week 96
NCT02629822 (14) [back to overview]Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 48
NCT02629822 (14) [back to overview]Change From Baseline in CD4 Cell Count at Week 48
NCT02629822 (14) [back to overview]Change From Baseline in CD4 Cell Count at Week 192
NCT02629822 (14) [back to overview]Time to Loss of Virologic Response
NCT02629822 (14) [back to overview]Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 96
NCT02629822 (14) [back to overview]Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 48.
NCT02629822 (14) [back to overview]Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 96
NCT02629822 (14) [back to overview]Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 48
NCT02629822 (14) [back to overview]Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 192
NCT02629822 (14) [back to overview]Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 96
NCT02629822 (14) [back to overview]Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 48
NCT02629822 (14) [back to overview]Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 192
NCT02629822 (14) [back to overview]Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 96
NCT02634073 (20) [back to overview]Time to Observed Maximum Lamivudine Plasma Concentration (Tmax), Time of Last Measurable Plasma Concentration (Tlast) and Absorption Lag Time in Plasma (Tlag)
NCT02634073 (20) [back to overview]Plasma Lamivudine Maximum Observed Concentration (Cmax), Concentration at 24 Hour (h) Post-dose (C24) and Last Measurable Concentration (Ct)
NCT02634073 (20) [back to overview]Plasma Lamivudine Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point (AUC[0-t]), AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) and AUC From Time Zero to 24 Hours (AUC[0-24])
NCT02634073 (20) [back to overview]Number of Participants With Treatment Emergent Laboratory Abnormality Grade
NCT02634073 (20) [back to overview]Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAE)
NCT02634073 (20) [back to overview]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
NCT02634073 (20) [back to overview]Change From Baseline in Pulse Rate
NCT02634073 (20) [back to overview]Change From Baseline in Platelets, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
NCT02634073 (20) [back to overview]Change From Baseline in Mean Corpuscular Volume (MCV)
NCT02634073 (20) [back to overview]Change From Baseline in Mean Corpuscular Hemoglobin (MCH)
NCT02634073 (20) [back to overview]Change From Baseline in Hematocrit
NCT02634073 (20) [back to overview]Change From Baseline in Erythrocytes
NCT02634073 (20) [back to overview]Change From Baseline in Creatinine, Total Bilirubin and Direct Bilirubin
NCT02634073 (20) [back to overview]Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphates
NCT02634073 (20) [back to overview]Change From Baseline in Body Temperature
NCT02634073 (20) [back to overview]Change From Baseline in Albumin
NCT02634073 (20) [back to overview]Plasma Lamivudine Apparent Oral Clearance (CL/F)
NCT02634073 (20) [back to overview]Lamivudine Elimination Half-life in Plasma (t1/2)
NCT02634073 (20) [back to overview]Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Glucose, Calcium
NCT02634073 (20) [back to overview]Change From Baseline in Hemoglobin
NCT02652260 (20) [back to overview]Percentage of Participants With at Least One Central Nervous System (CNS) Toxicity of at Least Grade 2 Intensity at Week 12
NCT02652260 (20) [back to overview]Percentage of Participants With at Least One CNS Toxicity of at Least Grade 2 Intensity at Time of Switch, and at 24 Weeks Post-switch for the Combined Treatment Groups
NCT02652260 (20) [back to overview]Percentage of Participants With at Least One CNS Toxicity of at Least Grade 2 Intensity at Week 4
NCT02652260 (20) [back to overview]Change From Baseline in Fasting Lipids at Week 12
NCT02652260 (20) [back to overview]Change in Fasting Lipids Between Time of Switch and Week 24 Post-switch for the Combined Treatment Groups
NCT02652260 (20) [back to overview]Change From Baseline in CNS Toxicity Score at Week 4
NCT02652260 (20) [back to overview]Change From Time of Switch to Week 24 Post Switch in CD4 T-cell Count for the Combined Treatment Groups
NCT02652260 (20) [back to overview]CNS Toxicity Scores at Time of Switch, and at 24 Weeks Post-switch for the Combined Treatment Groups
NCT02652260 (20) [back to overview]Number of Participants Who Discontinued Treatment Due to an AE for the Combined Treatment Groups 24 Weeks After the Switch
NCT02652260 (20) [back to overview]Number of Participants Who Discontinued Treatment Due to an AE Through Study Week 12
NCT02652260 (20) [back to overview]Number of Participants With One or More Adverse Events (AEs) Through Study Week 12
NCT02652260 (20) [back to overview]Number of Participants With One or More AEs for the Combined Treatment Groups 24 Weeks After the Switch
NCT02652260 (20) [back to overview]Percentage of Participants With HIV-1 RNA <50 and <40 Copies/ml at Week 24 Post-switch for the Combined Treatment Groups
NCT02652260 (20) [back to overview]Number of Participants With One or More Drug-related AEs for the Combined Treatment Groups 24 Weeks After the Switch
NCT02652260 (20) [back to overview]Number of Participants With One or More Drug-related AEs Through Study Week 12
NCT02652260 (20) [back to overview]Number of Participants With One or More Drug-related SAEs for the Combined Treatment Groups 24 Weeks After the Switch
NCT02652260 (20) [back to overview]Change From Baseline in CNS Toxicity Score at Week 12
NCT02652260 (20) [back to overview]Number of Participants With One or More SAEs for the Combined Treatment Groups 24 Weeks After the Switch
NCT02652260 (20) [back to overview]Number of Participants With One or More Serious Adverse Events (SAEs) Through Study Week 12
NCT02652260 (20) [back to overview]Number of Participants With One or More Drug-related SAEs Through Study Week 12
NCT02831673 (64) [back to overview]Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48
NCT02831673 (64) [back to overview]Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 96
NCT02831673 (64) [back to overview]Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144
NCT02831673 (64) [back to overview]Change From Baseline in EQ-5D-5L Utility Score at Week 96
NCT02831673 (64) [back to overview]Change From Baseline in EQ-5D-5L Utility Score at Week 144
NCT02831673 (64) [back to overview]Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96
NCT02831673 (64) [back to overview]Change From Baseline in EQ-5D-5L Thermometer Scores at Week 144
NCT02831673 (64) [back to overview]Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96
NCT02831673 (64) [back to overview]Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144
NCT02831673 (64) [back to overview]CD4+ Cell Counts at Week 96
NCT02831673 (64) [back to overview]CD4+ Cell Counts at Week 144
NCT02831673 (64) [back to overview]Number of Participants Who Discontinue Treatment Due to AEs Over Week 144
NCT02831673 (64) [back to overview]Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48
NCT02831673 (64) [back to overview]Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96
NCT02831673 (64) [back to overview]Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144
NCT02831673 (64) [back to overview]Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48
NCT02831673 (64) [back to overview]Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24
NCT02831673 (64) [back to overview]Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96
NCT02831673 (64) [back to overview]Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48
NCT02831673 (64) [back to overview]Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144
NCT02831673 (64) [back to overview]Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48
NCT02831673 (64) [back to overview]Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144
NCT02831673 (64) [back to overview]Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144
NCT02831673 (64) [back to overview]Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144
NCT02831673 (64) [back to overview]Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144
NCT02831673 (64) [back to overview]Number of Participants With HIV-1 Disease Progression up to Week 144
NCT02831673 (64) [back to overview]Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 144
NCT02831673 (64) [back to overview]Number of Participants With Any AE and SAE up to Week 148
NCT02831673 (64) [back to overview]Number of Participants With AEs by Maximum Severity Grades up to Week 144
NCT02831673 (64) [back to overview]Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96
NCT02831673 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups
NCT02831673 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups
NCT02831673 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups
NCT02831673 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 24 and 48
NCT02831673 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups
NCT02831673 (64) [back to overview]Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96
NCT02831673 (64) [back to overview]Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144
NCT02831673 (64) [back to overview]Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48
NCT02831673 (64) [back to overview]Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48
NCT02831673 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48
NCT02831673 (64) [back to overview]Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96
NCT02831673 (64) [back to overview]Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144
NCT02831673 (64) [back to overview]Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48
NCT02831673 (64) [back to overview]Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24 48
NCT02831673 (64) [back to overview]Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96
NCT02831673 (64) [back to overview]Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144
NCT02831673 (64) [back to overview]Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48
NCT02831673 (64) [back to overview]Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48
NCT02831673 (64) [back to overview]CD4+ Cell Counts at Weeks 24 and 48
NCT02831673 (64) [back to overview]Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144
NCT02831673 (64) [back to overview]Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48
NCT02831673 (64) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96
NCT02831673 (64) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24
NCT02831673 (64) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144
NCT02831673 (64) [back to overview]Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 96
NCT02831673 (64) [back to overview]Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 144
NCT02831673 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 96
NCT02831673 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 144
NCT02831673 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum RBP at Week 96
NCT02831673 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum RBP at Week 144
NCT02831673 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96
NCT02831673 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144
NCT02831673 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96
NCT02831673 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144
NCT02831764 (64) [back to overview]Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144
NCT02831764 (64) [back to overview]Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96
NCT02831764 (64) [back to overview]Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48
NCT02831764 (64) [back to overview]Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96
NCT02831764 (64) [back to overview]CD4+ Cell Counts at Week 144
NCT02831764 (64) [back to overview]CD4+ Cell Counts at Week 96
NCT02831764 (64) [back to overview]Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144
NCT02831764 (64) [back to overview]Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96
NCT02831764 (64) [back to overview]Change From Baseline in EQ-5D-5L Thermometer Scores at Week 144
NCT02831764 (64) [back to overview]Change From Baseline in EQ-5D-5L Utility Score at Week 144
NCT02831764 (64) [back to overview]Change From Baseline in EQ-5D-5L Utility Score at Week 96
NCT02831764 (64) [back to overview]Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144
NCT02831764 (64) [back to overview]Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 96
NCT02831764 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144
NCT02831764 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96
NCT02831764 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144
NCT02831764 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96
NCT02831764 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum RBP at Week 144
NCT02831764 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum RBP at Week 96
NCT02831764 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 144
NCT02831764 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 96
NCT02831764 (64) [back to overview]Number of Participants Who Discontinue Treatment Due to AEs Over Week 144
NCT02831764 (64) [back to overview]Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 144
NCT02831764 (64) [back to overview]Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 96
NCT02831764 (64) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24
NCT02831764 (64) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96
NCT02831764 (64) [back to overview]Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48
NCT02831764 (64) [back to overview]Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144
NCT02831764 (64) [back to overview]CD4+ Cell Counts at Weeks 24 and 48
NCT02831764 (64) [back to overview]Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48
NCT02831764 (64) [back to overview]Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48
NCT02831764 (64) [back to overview]Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144
NCT02831764 (64) [back to overview]Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96
NCT02831764 (64) [back to overview]Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144
NCT02831764 (64) [back to overview]Change From Baseline in European Quality of Life [EuroQoL] - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48
NCT02831764 (64) [back to overview]Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24, 48
NCT02831764 (64) [back to overview]Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96
NCT02831764 (64) [back to overview]Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48
NCT02831764 (64) [back to overview]Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48
NCT02831764 (64) [back to overview]Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48
NCT02831764 (64) [back to overview]Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144
NCT02831764 (64) [back to overview]Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96
NCT02831764 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups
NCT02831764 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 24 and 48
NCT02831764 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups
NCT02831764 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups
NCT02831764 (64) [back to overview]Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups
NCT02831764 (64) [back to overview]Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96
NCT02831764 (64) [back to overview]Number of Participants With AEs by Maximum Severity Grades up to Week 148
NCT02831764 (64) [back to overview]Number of Participants With Any Adverse Event (AE) and Serious AE (SAE) up to Week 148
NCT02831764 (64) [back to overview]Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 148
NCT02831764 (64) [back to overview]Number of Participants With HIV-1 Disease Progression up to Week 144
NCT02831764 (64) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144
NCT02831764 (64) [back to overview]Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144
NCT02831764 (64) [back to overview]Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144
NCT02831764 (64) [back to overview]Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144
NCT02831764 (64) [back to overview]Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144
NCT02831764 (64) [back to overview]Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48
NCT02831764 (64) [back to overview]Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48
NCT02831764 (64) [back to overview]Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144
NCT02831764 (64) [back to overview]Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48
NCT02831764 (64) [back to overview]Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96
NCT02831764 (64) [back to overview]Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24
NCT02831764 (64) [back to overview]Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48
NCT03078556 (59) [back to overview]Apparent Elimination Rate Constant (Lambda z) of DTG and 3TC in the Fasted State: Part 1
NCT03078556 (59) [back to overview]Apparent Oral Clearance (CL/F) of DTG and 3TC in the Fasted State: Part 1
NCT03078556 (59) [back to overview]Apparent Oral Volume of Distribution (Vz/F) of DTG and 3TC in the Fasted State: Part 1
NCT03078556 (59) [back to overview]Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity [AUC (0-Inf)] of Plasma DTG and 3TC in the Fasted State: Part 1
NCT03078556 (59) [back to overview]Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Time Point (AUC[0-t]) of Plasma DTG and 3TC in the Fasted State: Part 1
NCT03078556 (59) [back to overview]AUC (0-Inf) of Plasma DTG and 3TC in the Fasted State: Part 2
NCT03078556 (59) [back to overview]AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 1
NCT03078556 (59) [back to overview]AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 2
NCT03078556 (59) [back to overview]AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 1
NCT03078556 (59) [back to overview]AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 2
NCT03078556 (59) [back to overview]AUC of 0 to 24 Hours (AUC[0-24]) of DTG and 3TC in the Fasted State: Part 1
NCT03078556 (59) [back to overview]AUC(0-24) of DTG and 3TC in the Fasted State: Part 2
NCT03078556 (59) [back to overview]AUC(0-24) of DTG and 3TC in the Fed State: Part 1
NCT03078556 (59) [back to overview]AUC(0-24) of DTG and 3TC in the Fed State: Part 2
NCT03078556 (59) [back to overview]AUC(0-t) of Plasma DTG and 3TC in the Fasted State: Part 2
NCT03078556 (59) [back to overview]C24 of DTG and 3TC in the Fasted State: Part 2
NCT03078556 (59) [back to overview]C24 of DTG and 3TC in the Fed State: Part 1
NCT03078556 (59) [back to overview]C24 of DTG and 3TC in the Fed State: Part 2
NCT03078556 (59) [back to overview]Change From Baseline in Heart Rate (HR): Part 1 and 2
NCT03078556 (59) [back to overview]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2
NCT03078556 (59) [back to overview]CL/F of DTG and 3TC in the Fasted State: Part 2
NCT03078556 (59) [back to overview]CL/F of DTG and 3TC in the Fed State: Part 1
NCT03078556 (59) [back to overview]CL/F of DTG and 3TC in the Fed State: Part 2
NCT03078556 (59) [back to overview]Clast of DTG and 3TC in in the Fed State: Part 1
NCT03078556 (59) [back to overview]Clast of DTG and 3TC in in the Fed State: Part 2
NCT03078556 (59) [back to overview]Clast of DTG and 3TC in the Fasted State: Part 2
NCT03078556 (59) [back to overview]Cmax of Plasma DTG and 3TC in the Fasted State: Part 2
NCT03078556 (59) [back to overview]Cmax of Plasma DTG and 3TC in the Fed State: Part 1
NCT03078556 (59) [back to overview]Cmax of Plasma DTG and 3TC in the Fed State: Part 2
NCT03078556 (59) [back to overview]Concentration at 24 Hours Post-dose (C24) of DTG and 3TC in the Fasted State: Part 1
NCT03078556 (59) [back to overview]Lambda z of DTG and 3TC in in the Fasted State: Part 2
NCT03078556 (59) [back to overview]Lambda z of DTG and 3TC in in the Fed State: Part 1
NCT03078556 (59) [back to overview]Lambda z of DTG and 3TC in in the Fed State: Part 2
NCT03078556 (59) [back to overview]Maximum Observed Concentration (Cmax) of Plasma DTG and 3TC in the Fasted State: Part 1
NCT03078556 (59) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2
NCT03078556 (59) [back to overview]Percentage of Extrapolated AUC (0 to Inf) of DTG and 3TC in the Fasted State: Part 1
NCT03078556 (59) [back to overview]Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 1
NCT03078556 (59) [back to overview]Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 2
NCT03078556 (59) [back to overview]Percentage of Extrapolated AUC(0 to Inf) of DTG and 3TC in the Fasted State: Part 2
NCT03078556 (59) [back to overview]t1/2 of DTG and 3TC in the Fasted State: Part 2
NCT03078556 (59) [back to overview]T1/2 of DTG and 3TC in the Fed State: Part 1
NCT03078556 (59) [back to overview]T1/2 of DTG and 3TC in the Fed State: Part 2
NCT03078556 (59) [back to overview]Time of the Last Quantifiable Concentration (Tlast) of DTG and 3TC in the Fasted State: Part 1
NCT03078556 (59) [back to overview]Time to Reach Half the Maximum Plasma Concentration (t1/2) of DTG and 3TC in the Fasted State: Part 1
NCT03078556 (59) [back to overview]Time to Reach Maximum Plasma Concentration (Tmax) of DTG and 3TC in the Fasted State: Part 1
NCT03078556 (59) [back to overview]Tlag of DTG and 3TC in Fasted State: Part 2
NCT03078556 (59) [back to overview]Tlag of DTG and 3TC in Fed State: Part 1
NCT03078556 (59) [back to overview]Tlag of DTG and 3TC in Fed State: Part 2
NCT03078556 (59) [back to overview]Tlast of DTG and 3TC in the Fasted State: Part 2
NCT03078556 (59) [back to overview]Tlast of DTG and 3TC in the Fed State: Part 1
NCT03078556 (59) [back to overview]Tlast of DTG and 3TC in the Fed State: Part 2
NCT03078556 (59) [back to overview]Tmax of DTG and 3TC in the Fasted State: Part 2
NCT03078556 (59) [back to overview]Tmax of DTG and 3TC in the Fed State: Part 1
NCT03078556 (59) [back to overview]Tmax of DTG and 3TC in the Fed State: Part 2
NCT03078556 (59) [back to overview]Vz/F of DTG and 3TC in the Fasted State: Part 2
NCT03078556 (59) [back to overview]Vz/F of DTG and 3TC in the Fed State: Part 1
NCT03078556 (59) [back to overview]Vz/F of DTG and 3TC in the Fed State: Part 2
NCT03078556 (59) [back to overview]Last Quantifiable Concentration (Clast) of DTG and 3TC in the Fasted State: Part 1
NCT03078556 (59) [back to overview]Absorption Lag Time (Tlag) of DTG and 3TC in Fasted State: Part 1
NCT03144804 (2) [back to overview]Overall Response Rate
NCT03144804 (2) [back to overview]Progression Free Survival
NCT03205566 (5) [back to overview]The Time to Cessation of Mucosal ex Vivo Protection From HIV After Stopping ART at Steady State.
NCT03205566 (5) [back to overview]The Time From First Dose of Drug to Maximum Mucosal ex Vivo Protection From HIV.
NCT03205566 (5) [back to overview]The Time From First Dose of Drug to Maximum Mucosal ex Vivo Protection From HIV.
NCT03205566 (5) [back to overview]The Level of Raltegravir Alone or Raltegravir /Lamivudine Required in the Plasma, Vagina and Rectum for 100% ex Vivo Protection From HIV
NCT03205566 (5) [back to overview]Number of Adverse Events Based on PE, Blood Test and Event Reporting on Raltegravir Based PrEP, in HIV Negative Individuals
NCT03272347 (18) [back to overview]Number of Participants Experiencing Adverse Events (AEs) up to Week 144
NCT03272347 (18) [back to overview]Number of Participants Discontinuing Study Drug Due to AEs up to Week 144
NCT03272347 (18) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 48 Weeks After Starting Open-label Doravirine/Islatravir Regimen (Part 4)
NCT03272347 (18) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 48 Weeks After 3TC and Placebo Are Discontinued From the Regimen
NCT03272347 (18) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen
NCT03272347 (18) [back to overview]Change From Baseline in CD4+ T-cell Count at Week 192 (Part 4)
NCT03272347 (18) [back to overview]Change From Baseline in CD4+ T-cell Count at Week 48
NCT03272347 (18) [back to overview]Number of Participants Discontinuing Study Drug Due to AEs From Week 96 Through Study Duration
NCT03272347 (18) [back to overview]Change From Baseline in CD4+ T-cell Count at Week 96
NCT03272347 (18) [back to overview]Change From Baseline in CD4+ T-cell Count at Week 144
NCT03272347 (18) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 24
NCT03272347 (18) [back to overview]Change From Baseline in Mature T-helper (CD4+ T)-Cell Count at Week 24
NCT03272347 (18) [back to overview]Number of Participants Discontinuing Study Drug Due to AEs Through 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen
NCT03272347 (18) [back to overview]Number of Participants Discontinuing Study Drug Due to AEs During Open Label Doravirine/Islatravir Treatment After Week 144 up to Week 192 (Part 4)
NCT03272347 (18) [back to overview]Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
NCT03272347 (18) [back to overview]Number of Participants Experiencing AEs Through 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen
NCT03272347 (18) [back to overview]Number of Participants Experiencing AEs From Week 96 Through Study Duration
NCT03272347 (18) [back to overview]Number of Participants Experiencing AEs During Open Label Doravirine/Islatravir Treatment After Week 144 up to Week 192 (Part 4)
NCT03332095 (38) [back to overview]Summary of Changes in CD4 Count From Baseline to Week 24 (Cohort 2)
NCT03332095 (38) [back to overview]Summary of Changes in CD4 Count From Baseline to Week 48 (Cohort 2)
NCT03332095 (38) [back to overview]Summary of Changes in CD4 Count From Baseline to Week 96 (Cohort 2)
NCT03332095 (38) [back to overview]Summary of Changes in CD4% From Baseline to Week 24 (Cohort 2)
NCT03332095 (38) [back to overview]Summary of Changes in CD4% From Baseline to Week 48 (Cohort 2)
NCT03332095 (38) [back to overview]Summary of Changes in CD4% From Baseline to Week 96 (Cohort 2)
NCT03332095 (38) [back to overview]Summary of log10 Drop From Baseline to Week 24 in Plasma HIV-1 RNA (ART-naive Participants) (Cohort 2)
NCT03332095 (38) [back to overview]Summary of log10 Drop From Baseline to Week 48 in Plasma HIV-1 RNA (ART-naive Participants) (Cohort 2)
NCT03332095 (38) [back to overview]Summary of log10 Drop From Baseline to Week 96 in Plasma HIV-1 RNA (ART-naive Participants) (Cohort 2)
NCT03332095 (38) [back to overview]PK Parameter: C24hr of Tenofovir (Cohort 2)
NCT03332095 (38) [back to overview]Percentage of Participants With Grade 3 or Higher Adverse Events (AEs) Assessed as Related to Study Drug
NCT03332095 (38) [back to overview]Percentage of Participants With Grade 3 or Higher Adverse Events Assessed as Related to Study Drug (Cohort 2) Through End of Study
NCT03332095 (38) [back to overview]Percentage of Participants With Grade 5 Adverse Events (Death) Regardless of Relationship to Study Drug
NCT03332095 (38) [back to overview]Percentage of Participants With Permanent Discontinuation of Study Drug Due to Adverse Events Assessed as Related to Study Drug
NCT03332095 (38) [back to overview]Percentage of Participants With Permanent Discontinuation of Study Drug Due to Adverse Events Assessed as Related to Study Drug (Cohort 2) Through End of Study
NCT03332095 (38) [back to overview]Percentage of Participants With Plasma HIV-1 RNA Less Than 200 Copies/mL at Week 24 (Cohort 2)
NCT03332095 (38) [back to overview]Percentage of Participants With Grade 5 Adverse Events (Death) Regardless of Relationship to Study Drug (Cohort 2) Through End of Study
NCT03332095 (38) [back to overview]Percentage of Participants With Plasma HIV-1 RNA Less Than 200 Copies/mL at Week 48 (Cohort 2)
NCT03332095 (38) [back to overview]Percentage of Participants With Plasma HIV-1 RNA Less Than 200 Copies/mL at Week 96 (Cohort 2)
NCT03332095 (38) [back to overview]Percentage of Participants With Plasma HIV-1 RNA Less Than 40 Copies/mL at Week 24 (Cohort 2)
NCT03332095 (38) [back to overview]Percentage of Participants With Plasma HIV-1 RNA Less Than 40 Copies/mL at Week 48 (Cohort 2)
NCT03332095 (38) [back to overview]Percentage of Participants With Plasma HIV-1 RNA Less Than 40 Copies/mL at Week 96 (Cohort 2)
NCT03332095 (38) [back to overview]Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/mL at Week 24 (Cohort 2)
NCT03332095 (38) [back to overview]Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/mL at Week 48 (Cohort 2)
NCT03332095 (38) [back to overview]Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/mL at Week 96 (Cohort 2)
NCT03332095 (38) [back to overview]Percentage of Participants With Serious Adverse Events (SAEs) Assessed as Related to Study Drug
NCT03332095 (38) [back to overview]Percentage of Participants With Serious Adverse Events Assessed as Related to Study Drug (Cohort 2) Through End of Study
NCT03332095 (38) [back to overview]Pharmacokinetic (PK) Parameter: Single-dose Area-under-the-curve (AUC0-∞) of Doravirine (DOR) (Cohort 1)
NCT03332095 (38) [back to overview]PK Parameter: AUC0-24hr of 3TC (Cohort 2)
NCT03332095 (38) [back to overview]PK Parameter: AUC0-24hr of DOR (Cohort 2)
NCT03332095 (38) [back to overview]PK Parameter: AUC0-24hr of Tenofovir (Cohort 2)
NCT03332095 (38) [back to overview]PK Parameter: C24hr of 3TC (Cohort 2)
NCT03332095 (38) [back to overview]PK Parameter: C24hr of DOR (Cohort 2)
NCT03332095 (38) [back to overview]PK Parameter: Cmax of 3TC (Cohort 2)
NCT03332095 (38) [back to overview]PK Parameter: Cmax of DOR (Cohort 2)
NCT03332095 (38) [back to overview]PK Parameter: Cmax of Tenofovir (Cohort 2)
NCT03332095 (38) [back to overview]PK Parameter: Single-dose 24 Hour-concentration (C24hr) of DOR (Cohort 1)
NCT03332095 (38) [back to overview]PK Parameter: Single-dose Maximum Concentration (Cmax) of DOR (Cohort 1)
NCT03760458 (52) [back to overview]Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve
NCT03760458 (52) [back to overview]Median (Q1,Q3) Change From Baseline in Triglycerides
NCT03760458 (52) [back to overview]Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 24
NCT03760458 (52) [back to overview]Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 48
NCT03760458 (52) [back to overview]Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC
NCT03760458 (52) [back to overview]Median (Q1, Q3) CD4+ Cell Count
NCT03760458 (52) [back to overview]Percentage of Participants Who Experienced Virologic Failure Through Week 60
NCT03760458 (52) [back to overview]Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm
NCT03760458 (52) [back to overview]Percentage of Participants Who Experienced Virologic Failure Through Week 60
NCT03760458 (52) [back to overview]Percentage of Participants Who Experienced Virologic Failure Through Week 48
NCT03760458 (52) [back to overview]Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC
NCT03760458 (52) [back to overview]Percentage of Participants Who Experienced Virologic Failure Through Week 48
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 24
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 48
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 60
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Adverse Event Through Week 24
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Adverse Event Through Week 60
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 24
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 48
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 24
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 48
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 60
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 24
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 48
NCT03760458 (52) [back to overview]Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 60
NCT03760458 (52) [back to overview]Parent/Guardian-reported Time for Study Drug Tablets to Dissolve
NCT03760458 (52) [back to overview]Median (Q1,Q3) Change From Baseline in LDL
NCT03760458 (52) [back to overview]Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to
NCT03760458 (52) [back to overview]Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to
NCT03760458 (52) [back to overview]Parent/Guardian-reported Response of Child's Face When Taking Study Drug
NCT03760458 (52) [back to overview]Parent/Guardian-reported Response of Child's Face When Taking Favorite Food
NCT03760458 (52) [back to overview]Parent/Guardian-reported Reason for Missed Doses of Study Drug
NCT03760458 (52) [back to overview]Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 60
NCT03760458 (52) [back to overview]Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC
NCT03760458 (52) [back to overview]Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC
NCT03760458 (52) [back to overview]Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC
NCT03760458 (52) [back to overview]Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC
NCT03760458 (52) [back to overview]Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC
NCT03760458 (52) [back to overview]Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC
NCT03760458 (52) [back to overview]Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 60
NCT03760458 (52) [back to overview]Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC
NCT03760458 (52) [back to overview]Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm
NCT03760458 (52) [back to overview]Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL
NCT03760458 (52) [back to overview]Antiretroviral (ARV) Resistance Mutations
NCT03760458 (52) [back to overview]Percentage of Participants With at Least One Adverse Event Through Week 48
NCT03760458 (52) [back to overview]Median (Q1, Q3) CD4+ Percentage
NCT03760458 (52) [back to overview]Parent/Guardian-reported Ease of Giving Study Drug
NCT03760458 (52) [back to overview]Parent/Guardian-reported Percent Adherence to Study Drug
NCT03760458 (52) [back to overview]Parent/Guardian-reported Number of Missed Doses of Study Drug
NCT03760458 (52) [back to overview]Median (Q1,Q3) Change From Baseline in HDL
NCT03760458 (52) [back to overview]Median (Q1,Q3) Change From Baseline in Total Cholesterol
NCT03945981 (18) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 c/mL Regardless of ART Regimen at Week 48 by ITT-E Missing = Failure Analysis
NCT03945981 (18) [back to overview]Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) Regardless of Antiretroviral Therapy (ART) Regimen at Week 24 by ITT-E Missing = Failure Analysis
NCT03945981 (18) [back to overview]Time to Viral Suppression (HIV-1 RNA<50 c/mL) for Participants Who Had HIV-1 RNA >= 50 c/mL at Baseline
NCT03945981 (18) [back to overview]Change From Baseline in CD4+/CD8+ Cell Count Ratio for Participants Under Treatment With DTG + 3TC FDC
NCT03945981 (18) [back to overview]Change From Baseline in Cluster of Differentiation (CD4+) Cell Counts for Participants Under Treatment With DTG + 3TC FDC
NCT03945981 (18) [back to overview]Number of Participants Who Changed First Line Regimen of DTG + 3TC FDC Due to Baseline Laboratory Results or HIV-1 Resistance Mutation Results
NCT03945981 (18) [back to overview]Number of Participants Who Completed 24 and 48 Weeks on Study
NCT03945981 (18) [back to overview]Number of Participants With Any Serious Adverse Events (SAEs) and Any Common (>=2%) Non-serious Adverse Events (Non-SAEs) Under Treatment With DTG + 3TC FDC
NCT03945981 (18) [back to overview]Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC
NCT03945981 (18) [back to overview]Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Under Treatment With DTG + 3TC FDC
NCT03945981 (18) [back to overview]Number of Participants With Treatment-emergent Genotypic Resistance
NCT03945981 (18) [back to overview]Percentage of Participants With HIV-1 RNA < 50 c/mL at Weeks 24 and 48 Among Participants With Available HIV-1 RNA Assessment Regardless of ART
NCT03945981 (18) [back to overview]Percentage of Participants With Plasma HIV-1 RNA <50 c/mL Using Food and Drug Administration (FDA) Snapshot Algorithm
NCT03945981 (18) [back to overview]Number of Participants Who Discontinued the Study Treatment (DTG+3TC FDC) Due to Drug-related AEs
NCT03945981 (18) [back to overview]Number of Participants With HIV-1 Disease Progression to Stage 3 HIV-associated Conditions, Acquired Immunodeficiency Syndrome (AIDS) or Death (for Participants Under Treatment With DTG + 3TC FDC)
NCT03945981 (18) [back to overview]Number of Participants Retained in Care for 24 and 48 Weeks on Study and Have HIV-1 RNA <200 c/mL
NCT03945981 (18) [back to overview]Number of Participants With Treatment-emergent Phenotypic Resistance
NCT03945981 (18) [back to overview]Number of Participants Who Discontinued the Study Treatment (DTG+3TC FDC) Due to AEs
NCT04900038 (11) [back to overview]Change From Baseline in HIV-1 RNA Through Week 24
NCT04900038 (11) [back to overview]Number of Participants Who Develop Genotypic Resistance up to Week 24
NCT04900038 (11) [back to overview]Number of Participants Who Develop Phenotypic Resistance up to Week 24
NCT04900038 (11) [back to overview]Number of Participants With Adverse Events (AEs) Leading to Discontinuation, up to End of Continued Access to Treatment Post-study Termination (Day 478)
NCT04900038 (11) [back to overview]Absolute Values of Cluster of Differentiation 4+ (CD4+) T-cell Counts Through Week 24
NCT04900038 (11) [back to overview]Absolute Values of HIV-1 RNA Through Week 24
NCT04900038 (11) [back to overview]Number of Participants With Adverse Events of Special Interest (AESIs), up to End of Continued Access to Treatment Post-study Termination (Day 478)
NCT04900038 (11) [back to overview]Number of Participants With Serious Adverse Events (SAEs) and Deaths, up to End of Continued Access to Treatment Post-study Termination (Day 478)
NCT04900038 (11) [back to overview]Trough Concentration (Ctrough) of GSK3640254 at Weeks 2, 4, 8, 12 and 24
NCT04900038 (11) [back to overview]Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (c/mL) at Week 24
NCT04900038 (11) [back to overview]Change From Baseline in CD4+ T-cell Counts Through Week 24

Virological Response

A virological response was defined as a decrease in HBV DNA levels to undetectable by the Amplicor assay (<500 copies/mL). (NCT00023309)
Timeframe: Week 196 from randomization

,
Interventionparticipants (Number)
YesNo
Adefovir613
Lamivudine and Adefovir175

[back to top]

Biological Response

A biochemical response was defined as a decrease in serum ALT levels into the normal range (<41 U/L). (NCT00023309)
Timeframe: week 196 from randomization

,
Interventionparticipants (Number)
YesNo
Adefovir127
Lamivudine and Adefovir211

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Histological Response

A histological response was defined as a decrease in the HAI score by at least three points with no worsening of the Ishak fibrosis score. (NCT00023309)
Timeframe: week 196 from randomization

,
Interventionparticipants (Number)
YesNo
Adefovir55
Lamivudine and Adefovir153

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HBeAg Loss at Week 196

Loss of hepatitis B surface antigen (HBsAg) at week 196 (NCT00023309)
Timeframe: Week 196 from randomization

,
Interventionparticipants (Number)
YesNo
Adefovir59
Lamivudine and Adefovir134

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Maintained Combined Response (Virological, Biochemical and Histological Response).

A maintained combined response was defined as a combination of a virological, biochemical and histological responses at weeks 48 and 192. A virological response was defined as a decrease in HBV DNA levels to undetectable by the Amplicor assay (<500 copies/mL). A biochemical response was defined as a decrease in serum ALT levels into the normal range (<41 U/L). A histological response was defined as a decrease in the HAI score by at least three points with no worsening of the Ishak fibrosis score. (NCT00023309)
Timeframe: 196 weeks from randomization

,
Interventionparticipants (Number)
YesNo
Adefovir613
Lamivudine and Adefovir157

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Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms

incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm. Only acquisition from the index partner were included in the primary analysis, therefore, each endpoint was required to be confirmed (by genotyping) such that the viral envelop sequence in the index case matched that of the partner. (NCT00074581)
Timeframe: Throughout study

Interventionevent rate per 100 person-yr (Number)
Early-ART0.07
Delayed-ART1.03

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All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms

All Incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm. (NCT00074581)
Timeframe: Throughout study

Interventionevent rate per 100 person-yr (Number)
Early-ART0.44
Delayed-ART1.41

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Number of Participants With Improvement, Stabilization, and Worsening in Child-Turcotte-Pugh (CTP) Score at Week 52 and Week 104

"Child-Turcotte-Pugh (CTP) uses 2 clinical variables, ascites and encephalopathy, and 3 laboratory parameters, serum bilirubin, albumin, and prothrombin time. Each variable is assigned a score from 1 to 3, with the combined score comprising the CTP score range of 5 to 15 points. Higher scores indicate more impaired liver function. Worsening of CTP score was defined as a 2-point or greater increase from baseline, improvement in CTP score was defined as a 2-point or greater reduction from baseline, and stabilization of CTP score was defined as a change of 1-point or less from baseline." (NCT00076336)
Timeframe: From Baseline to weeks 52 and 104

,
InterventionParticipants (Number)
Improvement At Week 52Stabilization At Week 52Worsening At Week 52Improvement At Week 104Stabilization At Week 104Worsening At Week 104
Lamivudine 100 mg445218463830
Telbivudine 600 mg366018444228

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Number of Participants With Improvement, Stabilization, and Worsening in a Modified (3-component) CTP Score

Modified CTP was calculated using the 3 biochemical-components (serum bilirubin, albumin, and prothrombin). Total scores range from 3-9; higher scores indicate more liver impairment. Improvement was defined as 2-point or greater reduction in score from baseline. Stabilization comprises a score change of 1-point or less from baseline. Worsening of CTP score was defined as a 2-point or greater increase from baseline. The rationale for assessing changes in this modified (3-component) CTP score is that this maneuver removed the two subjective components of CTP scoring (ascites and encephalopathy). (NCT00076336)
Timeframe: Baseline and Week 104

,
InterventionParticipants (Number)
Improvement at Week 104Stabilization at Week 104Worsening at Week 104
Lamivudine 100 mg315429
Telbivudine 600 mg305727

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Number of Participants With Clinical Response

Clinical response defined as achieving all of the following 3 criteria on at least 2 consecutive visits or at the last on-treatment visit: Serum hepatitis B virus (HBV) DNA < 4 log10 copies/mL, normal Alanine transaminase (ALT) level (ALT ≤ Upper Limit of Normal (ULN)), and improvement (a 2- point or greater reduction in Child-Turcotte-Pugh (CTP) score) or stabilization (not more than a 1-point change in CTP score), compared to the baseline value. CTP scores range from 5-15, higher scores indicate more liver impairment. For Improvement/Stabilization, either of the individual criteria were met. (NCT00076336)
Timeframe: From Baseline to Week 52

,
InterventionParticipants (Number)
Clinical ResponseHBV DNA < 4log10copies/mLNormal ALTImprovement/stabilization in CTPImprovement in CTP (reduction ≥ 2)Stabilization in CTP (absolute change ≤ 1)
Lamivudine 100 mg628281964348
Telbivudine 600 mg658578963456

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Time to Initial Clinical Response

Time to Clinical Response defined as the number of days elapsed from the baseline visit to achieving initial Clinical Response. (NCT00076336)
Timeframe: From Baseline to Week 104

InterventionDays (Mean)
Telbivudine 600 mg137.5
Lamivudine 100 mg125.2

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Duration of Initial Clinical Response

Kaplan-Meier method was used. The duration was calculated as: date of last visit before initial loss of clinical response - date of initial clinical response occurred+1. If a patient did not lose clinical response, it was then censored at the efficacy overall censoring date. (NCT00076336)
Timeframe: Baseline to Week 104

InterventionDays (Mean)
Telbivudine 600 mg473.1
Lamivudine 100 mg456.3

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Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison)

Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile
ddI+FTC+ATV0048
ZDV/3TC+EFV0032

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Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)

Time from randomization to any of the following events occurring prior to week 96: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 96 (using follow-up through to study closure on May 31,2010)

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile
TDF/FTC+EFV024NA
ZDV/3TC+EFV016NA

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Time to Treatment Failure (PI Comparison)

Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005), plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier). (NCT00084136)
Timeframe: Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up until ddI+FTC+ATV arm closed (May 22, 2008).

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile
ddI+FTC+ATV1624120
ZDV/3TC+EFV1640NA

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Time to Treatment Failure (NRTI Comparison)

Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005) plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier). (NCT00084136)
Timeframe: Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up through study closure (May 31, 2010).

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile
TDF/FTC+EFV1640NA
ZDV/3TC+EFV1640NA

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Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison)

Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile
ddI+FTC+ATV0048
ZDV/3TC+EFV016NA

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Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)

Time to any of the following events occurring prior to week 96: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 96 using follow-up through study closure on May 31,2010

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile
TDF/FTC+EFV00NA
ZDV/3TC+EFV0032

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Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison)

Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored. (NCT00084136)
Timeframe: At Weeks 24 and 48 (including only follow-up until ddI+FTC+ARV arm closed - May 22, 2008)

,
Interventionparticipants (Number)
Week 24: Number with RNA <400 c/mL (N=495; N=506)Week 48: Number with RNA <400 c/mL (N=476; N=478)
ddI+FTC+ATV431424
ZDV/3TC+EFV459437

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Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison)

Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir). (NCT00084136)
Timeframe: Throughout follow-up until ddI+FTC+ATV arm closed (May 22,2008)

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile
ddI+FTC+ATV71876
ZDV/3TC+EFV1634NA

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Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison)

Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3). (NCT00084136)
Timeframe: weeks 24, 48 and 96 (including all follow-up through to study closure on May 31, 2010)

,
Interventioncells/mm^3 (Median)
Change from screening to week 24 (N=490; N=498)Change from screening to week 48 (N=480; N=485)Change from screening to week 96 (N=458; N=471)
TDF/FTC+EFV120.5159226
ZDV/3TC+EFV112.5151.5220.5

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Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison)

Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3). (NCT00084136)
Timeframe: weeks 24, 48 and 96 (including follow-up until ddI+FTC+ARV arm closed - May 22, 2008)

,
Interventioncells/mm^3 (Median)
Change from screening to week 24 (N=490; N=502)Change from screening to week 48 (N=474; N=477)Change from screening to week 96 (N= 188; N=188)
ddI+FTC+ATV146.5187.0256.0
ZDV/3TC+EFV112.5152.0216.0

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Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison)

Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored. (NCT00084136)
Timeframe: At Weeks 24 and 48 (including follow-up through to study closure on May 31, 2010)

,
Interventionparticipants (Number)
Week 24: Number with RNA <400 c/mL (N=495; N=500)Week 48: Number with RNA <400 c/mL (N=482; N=487)
TDF/FTC+EFV448455
ZDV/3TC+EFV459442

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Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison)

Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir). (NCT00084136)
Timeframe: Throughout follow-up until study closed (May 31,2010)

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile
TDF/FTC+EFV1836201
ZDV/3TC+EFV1634163

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Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison)

Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. (NCT00084136)
Timeframe: Throughout study follow-up until study closure (May 31, 2010)

,
Interventionweeks (Number)
10th percentile25th percentile50th percentile
TDF/FTC+EFV432224
ZDV/3TC+EFV412112

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Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison)

Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. (NCT00084136)
Timeframe: Throughout study follow-up until ddI+FTC+ATV arm closed (May 22, 2008)

,
Interventionweeks (Number)
10th percentile25th percentile50th percentile
ddI+FTC+ATV432144
ZDV/3TC+EFV41296

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Time to Immunologic Failure (NRTI Comparison)

Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3. (NCT00084136)
Timeframe: At or after Week 48 (including all follow-up through study closure - May 31,2010)

,
Interventionweeks (Number)
1st percentile5th percentile10th percentile
TDF/FTC+EFV48104NA
ZDV/3TC+EFV48128NA

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Time to Immunologic Failure (PI Comparison)

Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3. (NCT00084136)
Timeframe: At or after Week 48 (including only follow-up until ddI+FTV+ATV arm closed - May 22,2008)

,
Interventionweeks (Number)
1st percentile5th percentile
ddI+FTC+ATV48NA
ZDV/3TC+EFV48112

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Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)

Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 48 (using follow-up through study closure on May 31,2010)

,
Interventionweeks (Number)
5th percentile10th percentile
TDF/FTC+EFV024
ZDV/3TC+EFV016

[back to top]

Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)

Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 48 using follow-up through study closure on May 31,2010

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile
TDF/FTC+EFV00NA
ZDV/3TC+EFV0032

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Number of Patients With Viral Load Less Than 50 Copies/ml

(NCT00084149)
Timeframe: Week 48

InterventionParticipants (Count of Participants)
Cyclosporine27
No Cyclosporine13

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Proviral DNA (log10)

(NCT00084149)
Timeframe: At Week 12

Interventionlog10(copies/mL) (Median)
Cyclosporine2.22
No Cyclosporine2.13

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Levels of Proviral DNA in Peripheral Blood Mononuclear Cells (PBMC) (log10)

(NCT00084149)
Timeframe: At 48 weeks after the start of treatment

Interventionlog10(copies/mL) (Median)
Cyclosporine1.88
No Cyclosporine1.92

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HIV-1 Viral Load Levels

(NCT00084149)
Timeframe: At Week 48

Interventionlog10(copies/mL) (Mean)
Cyclosporine1.70
No Cyclosporine1.70

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Proviral DNA Levels (log10)

(NCT00084149)
Timeframe: At Week 24

Interventionlog10(copies/mL) (Median)
Cyclosporine2.12
No Cyclosporine1.96

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CD4 T Cell Levels

(NCT00084149)
Timeframe: At Week 48

Interventioncells/mm^3 (Median)
Cyclosporine301
No Cyclosporine287

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Change From ADV Baseline to ADV Week 192 for ALT

Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192). (NCT00095121)
Timeframe: ADV baseline to ADV 192 weeks

InterventionU/L (Mean)
ADV - ADV-66.06
PLB - ADV-38.88

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Change From ADV Baseline to ADV Week 192 for Serum HBV DNA

Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192). (NCT00095121)
Timeframe: ADV baseline to ADV 192 weeks

Interventionlog10 HBV DNA copies/mL (Mean)
ADV - ADV-5.89
PLB - ADV-5.41

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Change From ADV Baseline to ADV Week 240 for Serum HBV DNA

(NCT00095121)
Timeframe: ADV baseline to ADV 240 weeks

Interventionlog10 HBV DNA copies/mL (Mean)
ADV - ADV-5.87

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Change From ADV Baseline to ADV Week 240 for ALT

(NCT00095121)
Timeframe: ADV baseline to ADV 240 weeks

InterventionU/L (Mean)
ADV - ADV-64.33

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Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Baseline)

The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]). (NCT00095121)
Timeframe: ADV baseline

Interventionpercentage of participants (Number)
ADV - ADV0
PLB - ADV0

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Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < 1000 Copies/mL (Polymerase Chain Reaction [PCR]-Based Assay) and Normal Alanine Aminotransferase (ALT) at Week 48 (Missing = Failure)

In the absence of biopsy data from these pediatric participants, this endpoint enables assessments of drug effect on viral replication and the underlying degree of inflammation in the liver. (NCT00095121)
Timeframe: Week 48

,
Interventionpercentage of participants (Number)
BaselineWeek 24Week 48 or End of Double-blind Treatment
Adefovir Dipivoxil (ADV)0519
Placebo (PLB)002

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Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss or Seroconversion by End of Blinded Treatment (Study Week 48; Randomized and Treated Analysis Set)

HBeAg loss is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg- post baseline. HBeAg seroconversion is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg- and hepatitis B e antibody + (anti-HBe+) post baseline. (NCT00095121)
Timeframe: Study Week 0 to Study Week 48 (double-blind period)

,
Interventionpercentage of participants (Number)
HBeAg LossSeroconversion to Anti-HBe
Adefovir Dipivoxil (ADV)1716
Placebo (PBL)55

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Percentage of Participants With HBeAg Loss or Seroconversion by ADV Week 240 (Open Label Analysis Set, Participants Who Were HBeAg Positive at ADV Baseline; Missing = Excluded)

Per protocol, participants could discontinue study medication due to HBeAg seroconversion and remain in the study in order to evaluate the durability of seroconversion. HBeAg loss is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg- post baseline. HBeAg seroconversion is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg- and anti-HBe+ post baseline. (NCT00095121)
Timeframe: ADV baseline to ADV Week 240

Interventionpercentage of participants (Number)
HBeAg LossSeroconversion to Anti-HBe
ADV - ADV3317

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Percentage of Participants With HBeAg Loss or Seroconversion by ADV Week 192 (Open Label Analysis Set, Participants Who Were HBeAg Positive at ADV Baseline; Missing = Excluded)

ADV baseline = 1st ADV-dose day = Week 0 for ADV-ADV group and Week 48 for PLB-ADV group. ADV week = windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192). HBeAg loss is defined per individual participant as HBeAg+ at ADV baseline and HBeAg- post baseline. HBeAg seroconversion is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg- and anti-HBe+ post baseline. (NCT00095121)
Timeframe: ADV baseline to ADV Week 192

,
Interventionpercentage of participants (Number)
HBeAg LossSeroconversion to Anti-HBe
ADV - ADV5644
PLB - ADV3311

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Cumulative Summary of Participants With HBV Genotypic Changes From Baseline (Resistance Surveillance) for Subjects Who Received Combination ADV + Lamivudine Therapy

Resistance surveillance was conducted at Week 240/last on-treatment study visit for all participants who had HBV DNA concentrations greater than or equal to the level of detection (>= 169 copies/mL) by PCR while on combination ADV + lamivudine treatment. (NCT00095121)
Timeframe: 240 weeks

,
InterventionParticipants (Number)
No genotypic changes from baselinePolymorphic site changesChanges at conserved sites in HBV polymeraseDeveloped mutations specific to ADV and/or LAMUnable to be genotyped
ADV - ADV53323
PLB - ADV11100

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Cumulative Summary of Participants With HBV Genotypic Changes From Baseline (Resistance Surveillance)

Resistance surveillance was conducted annually for all participants who remained on treatment and had HBV DNA concentrations greater than or equal to the level of detection (>= 169 copies/mL) by PCR. The last on-ADV sample for all participants in the study was analyzed in the cumulative Week 240 resistance surveillance analysis. (NCT00095121)
Timeframe: 240 weeks

,
InterventionParticipants (Number)
No genotypic changes from baselinePolymorphic site changesChanges at conserved sites in HBV polymeraseDeveloped mutations specific to ADV/lamivudineUnable to be genotyped
ADV - ADV4817316
PLB - ADV1812304

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Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 240)

(NCT00095121)
Timeframe: ADV Week 240

Interventionpercentage of participants (Number)
ADV - ADV6

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Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 192)

Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192). (NCT00095121)
Timeframe: ADV Week 192

Interventionpercentage of participants (Number)
ADV - ADV11
PLB - ADV13

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Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Baseline)

The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]). (NCT00095121)
Timeframe: ADV baseline

Interventionpercentage of participants (Number)
ADV - ADV0
PLB - ADV0

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Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 240)

(NCT00095121)
Timeframe: ADV Week 240

Interventionpercentage of participants (Number)
ADV - ADV6

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Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment - Missing = Failure) (ADV Week 192)

Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192). (NCT00095121)
Timeframe: ADV Week 192

Interventionpercentage of participants (Number)
ADV - ADV15
PLB - ADV15

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Percentage of Participants With Normal ALT at ADV Week 240 (Missing = Failure)

Normal ALT: 0-1 year old = <=54 U/L; females 1-88 years old and males 1-10 years old = 8-34 U/L; males 10-88 years old = 8-43 U/L. (NCT00095121)
Timeframe: ADV Week 240

Interventionpercentage of participants (Number)
ADV - ADV5

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Percentage of Participants With Normal ALT at ADV Week 192 (Missing = Failure)

Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192). Normal ALT: 0-1 year old = <=54 U/L; females 1-88 years old and males 1-10 years old = 8-34 U/L; males 10-88 years old = 8-43 U/L. (NCT00095121)
Timeframe: ADV Week 192

Interventionpercentage of participants (Number)
ADV - ADV14
PLB - ADV13

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Percentage of Participants With Normal ALT at Adefovir Baseline (Missing = Failure)

The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]). Normal ALT: 0-1 year old = <=54 U/L; females 1-88 years old and males 1-10 years old = 8-34 U/L; males 10-88 years old = 8-43 U/L. (NCT00095121)
Timeframe: ADV baseline

Interventionpercentage of participants (Number)
ADV - ADV7
PLB - ADV15

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Percentage of Participants With Durable HBeAg Seroconversion

A participant was defined to have durable HBeAg seroconversion only if she/he remained in a seroconverted state (HBeAg-, hepatitis B e antibody + [anti-HBe+]) from the date that she/he first seroconverted through and including her/his last study visit. This endpoint could only be assessed for participants who (HBeAg-) seroconverted on-treatment and subsequently discontinued open-label dosing. (NCT00095121)
Timeframe: 240 weeks

InterventionPercentage of participants (Number)
ADV - ADV82
PLB - ADV71

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Adefovir (ADV) Baseline Serum HBV DNA

The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]). (NCT00095121)
Timeframe: ADV baseline

Interventionlog10 HBV DNA copies/mL (Mean)
ADV - ADV8.76
PLB - ADV8.24

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ADV Baseline ALT

The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]). (NCT00095121)
Timeframe: ADV baseline

InterventionU/L (Mean)
ADV - ADV108.69
PLB - ADV99.81

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Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48

Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} [R5], C-X-C chemokine receptor type 4 {CXCR4} [X4], Dual/mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at baseline and time of treatment failure analyzed through week 48 visit. Treatment failure: discontinuation due to insufficient clinical response. Tropism result was censored for participants with viral load <500 copies/mL at time of treatment failure categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as last on treatment assessment. (NCT00098293)
Timeframe: Baseline, time of failure through Week 48

,,
Interventionparticipants (Number)
Baseline: R5; Treatment failure: R5Baseline: R5; Treatment failure: X4Baseline: R5; Treatment failure: DMBaseline: R5; Treatment failure: NR/NPBaseline: DM; Treatment failure: R5Baseline: DM; Treatment failure: X4Baseline: DM; Treatment failure: DMBaseline: DM; Treatment failure: NR/NP
Efavirenz Once Daily + CBV (DB)60040000
Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)50350050
Maraviroc Twice Daily + CBV (DB)1101051240

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Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 48 and 96

Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose. Change from baseline in lymphocyte CD8 count at Week 48 and 96 was not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis. (NCT00098293)
Timeframe: Baseline, Week 48, Week 96

,
Interventioncells/µL (Mean)
BaselineChange at Week 48Change at Week 96
Efavirenz Once Daily + CBV (DB)935.78-126.83-150.27
Maraviroc Twice Daily + CBV (DB)938.8038.3420.74

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Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 48 and 96

Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose. (NCT00098293)
Timeframe: Baseline, Week 48, Week 96

,,
Interventioncells per microliter (cells/µL) (Mean)
BaselineChange at Week 48Change at Week 96
Efavirenz Once Daily + CBV (DB)271.87143.52171.50
Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)274.1172.50183.75
Maraviroc Twice Daily + CBV (DB)264.70169.53206.31

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Change From Baseline in Log 10-transformed Plasma Viral Load (HIV-1 RNA) Levels at Week 48 and 96

Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose. (NCT00098293)
Timeframe: Baseline, Week 48, Week 96

,,
Interventionlog10 copies/mL (Mean)
BaselineChange at Week 48Change at Week 96
Efavirenz Once Daily + CBV (DB)4.857-2.347-2.053
Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)4.899-2.665-2.565
Maraviroc Twice Daily + CBV (DB)4.851-2.240-1.961

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Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population

(NCT00098293)
Timeframe: Week 48

,,
InterventionPercentage of participants (Number)
Less than 400 copies/mLLess than 50 copies/mL
Efavirenz Once Daily + CBV (DB)73.169.3
Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)61.555.8
Maraviroc Twice Daily + CBV (DB)70.665.3

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Time-Averaged Difference (TAD) in log10-transformed HIV-1 RNA Levels

TAD from baseline was calculated as area under the curve (AUC) of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose. Data not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis. (NCT00098293)
Timeframe: Baseline up to Week 48 and Week 96

,
Interventionlog10 copies/mL (Least Squares Mean)
Week 48Week 96
Efavirenz Once Daily + CBV (DB)-2.262-2.034
Maraviroc Twice Daily + CBV (DB)-2.152-1.945

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Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 for Enhanced Sensitivity Trofile Assay (ESTA) R5 Participants

Percentage of participants with HIV-1 RNA levels of less than 400 copies/mL and less than 50 copies/mL were not analyzed for maraviroc once daily, then twice daily arm in order to avoid misinterpretation due to possible bias due to the fact that only a non-random sample of participants in the terminated arm were re-assayed with ESTA. (NCT00098293)
Timeframe: Week 48

,
InterventionPercentage of participants (Number)
Less than 400 copies/mLLess than 50 copies/mL
Efavirenz Once Daily + CBV (DB)72.368.3
Maraviroc Twice Daily + CBV (DB)73.368.5

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Time to Virologic Failure

Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up [LTFU];new anti-retroviral drug added [except background drug change to drug of same class];or on open label for early non-response or rebound). Failure:at Time 0 if level not <400 copies/mL(2 consecutive visits) before events or last available visit;at time of earliest event if level <400 copies/mL(2 consecutive visits);failure if level >=400 copies/mL(2 consecutive visits) or 1 visit >=400 copies/mL followed by permanent discontinuation of drug or LTFU. (NCT00098293)
Timeframe: Week 48, Week 96

,
Interventiondays (Median)
Week 48Week 96
Efavirenz Once Daily + CBV (DB)NANA
Maraviroc Twice Daily + CBV (DB)NANA

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Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 96

(NCT00098293)
Timeframe: Week 96

,,
InterventionPercentage of participants (Number)
Less than 400 copies/mLLess than 50 copies/mL
Efavirenz Once Daily + CBV (DB)64.562.6
Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)52.948.3
Maraviroc Twice Daily + CBV (DB)61.456.9

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Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 48 for Per Protocol (PP) Population

Percentage of participants with viral load of less than 400 copies/mL and less than 50 copies/mL of HIV-1 RNA were not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis. (NCT00098293)
Timeframe: Week 48

,
InterventionPercentage of participants (Number)
Less than 400 copies/mLLess than 50 copies/mL
Efavirenz Once Daily + CBV (DB)78.2774.44
Maraviroc Twice Daily + CBV (DB)75.0070.00

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Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 for Enhanced Sensitivity Trofile Assay (ESTA) R5 Participants

Percentage of participants with HIV-1 RNA levels of less than 400 copies/mL and less than 50 copies/mL were not analyzed for maraviroc once daily, then twice daily arm in order to avoid misinterpretation due to possible bias due to the fact that only a non-random sample of participants in the terminated arm were re-assayed with ESTA. (NCT00098293)
Timeframe: Week 96

,
InterventionPercentage of participants (Number)
Less than 400 copies/mLLess than 50 copies/mL
Efavirenz Once Daily + CBV (DB)64.462.7
Maraviroc Twice Daily + CBV (DB)64.058.8

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Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 96

Number of participants per tropism status (R5, X4, DM, or NR/NP) at baseline and time of treatment failure analyzed through week 96 visit. Treatment failure defined as insufficient clinical response. Tropism result was censored for participants with viral load <500 copies/mL at time of treatment failure categorized as BLQ. The assessment for time of treatment failure was defined as last on treatment assessment. (NCT00098293)
Timeframe: Baseline, time of failure through Week 96

,,
Interventionparticipants (Number)
Baseline: R5; Treatment failure: R5Baseline: R5; Treatment failure: X4Baseline: R5; Treatment failure: DMBaseline: R5; Treatment failure: NR/NPBaseline: DM; Treatment failure: R5Baseline: DM; Treatment failure: X4Baseline: DM; Treatment failure: DMBaseline: DM; Treatment failure: NR/NPBaseline: NR/NP; Treatment failure: R5Baseline: NR/NP; Treatment failure: X4Baseline: NR/NP; Treatment failure: DMBaseline: NR/NP; Treatment failure: NR/NP
Efavirenz Once Daily + CBV (DB)1000510000000
Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)904600500000
Maraviroc Twice Daily + CBV (DB)14111712401001

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Number of Participants With Efavirenz Associated Mutations at Time of Treatment Failure Through Week 48 and 96

Genotypic resistance: mutations at screening by MBPSGT assay, repeated if viral load >500 copies/mL at treatment failure through week 48, 96. Efavirenz mutation:lysine to aspargine at r103(K103N);tyrosine to cysteine/isoleucine at r181(Y181C/I);tyrosine to cysteine/leucine/histidine at r188(Y188C/L/H);glycine to alanine/serine at r190(G190A/S);valine to alanine to r106(V106A);leucine to isoleucine at r100(L100I);alanine to glycine at r98(A98G);lysine to glutamic acid at r101(K101E);valine to isoleucine at r108(V108I);proline to histidine at r225(P225H);methionine to leucine at r230(M230L). (NCT00098293)
Timeframe: Screening, time of failure through Week 48, Week 96

,
Interventionparticipants (Number)
L100I Mutation: Week 48 (n= 43, 15)K103N Mutation: Week 48 (n= 43, 15)V106M Mutation: Week 48 (n= 43, 15)V108I Mutation: Week 48 (n= 43, 15)Y181C/I Mutation: Week 48 (n= 43, 15)Y188L Mutation: Week 48 (n= 43, 15)G190S/A Mutation: Week 48 (n= 43, 15)P225H Mutation: Week 48 (n= 43, 15)L100I Mutation: Week 96 (n= 55, 23)K103N Mutation: Week 96 (n= 55, 23)V106M Mutation: Week 96 (n= 55, 23)V108I Mutation: Week 96 (n= 55, 23)Y181C/I Mutation: Week 96 (n= 55, 23)Y188L Mutation: Week 96 (n= 55, 23)G190S/A Mutation: Week 96 (n= 55, 23)P225H Mutation: Week 96 (n= 55, 23)
Efavirenz Once Daily + CBV (DB)06000010012110021
Maraviroc Twice Daily + CBV (DB)0001000000010000

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Number of Participants With NRTI Associated Mutations at Time of Treatment Failure Through Week 48 and 96

Genotypic resistance to NRTIs was assessed by identification of relevant mutations at screening using MBPSGT assay and repeated for all participants with HIV-1 viral load more than 500 copies/mL at treatment failure through week 48 and week 96. Following mutations associated with NRTIs were summarized at time of failure: Any zidovudine/lamivudine (Zid/Lam), Any thymidine analogue-associated mutation (TAM), methionine (M) to valine/isoleucine (V/I) substitution at residue (r) 184 (M184V/I), lysine (K) to arginine (R) substitution at residue 65 (K65R) and any other NRTI mutations. (NCT00098293)
Timeframe: Screening, time of failure through Week 48, Week 96

,,
Interventionparticipants (Number)
Any Zid/Lam Mutation: Week 48 (n= 20, 43, 15)Any TAM Mutation: Week 48 (n= 20, 43, 15)K65R Mutation: Week 48 (n= 20, 43, 15)M184V/I Mutation: Week 48 (n= 20, 43, 15)Other NRTI Mutation: Week 48 (n= 20, 43, 15)Any Zid/Lam Mutation: Week 96 (n= 27, 55, 23)Any TAM Mutation: Week 96 (n= 27, 55, 23)K65R Mutation: Week 96 (n= 27, 55, 23)M184V/I Mutation: Week 96 (n= 27, 55, 23)Other NRTI Mutation: Week 96 (n= 27, 55, 23)
Efavirenz Once Daily + CBV (DB)3003082080
Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)14101402030200
Maraviroc Twice Daily + CBV (DB)27612713361331

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Number of Participants With Phenotypic Resistance at Time of Treatment Failure Through Week 48 and 96

Phenotypic resistance to nucleoside reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs) assessed at screening by Monogram Bioscience PhenoSense genotype (MBPSGT) assay, repeated if viral load >500 copies/mL at treatment failure through week 48, 96. Phenotypic resistance to maraviroc was assumed in maraviroc treatment failures with X4-using virus and in R5 maraviroc treatment failures using Monogram Bioscience PhenoSense Entry Assay. Phenotypic resistance to zidovudine, lamivudine, efavirenz and maraviroc at time of failure was summarized. (NCT00098293)
Timeframe: Screening, time of failure through Week 48, Week 96

,,
Interventionparticipants (Number)
Resistance to Zidovudine: Week 48 (n= 20, 43, 15)Resistance to Lamivudine: Week 48 (n= 20, 43, 15)Resistance to Efavirenz: Week 48 (n= 20, 43, 15)Resistance to Maraviroc: Week 48 (n= 20, 43, 15)Resistance to Zidovudine: Week 96 (n= 27, 55, 23)Resistance to Lamivudine: Week 96 (n= 27, 55, 23)Resistance to Efavirenz: Week 96 (n= 27, 55, 23)Resistance to Maraviroc: Week 96 (n= 27, 55, 23)
Efavirenz Once Daily + CBV (DB)037NA0813NA
Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)0140NA0200NA
Maraviroc Twice Daily + CBV (DB)0270120330NA

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Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 Analyzed Using Logistic Regression

(NCT00098293)
Timeframe: Week 96

,,
InterventionPercentage of participants (Number)
Less than 400 copies/mLLess than 50 copies/mL
Efavirenz Once Daily + CBV (DB)64.562.6
Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)52.948.3
Maraviroc Twice Daily + CBV (DB)61.456.9

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Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 Analyzed Using Logistic Regression

(NCT00098293)
Timeframe: Week 48

,,
InterventionPercentage of participants (Number)
Less than 400 copies/mLLess than 50 copies/mL
Efavirenz Once Daily + CBV (DB)73.169.3
Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)61.555.8
Maraviroc Twice Daily + CBV (DB)70.665.3

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Infant HIV Infection Status

Intrapartum HIV infection at 3 Months (NCT00099359)
Timeframe: 3 months

Interventionparticipants (Number)
ARM A (ZDV - Standard of Care)24
ARM B (ZDV + NVP)11
ARM C (ZDV +3TC+NFV)12

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Infant HIV-1 Infection Status

In utero HIV-1 infection rate (NCT00099359)
Timeframe: birth

Interventionparticipants (Number)
Arm A (ZDV Only)37
ARM B (ZDV + NVP)28
ARM C (ZDV + 3TC + NFV)28

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Participant Deaths

(NCT00099359)
Timeframe: through age 6 months

Interventionparticipants (Number)
Arm A (ZDV Only)11
ARM B (ZDV + NVP)15
ARM C (ZDV + 3TC + NFV)17

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Participants With Serious Adverse Events

Serious Adverse Events by System Organ Class=Blood and lymphatic system disorders (NCT00099359)
Timeframe: through age 6 months.

Interventionparticipants (Number)
ARM A (ZDV Only)86
ARM B (ZDV + NVP)59
ARM C (ZDV + 3TC/NFV)110

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3TC and NFV Pharmacokinetics

Descriptive study of 3TC and NFV pharmacokinetics during first two weeks of life using weight band dosing regimen in a subset of enrolled infants. (NCT00099359)
Timeframe: through age 14 days

Interventionug*h/mL (Median)
(NFV-AUC-12h) 4-7 day(NFV-AUC-12h) 10-14 day(3TC-AUC-12 h) 4-7 day(3TC-AUC-12h) 10-14 day
ARM C (ZDV + 3TC/NFV)20.725.54.07.9

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NVP Pharmacokinetics

Descriptive study of NVP pharmacokinetics during first two weeks of life using weight band dosing in a subset of enrolled infants. (NCT00099359)
Timeframe: 14 days

Interventionng/mL (Median)
NVP conc prior to 3rd doseNVP peak conc (Cmax) post 3rd doseNVP conc 3-5 day post 3rd doseNVP conc 7 day post 3rd dose
ARM B (ZDV + NVP)362228645976

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Risk Factors for Perinatal HIV-1 Transmission

Risk factors to be assessed include maternal HIV-1 RNA levels at delivery, maternal syphilis and other infections, obstetrical factors such as duration of membrane rupture, and adherence to neonatal medication. (NCT00099359)
Timeframe: through age 3 months

,
Interventionparticipants (Number)
Treatment Arm C (ZDV+3TC/NFV)Treatment Arm B (ZDV+NFV)Treatment Arm A (ZDV only)Illegal Substance Abuse during pregnancy
Infected1211247
Uninfected516523505130

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Number of Participants With New PI-resistant Variants as Detected by Standard Composite (Bulk) Genotyping.

For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed. (NCT00099632)
Timeframe: 2 and 6 weeks after completion of treatment

Interventionparticipants (Number)
7-day Lamivudine/Zidovudine (3TC/ZDV)0
21-day Lamivudine/Zidovudine (3TC/ZDV)0
7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)0
21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)0
7-day Lopinavir/Ritonavir (LPV/r)0
21-day Lopinavir/Ritonavir (LPV/r)0

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Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping.

For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed. (NCT00099632)
Timeframe: 2 and 6 weeks after completion of treatment

Interventionparticipants (Number)
7-day Lamivudine/Zidovudine (3TC/ZDV)0
21-day Lamivudine/Zidovudine (3TC/ZDV)1
7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)1
21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)1
7-day Lopinavir/Ritonavir (LPV/r)1
21-day Lopinavir/Ritonavir (LPV/r)0

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Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping

"For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed to the primary endpoint; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed to primary endpoint.~10 participants who did not have resistance samples available were excluded from the primary endpoint analysis." (NCT00099632)
Timeframe: 2 and 6 weeks after completion of treatment

Interventionparticipants (Number)
7-day Lamivudine/Zidovudine (3TC/ZDV)1
21-day Lamivudine/Zidovudine (3TC/ZDV)0
7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)0
21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)0
7-day Lopinavir/Ritonavir (LPV/r)3
21-day Lopinavir/Ritonavir (LPV/r)1

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Number of Participants Who Discontinued Study Treatment Prematurely

participants assigned to 7-day treatment arm and 21-day treatment arm were supposed to stay in study treatment for 7 days and 21 days respectively. (NCT00099632)
Timeframe: From first day of study treatment to last day of study treatment (up to 21 days)

Interventionparticipants (Number)
7-day Lamivudine/Zidovudine (3TC/ZDV)0
21-day Lamivudine/Zidovudine (3TC/ZDV)2
7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)0
21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)0
7-day Lopinavir/Ritonavir (LPV/r)0
21-day Lopinavir/Ritonavir (LPV/r)5

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Severe (Grade 3) and Higher Adverse Events and Any Grade Adverse Event That Leads to a Treatment Change From First Day of Study Treatment to Week 12

"Grade 3 or higher signs and symptoms, laboratory abnormalities, events that are reported through the EAE system, and any grade event that leads to a treatment change from first day of study treatment to week 12.~Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death" (NCT00099632)
Timeframe: From first day of study treatment to week 12

Interventionparticipants (Number)
7-day Lamivudine/Zidovudine (3TC/ZDV)5
21-day Lamivudine/Zidovudine (3TC/ZDV)1
7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)1
21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)0
7-day Lopinavir/Ritonavir (LPV/r)2
21-day Lopinavir/Ritonavir (LPV/r)2

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Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II)

Mean change from baseline at Week 24 in plasma HIV RNA (copies/mL) (NCT00100048)
Timeframe: Baseline and Week 24

Interventioncopies/mL (Mean)
MK0518 100 mg b.i.d.-2.39
MK0518 200 mg b.i.d-2.20
MK0518 400 mg b.i.d.-2.33
MK0518 600 mg b.i.d.-2.49
EFV Combo Therapy-2.44

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Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II)

Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3) (NCT00100048)
Timeframe: Baseline and Week 24

Interventioncells/mm3 (Mean)
MK0518 100 mg b.i.d.184
MK0518 200 mg b.i.d122
MK0518 400 mg b.i.d.147
MK0518 600 mg b.i.d.134
EFV Combo Therapy101

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Change From Baseline in CD4 Cell Count at Week 96

(NCT00100048)
Timeframe: Baseline and Week 96

Interventioncells/mm3 (Mean)
MK0518 b.i.d.221.2
EFV Combo Therapy232.4

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Change From Baseline in CD4 (T-helper) Cell Count at Week 240

Change in number of CD4 cells/mm^3 from baseline to Week 240. (NCT00100048)
Timeframe: Baseline and Week 240

Interventioncells/mm^3 (Mean)
MK-0518 b.i.d.301.7
EVF Combo Therapy275.6

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Change From Baseline in Plasma HIV RNA at Week 96

(NCT00100048)
Timeframe: Baseline and Week 96

Interventioncopies/mL (Mean)
MK0518 b.i.d.-2.30
EFV Combo Therapy-2.28

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Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II)

(NCT00100048)
Timeframe: Week 24

Interventionparticipants (Number)
MK0518 100 mg b.i.d.28
MK0518 200 mg b.i.d27
MK0518 400 mg b.i.d.33
MK0518 600 mg b.i.d.32
EFV Combo Therapy31

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Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96

(NCT00100048)
Timeframe: 96 Weeks

,
Interventionparticipants (Number)
HIV RNA <50 copies/mLHIV RNA <400 copies/mL
EFV Combo Therapy3232
MK0518 b.i.d.133135

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Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I)

"An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.~Serious CAEs are any AEs occurring at any dose that; Results~in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or~prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an~overdose." (NCT00100048)
Timeframe: 10 days

,,,,
Interventionparticipants (Number)
With CAEsWithout CAEsWith Serious CAEsWithout Serious CAEs
MK0518 100 mg b.i.d.4307
MK0518 200 mg b.i.d.2507
MK0518 400 mg b.i.d.3306
MK0518 600 mg b.i.d.5308
Placebo5207

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Number of Patients With Clinical Adverse Experiences (CAEs)

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. (NCT00100048)
Timeframe: 48 weeks

,,,,
Interventionparticipants (Number)
With CAEsWithout CAEs
EFV Combo Therapy344
MK0518 100 mg b.i.d.318
MK0518 200 mg b.i.d.355
MK0518 400 mg b.i.d.365
MK0518 600 mg b.i.d.355

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Number of Patients That Discontinued With LAEs

(NCT00100048)
Timeframe: 48 Weeks

,,,,
Interventionparticipants (Number)
Discontinued With LAEsDid Not Discontinue With LAEs
EFV Combo Therapy038
MK0518 100 mg b.i.d.039
MK0518 200 mg b.i.d040
MK0518 400 mg b.i.d.041
MK0518 600 mg b.i.d.139

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Number of Patients That Discontinued With CAEs

(NCT00100048)
Timeframe: 48 Weeks

,,,,
Interventionparticipants (Number)
Discontinued with CAEsDid Not Discontinue with CAEs
EFV Combo Therapy038
MK0518 100 mg b.i.d.039
MK0518 200 mg b.i.d040
MK0518 400 mg b.i.d.041
MK0518 600 mg b.i.d.040

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Number of Patients With Laboratory Adverse Experiences (LAEs)

A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product (NCT00100048)
Timeframe: 48 Weeks

,,,,
Interventionparticipants (Number)
With LAEsWithout LAEs
EFV Combo Therapy830
MK0518 100 mg b.i.d.831
MK0518 200 mg b.i.d.733
MK0518 400 mg b.i.d.1130
MK0518 600 mg b.i.d.535

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Number of Patients With Serious CAEs (Cohort I and II Combined)

Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose (NCT00100048)
Timeframe: 48 weeks

,,,,
Interventionparticipants (Number)
With Serious CAEsWithout Serious CAEs
EFV Combo Therapy236
MK0518 100 mg b.i.d.237
MK0518 200 mg b.i.d.535
MK0518 400 mg b.i.d.041
MK0518 600 mg b.i.d.238

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Number of Patients With Serious CAEs and Non-serious CAEs at Week 144

"An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product~An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product" (NCT00100048)
Timeframe: 144 Weeks

,
Interventionparticipants (Number)
With CAEsWithout CAEsWith serious CAEsWithout serious CAEs
EFV Combo Therapy353434
MK0518 b.i.d.153718142

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Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs)

"An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to its use. Any worsening of a preexisting condition which was temporally associated with the use of the study drug, was also an AE.~A SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was cancer, or was an overdose." (NCT00100048)
Timeframe: Week 240

,
InterventionParticipants (Number)
Adverse experiencesSerious adverse experiences
EVF Combo Therapy354
MK-0518 b.i.d.15425

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Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 48

(NCT00100048)
Timeframe: 48 weeks

Interventionparticipants (Number)
MK0518 100 mg b.i.d.38
MK0518 200 mg b.i.d34
MK0518 400 mg b.i.d.40
MK0518 600 mg b.i.d.36
EFV Combo Therapy33

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Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240

HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay. (NCT00100048)
Timeframe: Week 240

InterventionParticipants (Number)
MK-0518 b.i.d.115
EVF Combo Therapy25

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Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II)

(NCT00100048)
Timeframe: Week 24

Interventionparticipants (Number)
MK0518 100 mg b.i.d.31
MK0518 200 mg b.i.d27
MK0518 400 mg b.i.d.35
MK0518 600 mg b.i.d.32
EFV Combo Therapy32

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Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240

HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ UltraSensitive Assay. (NCT00100048)
Timeframe: Week 240

InterventionParticipants (Number)
MK-0518 b.i.d.110
EFV Combo Therapy24

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Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I)

Mean change from baseline on Day 10 in plasma Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) (copies/mL) (NCT00100048)
Timeframe: Baseline and Day 10

Interventioncopies/mL (Mean)
MK0518 100 mg b.i.d.-1.93
MK0518 200 mg b.i.d-1.98
MK0518 400 mg b.i.d.-1.66
MK0518 600 mg b.i.d.-2.16
Placebo-0.17

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Change From Baseline in Plasma HIV RNA at Week 240

HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay. (NCT00100048)
Timeframe: Baseline and Week 240

InterventionLog10Copies/mL (Mean)
MK-0518 b.i.d.-2.29
EVF Combo Therapy-2.07

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Number of Patients With Serious LAEs

Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose (NCT00100048)
Timeframe: 48 Weeks

,,,,
Interventionparticipants (Number)
With serious LAEsWithout serious LAEs
EFV Combo Therapy038
MK0518 100 mg b.i.d.039
MK0518 200 mg b.i.d.040
MK0518 400 mg b.i.d.041
MK0518 600 mg b.i.d.040

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Number of Participants Who Experienced Regimen-limiting ART Drug Toxicity

Development of toxicity requiring more than one drug substitution within the same class or a switch to a new class of drugs (regimen-limiting toxicity failure) or requiring a permanent treatment discontinuation. This was part of the primary outcome measure that was a composite endpoint. (NCT00102960)
Timeframe: Regimen limiting drug toxicity was monitored from randomization up to the entire study duration of 4.8 years.

InterventionParticipants (Count of Participants)
Deferred Therapy0
Early Therapy 40 Weeks0
Early Therapy 96 Weeks0

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Number of Participants Who Experienced Virological Failure Defined as Confirmed HIV-1 RNA Value of at Least 10,000 Copies Per/ml Recorded on Two Consecutive Separate Occasions After 24 Weeks of Treatment (Initial Therapy or Restart)

This was part of the primary outcome measure that was a composite endpoint that included confirmed HIV-1 RNA value of at least 10,000 copies per/ml recorded on two consecutive separate occasions after 24 weeks of treatment (initial therapy or restart). (NCT00102960)
Timeframe: Virological failure was assessed from randomization through the entire study duration of 4.8 years.

InterventionParticipants (Count of Participants)
Deferred Therapy10
Early Therapy 40 Weeks1
Early Therapy 96 Weeks1

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Number of Participants Who Experienced Clinical Failure (Defined as Development of Severe CDC Stage B or Stage C Disease.) on Therapy.

This included development of severe CDC Stage B or Stage C disease.This was part of the primary outcome measure that was a composite endpoint (NCT00102960)
Timeframe: Clinical failure on therapy was assessed at each visit for the entire study duration of 4.8 years.

InterventionParticipants (Count of Participants)
Deferred Therapy8
Early Therapy 40 Weeks6
Early Therapy 96 Weeks5

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Total Occurrence of Grade 3 or 4 Laboratory Events

(NCT00102960)
Timeframe: From randomization up to 4.8 years

InterventionCount of events (Number)
Deferred Therapy35
Early Therapy 40 Weeks44
Early Therapy 96 Weeks33

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Time to Failure of First Line Therapy or Death

To compare time to failure of first line ART (due to clinical, virological or immunological disease progression, or regimen-limiting ART toxicities) or death among three randomized arms (infants who receive early ART in Arms 2 and 3 and infants in whom ART is deferred until clinical or immunological disease progression in Arm 1) during the study (up to 4.8 years). The number of participants experiencing the events did not reach the 50% survival and thus median time-to-event is not be presented. Therefore we report the number of participants experiencing the events per Arm. (NCT00102960)
Timeframe: From date of randomization up to failure of first-line therapy or death from any cause, whichever came first, assessed up to 4.8 years

InterventionParticipants (Count of Participants)
Deferred Therapy48
Early Therapy up to 40 Weeks32
Early Therapy up to 96 Weeks26

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Time to First Hospitalization

To compare time to first hospitalization in the three randomized arms (infants who received early ART in Arms 2 and 3 and those who received deferred ART in Arm 1). Not all participants were hospitalized and thus the upper limits could not be evaluated. (NCT00102960)
Timeframe: From randomization up to 4.8 years

InterventionWeeks (Median)
Deferred Therapy73.1
Early Therapy 40 WeeksNA
Early Therapy 96 WeeksNA

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Total Occurrence of Grade 3 or 4 Clinical Events

This was a secondary outcome measure that assessed the total count of Grade 3 or 4 (clinical or laboratory) adverse events. (NCT00102960)
Timeframe: 4.8 years

InterventionCount of events (Number)
Deferred Therapy170
Early Therapy 40 Weeks118
Early Therapy 96 Weeks88

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Time to Death Alone or Death Plus Life Threatening Stage C Events or HIV Events Associated With Permanent End-organ Damage.

This was a composite endpoint in which the number of children experiencing the events is reported. The number of participants experiencing the events did not reach the 50% survival and thus median time-to-event is not be presented. Therefore, we report the number of participants experiencing the events per Arm. (NCT00102960)
Timeframe: 4.8 years

InterventionParticipants (Count of Participants)
Deferred Therapy34
Early Therapy 40 Weeks18
Early Therapy 96 Weeks13

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Duration of Hospitalisation

This is the total number of days spent in hospital by the participants and is reported per arm (NCT00102960)
Timeframe: 4.8 years, the study duration

InterventionDays (Number)
Deferred Therapy1018
Early Therapy 40 Weeks533
Early Therapy 96 Weeks414

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Hospitalization Rates

Hospitalisation rates in the three arms enrolled in the CHER study (NCT00102960)
Timeframe: 4.8 years

InterventionEvents per 100 person years (Number)
Deferred Therapy27.6
Early Therapy 40 Weeks16.4
Early Therapy 96 Weeks14.2

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Number of Children Experiencing Severe CDC Stage B or Stage C Disease or Death (Cumulative After 3.5 Years)

The outcome measure is defined as a number because it represents the number of children that experienced severe CDC Stage B or Stage C disease or death as defined in the outcome measure title above (NCT00102960)
Timeframe: Occurrence of severe CDC Stage B or Stage C disease or death (cumulative after 3.5 years), whichever came first, was assessed from randomization up to at least 3.5 years.

InterventionParticipants (Count of Participants)
Deferred Therapy41
Early Therapy 40 Weeks28
Early Therapy 96 Weeks21

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Number of Participants Who Experienced Immunological Failure Defined as Failure of CD4% to Reach 20% or CD4% Falls Below 20% on Two Occasions, Within 4 Weeks, at Any Time After the First 24 Weeks of Therapy (Initial Therapy or Restart)

This was part of the primary outcome measure above. The primary outcome was a composite endpoint. The primary outcome analysis only considered the initially enrolled children that were 377 in total (ART-Deferred n=125, Early therapy 40 weeks n=126 and Early therapy 96 weeks n=126). This was part of the primary outcome measure that was a composite endpoint. (NCT00102960)
Timeframe: This outcome was assessed from the date of randomization to immunological failure. Immunological failure was assessed in the entire study duration of 4.8 years.

InterventionParticipants (Count of Participants)
Deferred Therapy9
Early ART for 40 Weeks14
Early Therapy for 96 Weeks11

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Time From Randomization to Starting or Needing to Start Continuous Therapy

Time from randomization to starting (deferred therapy Arm) or needing to start continuous therapy (early therapy 40 or 96 weeks) (NCT00102960)
Timeframe: 4.8 years

InterventionWeeks (Median)
Deferred Therapy20
Early Therapy 40 Weeks33
Early Therapy 96 Weeks70

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Change in Trunk Fat (kg) From Week 48 to Week 144

Change from Week 48 to Week 144 in trunk fat = Week 144 trunk fat value minus Week 48 trunk fat value (NCT00112047)
Timeframe: Week 48 to Week 144

Interventiontrunk fat (kg) (Mean)
EFV+FTC+TDF1.30
CBV+EFV-0.10

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Change in Trunk Fat (kg) From Week 48 to Week 96

Change from Week 48 to Week 96 in trunk fat = Week 96 trunk fat value minus Week 48 trunk fat value (NCT00112047)
Timeframe: Week 48 to Week 96

Interventiontrunk fat (kg) (Mean)
EFV+FTC+TDF0.94
CBV+EFV-0.04

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Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm

Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 240 visit. (NCT00112047)
Timeframe: Week 144 (Atripla baseline) to Week 240 (Atripla Week 96)

InterventionPercentage of Participants (Number)
All Atripla87

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Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time-to-Loss-of Virologic Response [TLOVR] Algorithm

Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 48 visit (ie, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 48 visit. (NCT00112047)
Timeframe: 48 weeks

InterventionPercentage of participants (Number)
EFV+FTC+TDF84.4
CBV+EFV72.8

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Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)

Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 96 visit. (NCT00112047)
Timeframe: 96 Weeks

InterventionPercentage of Participants (Number)
EFV+FTC+TDF74.6
CBV+EFV61.9

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Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)

Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL (c/mL) had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 144 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV-1 RNA levels < 50 c/mL prior to Week 144 visit. (NCT00112047)
Timeframe: Week 144

InterventionPercentage of participants (Number)
EFV+FTC+TDF64.3
CBV+EFV56.3

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Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm

Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 240 visit. (NCT00112047)
Timeframe: Week 144 (Atripla baseline) to Week 240 (Atripla Week 96)

InterventionPercentage of Participants (Number)
All Atripla85

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Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 48 (Defined by FDA TLOVR Algorithm)

Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 48 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 48 visit. (NCT00112047)
Timeframe: Week 48

InterventionPercentage of Participants (Number)
EFV+FTC+TDF79.5
CBV+EFV70.4

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Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)

Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 96 visit. (NCT00112047)
Timeframe: Week 96

InterventionPercentage of Participants (Number)
EFV+FTC+TDF67.2
CBV+EFV60.9

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Percentage of Participants With HIV-1 RNA < 50 c/mL at Week 48

The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis). (NCT00112047)
Timeframe: 48 Weeks

InterventionPercentage of Participants (Number)
EFV+FTC+TDF74.5
CBV+EFV66.9

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Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 144

"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Week 144

InterventionPercentage of Participants (Number)
EFV+FTC+TDF28
CBV+EFV41

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Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 48

"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Baseline to 48 weeks

InterventionPercentage of Participants (Number)
EFV+FTC+TDF19
CBV+EFV30

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Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 96

TLOVR for participants with confirmed virologic response (2 consecutive HIV-1 RNA < 400 c/mL) prior to study drug discontinuation, was the time to the earliest of premature study regimen discontinuation, or confirmed HIV-1 RNA > 400 c/mL (2 consecutive HIV-1 RNA ≥ 400 c/mL, or the last HIV-1 RNA ≥ 400 c/mL followed by premature study regimen discontinuation due to loss to follow-up). Participants who did not achieve confirmed virologic response before premature study regimen discontinuation or last HIV-1 RNA, were assumed to have lost virologic response on Study Day 1. (NCT00112047)
Timeframe: Week 96

InterventionPercentage of Participants (Number)
EFV+FTC+TDF25
CBV+EFV37

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Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)

"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

InterventionPercentage of Participants (Number)
All Atripla13

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Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 144

"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Week 144

InterventionPercentage of Participants (Number)
EFV+FTC+TDF34
CBV+EFV43

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Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 48

"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Baseline to 48 Weeks

InterventionPercentage of Participants (Number)
EFV+FTC+TDF23
CBV+EFV32

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Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 96

"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Week 96

InterventionPercentage of Participants (Number)
EFV+FTC+TDF32
CBV+EFV38

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Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)

"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

InterventionPercentage of Participants (Number)
All Atripla15

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Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 144

The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis). (NCT00112047)
Timeframe: Week 144

InterventionPercentage of Participants (Number)
EFV+FTC+TDF63.1
CBV+EFV51.6

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Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96)

The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis). (NCT00112047)
Timeframe: Week 240 (Atripla Week 96)

InterventionPercentage of Participants (Number)
EFV+FTC+TDF/Atripla (From Study Baseline)87
All Atripla (From Atripla Baseline)85

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Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 48.

The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis). (NCT00112047)
Timeframe: 48 weeks

InterventionPercentage of Participants (Number)
EFV+FTC+TDF80.4
CBV+EFV69.3

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Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 144

The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis). (NCT00112047)
Timeframe: Week 144

InterventionPercentage of Participants (Number)
EFV+FTC+TDF60.8
CBV+EFV50.4

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Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96)

The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis). (NCT00112047)
Timeframe: Week 240 (Atripla Week 96)

InterventionPercentage of Participants (Number)
EFV+FTC+TDF/Atripla (From Study Baseline)84
All Atripla (From Atripla Baseline)82

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Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 48

Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Baseline to 48 Weeks

InterventionPercentage of Participants (Number)
EFV+FTC+TDF9
CBV+EFV16

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Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 96

Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Week 96

InterventionPercentage of Participants (Number)
EFV+FTC+TDF9
CBV+EFV17

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Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 48

Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Baseline to 48 Weeks

InterventionPercentage of participants (Number)
EFV+FTC+TDF16
CBV+EFV24

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Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 96

Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Week 96

InterventionPercentage of Participants (Number)
EFV+FTC+TDF20
CBV+EFV23

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Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) at Week 144

Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Week 144

InterventionPercentage of participants (Number)
EFV+FTC+TDF11
CBV+EFV17

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Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) Through Week 240 (Atripla Week 96)

Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Week 240 (Atripla Week 96)

InterventionPercentage of Participants (Number)
EFV+FTC+TDF/Atripla (From Study Baseline)11
All Atripla (From Atripla Baseline)2

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Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) at Week 144

Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Week 144

InterventionPercentage of Participants (Number)
EFV+FTC+TDF21
CBV+EFV25

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Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) Through Week 240 (Atripla Week 96)

Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Week 240 (Atripla Week 96)

InterventionPercentage of Participants (Number)
EFV+FTC+TDF/Atripla (From Study Baseline)22
All Atripla (From Atripla Baseline)4

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Quality of Life (SF-12v2 Health Survey: Mental Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey MCS. The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the MCS. PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and a SD of 10 (in the general population). (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

InterventionComposite Score (Mean)
All Atripla0.9

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Quality of Life (SF-12v2 Health Survey: Physical Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey: Physical Component Summary (PCS). The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the Mental Component Summary (MCS). PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and SD of 10 (in the general population). (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

InterventionComposite Score (Mean)
All Atripla0.0

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Treatment Satisfaction Questionnaire (Bothered With the Side Effects of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.

"Participants were asked: How bothered are you with the side effects of your current treatment regimen? Possible responses were on a 4-category scale: does not bother me; bothers me a little bit; bothers me a lot; and bothers me terribly. For the evaluation of the change in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into does not bother me and bothers me (bothers me included bothers me a little bit; bothers me a lot; bothers me terribly)." (NCT00112047)
Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)

InterventionParticipants (Number)
Bothers me (W 144 and W 240)Does not bother me (W 144 and W 240)Bothers me (W 144); does not bother me (W 240)Does not bother me (W 144); bothers me (W 240)
All Atripla411263128

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Treatment Satisfaction Questionnaire (General Satisfaction With Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.

"Participants were asked: In general, how satisfied are you with your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)." (NCT00112047)
Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)

InterventionParticipants (Number)
Very satisfied (W 144 and W 240)Not very satisfied (W 144 and W 240)Very satisfied (W 144); not very satisfied (W 240)Not very satisfied (W 144); very satisfied (W 240)
All Atripla18010923

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Treatment Satisfaction Questionnaire (Satisfaction With Convenience and Simplicity of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.

"Participants were asked: In general, how satisfied are you with the convenience and simplicity of your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)." (NCT00112047)
Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)

InterventionParticipants (Number)
Very satisfied (W 144 and W 240)Not very satisfied (W 144 and W 240)Very satisfied (W 144); not very satisfied (W 240)Not very satisfied (W 144); very satisfied (W 240)
All Atripla1826829

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Treatment Satisfaction Questionnaire (Satisfaction With Current Treatment Regimen to Control HIV): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.

"Participants were asked: In general, how satisfied are you with the ability of your current treatment regimen to control your HIV infection? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)." (NCT00112047)
Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)

InterventionParticipants (Number)
Very satisfied (W 144 and W 240)Not very satisfied (W 144 and W 240)Very satisfied (W 144); not very satisfied (W 240)Not very satisfied (W 144); very satisfied (W 240)
All Atripla1928917

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Treatment Satisfaction Questionnaire (Satisfaction With Tolerability of Current Treatment Regimen) Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.

"Participants were asked: In general, how satisfied are you with your ability to tolerate your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)." (NCT00112047)
Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)

InterventionParticipants (Number)
Very satisfied (W 144 and W 240)Not very satisfied (W 144 and W 240)Very satisfied (W 144); not very satisfied (W 240)Not very satisfied (W 144); very satisfied (W 240)
All Atripla166211326

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Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)

Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 144 visit (i.e., the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV-1 RNA levels < 400 c/mL prior to Week 144 visit. (NCT00112047)
Timeframe: 144 weeks

InterventionPercentage of Participants (Number)
EFV+FTC+TDF70.9
CBV+EFV58.1

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Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 240 (Atripla Week 96)

Change from baseline to Week 240 (Atripla Week 96) in CD4 cell count = Week 240 (Atripla Week 96) CD4 cell count value minus baseline CD4 cell count value (NCT00112047)
Timeframe: Study/Atripla baseline to Week 240 (Atripla Week 96)

InterventionCD4 Cell count (Cells/mm^3) (Mean)
EFV+FTC+TDF/Atripla (From Study Baseline)346
All Atripla (From Atripla Baseline)42

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Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 144

Change from study baseline to Week 144 in CD4 cell count = Week 144 CD4 cell count value minus study baseline CD4 cell count value (NCT00112047)
Timeframe: Baseline to Week 144

InterventionCD4 Cell Count (cells/mm^3) (Mean)
EFV+FTC+TDF312
CBV+EFV271

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Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 48

Change from study baseline to Week 48 in CD4 cell count = Week 48 CD4 cell count value minus study baseline CD4 cell count value (NCT00112047)
Timeframe: Study baseline to Week 48

InterventionCD4 Cell Count (cells/mm^3) (Mean)
EFV+FTC+TDF190
CBV+EFV158

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Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 96

Change from study baseline to Week 96 in CD4 cell count = Week 96 CD4 cell count value minus study baseline CD4 cell count value (NCT00112047)
Timeframe: Baseline to Week 96

InterventionCD4 Cell Count (cells/mm^3) (Mean)
EFV+FTC+TDF270
CBV+EFV237

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Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 144

Change from study baseline to Week 144 in HIV-1 RNA in log10 scale (Week 144 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale). (NCT00112047)
Timeframe: Study baseline to Week 144

InterventionLog10 c/mL (Mean)
EFV+FTC+TDF-3.32
CBV+EFV-3.30

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Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 48

Change from study baseline to Week 48 in HIV-1 RNA in log10 scale (Week 48 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale). (NCT00112047)
Timeframe: Study baseline to Week 48

InterventionLog10 c/mL (Mean)
EFV+FTC+TDF-3.31
CBV+EFV-3.26

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Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 96

Change from study baseline to Week 96 in HIV-1 RNA in log10 scale (Week 96 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale). (NCT00112047)
Timeframe: Study baseline to Week 96

InterventionLog10 c/mL (Mean)
EFV+FTC+TDF-3.30
CBV+EFV-3.25

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Change in Limb Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in limb fat = Week 240 (Atripla Week 96) limb fat value minus Week 144 (Atripla Baseline) limb fat value (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

Interventionlimb fat (kg) (Mean)
All Atripla0.12

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Change in Limb Fat (kg) From Week 48 to Week 144

Change from Week 48 to Week 144 in limb fat = Week 144 limb fat value minus Week 48 limb fat value (NCT00112047)
Timeframe: Week 48 to Week 144

Interventionlimb fat (kg) (Mean)
EFV+FTC+TDF1.13
CBV+EFV-1.09

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Change in Limb Fat (kg) From Week 48 to Week 96

Change from Week 48 to Week 96 in limb fat = Week 96 limb fat value minus Week 48 limb fat value. (NCT00112047)
Timeframe: Week 48 to Week 96

Interventionlimb fat (kg) (Mean)
EFV+FTC+TDF0.74
CBV+EFV-0.77

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Change in Total Body Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in total body fat = Week 240 (Atripla Week 96) total body fat value minus Week 144 (Atripla Baseline) total body fat value (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

Interventiontotal body fat (kg) (Mean)
All Atripla0.37

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Change in Total Body Fat (kg) From Week 48 to Week 144

Change from Week 48 to Week 144 in total body fat = Week 144 total body fat value minus Week 48 total body fat value (NCT00112047)
Timeframe: Week 48 to Week 144

Interventiontotal body fat (kg) (Mean)
EFV+FTC+TDF2.47
CBV+EFV-1.18

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Change in Total Body Fat (kg) From Week 48 to Week 96

Change from Week 48 to Week 96 in total body fat = Week 96 total body fat value minus Week 48 total body fat value (NCT00112047)
Timeframe: 48 weeks to 96 weeks

Interventiontotal body fat (kg) (Mean)
EFV+FTC+TDF1.69
CBV+EFV-0.82

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Change in Trunk Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in trunk fat = Week 240 (Atripla Week 96) trunk fat value minus Week 144 (Atripla Baseline) trunk fat value (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)

Interventiontrunk fat (kg) (Mean)
All Atripla0.27

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Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline

Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
Interventionmg/dL (Median)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC89
EFV, Placebo FTC/TDF, and ABC/3TC1011
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC54
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC87

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Change in CD4 Count (Cells/mm3) From Baseline

Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (mean of pre-entry and entry values). (NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
InterventionCells/mm3 (Median)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC163220.5
EFV, Placebo FTC/TDF, and ABC/3TC188250.5
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC175251.5
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC177.5250.3

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Number of Participants With Virologic Failure and Emergence of Major Resistance

Emergence of resistant virus was assessed by genotypic testing performed at Stanford University for all participants who met criteria for virologic failure and retrospectively on baseline samples from these participants. Major mutations were defined by International AIDS Society-United States of America (2008), as well as T69D, L74I, G190C/E/Q/T/V for reverse transcriptase and L24I, F53L, I54V/A/T/S, G73C/S/T/A, N88D for protease. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Interventionparticipants (Number)
EFV, FTC/TDF, and Placebo ABC/3TC27
EFV, Placebo FTC/TDF, and ABC/3TC41
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC5
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC12

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Number of Participants With Virologic Failure

Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Interventionparticipants (Number)
EFV, FTC/TDF, and Placebo ABC/3TC57
EFV, Placebo FTC/TDF, and ABC/3TC72
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC57
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC83

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Number of Participants With Treatment Modification

Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Interventionparticipants (Number)
EFV, FTC/TDF, and Placebo ABC/3TC152
EFV, Placebo FTC/TDF, and ABC/3TC239
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC138
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC216

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Number of Participants With Regimen Failure

Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Interventionparticipants (Number)
EFV, FTC/TDF, and Placebo ABC/3TC162
EFV, Placebo FTC/TDF, and ABC/3TC246
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC157
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC233

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Number of Participants With a Grade 3/4 Safety Event

Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded. (NCT00118898)
Timeframe: Over all study follow-up while on initially assigned treatment, median follow-up was 120 weeks

Interventionparticipants (Number)
EFV, FTC/TDF, and Placebo ABC/3TC145
EFV, Placebo FTC/TDF, and ABC/3TC182
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC137
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC156

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Amount of Study Follow-up

Participants were to be followed for 96 weeks after the last enrollment. Accrual was expected to take 96 weeks, thus the planned follow-up time was 96 to 192 weeks, dependent on when in the study the participant enrolled. This outcome summarizes that total amount of actual follow-up in weeks from randomization to last contact. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks

InterventionWeeks (Median)
EFV, FTC/TDF, and Placebo ABC/3TC141.4
EFV, Placebo FTC/TDF, and ABC/3TC133.3
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC141.6
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC137.3

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Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline

Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
Interventionmg/dL (Median)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC1413.5
EFV, Placebo FTC/TDF, and ABC/3TC2318
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC810
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC2018

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Cumulative Probability of Not Experiencing Regimen Failure

Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: At week 48 and 96

,,,
Interventionpercentage of participants (Number)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC7970
EFV, Placebo FTC/TDF, and ABC/3TC6454
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC8073
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC6657

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The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL

(NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
InterventionParticipants (Number)
Number of Participants with RNA data at Week 48Number with HIV-1 RNA <50 copies/ml at Week 48Number of Participants with RNA data at Week 96Number with HIV-1 RNA <50 copies/ml at Week 96
EFV, FTC/TDF, and Placebo ABC/3TC415372379345
EFV, Placebo FTC/TDF, and ABC/3TC400346361328
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC416348384345
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC411322374317

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Time From Treatment Dispensation to Treatment Modification

Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

,,,
InterventionWeeks (Number)
5th percentile time to treatment modification10th percentile time to treatment modification25th percentile time to treatment modification
EFV, FTC/TDF, and Placebo ABC/3TC3.415.083.7
EFV, Placebo FTC/TDF, and ABC/3TC1.42.127.4
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC7.924.9108.9
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC1.65.043.6

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Cumulative Probability of Not Experiencing Treatment Modification

Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: At week 48 and 96

,,,
Interventionpercentage of participants (Number)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC8073
EFV, Placebo FTC/TDF, and ABC/3TC6756
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC8677
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC7362

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Cumulative Probability of Not Experiencing Virologic Failure

Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. (NCT00118898)
Timeframe: At week 48 and 96

,,,
Interventionpercentage of participants (Number)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC9490
EFV, Placebo FTC/TDF, and ABC/3TC8885
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC9289
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC8883

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Time From Randomization to Virologic Failure

Blood samples for determining virologic failure were obtained at visit weeks 16 and 24 , and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks after randomization and before 24 weeks, or >=200 copies/mL at or after 24 weeks. The 5th percentile for time to virologic failure is the time (in weeks) at which 5% of the participants have experienced virologic failure. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

,,,
InterventionWeeks (Number)
5th percentile time to virologic failure10th percentile time to virologic failure
EFV, FTC/TDF, and Placebo ABC/3TC3696
EFV, Placebo FTC/TDF, and ABC/3TC2436
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC2484
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC2436

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Time From Treatment Dispensation to a Grade 3/4 Safety Event

Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. (NCT00118898)
Timeframe: All follow-up while on initially assigned regimen; the median (25th, 75th percentile) follow-up while on initial regimen was 120 (54, 156) weeks and the range was 0 to 205 weeks.

,,,
InterventionWeeks (Number)
5th percentile time to a grade 3/4 safety event10th percentile time to a grade 3/4 safety event25th percentile time to a grade 3/4 safety event
EFV, FTC/TDF, and Placebo ABC/3TC2.67.959.3
EFV, Placebo FTC/TDF, and ABC/3TC1.32.016.0
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC3.08.181.4
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC1.33.944.4

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Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)

Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

,,,
InterventionWeeks (Number)
5th percentile time to regimen failure10th percentile time to regimen failure25th percentile time to regimen failure
EFV, FTC/TDF, and Placebo ABC/3TC41672
EFV, Placebo FTC/TDF, and ABC/3TC4424
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC41684
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC4436

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Change in Fasting Total Cholesterol Level From Baseline

Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
Interventionmg/dL (Median)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC2223
EFV, Placebo FTC/TDF, and ABC/3TC3533
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC1114
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC3025

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Change in Fasting Triglyceride Level From Baseline

Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
Interventionmg/dL (Median)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC109
EFV, Placebo FTC/TDF, and ABC/3TC1514
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC1411
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC2433

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Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event

Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded. (NCT00118898)
Timeframe: At week 48 and 96

,,,
Interventionpercentage of participants (Number)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC7870
EFV, Placebo FTC/TDF, and ABC/3TC6458
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC7973
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC7366

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Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL

(NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
InterventionParticipants (Number)
Number of Participants with RNA data at Week 48Number with HIV-1 RNA <200 copies/ml at Week 48Number of Participants with RNA data at Week 96Number with HIV-1 RNA <200 copies/ml at Week 96
EFV, FTC/TDF, and Placebo ABC/3TC415398379362
EFV, Placebo FTC/TDF, and ABC/3TC400377361342
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC416391384368
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC411372374346

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Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks

A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of failure was tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. (NCT00244712)
Timeframe: Baseline and time of virologic failure (up to Week 96)

,
Interventionparticipants (Number)
No. with paired genotypes at baseline and wk 96Participants with treatment-emergent mutationsNRTI-associated mutationsNNRTI-associated mutationsPI-associated mutations
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)451811411
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV41221737

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Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96

The number of participants that failed to respond to therapy based on the protocol definition of virologic failure (PDVF) was tabulated. PDVF was defined as either no confirmed HIV-1 RNA <200 copies/mL or HIV-1 RNA rebound >= 200 copies/mL on two consecutive occasions. (NCT00244712)
Timeframe: Baseline to Week 96

,
Interventionparticipants (Number)
Protocol-defined virologic failureFail to confirm HIV-1 RNA <200 copies/mL by wk 24Confirmed HIV-1 RNA rebound to >= 200 copies/mLSuspected HIV-1 RNA rebound to >= 200 copies/mL
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)49212812
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV48242411

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Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction

The number of participants that experienced symptoms of a suspected abacavir hypersensitivity reaction was tabulated. The number of participants that developed laboratory signs of proximal renal tubule dysfunction was tabulated. (NCT00244712)
Timeframe: Baseline through 96 weeks

,
Interventionparticipants (Number)
Participants (Par.) with suspected ABC HSRMild or Grade 1Moderate or Grade 2Severe or Grade 3Not ApplicablePar. with proximal renal tubule dysfunction
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)1418410
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV302105

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Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96

A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL). (NCT00244712)
Timeframe: Weeks 48 and 96

,
Interventionpercentage of participants (Number)
M=F, Switch Included, Week 48TLOVR, Week 48Obs, Week 48M/D=F, Week 48M=F, Switch Included, Week 96TLOVR, Week 96Obs, Week 96M/D=F, Week 96
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)75.270.993.871.463.958.492.860.1
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV71.366.492.266.261.256.396.356.9

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Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL

A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL. (NCT00244712)
Timeframe: Weeks 48 and 96

,
Interventionpercentage of participants (Number)
M=F, Switch Included, Week 48TLOVR, Week 48Obs, Week 48M/D=F, Week 48M=F, Switch Included, Week 96TLOVR, Week 96Obs, Week 96M/D=F, Week 96
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)7672947265609261
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV7166916560559756

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Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL

A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA >=100,000 copies/mL. (NCT00244712)
Timeframe: Weeks 48 and 96

,
Interventionpercentage of participants (Number)
M=F, Switch Included, Week 48TLOVR, Week 48Obs, Week 48M/D=F, Week 48M=F, Switch Included, Week 96TLOVR, Week 96Obs, Week 96M/D=F, Week 96
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)7570947163569359
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV7167946863589658

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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48

A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL). (NCT00244712)
Timeframe: Week 48

,
Interventionpercentage of participants (Number)
TLOVRObsM/D=F
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)62.684.364.3
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV61.186.862.3

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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96

A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL). (NCT00244712)
Timeframe: Week 96

,
Interventionpercentage of participants (Number)
M=F, Switch IncludedTLOVRObsM/D=F
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)59.952.186.956.4
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV58.051.091.354.5

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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL

A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL. (NCT00244712)
Timeframe: Weeks 48 and 96

,
Interventionpercentage of participants (Number)
M=F, Switch Included, Week 48TLOVR, Week 48Obs, Week 48MD=F, Week 48M=F, Switch Included, Week 96TLOVR, Week 96Obs, Week 96MD=F, Week 96
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)7167896863578959
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV6962886258529454

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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL

A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA >=100,000 copies/mL. (NCT00244712)
Timeframe: Weeks 48 and 96

,
Interventionpercentage of participants (Number)
M=F, Switch Included, Week 48TLOVR, Week 48Obs, Week 48M/D=F, Week 48M=F, Switch Included, Week 96TLOVR, Week 96Obs, Week 96M/D=F, Week 96
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)6357785956468454
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV6560866258518855

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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.

A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL were tabulated by treatment arm with stratification by baseline HIV-1 RNA (<100,000 copies/mL and >=100,000 copies/mL). (NCT00244712)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)67.5
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV67.2

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Median Change From Baseline in CD4+ Cells at Weeks 48 and 96

A blood sample was drawn to determine the CD4+ cell count at Weeks 48 and 96. Change from baseline was defined as CD4+ cell count at week 96 minus CD4+ cell count at baseline. (NCT00244712)
Timeframe: Weeks 48 and 96

,
Interventioncells per cmm (Median)
Week 48Week 96
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)201.0250.0
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV173.0246.5

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Median Change From Baseline in HIV-1 RNA at Week 48 and 96

A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. Change from baseline was defined as HIV-1 RNA level at Weeks 48 and 96 minus HIV-1 RNA level at baseline. (NCT00244712)
Timeframe: Weeks 48 and 96

,
Interventionlog10 copies/mL (Median)
Week 48Week 96
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)-3.142-3.114
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV-3.131-3.165

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Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility

A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. New mutations that developed to the NRTI class at the time of failure that no longer responded to lamivudine or emtricitabine were tabulated by drug class. (NCT00244712)
Timeframe: Baseline and time of virologic failure (up to Week 96)

,
Interventionparticipants (Number)
Resistance NRTI class (M184V, M/V,M/I,A/V,I,M/I/V)Reduced pheno susceptibility to lamivudine/M184VReduced phen susceptibility to lamivudine/M184M/VReduced pheno susceptibility to lamivudine/M184M/IReduced pheno susceptibility to lamivudine/M184A/VReduced pheno susceptibility to lamivudine/M184IReduced pheno suscept. to lamivudine/M184M/I/VReduced pheno suscept. to emtricitabine/M184VReduced pheno suscept. to emtricitabine/M184M/VReduced pheno suscept. to emtricitabine/M184M/IReduced pheno suscept. to emtricitabine/M184A/VReduced pheno suscept. to emtricitabine/M184IReduced pheno suscept. to emtricitabine/M184M/I/V
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)11430000430000
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV17901111901111

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Cumulative Treatment Failure Rate of Participants on First Line Antiretroviral Therapy Monitored by Primary Health Care Nurses (Investigative Arm)is Not Inferior to the Cumulative Treatment Failure Rate of Participants Monitored by Doctors (Control Arm).

Cumulative treatment failure is a composite endpoint made up of death, virological failure, toxicity failure and protocol-defined loss to follow-up failure. (NCT00255840)
Timeframe: 96 weeks

InterventionPercentage of participants (Number)
Antiretroviral Therapy Monitored by Medical Officer44
Antiretroviral Therapy Managed by Primary Health Care Nurse48

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Number of Participants With Virologic Suppression

Suppression of the plasma HIV-1 RNA level to less than 400 copies per milliliter (NCT00270296)
Timeframe: Throughout study, including breastfeeding, assessed up to 24 months

InterventionParticipants (Count of Participants)
TZV Arm274
Kaletra Arm256
NVP Arm160

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Number of HIV+ Infants

Number of infants with HIV-positive status (NCT00270296)
Timeframe: Throughout study, including breastfeeding, assessed up to 24 months

InterventionInfants (Number)
TZV Arm6
Kaletra Arm1
NVP Arm1

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Number of Participants Developing New NRTI, NNRTI or PI-resistant Virus

Numbers of participants developing new NRTI, NNRTI or PI-resistant virus after reaching a virologic failure endpoint (NCT00307151)
Timeframe: Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)

Interventionparticipants (Number)
Coh I: NVP16
Coh I: LPV/r1
Coh II: NVP10
Coh II: LPV/r4

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Change in CD4 Percent From Entry to Week 48

Change was calculated as CD4 percent at week 48 minus entry CD4 percent (last CD4 percent before randomization date). Only subjects who reached 48 weeks of follow-up before DSMB decisions to unblind each Cohort were included in summary. (NCT00307151)
Timeframe: 48 weeks if before date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)

InterventionPercent of CD4 (Mean)
Coh I: NVP13.9
Coh I: LPV/r12.0
Coh II: NVP15.2
Coh II: LPV/r14.3

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Time From Randomization to Treatment Failure, Defined as Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment

Treatment failure is defined as a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR a confirmed viral rebound >4000 copies/mL after week 24 OR permanent discontinuation of the randomized NNRTI or PI component of study treatment for any reason including death. (NCT00307151)
Timeframe: Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)

,,,
InterventionWeeks (Number)
10th percentile25th percentile
Coh I: LPV/r436
Coh I: NVP1216
Coh II: LPV/r1436
Coh II: NVP416

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Time From Randomization to Virologic Failure

Virologic failure is defined as the earlier of a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR a confirmed viral rebound >4000 copies/mL after week 24 OR death. (NCT00307151)
Timeframe: Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)

,,,
InterventionWeeks (Number)
5th percentile10th percentile
Coh I: LPV/r1624
Coh I: NVP1212
Coh II: LPV/r1624
Coh II: NVP1216

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Time From Start of Study Treatment to First New Grade >=3 Lab Abnormality, Sign or Symptom Occurring on Study Treatment

Safety events include lab abnormalities, signs or symptoms of grade 3 or higher. Events were graded according to the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events, Version 1.0. Events defined as new if first occurrence was after initiation of study treatment or if severity increased from entry and while on the NNRTI or PI component of study treatment. (NCT00307151)
Timeframe: On randomized NNRTI or PI component of study treatment and until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)

,,,
InterventionWeeks (Number)
10th percentile25th percentile
Coh I: LPV/r836
Coh I: NVP424
Coh II: LPV/r412
Coh II: NVP34

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Time From Randomization to Death

Results report 2nd percentile of time from randomization to death (NCT00307151)
Timeframe: Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)

InterventionWeeks (Number)
Coh I: NVP11
Coh I: LPV/r3
Coh II: NVP2
Coh II: LPV/r83

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Percent of Participants With Treatment Failure, Defined as a Confirmed Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment

Treatment failure is defined as a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR permanent discontinuation of the randomized NNRTI or PI component of study treatment at or prior to 24 weeks of treatment for any reason including death. Results report percent of participants reaching a treatment failure endpoint by week 24 calculated using the Kaplan-Meier method. (NCT00307151)
Timeframe: Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)

InterventionPercent of participants (Number)
Coh I: NVP39.6
Coh I: LPV/r21.7
Coh II: NVP40.8
Coh II: LPV/r19.3

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Percent of Participants Experiencing Virologic Failure

Virologic failure is defined as a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR death on or before 24 weeks. Results report percent of participants reaching a virologic failure endpoint by week 24 calculated using the Kaplan-Meier method. (NCT00307151)
Timeframe: Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)

InterventionPercent of participants (Number)
Coh I: NVP27.4
Coh I: LPV/r10.4
Coh II: NVP28.6
Coh II: LPV/r12.9

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Mean Alanine Aminotransferase (ALT) Level at Week 52

Summary statistics were displayed for serum ALT. (NCT00316719)
Timeframe: Week 52

InterventionUnits per Liter (Mean)
Adefovir (ADV)32.3
Lamivudine (LAM)33.0

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Time to Onset of ALT Normalization

Time to onset of ALT normalization was summarized using the Kaplan-Meier method. (NCT00316719)
Timeframe: From Baseline to Week 52

InterventionWeek 52 (Median)
Adefovir (ADV)12.0
Lamivudine (LAM)12.0

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Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 52

ALT normalization was defined as an ALT value that was in the normal range (<= 45IU/L; upper limit of normal [ULN]) at Week 52 of the participants whose ALT values were abnormal (>45IU/L) at baseline (NCT00316719)
Timeframe: Week 52

,
InterventionPercentage of participants (Number)
With ALT normalizationWithout ALT normalization
Adefovir (ADV)82.617.4
Lamivudine (LAM)78.421.6

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Percentage of Participants With HBV DNA Loss (<400 Copies/mL) at Week 52

The percentages of participants with an HBV DNA level in serum of less than 400 copies/mL, which is the lower limit of detection (HBV DNA loss) at Week 52 (NCT00316719)
Timeframe: Week 52

,
InterventionPercentage of participants (Number)
<400 copies/mL>400 copies/mL
Adefovir (ADV)46.054.0
Lamivudine (LAM)50.050.0

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Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 52

Participants with loss of Hepatitis B e antigen (HBeAg) in serum collected by blood draw: Cheminoluminescent Immuno Assay (CLIA) method (NCT00316719)
Timeframe: Week 52

,
Interventionpercentage of participants (Number)
With loss of HBeAgPositive for HBeAg
Adefovir (ADV)16.793.3
Lamivudine (LAM)16.293.8

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Percentage of Participants With Hepatitis B e Antigen/Antibody (HBeAg/Ab) Seroconversion at Week 52

Participants with loss of Hepatitis B e antigen (HBeAg) and positive for anti-Hepatitis B e antibody (HBeAb) in serum collected by blood draw: CLIA method (NCT00316719)
Timeframe: Week 52

,
InterventionPercentage of participants (Number)
With HBeAg/Ab seroconversionWithout HBeAg/Ab seroconversion
Adefovir (ADV)9.790.3
Lamivudine (LAM)5.994.1

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Percentage of Participants With Hepatitis B s Antigen (HBsAg) Loss at Week 52

Participants with loss of Hepatitis B s antigen (HBsAg) in serum collected by blood draw: CLIA method (NCT00316719)
Timeframe: Week 52

,
Interventionpercentage of participants (Number)
With loss of HBsAgPositive for HBsAg
Adefovir (ADV)0.0100.0
Lamivudine (LAM)0.0100.0

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Mean Change From Baseline in Hepatitis B Virus (HBV) DNA at Week 52

Change from baseline was the difference of the HBV DNA copy numbers (log10) in serum collected by blood draw between baseline and Week 52 (NCT00316719)
Timeframe: Baseline and Week 52

Interventionlog10 copies/mL (Mean)
Adefovir (ADV)-3.69
Lamivudine (LAM)-3.40

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Rate of Emergence of Resistant Virus at Week 52

Participants with resistant mutation at Week 52. LAM resistant mutation (enzyme-linked mini-sequencing assay): rtM204I/V; ADV resistant mutation (direct sequencing assay): rtN236T or rtA181T/V in HBV DNA ; rt: reverse transcriptase gene (NCT00316719)
Timeframe: Week 52

,
InterventionPercentage of participants (Number)
With resistant mutationWithout resistant mutation
Adefovir (ADV)0100
Lamivudine (LAM)28.871.2

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Percentage of Participants With Hepatitis B s Antigen/ Antibody (HBsAg/Ab) Seroconversion at Week 52

Participants with loss of Hepatitis B s antigen (HBsAg) and positive for anti-Hepatitis B s antibody (HBsAb) in serum collected by blood draw: CLIA method (NCT00316719)
Timeframe: Week 52

,
Interventionpercentage of participants (Number)
With HBsAg/Ab seroconversionWithout HBsAg/Ab seroconversion
Adefovir (ADV)0.0100.0
Lamivudine (LAM)0.0100.0

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Percentage of Participants With HIV-1 RNA > 50 and < 400 Copies/mL

(NCT00324649)
Timeframe: 48 weeks

InterventionPercentage of participants (Number)
Truvada0
Zidovudine/Lamivudine5

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Percentage of Participants With Any Adverse Event

"Participants with treatment-emergent adverse events were analyzed. Adverse events were defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with study treatment, and were categorized using the Medical Dictionary for Regulatory Activities (MedDRA) Version 11.~Treatment-emergent adverse events were events that met one of the following criteria:~Began or worsened in severity or relationship to study drug, on or after the date of the first dose of study drug and on or before the date of the last dose of study drug plus 30 days.~Had no recorded start date." (NCT00324649)
Timeframe: 72 weeks

InterventionPercentage of participants (Number)
Truvada77
Zidovudine/Lamivudine85

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Percentage of Participants Who Maintain Confirmed HIV-1 RNA < 50 Copies/mL

(NCT00324649)
Timeframe: 48 weeks

InterventionPercentage of participants (Number)
Truvada92.3
Zidovudine/Lamivudine78.0

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Percentage of Participants Who Discontinue the Study Prematurely (Before Week 48) Due to Adverse Events.

(NCT00324649)
Timeframe: 48 weeks

InterventionPercentage of participants (Number)
Truvada3
Zidovudine/Lamivudine10

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Percentage of Days for Which Participants Were Compliant With Study Drug

Compliance = [1 - [(sum of days with a missed dose [per Question 6 study medication assessment questionnaire (SMAQ)])/(sum of days between SMAQ visits)]] *100 for visits with SMAQ data. An assessable visit is one where the number of missed days was reported [Question 6] and the number of days between SMAQ visits could be calculated. (NCT00324649)
Timeframe: Baseline to Week 72

InterventionPercentage of days with compliance (Median)
Truvada100.0
Zidovudine/Lamivudine100.0

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Percent Change From Baseline in Hematocrit

Change = Week 48 value minus baseline value expressed as median percent change. (NCT00324649)
Timeframe: Baseline to Week 48

InterventionPercent change in hematocrit (Median)
Truvada2.7
Zidovudine/Lamivudine1.0

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Change From Baseline in Waist Circumference/Hip Circumference Ratio

Change = Week 48 value minus baseline value. (NCT00324649)
Timeframe: Baseline to Week 48

InterventionRatio (Median)
Truvada-0.01
Zidovudine/Lamivudine0.01

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Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Oral Mucosa)

Change = Week 48 value minus baseline value. (NCT00324649)
Timeframe: Baseline to Week 48

InterventionRatio (Median)
Truvada62.0
Zidovudine/Lamivudine97.0

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Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Lymphocytes)

Change = Week 48 value minus baseline value. (NCT00324649)
Timeframe: Baseline to Week 48

InterventionRatio (Median)
Truvada36.0
Zidovudine/Lamivudine43.0

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Change From Baseline in Limb Fat at Week 48

Limb fat was measured by DEXA. Change = Week 48 value minus baseline value. (NCT00324649)
Timeframe: Baseline to Week 48

Interventiongrams (g) (Median)
Truvada392
Zidovudine/Lamivudine-257

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Change From Baseline in Lactate Concentration

Change = Week 48 value minus baseline value. (NCT00324649)
Timeframe: Baseline to Week 48

Interventionmmol/L (Median)
Truvada-0.23
Zidovudine/Lamivudine0.09

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Change From Baseline in Hemoglobin

Change = Week 48 value minus baseline value. (NCT00324649)
Timeframe: Baseline to Week 48

Interventiong/dL (Median)
Truvada0.9
Zidovudine/Lamivudine0.3

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Change From Baseline in Fasting Serum Triglycerides

Change = Week 48 value minus baseline value. (NCT00324649)
Timeframe: Baseline to Week 48

Interventionmg/dL (Median)
Truvada1.5
Zidovudine/Lamivudine4.0

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Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL)

Change = Week 48 value minus baseline value. (NCT00324649)
Timeframe: Baseline to Week 48

Interventionmg/dL (Median)
Truvada7.0
Zidovudine/Lamivudine5.0

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Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL)

Change = Week 48 value minus baseline value. (NCT00324649)
Timeframe: Baseline to Week 48

Interventionmg/dL (Median)
Truvada-2.0
Zidovudine/Lamivudine2.0

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Change From Baseline in Cluster Determinant 4 (CD4) Cell Count

Change = Week 48 value minus baseline value. (NCT00324649)
Timeframe: Baseline to Week 48

Interventioncells/mm^3 (Median)
Truvada60.5
Zidovudine/Lamivudine9.0

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Change From Baseline in Fasting Total Cholesterol

Change = Week 48 value minus baseline value. (NCT00324649)
Timeframe: Baseline to Week 48

Interventionmg/dL (Median)
Truvada4.5
Zidovudine/Lamivudine1.0

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Percentage of Participants With Virologic Failure

Virologic failure was defined as two consecutive HIV RNA values > 400 copies/mL. (NCT00324649)
Timeframe: 48 weeks

InterventionPercentage of participants (Number)
Truvada0
Zidovudine/Lamivudine0

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Serious Adverse Events

Safety outcomes in four different randomly assigned regimens (NCT00342355)
Timeframe: January 2004 until March 31, 2008

Interventionparticipant (Number)
AZT+ddI+EFV73
AZT + ddI + r/LPV69
d4T + 3TC + EFV64
d4T + 3TC + r/LPV60

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Progression to AIDS or Death in tx naïve Pts With Adv HIV dx in the Four Randomly Assigned Regimens.

Progression of disease, AIDS, or death in treatment naive patients with advanced HIV diagnosis will be evaluated in the four randomly assigned regimens. (NCT00342355)
Timeframe: January 2004 until March 31 2008

Interventionparticipants (Number)
AZT+ddI+EFV93
AZT + ddI + r/LPV77
d4T + 3TC + EFV70
d4T + 3TC + r/LPV80

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The Proportion Of Participants With Virologic Response For 10 mg/Day Elvucitabine In HIV-1-Infected Participants By 12 Weeks Compared With The Proportion Of Participants With Lamivudine 300 mg/Day

The proportion of participants having achieved a virologic response for elvucitabine 10 mg/day in combination with efavirenz and tenofovir in HIV-1-infected participants over 12 weeks compared with the proportion of participants having achieved a virologic response for lamivudine 300 mg/day in combination with efavirenz and tenofovir. Virologic response was defined as having achieved undetectable (<50 copies/mL) HIV-1 RNA levels from baseline assessment. (NCT00350272)
Timeframe: 12 weeks

,
Interventionpercentage of participants (Number)
Week 2Week 4Week 6Week 8Week 10Week 12
Elvucitabine13.516.227.035.154.156.8
Lamivudine8.110.835.154.156.870.3

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The Safety Profile Of Elvucitabine.

Determination of the safety profile of elvucitabine as defined by the frequency, type and severity of treatment-emergent adverse events (AEs) and the frequency of Grade 3 and Grade 4 laboratory abnormalities. (NCT00350272)
Timeframe: 12 weeks

,
Interventionparticipants (Number)
Treatment emergent adverse eventsTreatment emergent severe adverse eventsTreatment related serious adverse eventsDiscontinuations due to adverse eventsTreatment emergent Grade 3/4 lab abnormalities
Elvucitabine, Efavirenz,Tenofovir363026
Lamivudine,Efavirenz,Tenofovir352005

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Number of Participants With Clinically or Statistically Significant Changes in Vital Sign Measurements at Week 24

Vital signs assessed included blood pressure, heart rate, body temperature, and respiration rate. (NCT00393484)
Timeframe: Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period

InterventionParticipants (Number)
Entecavir, 0.5 mg + Placebo0
Lamivudine, 100 mg + Placebo0

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Number of Participants With Normalization of Serum Alanine Aminotransferase (ALT) Levels at Weeks 24, 48, and 96

Normalization of serum ALT= ≤*institutional upper limit of normal. (NCT00393484)
Timeframe: At Weeks 24, 48, and 96

,
InterventionParticipants (Number)
At 24 WeeksAt 48 WeeksAt 96 Weeks
Entecavir, 0.5 mg + Placebo434849
Lamivudine, 100 mg + Placebo373833

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Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 24

ULN=upper limit of normal; ALT=alanine transaminase. WHO criteria: Grade 3=Severe (inability to carry out usual activity); Grade 4=Very severe (debilitating or significantly incapacitating patient despite symptomatic treatment). (NCT00393484)
Timeframe: Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to the end of the 24-week follow-up period

,
InterventionParticipants (Number)
Gr 4 Prothrombin time (>3*ULN)Gr 3 Glucose (251-500 mg/dL)Gr 3 ALT (5.1-10*ULN)Gr 3 Lipase (2.0-5.0*ULN)
Entecavir, 0.5 mg + Placebo1100
Lamivudine, 100 mg + Placebo0211

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Percentage of Participants With a Virologic Response as Defined by Undetectable Hepatitis B Virus DNA at Weeks 48, 96, 144, 192, and 240

Undetectable HBV DNA= <300 copies/mL by polymerase chain reaction assay (NCT00393484)
Timeframe: At Weeks 48, 96, 144, 192, and 240

,
InterventionPercetage of participants (Number)
At 48 WeeksAt 96 WeeksAt 144 WeeksAt 192 WeeksAt 240 Weeks
Entecavir, 0.5 mg + Placebo94.6494.6467.8669.6467.86
Lamivudine, 100 mg + Placebo60.9448.4434.3825.0015.63

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Mean Laboratory Test Values for Alanine Aminotransferase (ALT) at Week 24

Mean ALT values from baseline by laboratory test. . (NCT00393484)
Timeframe: At Week 24

InterventionU/L (Mean)
Entecavir, 0.5 mg + Placebo31.5
Lamivudine, 100 mg + Placebo43.26

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Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 96

ULN=upper limit of normal; ALT=alanine transaminase. WHO criteria: Grade 3=Severe (inability to carry out usual activity); Grade 4=Very severe (debilitating or significantly incapacitating patient despite symptomatic treatment). (NCT00393484)
Timeframe: Start of dosing (Day 1) until Week 96

,
InterventionParticipants (Number)
PlateletsProthrombin timeNeutrophilsASTALTTotal bilirubiinCreatinineLipasePotassiumGlucose, fasting
Entecavir, 0.5 mg + Placebo1100012203
Lamivudine, 100 mg + Placebo1013630412

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Number of Participants With Virologic Rebound at Week 24

Virologic rebound was defined as a confirmed ≥1 log10 increase in hepatitis B virus (HBV) DNA from nadir on blinded treatment (as determined by 2 sequential HBV DNA measurements or last on-treatment measurement). (NCT00393484)
Timeframe: At Week 24

InterventionParticipants (Number)
Entecavir, 0.5 mg + Placebo0
Lamivudine, 100 mg3

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Percentage of Participants Who Achieved a Virologic Response at Week 24

Virologic response=Hepatitis B virus DNA <300 copies/mL by polymerase chain reaction assay. (NCT00393484)
Timeframe: At Week 24

InterventionPercentage of participants (Number)
Entecavir, 0.5 mg + Placebo92.86
Lamivudine, 100 mg + Placebo67.19

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Mean Log10 Reduction From Baseline in Hepatitis B Virus (HBV) DNA at Weeks 24, 48, 96, 144, 192, and 240

Mean log10 reduction from Baseline in HBV DNA virus by the Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction (PCR) assay at Week 24. The extent of the decrease was estimated by comparing HBV DNA levels of all participants in each group with a linear regression model with covariates of treatment and baseline HBV DNA by PCR assay. (NCT00393484)
Timeframe: At Weeks 24, 48, 96, 144, 192, and 240

,
Interventionlog10 copies/mL (Mean)
At 24 WeeksAt 48 WeeksAt 96 WeeksAt 144 WeeksAt 192 WeeksAt 240 Weeks
Entecavir, 0.5 mg + Placebo3.583.563.59-3.60-3.60-3.53
Lamivudine, 100 mg+ Placebo2.952.652.42-2.74-2.75-2.69

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Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Most Common AEs, and Grade 3/4 AEs at Week 24

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Most common AEs=AEs affecting ≥3 participants. Grade 3 (Severe)/Grade 4 (Very Severe)AEs per World Health Organization (WHO) criteria.Serious adverse events/deaths reported for enrolled patients regardless of treatment status. (NCT00393484)
Timeframe: Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period

,
InterventionParticipants (Number)
DeathsSAEsDiscontinuations Due to AEsAny AEsMost common AEs: Upper Respiratory InfectionMost common AEs: NasopharyngitisMost common AEs: UrticariaWHO Grade 3/4 AEs
Entecavir, 0.5 mg + Placebo000143100
Lamivudine, 100 mg + Placebo031237430

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Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Most Common AEs, and Grade 3/4 AEs at Week 240

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. (NCT00393484)
Timeframe: Start of dosing (Day 1) until end of treatment (Week 240) + 5 days

,
InterventionParticipants (Number)
SAEsDiscontinuations due to AEsAny nonserious AEsNonserious AEs related to study conditionsSAEs related to study conditions
Entecavir, 0.5 mg + Placebo704810
Lamivudine, 100 mg + Placebo1714960

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Number of Participants With Elevations in Alanine Transaminase (ALT) and Aspartate Aminoaminase (AST) Levels, Elevations in ALT and AST Levels,Simultaneous Elevations in ALT and Total Bilirubin Levels, and ALT Flares at Week 24

ALT flares=ALT>2*Baseline and 10*upper limit of normal. Serious adverse events/deaths reported for enrolled patients regardless of treatment status. (NCT00393484)
Timeframe: Start of dosing (Day 1) until end of treatment (24 weeks) + 5 days and to end of 24-week follow-up period

,
InterventionParticipants (Number)
ALT elevations >2*Baseline (BL)AST elevations >2*BLALT elevations >3*BL & AST elevations >2*BLSimultaneous ALT & Total bilirubin elevationALT flares
Entecavir, 0.5 mg + Placebo00000
Lamivudine, 100 mg + Placebo11100

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Number of Participants With Viral Rebound and Drug-resistant Hepatitis B Virus (HBV) DNA Mutations at Week 96

Virologic rebound was defined as a confirmed ≥1 log10 increase in HBV DNA from nadir on blinded treatment (as determined by 2 sequential HBV DNA values or last on-treatment measurement). (NCT00393484)
Timeframe: At 96 weeks

,
InterventionParticipants (Number)
Viral reboundDrug-resistant mutations
Entecavir, 0.5 mg + Placebo10
Lamivudine, 100 mg + Placebo2613

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Number of Participants With Hepatitis B Virus (HBV) DNA <10^3, <10^4, or < 10^5 Copies/mL by Polymerase Chain Reaction (PCR) Assy at Weeks 24, 48, and 96

The number and percentage of participants achieving the following endpoints will be tabulated at each visit through Week 240 by treatment group: HBV DNA <300 copies/mL by PCR assay; HBV DNA <10^3, <10^4, or < 10^5 copies/mL by PCR assay. Treatment comparisons will be assessed using the same method as the primary endpoint. (NCT00393484)
Timeframe: At Weeks 24, 48, and 96

,
InterventionParticipants (Number)
Week 24: HBV DNA <10^3Week 24: HBV DNA <10^4Week 24: HBV DNA <10^5Week 48: HBV DNA <10^3Week 48: HBV DNA <10^4Week 48: HBV DNA <10^5Week 96: HBV DNA <10^3Week 96: HBV DNA <10^4Week 96: HBV DNA <10^5
Entecavir, 0.5 mg + Placebo545454545555535353
Lamivudine, 100 mg + Placebo465359455052384245

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Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at Week 96

HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. HBV DNA < 50 IU/mL = approximately 300 copies/mL. Percentage n/N: n= number of participants with HBV DNA <50 IU/mL; N = number of participants analyzed. (NCT00410202)
Timeframe: Week 96

InterventionPercentage of participants (Number)
ETV+ADV Combination Therapy43.5
ETV Monotherapy39.3
ADV+LVD Combination Therapy28.5

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Change in Mean log10 From Baseline in HBV DNA at Week 48

HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan TaqMan HPS assay. Reduction in log10 HBV count=reduced viral load, negative values means reduction. (NCT00410202)
Timeframe: Baseline, Week 48

,,
Interventionlog10 (IU/mL (Mean)
HBV DNA at Week 48Change from baseline
ADV+LVD Combination Therapy3.36-4.11
ETV Monotherapy4.01-3.35
ETV+ADV Combination Therapy2.79-4.65

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Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < 50 IU/mL (Approximately 300 Copies/mL) by Polymerase Chain Reaction (PCR) at Week 48

HBV DNA assessments were performed using the Roche COBAS® TaqMan High Pure System (HPS) assay. HBV DNA less than (<)50 International units per milliliter (IU/mL) = approximately 300 copies/mL. Percentage of participants calculated n/N; n= number of participants with HBV DNA <50 IU/mL; N = number of participants analyzed. (NCT00410202)
Timeframe: Week 48

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy25.4
ETV Monotherapy16.4
ADV+LVD Combination Therapy19.7

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Percentage of Participants With HBsAg Seroconversion at Week 48

HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb. (NCT00410202)
Timeframe: Week 48

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy0.7
ETV Monotherapy0
ADV+LVD Combination Therapy0

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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 96

HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week. (NCT00410202)
Timeframe: Week 96

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy0
ETV Monotherapy0
ADV+LVD Combination Therapy0

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Percentage of Participants With HBsAg Seroconversion at Week 96

HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb. (NCT00410202)
Timeframe: Week 96

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy0
ETV Monotherapy0
ADV+LVD Combination Therapy0

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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48

HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week. (NCT00410202)
Timeframe: Week 48

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy0.7
ETV Monotherapy0
ADV+LVD Combination Therapy0.7

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Percentage of Participants With HBeAg Seroconversion at Week 96 (Treated HBeAg-positive Participants Only)

HBeAg is a hepatitis B viral protein. It is an indicator of active viral replication. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb). (NCT00410202)
Timeframe: Week 96

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy7.2
ETV Monotherapy3.6
ADV+LVD Combination Therapy5.1

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Percentage of Participants With HBeAg Seroconversion at Week 48 (Treated HBeAg-positive Participants Only)

HBeAg is a hepatitis B viral protein. It is an indicator of active viral replication. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb). (NCT00410202)
Timeframe: Week 48

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy5.1
ETV Monotherapy2.9
ADV+LVD Combination Therapy3.7

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Percentage of Participants With Confirmed HBeAg Loss at Week 96 (Treated HBeAg Positive Participants Only)

HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week (NCT00410202)
Timeframe: Week 96

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy12.3
ETV Monotherapy10.7
ADV+LVD Combination Therapy13.9

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Percentage of Participants With Confirmed HBeAg Loss at Week 48 (Treated HBeAg Positive Participants Only)

HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week (NCT00410202)
Timeframe: Week 48

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy7.2
ETV Monotherapy6.5
ADV+LVD Combination Therapy5.9

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Percentage of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieve ALT Normalization at Week 96

ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 U/L. (NCT00410202)
Timeframe: Baseline, Week 96

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy76.9
ETV Monotherapy74.4
ADV+LVD Combination Therapy79.7

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Percentage of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieve ALT Normalization at Week 48

ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 or 48 U/L. (NCT00410202)
Timeframe: Week 48

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy75.6
ETV Monotherapy78.0
ADV+LVD Combination Therapy76.8

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Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 96

HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Percentage n/N: n= number of participants with outcome result; N = number of participants analyzed. (NCT00410202)
Timeframe: Week 96

InterventionPercentage of participants (Number)
ETV+ADV Combination Therapy38.4
ETV Monotherapy36.4
ADV+LVD Combination Therapy25.5

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Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 96

HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOD is the lowest amount or concentration of analyte in a sample, which can be reliably detected, but not necessarily quantified. (NCT00410202)
Timeframe: Week 96

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy33.3
ETV Monotherapy27.1
ADV+LVD Combination Therapy20.4

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Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 48

HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOD is the lowest concentration level that can be determined to be statistically different from a blank (99% confidence). The LOD is typically determined to be in the region where the signal to noise ratio is greater than 5. Limits of detection are matrix-, method-, and analyte-specific. (NCT00410202)
Timeframe: Week 48

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy20.3
ETV Monotherapy11.4
ADV+LVD Combination Therapy11.7

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Change in Mean log10 From Baseline in HBV DNA at Week 96

HBV DNA was analyzed by PCR, using the Roche COBAS® TaqMan HPS assay. Reduction in log10 HBV count=reduced viral load. (NCT00410202)
Timeframe: Baseline, Week 96

Interventionparticipants (Mean)
ETV+ADV Combination Therapy-5.06
ETV Monotherapy-4.17
ADV+LVD Combination Therapy-4.49

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Percentage of Participants With HBV DNA by PCR Category at Week 96

HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. (NCT00410202)
Timeframe: Week 96

,,
Interventionpercentage of participants (Number)
< LOQ (29 IU/mL)LOQ to < 5050 to < 172172 to < 1,7201,720 to < 17,20017,200 to < 172,000>= 172,000Missing
ADV+LVD Combination Therapy25.52.95.818.224.813.92.95.8
ETV Monotherapy36.42.93.66.410.015.716.48.6
ETV+ADV Combination Therapy38.45.110.115.220.35.805.1

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Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48

HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Percentage n/N: n= number of participants with outcome result; N = number of participants analyzed. (NCT00410202)
Timeframe: Week 48

Interventionpercentage of participants (Number)
ETV+ADV Combination Therapy25.4
ETV Monotherapy13.6
ADV+LVD Combination Therapy16.8

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Percentage of Participants With HBV DNA by PCR Category at Week 48

HBV DNA assessments were performed using the Roche COBAS® TaqMan High Pure System (HPS) assay. (NCT00410202)
Timeframe: Week 48

,,
Interventionpercentage of participants (Number)
< LOQ (29 IU/mL)LOQ to < 5050 to < 172172 to < 1,7201,720 to < 17,20017,200 to < 172,000>= 172,000Missing
ADV+LVD Combination Therapy16.82.95.812.431.424.84.41.5
ETV Monotherapy13.62.92.97.922.125.723.61.4
ETV+ADV Combination Therapy25.408.026.128.38.00.73.6

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Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to Adverse Events or Laboratory Abnormalities During Treatment

AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. Grade 1 = mild, Grade 2= moderate, Grade 3 = severe, Grade 4 = life threatening/disabling, Grade 5 = death. (NCT00410202)
Timeframe: From start of study therapy through Week 100 + 5 days

,,
Interventionparticipants (Number)
DeathsSAEsDiscontinuations due to AEsAEsGrade 2-4 Related AEsGrade 3-4 Related AEs
ADV+LVD Combination Therapy11229219
ETV Monotherapy0172109127
ETV+ADV Combination Therapy011110125

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Number of Participants With Laboratory Abnormalities: Serum Chemistry

ULN=upper limit of normal (Normal ranges are Central lab data and vary according to the site). ALT:>1.25*ULN, AST:>1.25*ULN, ALP:>1.25*ULN, Total Bilirubin:>1.1*ULN, Serum Lipase:>1.10*ULN, Creatinine:>1.1*ULN, Blood Urea Nitrogen:1.25*ULN, Hyperglycemia:>116 mg/dL, Hypoglycemia:<64 mg/dL, Hyponatremia:<132meq/L, Hypokalemia:<3.4 meq/L, Albumin:≥1g/dL decrease from baseline, <3 g/dL; Hypernatremia:>148 meq/L, Hyperkalemia:>5.6 meq/L, Hypokalemia:<3.4 meq/L, Hyperchloremia:>113 meq/L, Hypochloremia:<93 meq/L; ALT flare: on treatment (OT), >2*Baseline and >10*ULN; off treatment (OF), 2*end of dosing value and >10*ULN (NCT00410202)
Timeframe: On treatment : Day 1 through Week 100 + 5 days; Offtreatment = End of OT period through 24 weeks

,,
Interventionparticipants (Number)
Alanine aminotransferase (ALT)Aspartate aminotransferase (AST)Alkaline Phosphatase (ALP)AlbuminSerum LipaseCreatinineBlood Urea NitrogenHyperglycemiaHypoglycemiaHypernatremiaHyponatremiaHyperkalemiaHypokalemiaHyperchloremiaHypochloremiaALT flare - OntreatmentALT flare - Offtreatment
ADV+LVD Combination Therapy7453612442379100521020
ETV Monotherapy8362413321465100421020
ETV+ADV Combination Therapy7660812420399100341130

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Number of Participants With Laboratory Abnormalities: Hematology

Criteria for hematology abnormalities were: Hemoglobin: <=11.0 g/dL; White Blood Cells: <4000/mm^3; Absolute Neutrophils (includes absolute bands): <1500/mm^3; Platelets: <=99,000/mm^3; International Normalized Ratio: ≥ 1.5 and ≥ 0.5 from baseline. (NCT00410202)
Timeframe: From start of study through Week 100 + 5 days

,,
Interventionparticipants (Number)
HemoglobinWhite Blood CellsNeutrophilsPlateletsInternational Normalized Ratio
ADV+LVD Combination Therapy113815129
ETV Monotherapy94817147
ETV+ADV Combination Therapy85314138

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Cumulative Probability of Emergent Genotypic Resistance at Year 2

"Cumulative probability (CP): Ptotal=1-(1-Pyr1)*(1-Pyr2) where Pyear(i)= number of participants with events at Year i divided by number of participants at risk at Year i for i = 1,2. An event is defined as resistance or resistance with virologic breakthrough in a yearly interval. Participants 'at risk' are those who were treated during Year i and did not develop that resistance or resistance with virologic breakthrough prior to Year i. CP were calculated separately for ETV, ADV and TDF resistance. Participants who discontinue from study drug in Year i were assumed to be in follow up for the entire year. (VBT; a ≥ 1 log10 increase in HBV DNA from the on-treatment nadir, confirmed by 2 sequential HBV DNA results or observed at the last on-treatment HBV DNA). ETVr = ETV resistance (rtM204V/I/S plus any substitution at rtT184, rtS202, or rtM250); ADVr/TDFr = ADV/TDF resistance (rtA181T/V or rtN236T = ADVr and TDFr, rtA194T = TDFr only)." (NCT00410202)
Timeframe: Year 2

,,
Interventionpercentage of participants (Number)
ETVr : n=130, 128, 131ADVr/TDFr : n=132, 134, 131ETVr or ADVr/TDFr : n=128, 125, 127ETVr and ADVr/TDFr : n=134, 137, 135ETVr with VBT: n=130, 128, 131ADVr/TDFr with VBT: n=132, 134, 131ETVr or ADVr/TDFr with VBT: n=128, 125, 127ETVr and ADVr/TDFr with VBT: n=134, 137, 135
ADV+LVD Combination Therapy1.52.23.800000
ETV Monotherapy9.81.510.70.76.20.76.30.7
ETV+ADV Combination Therapy0.80.71.500000

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Cumulative Probability of Emergent Genotypic Resistance at Year 1

"yr=year. Cumulative probability (CP): Ptotal=1-(1-Pyr1)*(1-Pyr2) where Pyear(i)= number of participants with events at Year i divided by number of participants at risk at Year i for i = 1,2. An event is defined as resistance or resistance with virologic breakthrough in a yearly interval. Participants 'at risk' are those who were treated during Year i and did not develop that resistance or resistance with virologic breakthrough prior to Year i. CP were calculated separately for ETV, ADV and TDF resistance. Participants who discontinue from study drug in Year i were assumed to be in follow up for the entire year. (VBT; a ≥ 1 log10 increase in HBV DNA from the on-treatment nadir, confirmed by 2 sequential HBV DNA results or observed at the last on-treatment HBV DNA). ETVr = ETV resistance (rtM204V/I/S plus any substitution at rtT184, rtS202, or rtM250); ADVr/TDFr = ADV/TDF resistance (rtA181T/V or rtN236T = ADVr and TDFr, rtA194T = TDFr only)." (NCT00410202)
Timeframe: Year 1

,,
Interventionpercentage of participants (Number)
ETVr : n=134, 134, 134ADVr /TDFr : n=137, 137, 135ETVr or TDFr/ADVr : n=133, 132, 132ETVr and TDFr/ADVr : n=138, 139, 137ETVr with VBT: n=134, 134, 134ADVr /TDFr with VBT: n=137, 137, 135ETVr or ADVr/TDFr with VBT: n=133, 132, 132ETVr and ADVr/TDFr with VBT: n=138, 139, 137
ADV+LVD Combination Therapy0.71.52.300000
ETV Monotherapy30.73.800.700.80
ETV+ADV Combination Therapy00.70.800000

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Incidence of Severe Adverse Events (Excluding Mortality)

(NCT00427297)
Timeframe: 2 years

Interventionevent (Number)
NVP-containing21
NVP-sparing6

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Incidence of Mortality

Death during follow-up (NCT00427297)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
NVP-containing4
NVP-sparing5

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Immunologic Failure

Immunologic treatment failure was defined as CD4% dropping below 15%, after a previous result greater than or equal to 15% (following along WHO Guidelines). (NCT00427297)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
NVP-containing2
NVP-sparing1

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Viral Failure

Virologic treatment failure was defined as follow-up (at least 24 weeks after enrollment date) viral load > 400 copies. (NCT00427297)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
NVP-containing2
NVP-sparing2

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Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c) /Milliliter (ml) at the Week 84 Visit

The percentage of PAR with HIV-1 RNA virus <50 c/ml determined from a blood sample drawn at Week 84 was tabulated by treatment arm with stratification by baseline HIV-1 RNA (<100,000 c/ml and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed viral load <50 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <50 c/ml, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 50 c/ml, or had an unconfirmed HIV RNA of at least 50 c/ml at last visit. (NCT00440947)
Timeframe: Week 84

Interventionpercentage of participants (Number)
ABC/3TC + ATV: Randomized Phase86
ABC/3TC + ATV/r: Randomized Phase81

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Change From Baseline in CD4+ Cell Count at Week 144

A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 144 value minus the baseline value. Blood was drawn to analyze for CD4+ cell count. (NCT00440947)
Timeframe: Baseline and Week 144

Interventioncells/millimeters cubed (mm^3) (Mean)
ABC/3TC + ATV: Extension Phase317.7
ABC/3TC + ATV/r: Extension Phase325.1

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Change From Baseline in CD4+ Cell Count at Week 36

Blood was drawn to analyze for CD4+ cell count. A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 36 value minus the baseline value. (NCT00440947)
Timeframe: Baseline and Week 36

Interventioncells/millimeters cubed (mm^3) (Mean)
ABC/3TC + ATV/r: Induction Phase185.4

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Change From Baseline in CD4+ Cell Count at Week 84

A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 84 value minus the baseline value. Blood was drawn to analyze for CD4+ cell count. (NCT00440947)
Timeframe: Baseline and Week 84

Interventioncells/millimeters cubed (mm^3) (Mean)
ABC/3TC + ATV: Randomized Phase265.7
ABC/3TC + ATV/r: Randomized Phase282.9

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Change From Baseline in HIV-1 RNA at Week 144

Change from baseline was calculated as the Week 144 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load. (NCT00440947)
Timeframe: Baseline and Week 144

Interventionlog10 c/ml (Mean)
ABC/3TC + ATV: Extension Phase-3.291
ABC/3TC + ATV/r: Extension Phase-3.239

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Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir

A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant. (NCT00440947)
Timeframe: Baseline through Week 36

Interventionparticipants (Number)
PAR with reduced abacavir susceptibilityPAR with reduced lamivudine susceptibilityPAR with reduced atazanavir susceptibilityPAR with reduced ritonavir susceptibility
ABC/3TC + ATV/r: Induction Phase0100

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Mean Percent Compliance at Week 84

Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen. (NCT00440947)
Timeframe: Week 84

,
Interventionpercent compliance (Mean)
Abacavir/LamivudineRitonavirAtazanavir
ABC/3TC + ATV: Randomized Phase92.092.998.9
ABC/3TC + ATV/r: Randomized Phase91.291.592.4

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Mean Percent Compliance at Week 36

Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen. (NCT00440947)
Timeframe: Week 36

Interventionpercent compliance (Mean)
Abacavir/LamivudineRitonavirAtazanavir
ABC/3TC + ATV/r: Induction Phase92.292.392.7

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Mean Percent Compliance at Week 144

Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen. (NCT00440947)
Timeframe: Week 144

,
Interventionpercent compliance (Mean)
Abacavir/LamivudineRitonavirAtazanavir
ABC/3TC + ATV: Extension Phase92.093.399.1
ABC/3TC + ATV/r: Extension Phase90.190.191.4

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Mean Age at Baseline of Participants Randomized to Treatment for the 48-Week Randomized Phase

The mean age of participants randomized to treatment in the Randomized Phase was calculated at Baseline. (NCT00440947)
Timeframe: Baseline of Randomized Phase

Interventionyears (Mean)
ABC/3TC + ATV: Randomized Phase37.5
ABC/3TC + ATV/r: Randomized Phase39.7

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Change From Baseline in HIV-1 RNA at Week 84

Change from baseline was calculated as the Week 84 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load. (NCT00440947)
Timeframe: Baseline and Week 84

Interventionlog10 c/ml (Mean)
ABC/3TC + ATV: Randomized Phase-3.261
ABC/3TC + ATV/r: Randomized Phase-3.270

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Change From Baseline in HIV-1 RNA at Week 36

Change from baseline was calculated as the Week 36 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load. (NCT00440947)
Timeframe: Baseline and Week 36

Interventionlog10 c/ml (Mean)
ABC/3TC + ATV/r: Induction Phase-3.241

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Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 84 Visit

A blood sample was drawn to determine the amount of HIV-1 RNA virus in c/ml at Week 84. The percentage of participants with HIV-1 RNA <50 c/ml at Week 84 was tabulated. The secondary analysis methods were: Observed (Obs; uses all visits with data in the analysis period), and missing/discontinuation=failure (M/D=F) analyses. M/D=F: participants with missing data or data collected after study medication DC were considered failures. (NCT00440947)
Timeframe: Week 84

,
Interventionpercentage of participants (Number)
ObsM/D=F
ABC/3TC + ATV: Randomized Phase9285
ABC/3TC + ATV/r: Randomized Phase9282

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Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit

The percentage of PAR with HIV-1 RNA virus <50 c/ml from a Week 36 blood sample was tabulated. Per TLOVR algorithm, responders were PAR with confirmed viral load <50 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <50 c/ml, prematurely discontinued (DC) study or study medication (any reason), had confirmed rebound to >=50 c/ml, or had an unconfirmed HIV RNA >=50 c/ml at last visit. ITT-E observed analysis (Obs): all observed data. ITT-E M/D=F analysis: PAR with missing data/data collected after study medication DC were failures. (NCT00440947)
Timeframe: Week 36

Interventionpercentage of participants (Number)
TLOVRObsM/D=F
ABC/3TC + ATV/r: Induction Phase808877

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Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit

Percentage of PAR with HIV-1 RNA <50 c/ml at Week 144 was tabulated; stratified by baseline HIV-1 RNA (<100,000 and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV RNA <50 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA <50 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to >=50 c/ml, or had an unconfirmed HIV RNA >=50 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures. (NCT00440947)
Timeframe: Week 144

,
Interventionpercentage of participants (Number)
TLOVRObsM/D=F
ABC/3TC + ATV: Extension Phase779580
ABC/3TC + ATV/r: Extension Phase739278

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Percentage of Participants Who Achieved Plasma HIV-1 RNA <400 c/ml at the Week 36 Visit

The percentage of PAR with HIV-1 RNA virus <400 c/ml from a Week 36 blood sample was tabulated. Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV RNA <400 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved CF HIV RNA <400 c/ml, prematurely discontinued (DC) study or study medication (Med; any reason), had CF rebound to >=400 c/ml, or had an unconfirmed HIV RNA >=400 c/ml at last visit. ITT-E observed analysis (Obs): all observed data. ITT-E M/D=F analysis: PAR with missing data/data collected after study Med DC were failures. (NCT00440947)
Timeframe: Week 36

Interventionpercentage of participants (Number)
TLOVRObsM/D=F
ABC/3TC + ATV/r: Induction Phase829884

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Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit

Percentage of PAR with HIV-1 RNA <400 c/ml at Week 84 was tabulated; stratified by baseline HIV-1 RNA (<100,000 and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV-RNA <400 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA <400 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to >=400 c/ml, or had an unconfirmed HIV RNA >=400 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures. (NCT00440947)
Timeframe: Week 84

,
Interventionpercentage of participants (Number)
TLOVRObsM/D=F
ABC/3TC + ATV: Randomized Phase929992
ABC/3TC + ATV/r: Randomized Phase869887

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Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit

Percentage of PAR with HIV-1 RNA <400 c/ml at Week 144 was tabulated; stratified by baseline HIV-1 RNA (<100,000 and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV-RNA <400 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA <400 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to >=400 c/ml, or had an unconfirmed HIV RNA >=400 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures. (NCT00440947)
Timeframe: Week 144

,
Interventionpercentage of participants (Number)
TLOVRObsM/D=F
ABC/3TC + ATV: Extension Phase849984
ABC/3TC + ATV/r: Extension Phase809782

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Number of Participants Who Met the Protocol-defined Virologic Failure (PDVF) Criteria at Week 36

The number of participants that failed to respond to therapy through 36 weeks on treatment, based on the protocol definition of virologic failure (PDVF), was tabulated. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA <400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound >=400 c/ml after achieving HIV-1 <400 c/ml. (NCT00440947)
Timeframe: Week 36

Interventionparticipants (Number)
Protocol-defined virologic failureFailure to achieve <400 c/ml by Week 30Confirmed rebound after achieving <400 c/ml
ABC/3TC + ATV/r: Induction Phase15510

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Number of Participants Who Met the PDVF Criteria at Week 84

The number of participants that failed to respond to therapy from the time of treatment randomization through Week 84, based on the protocol definition of virologic failure (PDVF), was tabulated. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA <400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound >=400 c/ml after achieving HIV-1 <400 c/ml. (NCT00440947)
Timeframe: Week 84

,
Interventionparticipants (Number)
Protocol-defined virologic failureConfirmed rebound after achieving <400 c/ml
ABC/3TC + ATV: Randomized Phase11
ABC/3TC + ATV/r: Randomized Phase77

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Number of Participants Who Met the PDVF Criteria at Week 144

The number of participants enrolled in the extension phase that failed to respond to therapy from Week 84 through Week 144, based on the protocol definition of virologic failure (PDVF) was tabulated,. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA <400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound >=400 c/ml after achieving HIV-1 <400 c/ml. (NCT00440947)
Timeframe: Week 144

,
Interventionparticipants (Number)
Protocol-defined virologic failureConfirmed rebound after achieving <400 c/ml
ABC/3TC + ATV: Extension Phase55
ABC/3TC + ATV/r: Extension Phase66

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Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144

A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDs Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. (NCT00440947)
Timeframe: Week 84 through Week 144

,
Interventionparticipants (Number)
PAR with paired genotypes at baseline and VFPAR with treatment-emergent mutationsPAR with NRTI mutationsPAR with NNRTI mutationsPAR with major PI mutationsPAR with minor PI mutations
ABC/3TC + ATV: Extension Phase520002
ABC/3TC + ATV/r: Extension Phase511011

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Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84

A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDs Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. (NCT00440947)
Timeframe: Randomization at Week 36 through Week 84

,
Interventionparticipants (Number)
PAR with paired genotypes at baseline and VFPAR with treatment-emergent mutationsPAR with NRTI mutationsPAR with NNRTI mutationsPAR with major PI mutationsPAR with minor PI mutations
ABC/3TC + ATV: Randomized Phase111000
ABC/3TC + ATV/r: Randomized Phase720002

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Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36

A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New resistance-associated mutations (defined by the International AIDS Society-USA guidelines) that developed at the time of failure were tabulated by drug class. PAR, participants; VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. (NCT00440947)
Timeframe: Baseline through Week 36

Interventionparticipants (Number)
PAR with paired genotypes at baseline and VFPAR with treatment-emergent mutationsPAR with NRTI mutationsPAR with NNRTI mutationsPAR with major PI mutationsPAR with minor PI mutations
ABC/3TC + ATV/r: Induction Phase1564102

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Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir

A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant. (NCT00440947)
Timeframe: Week 84 through Week 144

,
Interventionparticipants (Number)
PAR with reduced abacavir susceptibilityPAR with reduced lamivudine susceptibilityPAR with reduced atazanavir susceptibilityPAR with reduced ritonavir susceptibility
ABC/3TC + ATV: Extension Phase0100
ABC/3TC + ATV/r: Extension Phase1111

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Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir

A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant. (NCT00440947)
Timeframe: Randomization at Week 36 through Week 84

,
Interventionparticipants (Number)
PAR with reduced abacavir susceptibilityPAR with reduced lamivudine susceptibilityPAR with reduced atazanavir susceptibilityPAR with reduced ritonavir susceptibility
ABC/3TC + ATV: Randomized Phase0100
ABC/3TC + ATV/r: Randomized Phase0000

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Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96

mL, milliliter; min, minute; m^2, meters squared (NCT00549198)
Timeframe: Baseline, Week 96

,
Interventionparticipants (Number)
>=10 mL/min, MDRD>=10 mL/min, Cockcroft-Gault>=20 mL/min, MDRD>=20 mL/min, Cockcroft-Gault>=10%, MDRD>=10%, Cockcroft-Gault>=20%, MDRD>=20%, Cockcroft-Gault
ABC/3TC FDC151144151233
TDF/FTC FDC381975271664

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Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24

HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection. (NCT00549198)
Timeframe: Week 24

,
Interventionparticipants (Number)
<50 copies/mL<400 copies/mL
ABC/3TC FDC126147
TDF/FTC FDC144168

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Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48

HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection. (NCT00549198)
Timeframe: Week 48

,
Interventionparticipants (Number)
<50 copies/mL<400 copies/mL
ABC/3TC FDC121130
TDF/FTC FDC145151

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Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96

HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection. (NCT00549198)
Timeframe: Week 96

,
Interventionparticipants (Number)
<50 copies/mL<400 copies/mL
ABC/3TC FDC98110
TDF/FTC FDC113126

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Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24

Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram. (NCT00549198)
Timeframe: Baseline, Week 24

,
Interventionparticipants (Number)
NormalStage 1Stage 2Stage 3Stage 4Stage 5
ABC/3TC FDC97115100
TDF/FTC FDC114155100

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Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48

Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram. (NCT00549198)
Timeframe: Baseline, Week 48

,
Interventionparticipants (Number)
MissingNormalStage 1Stage 2Stage 3Stage 4Stage 5
ABC/3TC FDC129073000
TDF/FTC FDC1910653000

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Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96

Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram. (NCT00549198)
Timeframe: Baseline, Week 96

,
Interventionparticipants (Number)
MissingNormalStage 1Stage 2Stage 3Stage 4Stage 5
ABC/3TC FDC117534000
TDF/FTC FDC188344000

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high. (NCT00549198)
Timeframe: Baseline, Week 24

,
Interventionparticipants (Number)
Low to lowLow to normalLow to highNormal to lowNormal to normalNormal to highHigh to lowHigh to normalHigh to high
ABC/3TC FDC197210012260010
TDF/FTC FDC3666913012035

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high. (NCT00549198)
Timeframe: Baseline, Week 48

,
Interventionparticipants (Number)
Low to lowLow to normalLow to highNormal to lowNormal to normalNormal to highHigh to lowHigh to normalHigh to high
ABC/3TC FDC176718011270010
TDF/FTC FDC28731002320035

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high. (NCT00549198)
Timeframe: Baseline, Week 96

,
Interventionparticipants (Number)
Low to lowLow to normalLow to highNormal to lowNormal to normalNormal to highHigh to lowHigh to normalHigh to high
ABC/3TC FDC11662508300010
TDF/FTC FDC23751301727017

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter. (NCT00549198)
Timeframe: Baseline, Week 24

,
Interventionparticipants (Number)
Desirable to desirableDesirable to borderline highDesirable to highBorderline high to desirableBorderline high to borderline highBorderline high to highHigh to desirableHigh to borderline highHigh to high
ABC/3TC FDC5447321210003
TDF/FTC FDC104299396002

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter. (NCT00549198)
Timeframe: Baseline, Week 48

,
Interventionparticipants (Number)
Desirable to desirableDesirable to borderline highDesirable to highBorderline high to desirableBorderline high to borderline highBorderline high to highHigh to desirableHigh to borderline highHigh to high
ABC/3TC FDC4652361210003
TDF/FTC FDC96379198002

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter. (NCT00549198)
Timeframe: Baseline, Week 96

,
Interventionparticipants (Number)
Desirable to desirableDesirable to borderline highDesirable to highBorderline high to desirableBorderline high to borderline highBorderline high to highHigh to desirableHigh to borderline highHigh to high
ABC/3TC FDC3949461210003
TDF/FTC FDC864710198002

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150-<200 mg/dL, borderline high; 200-<500 mg/dL, high; >=500 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 24

,
Interventionparticipants (Number)
Normal to normalNormal to borderline highNormal to highNormal to very highBorderline high to normalBorderline high to borderline highBorderline high to highBorderline high to very highHigh to normalHigh to borderline highHigh to highHigh to very highVery high to normalVery high to borderline highVery high to highVery high to very high
ABC/3TC FDC63212305590251230001
TDF/FTC FDC781990710150631500010

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150-<200 mg/dL, borderline high; 200-<500 mg/dL, high; >=500 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 48

,
Interventionparticipants (Number)
Normal to normalNormal to borderline highNormal to highNormal to very highBorderline high to normalBorderline high to borderline highBorderline high to highBorderline high to very highHigh to normalHigh to borderline highHigh to highHigh to very highVery high to normalVery high to borderline highVery high to highVery high to very high
ABC/3TC FDC552230045110241240001
TDF/FTC FDC702312167190531500010

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150->200 mg/dL, borderline high; 200-<500 mg/dL, high;>= 500 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 96

,
Interventionparticipants (Number)
Normal to normalNormal to borderline highNormal to highNormal to very highBorderline high to normalBorderline high to borderline highBorderline high to highBorderline high to very highHigh to normalHigh to borderline highHigh to highHigh to very highVery high to normalVery high to borderline highVery high to highVery high to very high
ABC/3TC FDC472534144111241150001
TDF/FTC FDC553120158190521600010

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 24

,
Interventionparticipants (Number)
Optimal to optimalOptimal to near or above optimalOptimal to borderline highOptimal to highOptimal to very highNear or above optimal to optimalNear or above optimal to near or above optimalNear or above optimal to borderline highNear or above optimal to highNear or above optimal to very highBorderline high to optimalBorderline high to near or above optimalBorderline high to borderline highBorderline high to highBorderline high to very highHigh to optimalHigh to near or above optimalHigh to borderline highHigh to highHigh to very highVery high to optimalVery high to near or above optimalVery high to borderline highVery high to highVery high to very high
ABC/3TC FDC224122610617124012430001000101
TDF/FTC FDC464311105221151063320001000001

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 48

,
Interventionparticipants (Number)
Optimal to optimalOptimal to near or above optimalOptimal to borderline highOptimal to highOptimal to very highNear or above optimal to optimalNear or above optimal to near or above optimalNear or above optimal to borderline highNear or above optimal to highNear or above optimal to very highBorderline high to optimalBorderline high to near or above optimalBorderline high to borderline highBorderline high to highBorderline high to very highHigh to optimalHigh to near or above optimalHigh to borderline highHigh to highHigh to very highVery high to optimalVery high to near or above optimalVery high to borderline highVery high to highVery high to very high
ABC/3TC FDC203827810419124012340001000101
TDF/FTC FDC424612103211361035420001000001

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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96

Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 96

,
Interventionparticipants (Number)
Optimal to optimalOptimal to near or above optimalOptimal to borderline highOptimal to highOptimal to very highNear or above optimal to optimalNear or above optimal to near or above optimalNear or above optimal to borderline highNear or above optimal to highNear or above optimal to very highBorderline high to optimalBorderline high to near or above optimalBorderline high to borderline highBorderline high to highBorderline high to very highHigh to optimalHigh to near or above optimalHigh to borderline highHigh to highHigh to very highVery high to optimalVery high to near or above optimalVery high to borderline highVery high to highVery high to very high
ABC/3TC FDC183529930417126012340001000101
TDF/FTC FDC374617101191672035330001000001

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Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24

The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment. (NCT00549198)
Timeframe: Week 24

,
Interventionparticipants (Number)
Cholesterol, Grade 3Cholesterol, Grade 4LDL cholesterol, Grade 3LDL cholesterol, Grade 4Non-HDL cholesterol, Grade 3Non-HDL cholesterol, Grade 4Triglycerides, Grade 3Triglycerides, Grade 4Alanine aminotransferase, Grade 3Alanine aminotransferase, Grade 4Aspartate aminotransferase, Grade 3Aspartate aminotransferase, Grade 4Alkaline phosphatase, Grade 3Alkaline phosphatase, Grade 4Creatinine kinase, Grade 3Creatinine kinase, Grade 4Phosphorus inorganic, Grade 3Phosphorus inorganic, Grade 4Lipase, Grade 3Lipase, Grade 4Hyperkalaemia, Grade 3Hyperkalaemia, Grade 4Glomerular filtration rate, MDRD, Grade 3Glomerular filtration rate, MDRD, Grade 4Total neutrophils, Grade 3Total neutrophils, Grade 4Thrombocytopenia, Grade 3Thrombocytopenia, Grade 4
ABC/3TC FDC60801902011110001103201101110
TDF/FTC FDC1030500031021011101001100200

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Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48

The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment. (NCT00549198)
Timeframe: Week 48

,
Interventionparticipants (Number)
Cholesterol, Grade 3Cholesterol, Grade 4LDL cholesterol, Grade 3LDL cholesterol, Grade 4Non-HDL cholesterol, Grade 3Non-HDL cholesterol, Grade 4Triglycerides, Grade 3Triglycerides, Grade 4Alanine aminotransferase, Grade 3Alanine aminotransferase, Grade 4Aspartate aminotransferase, Grade 3Aspartate aminotransferase, Grade 4Alkaline phosphatase, Grade 3Alkaline phosphatase, Grade 4Total bilirubin Grade 3Total bilirubin, Grade 4Creatinine kinase, Grade 3Creatinine kinase, Grade 4Phosphorus inorganic, Grade 3Phosphorus inorganic, Grade 4Lipase, Grade 3Lipase, Grade 4Hyperkalaemia, Grade 3Hyperkalaemia, Grade 4Glomerular filtration rate, MDRD, Grade 3Glomerular filtration rate, MDRD, Grade 4Total neutrophils, Grade 3Total neutrophils, Grade 4Thrombocytopenia, Grade 4
ABC/3TC FDC7090200302222001001305202102310
TDF/FTC FDC103060004102100021101002100200

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Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96

The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug therapy. (NCT00549198)
Timeframe: Week 96

,
Interventionparticipants (Number)
Cholesterol, Grade 3Cholesterol, Grade 4LDL cholesterol, Grade 3LDL cholesterol, Grade 4Non-HDL cholesterol, Grade 3Non-HDL cholesterol, Grade 4Triglycerides, Grade 3Triglycerides, Grade 4Alanine aminotransferase, Grade 3Alanine aminotransferase, Grade 4Aspartate aminotransferase, Grade 3Aspartate aminotransferase, Grade 4Alkaline phosphatase, Grade 3Alkaline phosphatase, Grade 4Total bilirubin, Grade 3Total bilirubin, Grade 4Creatinine kinase, Grade 3Creatinine kinase, Grade 4Phosphorus inorganic, Grade 3Phosphorus inorganic, Grade 4Lipase, Grade 3Lipase, Grade 4Hyperkalaemia, Grade 3Hyperkalaemia, Grade 4Glomerular filtration rate, MDRD, Grade 3Glomerular filtration rate, MDRD, Grade 4Total neutrophils, Grade 3Total neutrophils, Grade 4Thrombocytopenia, Grade 3Thrombocytopenia, Grade 4
ABC/3TC FDC90130220212222001001406402103510
TDF/FTC FDC105050004112100022302200101300

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Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24

CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study. (NCT00549198)
Timeframe: Baseline, Week 24

Interventioncells/millimeters cubed (mm^3) (Median)
ABC/3TC FDC110.0
TDF/FTC FDC100.0

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Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48

CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study. (NCT00549198)
Timeframe: Baseline, Week 48

Interventioncells/mm^3 (Median)
ABC/3TC FDC150.0
TDF/FTC FDC150.0

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Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96

CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study. (NCT00549198)
Timeframe: Baseline, Week 96

Interventioncells/mm^3 (Median)
ABC/3TC FDC235.0
TDF/FTC FDC220.0

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Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96

Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline albumin value by the urine creatinine value. Albumin is measured in milligrams per millimole (mg/mmol). (NCT00549198)
Timeframe: Baseline, Week 96

Interventionratio (Geometric Mean)
ABC/3TC FDC0.872
TDF/FTC FDC0.973

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Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96

Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline B2M value by the urine creatinine value. B2M, beta 2 microglobulin (measured in mg/mmol). (NCT00549198)
Timeframe: Baseline, Week 96

Interventionratio (Geometric Mean)
ABC/3TC FDC0.542
TDF/FTC FDC0.984

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Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96

Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover. (NCT00549198)
Timeframe: Baseline, Week 96

Interventionug/L (Geometric Mean)
ABC/3TC FDC1.111
TDF/FTC FDC2.542

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Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96

Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline NAG value by the urine creatinine value. NAG, N-acetyl-B-glucosaminidase (measured in micromoles per hour per millimole [umol/h/mmol]). (NCT00549198)
Timeframe: Baseline, Week 96

Interventionratio (Geometric Mean)
ABC/3TC FDC0.868
TDF/FTC FDC0.939

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Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96

Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover. (NCT00549198)
Timeframe: Baseline, Week 96

Interventionug/L (Geometric Mean)
ABC/3TC FDC3.01
TDF/FTC FDC5.79

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Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96

P1NP is a bone biomarker that was analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover. (NCT00549198)
Timeframe: Baseline, Week 96

Interventionmicrograms per Liter (ug/L) (Geometric Mean)
ABC/3TC FDC1.2
TDF/FTC FDC1.4

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Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96

Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline RBP value by the urine creatinine value. RBP, retinol binding protein (measured in micrograms per millimole [ug/mmol]). (NCT00549198)
Timeframe: Baseline, Week 96

Interventionratio (Geometric Mean)
ABC/3TC FDC1.099
TDF/FTC FDC1.550

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Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96

Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover. (NCT00549198)
Timeframe: Baseline, Week 96

Interventionnanograms per Liter (ng/L) (Geometric Mean)
ABC/3TC FDC89.9
TDF/FTC FDC203.6

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Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24

Change from baseline was calculated as the Week 24 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram; CG, Cockcroft-Gault. (NCT00549198)
Timeframe: Baseline, Week 24

InterventionmL/min (Mean)
ABC/3TC FDC4.27
TDF/FTC FDC2.54

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Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48

Change from baseline was calculated as the Week 48 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram. (NCT00549198)
Timeframe: Baseline, Week 48

InterventionmL/min (Mean)
ABC/3TC FDC2.66
TDF/FTC FDC3.80

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Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96

Change from baseline was calculated as the Week 96 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram. (NCT00549198)
Timeframe: Baseline, Week 96

InterventionmL/min (Mean)
ABC/3TC FDC4.37
TDF/FTC FDC2.68

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Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24

Change from baseline was calculated as the Week 24 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine. (NCT00549198)
Timeframe: Baseline, Week 24

InterventionmL/min/1.73m^2 (Mean)
ABC/3TC FDC2.78
TDF/FTC FDC0.43

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Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48

Change from baseline was calculated as the Week 48 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine; BMI, body mass index. (NCT00549198)
Timeframe: Baseline, Week 48

Interventionmilliliters per minute (mL/min)/1.73 m^2 (Mean)
ABC/3TC FDC0.22
TDF/FTC FDC1.18

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Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96

Change from baseline was calculated as the Week 96 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^s, meters squared; Scr, serum creatinine. (NCT00549198)
Timeframe: Baseline, Week 96

InterventionmL/min/1.73m^2 (Mean)
ABC/3TC FDC1.48
TDF/FTC FDC-1.15

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Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24

BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 24

Interventionpercent change (Mean)
ABC/3TC FDC-1.19
TDF/FTC FDC-2.73

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Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48

BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 48

Interventionpercent change (Mean)
ABC/3TC FDC-1.90
TDF/FTC FDC-3.56

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Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96

BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 96

Interventionpercent change (Mean)
ABC/3TC FDC-2.17
TDF/FTC FDC-3.55

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Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24

BMD is a measure (grams [g] per centimeters cubed [cm^3]) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 24

Interventionpercent change (Mean)
ABC/3TC FDC-2.12
TDF/FTC FDC-3.30

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Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48

BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 48

Interventionpercent change (Mean)
ABC/3TC FDC-1.59
TDF/FTC FDC-2.41

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Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96

BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 96

Interventionpercent change (Mean)
ABC/3TC FDC-0.87
TDF/FTC FDC-1.70

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"Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized"

Participants were asked at each visit whether or not they utilized unplanned healthcare resources. (NCT00549198)
Timeframe: Baseline to Week 96

,
Interventionparticipants (Number)
Week 4, Yes, n=178, 183Week 4, No, n=178, 183Week 12, Yes, n=162, 177Week 12, No, n=162, 177Week 24, Yes, n=156, 173Week 24, No, n=156, 173Week 36, Yes, n=148, 169Week 36, No, n=148, 169Week 48, Yes, n=137, 161Week 48, No, n=137, 161Week 60, Yes, n=129, 148Week 60, No, n=129, 148Week 72, Yes, n=126, 139Week 72, No, n=126, 139Week 84, Yes, n=121, 136Week 84, No, n=121, 136Week 96, Yes, n=113, 135Week 96, No, n=113, 135
ABC/3TC FDC601185610670864810044934782487834873083
TDF/FTC FDC49134471305911450119361254410440992410817118

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Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96

Viral resistance was measured using blood samples collected from participants throughout the study. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor. Virological failure was defined as any one of: participant does not achieve a 1 log10 copies (cop)/mL decrease in plasma HIV-1 RNA by Week (Wk) 4, or has two consecutive plasma HIV-1 RNA measures >=400 cop/mL separated by at least 2-4 wk after being previously <=400 cop/mL on/after Wk 4, or has two consecutive plasma HIV-1 RNA measures >400 cop/mL separated by at least 2-4 wk on/after Wk 24. (NCT00549198)
Timeframe: Week 96

,
Interventionparticipants (Number)
Any treatment-emergent mutationNRTINNRTI
ABC/3TC FDC442
TDF/FTC FDC000

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Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24

An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented. (NCT00549198)
Timeframe: Baseline to Week 24

,
Interventionparticipants (Number)
Any eventDrug hypersensitivityRashDizzinessHypersensitivityDrug eruption
ABC/3TC FDC26112031
TDF/FTC FDC1413201

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Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48

An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented. (NCT00549198)
Timeframe: Baseline to Week 48

,
Interventionparticipants (Number)
Any eventDrug hypersensitivityBone density decreasedRashDizzinessHypersensitivityDrug eruption
ABC/3TC FDC291102131
TDF/FTC FDC21123301

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Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96

An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented. (NCT00549198)
Timeframe: Baseline to Week 96

,
Interventionparticipants (Number)
Any eventDrug hypersensitivityBone density decreasedRashDizzinessHypersensitivityAbnormal dreamsDrug eruptionDepression
ABC/3TC FDC33110213310
TDF/FTC FDC2818330012

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Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24

"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD." (NCT00549198)
Timeframe: Week 24

,
Interventionparticipants (Number)
Osteopenia, spine, n=147, 173Osteporosis, spine, n=147, 173Osteopenia, hip, n=149, 170Osteoporosis, hip, n=149, 170
ABC/3TC FDC4116384
TDF/FTC FDC689541

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Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48

"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD." (NCT00549198)
Timeframe: Week 48

,
Interventionparticipants (Number)
Osteopenia, spine, n=132, 147Osteporosis, spine, n=132, 147Osteopenia, hip, n=130, 147Osteoporosis, hip, n=130, 147
ABC/3TC FDC4115374
TDF/FTC FDC575500

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Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96

"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD." (NCT00549198)
Timeframe: Week 96

,
Interventionparticipants (Number)
Osteopenia, spine, n=64, 82Osteporosis, spine, n=64, 82Osteopenia, hip, n=65, 80Osteoporosis, hip, n=65, 80
ABC/3TC FDC215200
TDF/FTC FDC343310

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Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24

BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. (NCT00549198)
Timeframe: Baseline, Week 24

,
Interventionparticipants (Number)
>=2%, spine, n=142, 165>=6%, spine, n=142, 165>=2%, hip, n=137, 160>=6%, hip, n=137, 160
ABC/3TC FDC7310381
TDF/FTC FDC11517936

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Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48

BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. (NCT00549198)
Timeframe: Baseline, Week 48

,
Interventionparticipants (Number)
>=2%, spine, n=125, 141>=6%, spine, n=125, 141>=2%, hip, n=119, 140>=6%, hip, n=119, 140
ABC/3TC FDC515543
TDF/FTC FDC841311117

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Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96

BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. (NCT00549198)
Timeframe: Baseline, Week 96

,
Interventionparticipants (Number)
>=2%, spine, n=59, 79>=6%, spine, n=59, 79>=2%, hip, n=58, 76>=6%, hip, n=58, 76
ABC/3TC FDC213331
TDF/FTC FDC3985213

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Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24

mL, milliliter; min, minute; m^2, meters squared (NCT00549198)
Timeframe: Baseline, Week 24

,
Interventionparticipants (Number)
>=10 mL/min, MDRD>=10 mL/min, Cockcroft-Gault>=20 mL/min, MDRD>=20 mL/min, Cockcroft-Gault>=10%, MDRD>=10%, Cockcroft-Gault>=20%, MDRD>=20%, Cockcroft-Gault
ABC/3TC FDC161643151022
TDF/FTC FDC262064241733

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Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48

mL, milliliter; min, minute; m^2, meters squared (NCT00549198)
Timeframe: Baseline, Week 48

,
Interventionparticipants (Number)
>=10 mL/min, MDRD>=10 mL/min, Cockcroft-Gault>=20 mL/min, MDRD>=20 mL/min, Cockcroft-Gault>=10%, MDRD>=10%, Cockcroft-Gault>=20%, MDRD>=20%, Cockcroft-Gault
ABC/3TC FDC231544211143
TDF/FTC FDC21143221920

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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs or Laboratory Abnormalities

AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and/or is an important medical event. (NCT00605384)
Timeframe: Day 1 through end of treatment (Week 100 +/- 5 days)

,
Interventionparticipants (Number)
AEsSAEsDeathsDiscontinuations due to AEsDiscontinuations due to Laboratory Abnormalities
Adefovir + Continuing Lamivudine10000
Entecavir + Tenofovir10000

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Hepatitis B Virus (HBV) DNA

"HBV DNA carries the genetic blueprint of the virus. How many HBV DNA particles or copies are found in the blood indicates how rapidly the virus is reproducing in the liver." (NCT00662545)
Timeframe: week 24

Interventionlog 10 IU/ml (Median)
Entecavir Intensification2.4
Standard of Care0.8

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HIV RNA < 75 Copies/ml

(NCT00662545)
Timeframe: entry, week 12, and week 24

Interventionparticipants (Number)
Entecavir Intensification5
Standard of Care5

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Incidence of Permanent Discontinuation Due to Toxicity

(NCT00662545)
Timeframe: 24 weeks

Interventionparticipants (Number)
Entecavir Intensification0
Standard of Care0

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Incidence of New Hepatic Decompensation( Ascites, Variceal Hemorrhage, Encephalopathy)

(NCT00662545)
Timeframe: every 4 weeks for 24 weeks

Interventionparticipants (Number)
Entecavir Intensification0
Standard of Care0

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Incidence of ALT Flares

ALT flare: sudden increase in blood level of alanine transaminase (ALT) (NCT00662545)
Timeframe: every 4 weeks for 24 weeks

Interventionparticipants (Number)
Entecavir Intensification0
Standard of Care0

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Change From Baseline Fasting Lipid Parameters at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

,
Interventionmg/dL (Mean)
Total CholesterolLDL (low-density lipoprotein)HDL (high-density lipoprotein)Triglycerides
ABC/3TC + PI/r-420-23
TVD + PI/r-21-6-2-51

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Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

InterventionmL/min/1.73m^2 (Mean)
TVD + PI/r-9.0
ABC/3TC + PI/r-3.7

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Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

,
Interventionpg/mL (Mean)
IL-10IL-6TNF-alpha
ABC/3TC + PI/r-0.2-0.64.7
TVD + PI/r0.0-0.20.0

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Change From Baseline C-Reactive Protein at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

Interventionmg/dL (Mean)
TVD + PI/r-0.026
ABC/3TC + PI/r0.225

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Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48

The percentage of participants with HIV-1 RNA < 200 copies/mL at Week 48 was summarized. (NCT00724711)
Timeframe: 48 weeks

,
Interventionpercentage of participants (Number)
On-Treatment Response Analysis (Missing = Failure)Snapshot Responder Analysis (Virologic Success)
ABC/3TC + PI/r82.182.1
TVD + PI/r84.484.4

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Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

InterventionmL/min (Mean)
TVD + PI/r-8.4
ABC/3TC + PI/r-4.1

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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was summarized. (NCT00724711)
Timeframe: 48 weeks

,
Interventionpercentage of participants (Number)
TLOVR Responder AnalysisOn-Treatment Response Analysis (Missing = Failure)Snapshot Responder Analysis (Virologic Success)
ABC/3TC + PI/r76.377.677.6
TVD + PI/r77.979.979.9

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Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

InterventionRatio (Mean)
TVD + PI/r-0.1
ABC/3TC + PI/r-0.1

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Change From Baseline Fasting Glucose at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

Interventionmg/dL (Mean)
TVD + PI/r1
ABC/3TC + PI/r1

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Change From Baseline Fibrinogen at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

Interventionmg/dL (Mean)
TVD + PI/r-4
ABC/3TC + PI/r14

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Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48

Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks

Interventioncells/microliter (Mean)
TVD + PI/r8
ABC/3TC + PI/r34

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Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm

The percentage of participants with HIV-1 RNA < 200 copies/mL based on TLOVR algorithm at Week 48 was summarized. Participants were considered nonresponders in the TLOVR analysis if they experienced virologic rebound prior to or at Week 48, discontinued study before Week 48, or added a new antiretroviral (ARV) agent prior to completion of the study. Virologic rebound was defined as 2 consecutive HIV-1 RNA values >= 200 copies/mL or the last HIV-1 RNA value >= 200 copies/mL followed by discontinuation from the study. (NCT00724711)
Timeframe: Baseline to 48 weeks

Interventionpercentage of participants (Number)
TVD + PI/r86.4
ABC/3TC + PI/r83.3

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Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48

The percentage of participants with PVR for HIV-1 RNA cutoff at 200 copies/mL at Week 48 was summarized. Pure virologic response was the percentage of subjects who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values >= 200 copies/mL or the last HIV-1 RNA value >= 200 copies/mL followed by discontinuation from the study. (NCT00724711)
Timeframe: Baseline to 48 weeks

Interventionpercentage of participants (Number)
TVD + PI/r99.2
ABC/3TC + PI/r97.2

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Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48

The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 48 was summarized. Pure virologic response was the proportion of participants who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values >= 50 copies/mL or the last HIV-1 RNA value >= 50 copies/mL followed by discontinuation from the study. (NCT00724711)
Timeframe: Baseline to 48 weeks

Interventionpercentage of participants (Number)
TVD + PI/r93.0
ABC/3TC + PI/r91.1

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Tuberculosis-immune Reconstitution Inflammatory Syndrome Events

Tuberculosis-immune reconstitution inflammatory syndrome was defined by the protocol as: a) new persistent fevers (temperature >101.5 degrees Fahrenheit) developing after the initiation of antiretroviral therapy, and not believed to be associated with antiretroviral therapy and without an identifiable source, b) marked worsening or emergence of intrathoracic lymphadenopathy, pulmonary infiltrates or pleural effusions on radiologic examination, or c) worsening or emergence of lymphadenopathy on serial examinations or worsening of other tuberculous lesions. (NCT00851630)
Timeframe: 104 weeks

InterventionEvents (Number)
Early0
Delayed0

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HIV RNA Level < 50 Copies/ml

The number of subjects with plasma HIV RNA level <50 copies/ml. (NCT00851630)
Timeframe: 104 Weeks

InterventionParticipants (Number)
Early23
Delayed26

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Number of Serious Adverse Events (SAEs)

Feasibility and safety of fixed dose combination zidovudine/lamivudine/abacavir in HIV-infected subjects with tuberculosis in a resource-limited setting as assessed by the number of serious adverse events. Serious adverse events included any untoward medical occurrence that resulted in death, was considered life-threatening, required inpatient hospitalization or prolongation of existing hospitalization beyond what was required in the study, or resulted in persistent or resulted in significant disability/incapacity. (NCT00851630)
Timeframe: 104 weeks

InterventionEvents (Number)
Early12
Delayed7

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Plasma HIV Ribonucleic Acid (RNA) Level < 400 Copies/ml

The number of subjects with plasma HIV RNA level <400 copies/ml. (NCT00851630)
Timeframe: 104 Weeks

InterventionParticipants (Number)
Early26
Delayed31

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Virological Response[Viral Load <50 Copies/mL, TLOVR]

The analysis is based on virologic response defined as percentage of patients with confirmed plasma viral load <50 HIV-1 RNA copies/mL at Week 24 calculated according to the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) algorithm. (NCT00915655)
Timeframe: Week 24

InterventionParticipants (Number)
YesNo
DRV/Rtv111

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Virological Response [Viral Load <50 Copies/mL, FDA-SNAPSHOT]

The analysis is based on the last observed viral load (VL) data within the Week 24 window. Virologic response is defined as a VL<50 copies/mL (observed case). Virologic Failure includes a) patients who had >=50 copies/mL in the Week-24 window, b) patients who discontinued prior to Week 24 for lack or loss of efficacy, c) patients who had a switch in their background regimen that was not permitted by the protocol, and d) patients who discontinued for reasons other than adverse events (AEs)/death, and lack or loss of efficacy (provided their last available viral load was detectable). (NCT00915655)
Timeframe: Week 24

InterventionParticipants (Number)
DRV/Rtv12

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Change in Peak Oxygen Uptake.

change or difference in peak oxygen uptake after switching from zidovudine-based therapy, such as combivir or trizivir, to tenofovir, versus continuing on zidovudine-based therapy.The difference in peak oxygen uptake were calculated by subtracting peak oxygen uptake values at baseline from the peak oxygen uptake values after 6 months of study intervention. The changes were analyzed within each group and between groups. (NCT00960622)
Timeframe: baseline and 6 months

Interventionml/Kg/min (Mean)
Truvada 200/300 mg, Daily, by Mouth.2.2
Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily.2.8

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Placental Malaria Defined as Positive Placental RDT

Number of participants with positive placental RDT for malaria. Malaria rapid diagnostic tests (RDTs) assist in the diagnosis of malaria by detecting evidence of malaria parasites (antigens) in human blood. RDTs permit a reliable detection of malaria infections particularly in remote areas with limited access to good quality microscopy services. (NCT00993031)
Timeframe: Delivery

Interventionparticipants (Number)
With Protease Inhibitor6
Without Protease Inhibitor7

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Prevalence of Composite Clinical Outcome Defined by LBW, Stillbirth(Intrauterine Fetal Demise >20wks GA), Late Spontaneous Abortion(Miscarriage 12-20wks GA), Preterm Delivery(<37wks Gestation), Neonatal Death(Death of Liveborn Infant Within First 28days)

Percent of evaluated participants with composite clinical outcome defined by LBW, stillbirth (intrauterine fetal demise >20wks GA), late spontaneous abortion(miscarriage 12-20wks GA), preterm delivery(<37wks gestation), neonatal death(death of live-born infant within first 28 days) (NCT00993031)
Timeframe: Time from randomization until 24 months postpartum or cessation of breastfeeding

Intervention% of evaluated participants with outcome (Number)
With Protease Inhibitor33.9
Without Protease Inhibitor27.8

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Prevalence of Malaria Defined as Positive Placental Blood PCR

Number of participants with positive placental blood PCR for malaria (NCT00993031)
Timeframe: Delivery

Interventionparticipants (Number)
With Protease Inhibitor6
Without Protease Inhibitor7

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Prevalence of Malaria Defined as Positive Placental Blood Smear

Number of participants with positive placental blood smear for malaria (NCT00993031)
Timeframe: Delivery

Interventionparticipants (Number)
With Protease Inhibitor5
Without Protease Inhibitor6

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Placental Malaria Defined Placental Histopathologic Analysis

Number of participants with positive placental histopathology slide for malaria (NCT00993031)
Timeframe: Delivery

Interventionparticipants (Number)
With Protease Inhibitor62
Without Protease Inhibitor47

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Number of Participants With Severe Maternal Anemia Defined by Hemoglobin < 8g/dl at Any Point During the Trial in Each Treatment Group

Proportion of women with severe maternal Anemia (hemoglobin < 8g/dl by hemacue or CBC) at any point during the trial in Each Treatment Group (NCT00993031)
Timeframe: Time from randomization until one year follow up

InterventionParticipants (Count of Participants)
Without Protease Inhibitor11
With Protease Inhibitor11

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Number of Participants With Maternal to Child Transmission of HIV, Measured by Infant HIV DNA PCR

HIV tested by DNA PCR (NCT00993031)
Timeframe: Delivery to 48 weeks postpartum

InterventionParticipants (Count of Participants)
Without Protease Inhibitor0
With Protease Inhibitor2

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Number of Participants With Maternal HIV RNA Suppression of <400 Copies/mL

Virologic suppression was defined as plasma HIV-1 RNA 400 copies/ml or less based on the lower limit of detection of the available test. (NCT00993031)
Timeframe: Time from randomization until delivery, an average of 20 weeks

InterventionParticipants (Count of Participants)
Without Protease Inhibitor166
With Protease Inhibitor153

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Number of Participants With Grade 3 or 4 Toxicity in the Two Treatment Groups in Women

(NCT00993031)
Timeframe: Randomization to one month postpartum

InterventionParticipants (Count of Participants)
Without Protease Inhibitor12
With Protease Inhibitor8

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Maternal Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk After Pregnancy

(NCT00993031)
Timeframe: Number of treatments given for clinical malaria based on postive blood smear from time from delivery until 24 months after delivery or cessation of breastfeeding

Interventiontreatments (Number)
Group A21
Group B13

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Incidence of Pre-eclampsia Defined by Hypertension > 140/90 on Two Occasions Measured > 6 Hours Apart With ≥1+ Proteinuria on Clean Catch Urine Dipstick

Pre-eclampsia Defined by Hypertension > 140/90 on Two Occasions Measured > 6 Hours Apart With ≥1+ Proteinuria on Clean Catch Urine Dipstick (NCT00993031)
Timeframe: Time from randomization until delivery

InterventionParticipants (Count of Participants)
Without Protease Inhibitor0
With Protease Inhibitor0

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Change in Maternal CD4 Cell Counts

CD4 cell count recovery efavirenz at delivery (NCT00993031)
Timeframe: Time of randomization to delivery, an average of 20 weeks

InterventionCD4 cell count (Median)
Without Protease Inhibitor-7
With Protease Inhibitor57

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ART Levels in Hair Samples at Delivery

antiretroviral hair concentrations (per doubling) (NCT00993031)
Timeframe: delivery

Interventionantiretroviral hair concentration(ng/mg) (Mean)
Without Protease Inhibitor5.7
With Protease Inhibitor6.6

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Maternal Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk During Pregnancy

(NCT00993031)
Timeframe: Number of treatments given for clinical malaria based on postive blood smear from time from randomization until 24 months after delivery or cessation of breastfeeding

Interventiontreatments (Number)
With Protease Inhibitor17
Without Protease Inhibitor17

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Complete Virologic Response (CVR, Serum HBV DNA Undetectable by PCR or Less Than 60 IU/mL)

(NCT01023217)
Timeframe: at week 52 from randomization

Interventionparticipants (Number)
Adefovir Plus Entecavir13
Adefovir Plus Lamivudine2

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Maximum Plasma Concentration of Drug

Maximum concentration of drug in plasma that was attained post dosing (NCT01025830)
Timeframe: Assessed at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 10 and 12 hr post-dosing

Interventionmilligram/liter (Geometric Mean)
Generic Stavudine1.6
Brand Stavudine1.3
Generic Nevirapine8.8
Brand Nevirapine8.4
Generic Lamivudine1.0
Brand Lamivudine1.3

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Area Under the Concentration-Time Curve(AUC)

Mean Area Under the Plasma Concentration-Time Curve for each drug, log transformed (NCT01025830)
Timeframe: Assessed at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 10 and 12 hr post-dosing

Interventionhour*milligram/liter (Geometric Mean)
Generic Stavudine3.6
Brand Stavudine3.4
Generic Nevirapine85.8
Brand Nevirapine79.2
Generic Lamivudine5.2
Brand Lamivudine6.4

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Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events

These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). (NCT01061151)
Timeframe: Measured through the Week 1 postpartum study visit

InterventionParticipants (Count of Participants)
Period 2
Antepartum Arm C60

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Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies)

Composite outcome (NCT01061151)
Timeframe: Measured at birth

,
InterventionParticipants (Count of Participants)
Periods 1 and 2Period 2
Antepartum Arm A38991
Antepartum Arm B563123

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Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies)

Composite outcome (NCT01061151)
Timeframe: Measured at birth

InterventionParticipants (Count of Participants)
Period 2
Antepartum Arm C111

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Postpartum Component: Proportion of Mother-Infant Pairs With no Death or HIV Diagnosis Through 24 Months Post-delivery

Defined as infant HIV NAT positivity of a specimen drawn at any post-randomization visit, confirmed by HIV NAT positivity of a second specimen drawn at a different time point, or infant death. Analyses (Kaplan-Meier probabilities) were conducted at the Mother-Infant (M-I) pair level, hence the worst outcome for multiple births was counted as a single event. (NCT01061151)
Timeframe: Measured through 24 months post-delivery

InterventionProbability (Number)
Postpartum Arm A (Maternal Prophylaxis)0.971
Postpartum Arm B (Infant Prophylaxis)0.977

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Postpartum Component: Incidence of Grade 3 or Higher Adverse Events and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events

These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). (NCT01061151)
Timeframe: Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first

InterventionNew cases per 100 person-years (Number)
Postpartum Arm A (Maternal Prophylaxis)14.4
Postpartum Arm B (Infant Prophylaxis)14.1

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Postpartum Component: Incidence of Confirmed Infant HIV Infection

Defined as infant HIV NAT positivity of a specimen drawn at any post-randomization visit (i.e., any visit after the Week 1 [Day 6-14] visit), confirmed by HIV NAT positivity of a second specimen drawn at a different time point. Analyses were conducted at the Mother-Infant (M-I) pair level, hence the worst outcome for multiple births was counted as a single event. (NCT01061151)
Timeframe: Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first

InterventionNew cases per 100 person-years (Number)
Postpartum Arm A (Maternal Prophylaxis)0.56
Postpartum Arm B (Infant Prophylaxis)0.55

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Maternal Health Component: Toxicity: Incidence of Grade 3 or Greater Laboratory Results or Signs and Symptoms and Selected Grade 2 Hematologic, Renal, and Hepatic Laboratory Results

The maternal safety endpoints summarized include grade 2, 3 or 4 hematologies (hemoglobin (Hb), White Blood Cells (WBC), Absolute Neutrophil Count (ANC), platelet count), chemistries (Alanine Aminotransferase (ALT or SGPT), serum creatinine), and grade 3 or 4 signs and symptoms that occurred post-randomization. These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

InterventionNew cases per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)15.3
Maternal Health Arm B (Discontinue Triple ARVs)13.9

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Maternal Health Component: Other Targeted Medical Conditions

Other (non-cardiologic) medical conditions of particular concern were included in this outcome. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates. Events included were metabolic events, hepatic events, renal events, infections such as pulmonary tuberculosis, malaria, or other serious bacterial infections, and others. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Interventionevents per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)4.0
Maternal Health Arm B (Discontinue Triple ARVs)4.6

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Maternal Health Component: Incidence Rate of Progression to AIDS-defining Illness, Death, or a Serious Non-AIDS Cardiovascular, Hepatic, or Renal Event

"This outcome included AIDS-defining illnesses or cardiovascular, hepatic, or renal adverse events of particular concern which were evaluated as serious. Serious outcomes were both those defined as serious according to the International Conference on Harmonization (ICH) definition, or outcomes with grades equal to or worse than 3 (Severe). A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates. Cardiovascular events considered were hypertension, congestive heart failure, stroke, Transient Ischemia Event (TIA), pulmonary embolism, myocardial infarction (whether acute symptomatic or silent), coronary artery disease, deep vein thrombosis, peripheral vascular disease, or symptomatic HIV-associated cardiomyopathy. Hepatic events considered were cirrhosis and idiopathic sclerosing cholangitis. Renal events considered were renal insufficiency, acute or chronic." (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Interventionevents per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)0.5
Maternal Health Arm B (Discontinue Triple ARVs)0.9

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Maternal Health Component: Incidence Rate of Cardiovascular or Other Metabolic Events

"Cardiovascular or metabolic events of particular concern were included in this analysis. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates.~Metabolic events considered were diabetes mellitus, lipodystrophy, or dyslipidemia. Cardiovascular events considered were hypertension, congestive heart failure, stroke, Transient Ischemia Event (TIA), pulmonary embolism, myocardial infarction (whether acute symptomatic or silent), coronary artery disease, deep vein thrombosis, peripheral vascular disease, or symptomatic HIV-associated cardiomyopathy." (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Interventionevents per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)2.9
Maternal Health Arm B (Discontinue Triple ARVs)5.7

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Maternal Health Component: Incidence of Tuberculosis

Incidence of tuberculosis. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

InterventionNew cases per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)0.40
Maternal Health Arm B (Discontinue Triple ARVs)0.31

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Maternal Health Component: Incidence of Progression to AIDS-defining Illness or Death

AIDS-defining illness refers to the WHO Clinical Stage 4 illnesses in Appendix IV of the protocol. These events were reviewed and confirmed by an Endpoint review group. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

InterventionNew cases per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)0.24
Maternal Health Arm B (Discontinue Triple ARVs)0.49

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Maternal Health Component: Incidence of Death

Number of women who died during the maternal health component; that is, who had been randomized to either continue or discontinue ART after risk of HIV vertical transmission through breastfeeding was over. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

InterventionNew cases per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)0.24
Maternal Health Arm B (Discontinue Triple ARVs)0.43

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Maternal Health Component: Incidence of AIDS-defining Illness

"AIDS-defining illness refers to the WHO Clinical Stage 4 illnesses listed in Appendix IV. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group." (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

InterventionNew cases per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)0.08
Maternal Health Arm B (Discontinue Triple ARVs)0.25

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Antepartum Component: Number of Infant HIV Infections

Detected by HIV NAT positivity (NCT01061151)
Timeframe: Measured at the birth (<= 3 days postpartum) visit

InterventionParticipants (Count of Participants)
Antepartum Arm A22
Antepartum Arm B4
Antepartum Arm C2

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Maternal Health Component: Incidence Rate of Death or Any Condition of Particular Concern

Particular events were targeted as those of particular concern. This outcome considered all such events: death, events defining WHO stages II, III, or IV, targeted cardiovascular adverse events, other targeted adverse events, or cancers which were not AIDS-defining. A complete list can be found in Appendix IV of the Protocol. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Interventionevents per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)9.0
Maternal Health Arm B (Discontinue Triple ARVs)14.0

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Antepartum Component: Number of Confirmed Infant HIV Infections

Defined as HIV nucleic acid test (NAT) positivity of the specimen drawn at either the birth (Day 0-5) or Week 1 (Day 6-14) visit, confirmed by HIV NAT positivity of a second specimen collected at a different time point (NCT01061151)
Timeframe: Measured at birth or Week 1 study visit

InterventionParticipants (Count of Participants)
Antepartum Arm A25
Antepartum Arm B7
Antepartum Arm C2

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Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures

"Adherence is by maternal report; adherence through hair analysis is not included here.~The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since adherence was not a focus of the study." (NCT01061151)
Timeframe: Week 6 visit (14 days - 9 weeks postpartum); Week 14 visit (10-19 weeks postpartum); Week 26 visit (20 to 31 weeks postpartum); Week 50 visit (44 to 55 weeks postpartum); and Week 74 visit (68 to 80 weeks postpartum).

InterventionParticipants (Count of Participants)
Week 6 visit72329524Week 6 visit72329525Week 14 visit72329524Week 14 visit72329525Week 26 visit72329524Week 26 visit72329525Week 50 visit72329524Week 50 visit72329525Week 74 visit72329524Week 74 visit72329525
Missed dose over 1 month agoNever missed a doseMissed dose 2-4 weeks agoMissed dose within last 2 weeks
Postpartum Arm A (Maternal Prophylaxis)1003
Postpartum Arm B (Infant Prophylaxis)1104
Postpartum Arm A (Maternal Prophylaxis)12
Postpartum Arm A (Maternal Prophylaxis)17
Postpartum Arm B (Infant Prophylaxis)4
Postpartum Arm A (Maternal Prophylaxis)140
Postpartum Arm B (Infant Prophylaxis)74
Postpartum Arm A (Maternal Prophylaxis)956
Postpartum Arm B (Infant Prophylaxis)1081
Postpartum Arm A (Maternal Prophylaxis)20
Postpartum Arm B (Infant Prophylaxis)0
Postpartum Arm A (Maternal Prophylaxis)35
Postpartum Arm A (Maternal Prophylaxis)112
Postpartum Arm B (Infant Prophylaxis)50
Postpartum Arm A (Maternal Prophylaxis)888
Postpartum Arm B (Infant Prophylaxis)1035
Postpartum Arm A (Maternal Prophylaxis)48
Postpartum Arm A (Maternal Prophylaxis)31
Postpartum Arm B (Infant Prophylaxis)8
Postpartum Arm A (Maternal Prophylaxis)103
Postpartum Arm B (Infant Prophylaxis)47
Postpartum Arm A (Maternal Prophylaxis)716
Postpartum Arm B (Infant Prophylaxis)841
Postpartum Arm A (Maternal Prophylaxis)37
Postpartum Arm A (Maternal Prophylaxis)34
Postpartum Arm B (Infant Prophylaxis)7
Postpartum Arm A (Maternal Prophylaxis)64
Postpartum Arm B (Infant Prophylaxis)30
Postpartum Arm A (Maternal Prophylaxis)311
Postpartum Arm B (Infant Prophylaxis)377
Postpartum Arm A (Maternal Prophylaxis)15
Postpartum Arm B (Infant Prophylaxis)2
Postpartum Arm B (Infant Prophylaxis)1
Postpartum Arm B (Infant Prophylaxis)9

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Antepartum Component: Maternal HIV RNA Less Than 400 Copies/mL at Delivery

Analysis used the principle of intent to treat. (NCT01061151)
Timeframe: Measured at the time of delivery

InterventionParticipants (Count of Participants)Participants (Count of Participants)
Periods 1 and 272329519Periods 1 and 272329520Period 272329520Period 272329519Period 272329521
HIV RNA < 400 copies/mLHIV RNA >= 400 copies/mL
Antepartum Arm A415
Antepartum Arm B1092
Antepartum Arm A929
Antepartum Arm B275
Antepartum Arm A102
Antepartum Arm B259
Antepartum Arm C225
Antepartum Arm A210
Antepartum Arm B62
Antepartum Arm C79

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Postpartum Component: Proportion of Infants Alive Through 12 and 24 Months Post-delivery

Analyses (Kaplan-Meier probabilities) conducted for all individual infants (rather than M-I pair) (NCT01061151)
Timeframe: Measured at 12 and 24 months post-delivery

,
InterventionProbability (Number)
12 months post delivery24 months post delivery
Postpartum Arm A (Maternal Prophylaxis)0.9880.978
Postpartum Arm B (Infant Prophylaxis)0.9890.987

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Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component)

For overall survival, failure was defined to be death. For HIV-free survival, failure was defined to be either death or developing HIV. The probability of living, or living without HIV infection, at 104 weeks was calculated by Kaplan-Meier estimation of the survival function. (NCT01061151)
Timeframe: Measured from birth through 104 weeks of age

,
InterventionProportional probability (Number)
Overall survival, Periods 1 & 2 group (arms A & B only)Overall survival, period 2 groupHIV-free survival, Periods 1&2 group (arms A&B only)HIV-free survival, period 2 group
Antepartum Arm A0.9590.9510.9370.936
Antepartum Arm B0.9670.9820.9470.940

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Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component)

For overall survival, failure was defined to be death. For HIV-free survival, failure was defined to be either death or developing HIV. The probability of living, or living without HIV infection, at 104 weeks was calculated by Kaplan-Meier estimation of the survival function. (NCT01061151)
Timeframe: Measured from birth through 104 weeks of age

InterventionProportional probability (Number)
Overall survival, period 2 groupHIV-free survival, period 2 group
Antepartum Arm C0.9420.921

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Antepartum Component: Number of Mothers With Obstetrical Complications

"Complications included deaths, diagnoses, signs/symptoms, chemistry lab tests, or hematological lab tests, with grades of 3 (Severe) or worse. Obstetrical complications were those classified by the MedDra coding system as Pregnancy, puerperium and perinatal conditions, except if the condition was the death of the fetus: Abortions not specified as induced or spontaneous, Abortions spontaneous, or Stillbirth and foetal death." (NCT01061151)
Timeframe: Measured through the Week 1 postpartum study visit

,
InterventionParticipants (Count of Participants)
Periods 1 and 2Period 2
Antepartum Arm A8920
Antepartum Arm B7512

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Antepartum Component: Number of Mothers With Obstetrical Complications

"Complications included deaths, diagnoses, signs/symptoms, chemistry lab tests, or hematological lab tests, with grades of 3 (Severe) or worse. Obstetrical complications were those classified by the MedDra coding system as Pregnancy, puerperium and perinatal conditions, except if the condition was the death of the fetus: Abortions not specified as induced or spontaneous, Abortions spontaneous, or Stillbirth and foetal death." (NCT01061151)
Timeframe: Measured through the Week 1 postpartum study visit

InterventionParticipants (Count of Participants)
Period 2
Antepartum Arm C23

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Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events

These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). (NCT01061151)
Timeframe: Measured through the Week 1 postpartum study visit

,
InterventionParticipants (Count of Participants)
Periods 1 and 2Period 2
Antepartum Arm A26159
Antepartum Arm B31861

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HIV-1 Viral Suppression

HIV-1 virologic suppression to <400 copies/mL at 26-weeks after enrollment (NCT01075152)
Timeframe: 26 weeks

Interventionparticipants (Number)
Earlier HIV Therapy43
Deferred HIV Therapy49

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Incidence of Cryptococcal-relapse

Incidence of culture positive cryptococcal meningitis relapse (NCT01075152)
Timeframe: 46 weeks

Interventionparticipants (Number)
Earlier HIV Therapy2
Deferred HIV Therapy8

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Percentage of Participants, Per CSF WBC Subgroup, Who Died by Week 26

Percentage of Participants who died by week 26 based on CSF white blood cell (WBC) count at study entry (time of randomization at a median of 8 days of anti-fungal therapy). (NCT01075152)
Timeframe: 26 weeks

,
Interventionpercentage of participants (Number)
CSF WBC <5 /mcl (n=33, 31)CSF WBC >5/mcL (n=42, 40)
Deferred HIV Therapy16.145
Earlier HIV Therapy48.540.5

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Mortality

Intention to treat analysis of 26 week survival of all subjects enrolled. Reported below are the numbers of participants who died by Week 26. (NCT01075152)
Timeframe: 26 weeks from study entry

Interventionparticipants (Number)
Earlier HIV Therapy40
Deferred HIV Therapy27

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Karnofsky Functional Status

"Functional status via Karnofsky performance status score at 4, 26, 46 weeks.~Karnofsky Scale:~100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of his personal needs.~50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent.~20 - Very sick; hospital admission necessary; active supportive treatment necessary.~10 - Moribund; fatal processes progressing rapidly. 0 - Dead" (NCT01075152)
Timeframe: 46 weeks

,
InterventionScores on a scale (Mean)
4 weeks26 weeks46 weeks
Deferred HIV Therapy709395
Earlier HIV Therapy709392

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Microbiologic Clearance

Microbiologic clearance of cryptococcus as measured by serial quantitative cryptococcal cultures collected at diagnosis through 14 days of amphotericin therapy. The early fungicidal activity (EFA) of the rate of clearance is expressed as log10 colony forming units (CFU) of Cryptococcus neoformans per mL of CSF per day. (NCT01075152)
Timeframe: 4 weeks

,
Interventionlog10 CFU/mL/day (Mean)
EFA by mixed effects modelEFA by linear regression
Deferred HIV Therapy-0.31-0.35
Earlier HIV Therapy-0.31-0.39

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Safety of ART Initiation

Incidence of Adverse Events (Grade 3,4,5) through 46-weeks, as defined by the National Institute of Allergy and Infectious Diseases, Division of AIDS toxicity classification scale, version 2009. (NCT01075152)
Timeframe: 46 weeks

Interventionparticipants (Number)
Earlier HIV Therapy73
Deferred HIV Therapy75

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Incidence of Immune Reconstitution Inflammatory Syndrome

Incidence of cryptococcal-related immune reconstitution inflammatory syndrome through 46 weeks after enrollment. (NCT01075152)
Timeframe: 46 weeks

Interventionparticipants (Number)
Earlier HIV Therapy17
Deferred HIV Therapy9

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46-week Survival

46-week survival by time-to-event analysis of all subjects enrolled (NCT01075152)
Timeframe: 46 weeks

Interventionparticipants (Number)
Earlier HIV Therapy41
Deferred HIV Therapy29

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Antiretroviral Therapy Tolerability

Incidence of antiretroviral therapy interruption by >=3 consecutive days (NCT01075152)
Timeframe: 26 weeks

Interventionparticipants (Number)
Earlier HIV Therapy5
Deferred HIV Therapy1

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Percentage of Participants With Lamivudine Genotype Resistance During PEG-IFN+LAM96 Combined Therapy

Lamivudine resistance mutations were assessed by detection of the following mutations: rtL80V, rtL80I, rtV173G, rtV173L, rtL180M, rtA181T, rtA181V, rtM204V, rtM204I and rtN236T. (NCT01095835)
Timeframe: At the end of the treatment period at Week 96

Interventionpercentage of participants (Number)
PEG-IFN+LAM960

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Percentage of Participants With HBV-DNA Lowering to <3,400 IU/mL and to < 2,000 IU/mL

(NCT01095835)
Timeframe: At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144

,,
Interventionpercentage of participants (Number)
End of treatment: HBV-DNA < 3,400 IU/mL24 weeks of follow-up: HBV-DNA < 3,400 IU/mL48 weeks of follow-up: HBV-DNA < 3,400 IU/mLEnd of treatment: HBV-DNA < 2,000 IU/mL24 weeks of follow-up: HBV-DNA < 2,000 IU/mL48 weeks of follow-up: HBV-DNA < 2,000 IU/mL
PEG-IFN+LAM9676.024.020.072.020.020.0
PEG-IFN4860.823.511.858.821.611.8
PEG-IFN9667.330.830.867.328.828.8

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Percentage of Participants Achieving the Combined Response at the End of Treatment

Combined response was defined as ALT normalization plus lowering of HBV-DNA levels to <20,000 copies/mL (<3,400 IU/mL). In case of missing end of treatment measurements, the next available post-treatment value was used. (NCT01095835)
Timeframe: At end of treatment at Week 48 or 96 depending on the study arm

Interventionpercentage of participants (Number)
PEG-IFN4829.4
PEG-IFN9638.5
PEG-IFN+LAM9632.0

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Percentage of Participants With HBV-DNA Below Limit of Quantification

HBV-DNA limit < 6 IU/mL was defined as below quantification. (NCT01095835)
Timeframe: At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144

,,
Interventionpercentage of participants (Number)
End of treatment24 weeks of follow-up48 weeks of follow-up
PEG-IFN+LAM9624.04.08.0
PEG-IFN4817.60.02.0
PEG-IFN9630.87.77.7

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Percentage of Participants With ALT Normalization

(NCT01095835)
Timeframe: At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144

,,
Interventionpercentage of participants (Number)
End of treatment24 weeks of follow-up48 weeks of follow-up
PEG-IFN+LAM9640.040.036.0
PEG-IFN4835.345.135.3
PEG-IFN9640.446.234.6

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Percentage of Participants Achieving Combined Response Using a Cut-Off for HBV-DNA Levels to 2,000 IU/mL

Combined response was defined here as ALT normalization plus lowering HBV-DNA levels to a cutt-off <2,000 IU/mL. In case of missing end of treatment measurements, the next available post-treatment value was used. In case of missing week-24 post-treatment measurements, the nearest value with respect to the schedule time point in the time window 12 weeks post treatment until study end was used. Participants with missing 48 weeks follow-up measurements were considered as non-responders. However, if the scheduled 48-weeks post-treatment tests were performed earlier or later than 48 weeks post-treatment, but not earlier than 36 weeks post-treatment, the corresponding results were considered to determine response. (NCT01095835)
Timeframe: At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144

,,
Interventionpercentage of participants (Number)
End of treatment24 weeks of follow-up48 weeks of follow-up
PEG-IFN+LAM9628.020.020.0
PEG-IFN4829.421.611.8
PEG-IFN9638.526.923.1

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Change From Baseline of Quantitative Hepatitis B Surface Antigen (HbsAg) Level at the End of Treatment

(NCT01095835)
Timeframe: At the end of treatment at Week 48 or 96 depending on the study arm

,,
InterventionIU/mL (Mean)
Baseline (n=51, 51, 25)Change from baseline (n=44, 44, 20)
PEG-IFN+LAM968981.0-3121.2
PEG-IFN489642.6-2801.1
PEG-IFN967229.8-2282.1

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Percentage of Participants Achieving Histological Response

Histological response was defined as an improvement by >/= 2 in the Necroinflammatory Grading and/or by an improvement by >/= 1 score in Fibrosis Staging according to Ishak. Necroinflammatory Grading ranges 0-14 and is the combined score for necrosis, range 0-10 and inflammation, range 0-4. The participant is scored for only one inflammatory condition. A higher score indicates worse condition. Fibrosis Staging according to Ishak ranges 0-6 and a higher score indicates greater fibrosis. (NCT01095835)
Timeframe: At the end of the 48-week follow-up period at Week 144

Interventionpercentage of participants (Number)
PEG-IFN4813.7
PEG-IFN965.8
PEG-IFN+LAM968.0

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Percentage of Participants Achieving the Combined Response at 24 Weeks of Follow-up

Combined response was defined as ALT normalization plus lowering of HBV-DNA levels to <20,000 copies/mL (<3,400 IU/mL). In case of missing week-24 post-treatment measurements, the nearest value with respect to the schedule time point in the time window 12 weeks post treatment until study end was used. (NCT01095835)
Timeframe: At the end of 24 weeks of follow-up at Week 120

Interventionpercentage of participants (Number)
PEG-IFN4823.5
PEG-IFN9628.8
PEG-IFN+LAM9624.0

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Percentage of Participants Achieving the Combined Response at the End of the Follow-up Period

Combined response was defined as alanine aminotransferase (ALT) normalization plus lowering of hepatitis B virus (HBV) deoxyribo nucleic acid (DNA) levels to <20,000 copies/mL (<3,400 IU/mL) and was measured at the end of the 48-week follow-up period. Participants with missing 48 weeks follow-up measurements were considered as non-responders. However, if the scheduled 48-weeks post-treatment tests were performed earlier or later than 48 weeks post-treatment, but not earlier than 36 weeks post-treatment, the corresponding results were considered to determine response. (NCT01095835)
Timeframe: At the end of the 48-week follow-up period at Week 144

Interventionpercentage of participants (Number)
PEG-IFN4811.8
PEG-IFN9625.0
PEG-IFN+LAM9620.0

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Percentage of Participants With Loss of Hepatitis B Surface Antigen (HbsAg) and Hepatitis B Surface Antibodies (Anti-HBs) Seroconversion

This outcome measure presents percentage of participants with a combined response of HBsAg < 5 IU/mL and anti-HBs positive. Positive anti-HBs represents antibodies produced against Hepatitis B Surface Antigen (HBsAg) and is an indication of recovery and immunity from HBV infection. (NCT01095835)
Timeframe: At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144

,,
Interventionpercentage of participants (Number)
End of treatment24 weeks of follow-up48 weeks of follow-up
PEG-IFN+LAM960.00.00.0
PEG-IFN482.00.00.0
PEG-IFN963.85.87.7

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Change From Baseline in Plasma HIV-1 RNA at Weeks 2, 4, 8, 12, 16, 24, 32, 40,48, 60, 72, 84, 96, 108, 120, 132 and 144

Blood samples were collected for the measurement of HIV-1 RNA in plasma. Changes from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the indicated time points were assessed (represented by n=X, X in the category titles). (NCT01263015)
Timeframe: Baseline and at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144

,
Interventionlog10 copies/mL (Mean)
Week 2, n=387, 376Week 4, n=404, 391Week 8, n=395, 386Week 12, n=394, 377Week 16, n=386, 366Week 24, n=389, 364Week 32, n=380, 355Week 40, n=370, 345Week 48, n=370, 343Week 60, n=360, 330Week 72, n=354, 320Week 84, n=353, 314Week 96, n=345, 310Week 108, n=340, 300Week 120, n=333, 289Week 132, n=323, 284Week 144, n=313,269
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily-2.46-2.88-2.99-3.01-3.03-3.05-3.04-3.05-3.03-3.03-3.03-3.02-2.99-3.01-3.00-3.03-3.02
EFV/TDF/FTC 600/200/300 mg Once Daily-1.96-2.25-2.60-2.85-2.98-3.01-3.05-3.04-3.04-3.05-3.06-3.07-3.06-3.08-3.07-3.06-3.04

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Number of Participants With a Confirmed Plasma HIV-1 RNA Level >=1000 c/mL at or After Week 16 and Before Week 24, or a Confirmed Plasma HIV-1 RNA Level >=200 c/mL at or After Week 24

Data are presented as Kaplan Meier estimates of virologic failure (VF), defined as a confirmed plasma HIV-1 RNA level >=1000 c/mL at or after Week 16 and before Week 24, or a confirmed plasma HIV-1 RNA level >=200 c/mL at or after Week 24. A plasma HIV-1 RNA value was considered to be confirmed failure if a consecutive measurement satisfied the same failure criterion. The number of participants who experienced autoimmune deficiency syndrome (AIDS) Clinical Trials Group (ACTG) VFs was measured. For participants who withdrew from the study/were not documented to have reached confirmed VF at the cut off date of the Week 48 analysis, time to VF was to be censored at the planned visit week of the last measured plasma HIV-1 RNA sample. Data for participants who missed three consecutive scheduled plasma HIV-1 RNA measurements were to be censored at the planned visit week of the last assessment prior to the 3 consecutive missed visits. (NCT01263015)
Timeframe: From Baseline until Week 144) (average of 877.4 days for DTG; average of 788.8 study days for EFV/TDF/FTC)

,
InterventionParticipants (Number)
ACTG virologic failuresCensored participants
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily11403
EFV/TDF/FTC 600/200/300 mg Once Daily8411

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Number of Participants With the Indicated Genotypic Resistance With Virological Failure (VF) Through 144

Whole blood samples were collected from participants to provide plasma for storage samples for potential viral genotypic and phenotypic analyses. Participants with confirmed virological failure (confirmed HIV-1 RNA >=50 copies/mL throughout the study and/or confirmed HIV-1 RNA >=200 copies/mL at Week 144) had plasma samples tested for HIV-1 RT genotype and HIV-1 integrase genotype from Baseline samples and from samples collected at the time of virological failure. Genotype testing was conducted at Day 1 and at the time of suspected protocol-defined virological failure (PDVF). A genotyping assessment was made of change across all amino acids within the integrase (IN)-encoding region, with particular attention paid to specific amino acid changes associated with the development of resistance to RAL, ELV, or DTG. (NCT01263015)
Timeframe: Through Week 144

,
InterventionParticipants (Number)
Week 144, RT mutation K65K/RWeek 144, RT mutation K101EWeek 144, RT mutation K103K/NWeek 144, RT mutation K103NWeek 144, RT mutation G190G/A
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily00000
EFV/TDF/FTC 600/200/300 mg Once Daily11222

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Number of Participants With the Indicated Post-baseline HIV-associated Conditions and Progression, Excluding Recurrences at Week 144

Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline (BS) to a CDC CAT C event (EV); CDC CAT B at BS to a CDC CAT C EV; CDC CAT C at BS to a new CDC CAT C EV; or CDC CAT A, B, or C at BS to death. (NCT01263015)
Timeframe: From Baseline until Week 144

,
InterventionParticipants (Number)
Week 144, Any category conditionWeek 144, Any Category B conditionWeek 144, Any Category C conditionWeek 144, Any deathWeek 144, Progression from CAT A to CAT CWeek 144, Progression from CAT C to new CAT CWeek 144, Progression from CAT A, B, or C to death
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily171250410
EFV/TDF/FTC 600/200/300 mg Once Daily241762422

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Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 96 and Week 144

The percentage of participants with plasma HIV-1 RNA <50 c/mL at Week 96 and Week 144 was assessed. Plasma samples were collected for the quantitative assessment of HIV-1 RNA based on the Missing, Switch, or Discontinuation equals Failure (MSDF) algorithm,as codified by the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigationl product prior to the visit window) as non-responders, as well as participants who switched their concomitant antiretroviral therapy (ART) in certain scenarios. Since changes in ART were not permitted in this protocol, all such participants who changed ART were to be considered non-responders. Otherwise, virologic success or failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the visit of interest window. (NCT01263015)
Timeframe: Week 96 and Week 144

,
InterventionPercentage of participants (Number)
Week 96Week 144
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily7771
EFV/TDF/FTC 600/200/300 mg Once Daily7063

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Number of Participants With the Indicated Grade 1 to 4 Clinical and Hematology Toxicities at Week144

All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), asparate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphorus inorganic, total bilirubin, and triglycerides. All Grade 1 to 4 post-Baseline-emergent hematology toxities included hemoglobin, platelet count, total neutrophils, and white blood cell count. The Division of AIDS (DAIDS) defined toxicity grades as follows: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening; Grade 5, death. (NCT01263015)
Timeframe: From Baseline until Week 144

,
InterventionParticipants (Number)
Week 144, ALTWeek 144, AlbuminWeek 144, ALPWeek 144, ASTWeek 144, CO2 content/bicarbonateWeek 144, CholesterolWeek 144, CKWeek 144, CreatinineWeek 144, HyperglycaemiaWeek 144, HyperkalemiaWeek 144, HypernatremiaWeek 144, HypoglycaemiaWeek 144, HypokalemiaWeek 144, HyponatremiaWeek 144, LDL cholesterol calculationWeek 144, LipaseWeek 144, Phosphorus, inorganicWeek 144, Total bilirubinWeek 144, TriglyceridesWeek 144, HemoglobinWeek 144, Platelet countWeek 144, Total neutrophilsWeek 144, White Blood Cell count
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily620177713515691171214112438631241111092211720709
EFV/TDF/FTC 600/200/300 mg Once Daily811538513414079610512921218611111013441111198018

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Proportion of Subjects Responding Based on Plasma HIV-1 RNA <50 c/mL at Week 48

The percentage of participants with plasma HIV-1 RNA <50 c/mL at Week 48 was assessed. Plasma samples were collected for the quantitative assessment of HIV-1 RNA based on the Missing, Switch, or Discontinuation equals Failure (MSDF) algorithm,as codified by the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigationl product prior to the visit window) as non-responders, as well as participants who switched their concomitant antiretroviral therapy (ART) in certain scenarios. Since changes in ART were not permitted in this protocol, all such participants who changed ART were to be considered non-responders. Otherwise, virologic success or failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the visit of interest window. (NCT01263015)
Timeframe: Week 48

InterventionPercentage of participants (Number)
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily88
EFV/TDF/FTC 600/200/300 mg Once Daily81

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Time to Viral Suppression (<50 c/mL)

Viral suppression is defined as the first viral load value<50 c/mL. The Kaplan-Meier method was used to estimate time to viral suppression, defined as the time from the first dose of study treatment until the first viral load value <50 c/mL was reached. Participants who withdrew for any reason without having suppressed prior to the analysis were censored. (NCT01263015)
Timeframe: From Baseline until Week 144) (average of 877.4 days for DTG; average of 788.8 study days for EFV/TDF/FTC)

InterventionDays (Median)
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily28
EFV/TDF/FTC 600/200/300 mg Once Daily84

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Change From Baseline in CD4+ Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144

CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immunocompromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy. Change from Baseline was calculated as the value at Indicated visit minus the Baseline value. Only those participants available at the indicated time points were assessed (represented by n=X, X in the category titles). (NCT01263015)
Timeframe: Baseline and Week 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144

,
Interventioncells per millimeters cubed (cells/mm^3) (Mean)
Week 4, n=404,390Week 8, n=396,382Week 12, n=394,378Week 16, n=386,366Week 24, n=388,361Week 32, n=380,353Week 40, n=364,347Week 48, n=368,344Week 60, n=359,330Week 72, n=354,319Week 84, n=352,314Week 96, n=343,309Week 108, n=339,300Week 120, n=332,287Week 132, n=323,283Week 144, n=313,270
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily117.6164.6187.5214.7216.9250.5265.5267.5271.3306.1315.2322.6349.3347.0377.9379.5
EFV/TDF/FTC 600/200/300 mg Once Daily80.9124.4153.0174.1177.8208.1216.2209.5235.3269.6272.1286.0298.9311.0327.2333.3

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Change From Baseline in CD4+ Cell Counts at Week 144

Cluster of differentiation (CD4) lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immunocompromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy. Change from Baseline was calculated as the Week 144 value minus the Baseline value. The least squares mean is the estimated mean change from Baseline in CD4+ cell counts at Week 144 calculated from a repeated measures model including the following covariates: treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, treatment*visit interaction, Baseline HIV-1 RNA*visit interaction, and Baseline CD4+ cell count*visit interaction. No assumptions were made about the correlations between a participant's readings of CD4+, i.e., the correlation matrix for within-participant errors is unstructured. (NCT01263015)
Timeframe: Baseline and Week 144

Interventioncells per millimeters cubed (cells/mm^3) (Least Squares Mean)
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily378.48
EFV/TDF/FTC 600/200/300 mg Once Daily331.57

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Change From Baseline in the Symptom Bother Score (SBS) at Week 4 Through Week 48

"The Symptom Distress Module (SDM) is a 20-item, self-reported questionnaire measuring the presence/perceived distress linked to symptoms associated with HIV/its treatments. Developed with support from the AIDS Clinical Trials Group of the U.S. National Institute of Allergy and Infectious Diseases, it has demonstrated construct validity and has shown strong associations with physical/mental health summary scores and with disease severity. The SDM consists of 2 main scores: symptom count and the SBS, ranging from 0 (best) to 80 (worst) and based on the degree of bother that each symptom present posed. The SBS was calculated by adding the 20 individual bother item scores, which were calculated as: 0, I do not have this symptom; 1, It doesn't bother me; 2, It bothers me a little; 3, It bothers me; 4, It bothers me a lot. Estimates are calculated from an analysis of covariance (ANCOVA) model adjusting for age, sex, race, Baseline (BL) viral load, BL CD4+ cell count, and BL SBS." (NCT01263015)
Timeframe: Baseline and Week 4 through 48

InterventionScores on a scale (Least Squares Mean)
DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily-1.818
EFV/TDF/FTC 600/200/300 mg Once Daily-1.246

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Number of Participants Non-adherent as Measured by 3-day Recall

Number of participants reporting a missed medication dose in the past 3 days. (NCT01338025)
Timeframe: 28 Weeks

Interventionparticipants (Number)
Arm A, Non-suppressive HAART Regimen3
Arm B, 3TC or FTC Monotherapy1

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Change in HIV-1 RNA Levels

Change in HIV-1 RNA levels from Entry to Week 28 (NCT01338025)
Timeframe: 28 Weeks

Interventioncopies/mL (Median)
Arm A, Non-suppressive HAART Regimen3087
Arm B, 3TC or FTC Monotherapy-2241

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Change in CD4+ T Cell Count

Change in CD4+ T cell count from entry to Week 28 (CD4+ at entry - CD4+ at Week 28). (NCT01338025)
Timeframe: Entry to week 28

InterventionCD4+ T cell count/mL (Median)
Arm A, Non-suppressive HAART Regimen27.5
Arm B, 3TC or FTC Monotherapy76

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Number of Participants With Immunologic Deterioration

"Immunologic deterioration was declared for a participant if any one of the following conditions is observed within the first 28 weeks:~greater than or equal to 30% decline in absolute CD4+ T cell count from entry, or~development of CDC class C events.~Results report number of participants with immunologic deterioration at week 28 calculated." (NCT01338025)
Timeframe: From entry to week 28

Interventionparticipants (Number)
Arm A, Non-suppressive HAART Regimen0
Arm B, 3TC or FTC Monotherapy5

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Number of Participants With Grade 3 or Higher Adverse Event (AE) at Least One Grade Higher Than Baseline

The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. (NCT01352715)
Timeframe: From start of randomized treatment to off randomized treatment (up to 96 weeks)

Interventionparticipants (Number)
Arm A: LPV/r Plus RAL62
Arm B: LPV/r Plus Best Available NRTIs81

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Number of Participants With a Targeted Serious Non-AIDS-defining Event or Death

Serious non-AIDS diagnoses were based on ACTG Appendix 60 Diagnosis Codes (NCT01352715)
Timeframe: From study entry throughout follow-up (up to 96 weeks)

Interventionparticipants (Number)
Arm A: LPV/r Plus RAL7
Arm B: LPV/r Plus Best Available NRTIs7

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Number of Participants With a New AIDS-defining Events or Death

AIDS-defining events were those recognized by the Centers for Disease Control (CDC) and World Health Organization (WHO) (NCT01352715)
Timeframe: From study entry throughout follow-up (up to 96 weeks)

Interventionparticipants (Number)
Arm A: LPV/r Plus RAL15
Arm B: LPV/r Plus Best Available NRTIs17

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Number of Participants Discontinuing Randomized Treatment for Toxicity

Discontinuation of randomized treatment for toxicity included participant decision to discontinue for low grade toxicity. Within class NRTI changes were not considered discontinuations. (NCT01352715)
Timeframe: From Start of Randomized Treatment to Off Randomized Treatment (up to 96 weeks)

Interventionparticipants (Number)
Arm A: LPV/r Plus RAL3
Arm B: LPV/r Plus Best Available NRTIs3

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Cumulative Probability of Virologic Failure by Week 48

The primary endpoint was time to virologic failure. Virologic failure was defined as confirmed viral load >400 copies/mL at or after week 24. The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 48 was used. (NCT01352715)
Timeframe: From study entry to week 48

Interventioncumulative probability per 100 persons (Number)
Arm A: LPV/r Plus RAL10.3
Arm B: LPV/r Plus Best Available NRTIs12.4

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Change in CD4+ Cell Count From Baseline to Week 48

Change in CD4+ cell count was calculated as CD4+ cell count at week 48 minus CD4+ cell count at study entry. (NCT01352715)
Timeframe: Study entry and week 48

Interventioncells/mm^3 (Mean)
Arm A: LPV/r Plus RAL199
Arm B: LPV/r Plus Best Available NRTIs190

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Number of Participants With HIV-1 Drug Resistance Mutations in Protease, Reverse Transcriptase, and Integrase in Participants With Virologic Failure at Baseline and at Time of Virologic Failure

Mutations were defined as major IAS mutations in the IAS-USA July 2014 list. New mutations were those detected at virologic failure but not at baseline. (NCT01352715)
Timeframe: From study entry through to week 96

,
Interventionparticipants (Number)
No new IAS mutations1-2 new IAS mutations3 new IAS mutations
Arm A: LPV/r Plus RAL2991
Arm B: LPV/r Plus Best Available NRTIs32130

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Changes in Fasting Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides, and Glucose From Baseline

Fasting was for 8 hours and the metabolic panel was drawn locally. (NCT01352715)
Timeframe: Study entry and week 48

,
Interventionmg/dL (Mean)
total cholesterol changehigh-density lipoprotein (HDL) cholesterol changelow-density lipoprotein (LDL) cholesterol changetriglycerides changeglucose change
Arm A: LPV/r Plus RAL31417802
Arm B: LPV/r Plus Best Available NRTIs15210313

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Percentage of Time Spent in Hospital

The percentage of total study time that participants were in hospital. (NCT01352715)
Timeframe: From study entry throughout follow-up (up to 96 weeks)

Interventionpercentage of time spent in hospital (Number)
Arm A: LPV/r Plus RAL0.08
Arm B: LPV/r Plus Best Available NRTIs0.12

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Incidence of Elevated Venous Lactate Levels More Than 2 mmol/L of Any Etiology

incidence of elevated venous lactate levels more than 2 mmol/L of any etiology until development of lactic acidosis, orthotropic liver transplantation (OLT), death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks. (NCT01354652)
Timeframe: participants will be followed for the duration of hospital stay, an expected average of 8 weeks

Interventionparticipants (Number)
Entecavir3
Lamivudine2

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Overall OLT-free Survival

Overall OLT-free survival until development of OLT and death and participants will be followed for the duration of hospital stay or outpatients visit, an expected average of 12 months (NCT01354652)
Timeframe: Participants will be followed for the duration of hospital stay or outpatients visit, an expected average of 12 months

Interventionday (Mean)
Entecavir411
Lamivudine175

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3TC-TP Drug Levels Compared Between HIV Negative and HIV Infected Subject

To compare 3TC- triphosphate concentrations in HIV-negative versus HIV-infected subjects. (NCT01386970)
Timeframe: Day 12 of dosing

Interventionpmol/10^6 cells (Median)
HIV-negative7.25
HIV-infected5.3

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ZDV-TP Drug Levels Compared Between HIV Negative and HIV Infected Subject

To compare ZDV- triphosphate concentrations in HIV-negative versus HIV-infected subjects. (NCT01386970)
Timeframe: Day 12 of dosing

Interventionpmol/10^6 cells (Median)
HIV-negative33.89
HIV-infected29.7

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Change in CD4+ Cell Count From Randomisation to 12 Months Post-randomisation

Difference between 12 months and randomisation CD4+ count was calculated and then summarised (NCT01387022)
Timeframe: Measured at 12 months post ART initiation

Interventioncells/uL (Median)
Tenofovir-containing Regimen217
Tenofovir-sparing Regimen174

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Reported Adverse Events With Severity Grades 3 and 4 Based on the DAIDS Toxicity Grading Tables

(NCT01387022)
Timeframe: From randomisation until either time of termination or time of death

InterventionParticipants (Count of Participants)
Tenofovir-containing Regimen7
Tenofovir-sparing Regimen12

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Tenofovir Resistance, Defined as Presence of K65R, K70E or Any of the TAMS Mutations

(NCT01387022)
Timeframe: From randomisation until either time of termination or time of death

InterventionParticipants (Count of Participants)
Tenofovir-containing Regimen1
Tenofovir-sparing Regimen1

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The Antiretroviral Treatment Failure Rate at 12 Months.

Treatment failure is defined as viral load > 50 copies/ml, antiretroviral regimen changes for treatment failure or death (NCT01387022)
Timeframe: 12 months post ART intiation or until time of death

Interventionparticipants (Number)
Tenofovir-containing Regimen4
Tenofovir-sparing Regimen5

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Overall Study: Percentage of Participants With HBeAg Seroconversion

Observed values. Seroconversion=negative HBeAg with detectable anti-HBe antibody. (NCT01438424)
Timeframe: Study entry to Week 216

InterventionPercentage of participants (Number)
At study entry (n=1051)Week 12 (n=931)Week 24 (n=934)Week 48 (n=862)Week 72 (n=755)Week 96 (n=678)Week 120 (n=607)Week 144 (n=587)Week 168 (n=517)Week 192 (n=491)Week 216 (n=434)
Entecavir, 1.0 mg, With or Without Lamivudine3033343632343637394240

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Overall Study: Percentage of Participants Who Achieved ALT Normalization

ULN=upper limit of normal. ALT normalization=ALT levels ≤1.0*ULN. (NCT01438424)
Timeframe: Study entry to Week 216

InterventionPercentage of participants (Number)
At study entry (n=1019)Week 48 (n=942)Week 144 (n=627)Week 216 (n=482)
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine40757478

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Overall Study: Percentage of Participants Who Achieved a Loss of Hepatitis B e Antigen (HBeAg)

Observed values. (NCT01438424)
Timeframe: Study entry to Week 216

InterventionPercentage of participants (Number)
At study entry (n=1051)Week 12 (n=935)Week 24 (n=939)Week 48 (n=864)Week 72 (n=752)Week 96 (n=679)Week 120 (n=609)Week 144 (n=587)Week 168 (n=518)Week 192 (n=491)Week 216 (n=436)
Entecavir, 1.0 mg, With or Without Lamivudine3440424645505153586059

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Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay

Observed values. (NCT01438424)
Timeframe: Baseline to Week 192

InterventionPercentage of participants (Number)
Baseline: <300 copies/mL (n=1051)Baseline: 300 - <1.0E3 copies/mL (n=1051)Baseline: 1.0E3 - <1.0E4 copies/mL (n=1051)Baseline: 1.0E4 - <1.0E5 copies/mL (n=1051)Baseline: 1.0E5 - <1.0E6 copies/mL (n=1051)Baseline: 1.0E6 - <1.0E7 copies/mL (n=1051)Baseline: 1.0E7 - <1.0E8 copies/mL (n=1051)Baseline: 1.0E8 - <1.0E9 copies/mL (n=1051)Baseline: 1.0E9 - <1.0E10 copies/mL (n=1051)Baseline: >= 1.0E10 copies/mL (n=1051)Week 192: < 300 copies/mL (n=485)Week 192: 300 - <1.0E3 copies/mL (n=485)Week 192: 1.0E3 - <1.0E4 copies/mL (n=485)Week 192: 1.0E4 - <1.0E5 copies/mL (n=485)Week 192: 1.0E5 - <1.0E6 copies/mL (n=485)Week 192: 1.0E6 - <1.0E7 copies/mL (n=485)Week 192: 1.0E7 - <1.0E8 copies/mL (n=485)Week 192: 1.0E8 - <1.0E9 copies/mL (n=485)Week 192: 1.0E9 - <1.0E10 copies/mL (n=485)Week 192: >= 1.0E10 copies/mL (n=485)
Entecavir, 1.0 mg, With or Without Lamivudine17488121381113678334221520

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Overall Study: Number of Participants With Normal Pancreatic Enzyme and Renal Function Values at Baseline and Abnormalities in Pancreatic Enzyme and Renal Function Laboratory Test Results at End of Dosing

Amylase: Grade 1=1.10-<1.40*ULN; Grade 2=1.40-< 2.10*ULN; Grade 3=2.10-5.00*ULN; Grade 4=>5.00*ULN. Lipase: Grade 1.1-<1.4*ULN; Grade 2=1.4-<2.1*ULN; Grade 3=2.1-5.0*ULN; Grade 4=>5.0*ULN. Creatinine: Grade 1=1.10-< 1.60*ULN; Grade 2=1.60-<3.10*ULN; Grade 3=3.10-6.00*ULN; Grade 4=>6.00*ULN. Blood urea nitrogen (BUN): Grade 1=1.25-<2.60*ULN; Grade 2=2.60-<5.10*ULN; Grade 3=5.10-10*ULN; Grade 4=>10*ULN. ULN=upper limit of normal. (NCT01438424)
Timeframe: Day 1 of treatment through Week 240

InterventionParticipants (Number)
Amylase (All grades) (n=875)Lipase (All grades) (n=390)Amylase (Grades 3-4) (n=875)Lipase (Grades 3-4) (n=390)BUN/Urea (All grades) (n=998)Creatinine (All grades) (n=1000)BUN/Urea (Grades 3-4) (n=998)Creatinine (Grades 3-4) (n=1000)
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine1791261338576102

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Overall Study: Number of Participants With Normal Hematology Values at Baseline and Abnormalities in Hematology Laboratory Test Results Through Week 240

Hemoglobin (g/dL): Grade (Gr) 1=9.5-11.0; Gr 2=8.0-<9.5; Gr 3=6.5-<8.0; Gr 4=<6.5 White blood cells (cells/mm^3): Gr 1=2,500-<4,000; Gr 2=1,000-<2,500; Gr 3=800-<1,000; Gr 4=<800. Neutrophils (cells/mm^3): Gr 1=1000-<1500; Gr 2=750-<1000; Gr 3=500-<750; Gr 4=<500. Platelets (cells/mm^3): Gr 1=75,000-99,000; Gr 2=50,000-<75,000; Gr 3=20,000-<50,000; Gr 4=<20,000. Prothrombin time (seconds): Gr 1=1.01-<1.26*ULN; Gr 2=1.26-<1.51 *ULN; Gr 3=1.51-3*ULN; Gr 4=>3*ULN. INR: Gr 1=1.24-1.5; Gr 2=1.5-2; Gr 3=2-3; Gr 4=>3. INR=international normalized ratio; ULN=upper limit of normal. . (NCT01438424)
Timeframe: Day 1 of treatment through Week 240

InterventionParticipants (Number)
Hemoglobin (All grades) (n=1007)White blood cells (All grades) (n=950)Neutrophils (All grades) (n=1002)Platelets (All grades) (n=979)Protrombin time (All grades) (n=746)INR (All grades)(n=746)Hemoglobin (Grades 3-4) (n=1007)White blood cells (Grades 3-4) (n=950)Neutrophils (Grades 3-4) (n=1002)Platelets (Grades 3-4) (n=979)Prothrombin time (Grades 3-4) (n=746)INR (Grades 3-4) (n=746)
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine4922610951226214212112112

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Overall Study: Number of Participants With Normal Electrolyte and Fasting Glucose Values at Baseline and Abnormalities in Electrolyte and Fasting Glucose Laboratory Test Results at End of Dosing

Hypochloremia: Grade (Gr) 1=90-93; Gr 2=85-<90; Gr 3=80-<85; Gr 4=40-<80. Hyperchloremia: Gr 1=113-<117; Gr 2=117-<121; Gr 3=121-125; Gr 4>125. Hypocarbia: Gr 1=19-21; Gr 2=15-<19; Gr 3=41-45; Gr 4=>45. Hypercarbia: Gr 1=31-36; Gr 2=37-40; Gr 3=41-45; Gr 4=>45. Hyponatremia: Gr 1=130-132; Gr 2=123-<130; Gr 3=116-<123; Gr 4<116. Hypernatremia: Gr 1=148-<151; Gr 2=151-<158; Gr 3=158-165; Gr 4=>165. Hypokalemia: Gr 1=3-3.4; Gr 2=2.5-<3; Gr 3=2-<2.5; Gr 4=<2. Hyperkalemia: Gr 1=5.6-<6.1; G2=6.1-<6.6; Gr 3=6.6-7; Gr 4=>7. Hypoglycemia: Gr 1=55-64; Gr 2=40-<55; Gr 3=30-< 40; G4=-<30. Hyperglycemia: Gr 1=116-<161; Gr 2=161-<251; Gr 3=251-500; Gr 4>500. (NCT01438424)
Timeframe: Day 1 of treatment through Week 240

InterventionParticipants (Number)
Hypochloremia (mEq/L) (All grades) (n=982)Hyperchloremia (mEq/L) (All grades) (n=982)Hypocarbia (mEq/L) (All grades) (n=831)Hypercarbia (mEq/L) (All grades) (n=831)Hyponatremia (mEq/L) (All grades) (n=1003)Hypernatremia (mEq/L) (All grades) (n=1003)Hypokalemia (mEq/L) (All grades) (n=993)Hyperkalemia (mEq/L) (All grades (n=993)Hypochloremia (mEq/L) (Grades 3-4) (n=982)Hyperchloremia (mEq/L) (Grades 3-4) (n=982)Hypocarbia (mEq/L) (Grades 3-4) (n=831)Hypercarbia (mEq/L) (Grades 3-4) (n=831)Hyponatremia (mEq/L)(Grades 3-4) (n=1003)Hypernatremia (mEq/L) (Grades 3-4) (n=1003)Hypokalemia (mEq/L) (Grades 3-4) (n=993)Hyperkalemia (mEq/L) (Grades 3-4) (n=993)Hypoglycemia (mg/dL) (All grades) (n=521)Hyperglycemia (mg/dL) (All grades) (n=521)Hypoglycemia (mg/dL) (Grades 3-4) (n=521)Hyperglycemia (mg/dL) (Grades 3-4) (n=521)
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine447628514868106135423714225164715034

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Overall Study: Number of Participants With Death As Outcome, Any Adverse Event (AE), Grade 3-4 AEs, Serious Adverse Events (SAEs), and Discontinuations Due to AEs

An AE is a new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not be causally related to treatment. An SAE is an unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling. ALT=alanine transaminase; ULN=upper limit of normal. (NCT01438424)
Timeframe: Continuously from Day 1 through Week 240

InterventionParticipants (Number)
Deaths on treatmentDeaths off treatmentSAEs on treatmentDiscontinuations due to AEs on treatmentAny AE on treatmentGrade 3 and 4 AEs on treatmentMalignancies on and off treatmentALT flares (ALT>2*entry and >10*ULN) on treatmentHepatic disease progression on and off treatment
Entecavir, 0.5 or 1.0 mg QD, With or Without Lamivudine18916914900203353233

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Overall Study: Mean Alanine Transaminase (ALT) Levels

Observed values. (NCT01438424)
Timeframe: Study entry to Week 216

InterventionU/L (Mean)
At study entry (n=1051)Week 12 (n=1049)Week 24 (n=1029)Week 48 (n=942)Week 72 (n=835)Week 96 (n=740)Week 120 (n=675)Week 144 (n=627)Week 168 (n=563)Week 192 (n=528)Week 216 (n=482)
Entecavir, 1.0 mg, With or Without Lamivudine109.448.7742.1037.0638.1039.3037.4338.5136.8037.3638.43

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Off-treatment Follow-up: Percentage of Participants With Sustained Hepatitis B Virus (HBV) DNA <10,000 Copies by Polymerase Chain Reaction (PCR) Assay (Amendment 11 Cohort)

The Amendment 11 Cohort consisted of participants who were hepatitis B e antigen (HBeAg) negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing.ALT=alanine aminotransferase; ULN=upper limit of normal. (NCT01438424)
Timeframe: End of dosing to Week 48 off-treatment follow-up

InterventionPercentage of participants (Number)
End of dosing current studyOff-treatment Week 48
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine10021

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Off-treatment Follow-up: Percentage of Participants With Sustained HBV DNA <1,000, <300, and <10,000 Copies/mL by PCR Assay and With ALT ≤1*ULN (Amendment 11 Cohort)

The Amendment 11 Cohort consisted of participants who were HBeAg negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR Assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing. ULN=upper limit of normal. (NCT01438424)
Timeframe: End of dosing to Weeks 48 and 96 off-treatment follow-up

InterventionPercentage of participants (Number)
Off-treatment Week 48 <1000 copies/mLOff-treatment Week 96 <1000 copies/mLOff-treatment Week 48 <300 copies/mLOff-treatment Week 96 <300 copies/mLOff treatment Week 96 <10,000 copies/mLOff treatment Week 48: ALT ≤1*ULNOff treatment Week 96: ALT ≤1*ULN
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine101073143124

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Off-treatment Follow-up: Mean Change in HBV DNA (Amendment 11 Cohort)

The Amendment 11 Cohort consisted of participants who were HBeAg negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing. (NCT01438424)
Timeframe: End of dosing to Weeks 48 and 96 off-treatment follow-up

InterventionLog10 copies/mL (Mean)
Off-treatment Week 48Off-treatment Week 96
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine1.541.18

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Overall Study: Percentage of Participants With a Confirmed ≥1 log10 Increase From Nadir in HBV DNA by PCR Assay

(NCT01438424)
Timeframe: Baseline to Week 144

InterventionPercentage of participants (Number)
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine18

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Overall Study: Mean HBV DNA Level by PCR Assay

(NCT01438424)
Timeframe: Study entry to Week 216

Interventionlog10 copies/mL (Mean)
At study entry (n=1051)Week 12 (n=1017)Week 24 (n=1010)Week 48 (n=905)Week 72 (n=769)Week 96 (n=691)Week 120 (n=629)Week 144 (n=597)Week 168 (n=514)Week 192 (n=485)Week 216 (n=455)
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine6.143.873.623.373.313.343.323.343.183.193.20

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Week 96: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay, Loss of HBeAg, HBeAg Seroconversion, and ALT ≤1.0*ULN (Lamivudine Continuous Switch Cohort)

The Lamivudine Continuous Switch Cohort consisted of participants who were nucleoside-naive, HBeAg-positive and received lamivudine in BMS study AI463-022 (NCT00035633) and enrolled in the current study with ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study. (NCT01438424)
Timeframe: Baseline to Week 96

InterventionPercentage of participants (Number)
HBV DNA <300 copies/mL (n=147)Achieved loss of HbeAg (n=129)Achieved HBeAg seroconversion (n=129)Achieved ALT ≤1.0*ULN (n=154)
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine5825876

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Week 96: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Retreatment Switch Cohort)

The Lamivudine Retreatment Switch Cohort consisted of participants who were nucleoside-naive HBeAg negative and enrolled from BMS study AI463-027 (NCT00035789) with >60 days between end of dosing in AI463-027 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study. (NCT01438424)
Timeframe: Baseline to Week 96

InterventionPercentage of participants (Number)
HBV DNA <300 copies/mL (n=69)ALT ≤1.0*ULN (n=81)
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine9781

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Week 192: Percentage of Participants With Improvement in Fibrosis (Efficacy Evaluable Cohort)

The Ishak Modification for Hepatic Activity Index (HAI) scores necroinflammatory activity in chronic hepatitis. 0=no fibrosis, 1=fibrosis expansion of some portal areas, 2=fibrosis expansion of most portal areas, 3=fibrosis expansion of most portal areas with occasional bridging, 4=fibrosis expansion of portal areas with marked bridging, 5=incomplete cirrhosis, 6=probable or definite cirrhosis. Higher score=more severe necrosis. Improvement in fibrosis=≥1-point reduction in HAI score. Cohort participants had to have adequate baseline and long-term biopsy samples and baseline Knodell scores ≥2. (NCT01438424)
Timeframe: Baseline to Week 192

InterventionPercentage of participants (Number)
Improvement in fibrosis (n=56) (Week 48)Improvement in fibrosis (n=57) (Long-term biopsy)
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine3288

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Week 192: Percentage of Participants With Histologic Improvement (Efficacy Evaluable Cohort)

The Knodell Histologic Activity Index scores stage of necrosis and grade of inflammation in liver biopsies. Components are necrosis near the portal vein, intralobular degeneration and focal necrosis, portal inflammation, and fibrosis. The 4 components are scored from 1 to 4 and 1 to 10 (necrosis near the portal vein) and combined for a total score, with 22 being the highest possible score. Higher the score for each component=greater liver damage. Histologic improvement=a ≥2-point reduction in total Knodell score and no worsening in fibrosis. Cohort participants had to have adequate baseline and long-term biopsy samples and baseline Knodell necroinflammatory scores ≥2. (NCT01438424)
Timeframe: Baseline to Week 192

InterventionPercentage of participants (Number)
Histologic improvement (n=56) (Week 48)Histologic improvement (n=57) (Long-term biopsy)
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine7396

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Week 192: Number of Participants With Death As Outcome, Any AE, Grade 3-4 AEs, SAEs, Discontinuations Due to AEs, and Abnormalities in Selected Laboratory Test Results

An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. CTC Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling. ALT=alanine aminotransferase; ULN=upper limit of normal. (NCT01438424)
Timeframe: Continuously from Day 1 through Week 192

InterventionParticipants (Number)
Deaths on studyMalignant neoplasmsSAEsDiscontinuations due to AEsAny AEGrade 3 and 4 AEsALT flares (ALT>2*entry and >10*ULN)ALT >5.0*ULNTotal bilirubin >2.5*ULNLipase >2.0*ULNCreatinine ≥0.3 mg/dL from baselineHypocarbia Grades 3-4
Entecavir, 0.5 or 1.0 mg QD, With or Without Lamivudine182713511862174301753281805

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Week 144: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Retreatment Switch Cohort)

The Lamivudine Retreatment Switch Cohort consisted of participants who were nucleoside-naive HBeAg negative and enrolled from BMS study AI463-027 (NCT00035789) with >60 days between end of dosing in AI463-027 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study. (NCT01438424)
Timeframe: Baseline to Week 144

InterventionPercentage of participants (Number)
HBV DNA <300 copies/mL (n=67)Achieved ALT ≤1.0*ULN (n=73)
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine9985

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Week 144: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Continuous Switch Cohort)

The Lamivudine Continuous Switch Cohort consisted of participants who were nucleoside-naive, HBeAg-positive and received lamivudine in BMS study AI463-022 (NCT00035633) and enrolled in the current study with ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study. (NCT01438424)
Timeframe: Baseline to Week 144

InterventionPercentage of participants (Number)
HBV DNA <300 copies/mL (n=130)Achieved ALT ≤1.0*ULN (n=135)
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine6568

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Week 144: Number of Participants With Death As Outcome, Any AE, Grade 3-4 AEs, SAEs, Discontinuations Due to AEs, and Abnormalities in Selected Laboratory Test Results

An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling. AST=aspartate aminotransferase; ULN=upper limit of normal. (NCT01438424)
Timeframe: Continuously from Day 1 through Week 144

InterventionParticipants (Number)
Deaths on studyMalignant neoplasmsSAEsDiscontinuations due to AEsAny AEGrade 3 and 4 AEsALT flares (ALT>2*entry and >10*ULN)ALT >5.0*ULNAST >5.0*ULNTotal bilirubin >2.5*ULNLipase >2.0*ULNCreatinine ≥0.5 mg/dL from baselineHypocarbia
Entecavir, 0.5 or 1.0 mg QD, With or Without Lamivudine131710713842156299353227164

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Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay, Loss of HBeAG, Seroconversion, and ALT ≤1.0*Upper Limit of Normal (ULN) (Entecavir Continuous Treatment Cohort)

The Entecavir Continuous Treatment Cohort consisted of participants from study AI463-022 (NCT00035633) who were nucleoside-naive HBeAg-positive and enrolled in the current study with ≤35 days off treatment between the last dose in AI463-022 and the first dose in the current. This cohort is considered to be on continuous entecavir treatment and permitted assessment of continuous administration of entecavir in AI463-022 and the current study. (NCT01438424)
Timeframe: Baseline to Weeks 48, 96, 144, 192, and 240

InterventionPercentage of participants (Number)
Week 48: HBV DNA <300 copies/mL (n=146)Week 96: HBV DNA <300 copies/mL (n=140)Week 144: HBV DNA <10^4 copies/mL (n=131)Week 192: HBV DNA < 10^4 copies/mL (n=108)Week 240: HBV DNA <300 copies/mL (n=94)Week 48: Loss of HBeAg (n=146)Week 96: Loss of HBeAg (n=140)Week 144: Loss of HBeAg (n=132)Week 192: Loss of HBeAg (n=111)Week 240: Loss of HBeAg (n=95)Week 48: Seroconversion (n=146)Week 96: Seroconversion (n=140)Week 144: Seroconversion (n=133)Week 192: Seroconversion (n=111)Week 240: Seroconversion (n=95)Week 48: ALT ≤1.0*ULN (n=146)Week 96: ALT ≤1.0*ULN (n=140)Week 144: ALT ≤1.0*ULN (n=134)Week 192: ALT ≤1.0*ULN (n=112)Week 240: ALT ≤1.0*ULN (n=98)
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine558389919414303941131716176578778680

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Percentage of Participants Who Achieved HBV DNA <300 and <10^4 Copies/mL by PCR Assay and ALT ≤1.0*Upper Limit of Normal (ULN) (Entecavir Retreatment Cohort)

The Entecavir Retreatment Cohort consisted of participants who were nucleoside-naive, HBeAg-negative and enrolled from BMS study AI463-027 with >60 days off treatment between the last dose in AI463-027 and the first dose in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as retreatment in the current study. (NCT01438424)
Timeframe: Baseline to Weeks 48, 96, and 144

InterventionPercentage of participants (Number)
Week 48: HBV DNA <300 copies/mL (n=119)Week 48: HBV DNA <10^4 copies/mL (n=88)Week: 48: ALT ≤1.0*ULN (n=95)Week 96: HBV DNA <300 copies/mL (n=74)Week: 96: ALT ≤1.0*ULN (n=76)Week 144: HBV DNA <300 copies/mL (n=57)Week 144: ALT ≤1.0*ULN (n=66)
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine88878391799586

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Overall Study: Percentage of Participants With Sustained HBV DNA Level <300 Copies/mL by PCR Assay

(NCT01438424)
Timeframe: Study entry to Week 192

InterventionPercentage of participants (Number)
At study entry (n=1051)Week 48 (n=905)Week 96 (n=691)Week 144 (n=597)Week 192 (n=485)
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine1763677378

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Overall Study: Percentage of Participants With Sustained HBV DNA <10^4 Copies/mL by PCR Assay

(NCT01438424)
Timeframe: Study entry to Week 192

InterventionPercentage of participants (Number)
At study entry (n=1051)Week 48 (n=905)Week 96 (n=691)Week 144 (n=597)Week 192 (n=485)
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine2876778185

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Proportion of Women With HIV-1 Drug Resistance Mutations at Screening, 2-4 Weeks Postpartum in Women Who Stopped Antiretroviral Therapy, and at the Time of Inadequate Virologic Response Using Standard and Ultrasensitive Methods.

"Consensus sequencing was performed on a sample from screening. Women were evaluated for integrase and reverse transcriptase resistance mutations separately.~Additionally, consensus sequencing was performed among women who had an inadequate virologic response (defined in the protocol) on a sample taken at that time of inadequate virologic response.~Genotypic resistance among women who stopped antiretroviral therapy was not assessed. Because World Health Organization guidelines have been updated to indicate all people living with HIV should remain on antiretroviral therapy, even postpartum women, no women stopped antiretroviral therapy after delivery. Therefore, this aspect of the outcome measure is no longer relevant and was not assessed." (NCT01618305)
Timeframe: Measured at screening and at the time of inadequate virologic response (from Week 2 antepartum through participants' last study visit 24 weeks after delivery).

InterventionProportion (Number)
Reverse transcriptase resistance at screeningIntegrase resistance at screeningReverse transcriptase resistance at viral failure
Arm A (Women).07.00.60

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Proportion of HIV-infected Infants With Genotypic Resistance to Study Drugs

Genotypic resistance to each class of study drug (reverse transcriptase inhibitors and integrase inhibitors) was assessed separately among HIV infected infants. (NCT01618305)
Timeframe: Measured on or after confirmation of HIV-infection up to the infants' last study visit at Week 24

,
InterventionProportion (Number)
Reverse transcriptase resistanceIntegrase resistance
Arm A (Infants).20.00
Arm B (Infants).00.00

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Log10 Change in Viral Load From Entry to Each Time Point Prior to Delivery

"Change in viral load from entry (or screening, if there was no entry viral load) to each study week prior to delivery, calculated on the log10 scale as log10(week X RNA) - log10(baseline RNA).~For this analysis, HIV-1 RNA values that were censored below the lower limit of quantification (LLQ) were imputed to be equal to the LLQ - 1." (NCT01618305)
Timeframe: Measured at antepartum Weeks 1, 2, 4, 6, 8, 10, 12, 14, and 16.

,
InterventionLog10 copies/mL (Median)
Week 1Week 2Week 4Week 6Week 8Week 10Week 12Week 14Week 16
Arm A (Women)-1.4-1.8-2.0-2.1-2.2-2.3-2.4-2.5-2.5
Arm B (Women)-1.5-2.1-2.4-2.4-2.4-2.3-2.5-2.5-2.7

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Proportion of Women With Plasma HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery

If there was no viral load measurement at the delivery visit, the last viral load within three weeks prior to delivery was considered. (NCT01618305)
Timeframe: Measured at participants' delivery visit (or last visit within three weeks prior to delivery)

InterventionProportion (Number)
Arm A (Women).84
Arm B (Women).94

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Proportion of Women With 1) Successful Viral Load (Plasma HIV-1 RNA VL) Decrease From Entry to Week 2 and VL Less Than 1,000 Copies/ml at All Time Points After 4 Weeks on Study Drugs, Until Delivery; and 2) Who Remain on the Assigned Study Regimen

A successful viral load decrease was defined as follows: for women having HIV-1 RNA viral load greater than or equal to 10,000 copies/mL at entry, a viral load <200 copies/mL; for women with VL less than 10,000 copies/mL at entry, a Log10 viral load decrease of at least 2.0 from entry. (NCT01618305)
Timeframe: Measured from entry through delivery (approximately 36 to 40 weeks gestation).

InterventionProportion (Number)
Arm A (Women).63
Arm B (Women).89

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Proportion of Women Who Experienced at Least One New Adverse Event of Greater Than or Equal to Grade 3 as Defined in the Division of AIDS (DAIDS) Toxicity Table

"New adverse events were those with an onset date on or after randomization. Adverse events present at baseline would only be considered New if they increased in grade on or after randomization.~All women who received at least one dose of study drug were eligible for this analysis." (NCT01618305)
Timeframe: Measured from entry through participants' last study visit, approximately 24 weeks after delivery

InterventionPropotion (Number)
Arm A (Women).30
Arm B (Women).30

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Proportion of Women Who Achieved HIV-1 RNA Virologic Suppression Below the Lower Limit of Quantification of the Assay at Delivery

"A successful outcome was defined as maternal HIV-1 RNA plasma viral load less than the lower limit of quantification (LLQ) for the testing assay, which could vary. Most (99%) women had their viral load measured using an assay with LLQ equal to 40 or 20 copies/mL.~If the viral load at delivery was missing, the last observed viral load within 21 days prior to the delivery date was considered." (NCT01618305)
Timeframe: Measured at participants' delivery visit (or last visit within three weeks prior to delivery)

InterventionProportion (Number)
Arm A (Women).58
Arm B (Women).86

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Proportion of Participants Who Discontinued Randomized Study Drug Prior to Labor and Delivery.

Only women who initiated (i.e. received at least one dose of) their randomized treatment were eligible for this outcome measure. Women were considered to have discontinued study drug if they stopped receiving efavirenz or raltegravir (whichever was assigned) prior to labor and delivery for any reason, including loss to follow-up. (NCT01618305)
Timeframe: Measured from entry through participants' delivery visit (approximately 36 to 40 weeks gestation)

InterventionProportion (Number)
Arm A (Women).05
Arm B (Women).03

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Proportion of Infants Who Experienced at Least One Adverse Event of Greater Than or Equal to Grade 3.

All infants who were live births on study were eligible for this analysis. Adverse event grades were defined based on the DAIDS toxicity table. (NCT01618305)
Timeframe: Measured from birth through infants' last study visit, approximately 24 weeks after delivery

InterventionProportion (Number)
Arm A (Infants).25
Arm B (Infants).25

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Proportion of Deliveries With a Low Birth Weight (Less Than 2,500 Grams)

The unit of analysis was the mother-infant pair or set; in the case of multiple gestation, the worst outcome was considered in analysis (e.g. if two twins were delivered to one mother, one at 2,000 grams and one at 3,000 grams, this mother-infant set would count as one instance of low birth weight in analysis because at least one of the infants had the outcome). (NCT01618305)
Timeframe: Measured within 72 hours after delivery

InterventionProportion (Number)
Arm A (Women).124
Arm B (Women).127

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Proportion of Deliveries With an Extremely Low Birth Weight (<1,500 Grams).

The unit of analysis was the mother-infant pair or set; in the case of multiple gestation, the worst outcome was considered in analysis (e.g. if two twins were delivered to one mother, one at 2,000 grams and one at 1,000 grams, this mother-infant set would count as one instance of extremely low birth weight in analysis because at least one of the infants had the outcome). (NCT01618305)
Timeframe: Measured within 72 hours after delivery

InterventionProportion (Number)
Arm A (Women).000
Arm B (Women).005

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Proportion of Women With HIV-1 RNA Vaginal Viral Load Less Than 1200 Copies/mL at Weeks 4 and 6 From Treatment Initiation

"The Week 4 and 6 participant viral loads were the viral load results obtained closest to (within four days of) the target date for that visit from initiation of treatment (for Week 4, day 24-32 after first dose; for Week 6, day 38-46 after first dose).~Vaginal swabs produce much less testable sample volume than blood plasma draws. Each vaginal swab specimen had to be diluted, and this dilution factor raised the lower limit of quantification (LLQ). The most commonly observed LLQs were 300 and 1200. For consistency, the higher LLQ was considered the threshold for this outcome measure." (NCT01618305)
Timeframe: Measured at Weeks 4 and 6 from first dose of randomized treatment, prior to delivery

,
InterventionProportion (Number)
Week 4Week 6
Arm A (Women).97.98
Arm B (Women).95.94

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Proportion of Women With HIV-1 RNA Plasma Viral Load Less Than 200 Copies/mL at Weeks 4 and 6 From Treatment Initiation

The Week 4 and 6 participant viral loads were the viral load results obtained closest to (within four days of) the target date for that visit from initiation of treatment (for Week 4, day 24-32 after first dose; for Week 6, day 38-46 after first dose). (NCT01618305)
Timeframe: Measured at Weeks 4 and 6 from first dose of randomized treatment, prior to delivery

,
InterventionProportion (Number)
Week 4Week 6
Arm A (Women).75.85
Arm B (Women).95.96

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Proportion of Women With HIV-1 Drug Resistance Mutations at Screening, 2-4 Weeks Postpartum in Women Who Stopped Antiretroviral Therapy, and at the Time of Inadequate Virologic Response Using Standard and Ultrasensitive Methods.

"Consensus sequencing was performed on a sample from screening. Women were evaluated for integrase and reverse transcriptase resistance mutations separately.~Additionally, consensus sequencing was performed among women who had an inadequate virologic response (defined in the protocol) on a sample taken at that time of inadequate virologic response.~Genotypic resistance among women who stopped antiretroviral therapy was not assessed. Because World Health Organization guidelines have been updated to indicate all people living with HIV should remain on antiretroviral therapy, even postpartum women, no women stopped antiretroviral therapy after delivery. Therefore, this aspect of the outcome measure is no longer relevant and was not assessed." (NCT01618305)
Timeframe: Measured at screening and at the time of inadequate virologic response (from Week 2 antepartum through participants' last study visit 24 weeks after delivery).

InterventionProportion (Number)
Reverse transcriptase resistance at screeningIntegrase resistance at screeningReverse transcriptase resistance at viral failureIntegrase resistance at viral failure
Arm B (Women).11.00.30.00

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Proportion of Deliveries That Were Premature (Less Than 37 Weeks Gestation)

"The unit of analysis for this outcome measure was the mother-infant set. A mother-infant set was counted as having a premature delivery if any infant in the mother-infant set was delivered prior to 37 weeks gestation (i.e. in the case of twins, if either of the twins was delivered prior to 37 weeks gestation then this set would count as one premature delivery outcome).~All mother-infant sets that delivered at least one live birth on study were eligible for this outcome." (NCT01618305)
Timeframe: Measured at delivery (within 72 hours).

InterventionProportion (Number)
Arm A (Women).105
Arm B (Women).123

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Proportion of Deliveries That Were Extremely Premature (Less Than 34 Weeks Gestation).

"The unit of analysis for this outcome measure was the mother-infant set. A mother-infant set was counted as having an extremely premature delivery if any infant in the mother-infant set was delivered prior to 34 weeks gestation (i.e. in the case of twins, if either of the twins was delivered prior to 34 weeks gestation then this set would count as one extremely premature delivery outcome).~Only women who enrolled prior to 34 weeks gestation were included in this analysis. Those that enrolled from 34 to less than 37 weeks gestation were excluded because they were already past the gestational age where this outcome could have occurred at entry." (NCT01618305)
Timeframe: At delivery (within 72 hours).

InterventionProportion (Number)
Arm A (Women).036
Arm B (Women).023

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Proportion of Deliveries That Had an Outcome of a Stillbirth/Fetal Demise.

The unit of analysis was the mother-infant set. All sets where the woman received at least one dose of study treatment and remained on study through delivery were eligible. In the case of twins, the worst outcome (i.e. a stillbirth) was used. (NCT01618305)
Timeframe: Measured at delivery (approximately 36 to 40 weeks gestation)

InterventionProportion (Number)
Arm A (Women).005
Arm B (Women).015

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Change From Baseline in Hemoglobin Level Over Time by Visit

Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

InterventionGrams per liter (Mean)
Week 2; n=57, 56, 59, 59Week 4; n=57, 57, 59, 57Week 8; n=58, 56, 56, 55Week 12; n=58, 53, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 55, 49Week 24; n=56, 53, 56, 47Week 26; n=48, 50, 53, 45Week 28; n=50, 52, 52, 45Week 32; n=51, 53, 55, 45Week 36; n=52, 53, 55, 44Week 40; n=51, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 47, 52, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 51, 42Week 96; n=46, 46, 52, 41
Efavirenz 600 mg0.70.72.02.81.10.81.92.20.10.6-0.8-0.20.02.32.41.71.9

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Change From Baseline in Hemoglobin Level Over Time by Visit

Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

,,
InterventionGrams per liter (Mean)
Week 2; n=57, 56, 59, 59Week 4; n=57, 57, 59, 57Week 8; n=58, 56, 56, 55Week 12; n=58, 53, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 55, 49Week 24; n=56, 53, 56, 47Week 26; n=48, 50, 53, 45Week 28; n=50, 52, 52, 45Week 32; n=51, 53, 55, 45Week 36; n=52, 53, 55, 44Week 40; n=51, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 47, 52, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 51, 42Week 96; n=46, 46, 52, 41Week 108; n=43, 46, 49, 0Week 120; n=41, 46, 49, 0Week 132; n=40, 46, 49, 0Week 144; n=37, 45, 46, 0Week 156; n=37, 42, 49, 0Week 168; n=35, 43, 47, 0Week 180; n=36, 41, 47, 0Week 192; n=35, 40, 47, 0Week 204; n=34, 39, 47, 0Week 216; n=32, 39, 44, 0Week 228; n=31, 39, 47, 0Week 240; n=32, 39, 47, 0Week 252; n=31, 36, 45, 0Week 264; n=32, 38, 46, 0Week 276; n=31, 38, 46, 0Week 288; n=30, 38, 44, 0Week 300; n=30, 37, 43, 0Week 312; n=31, 33, 42, 0Week 324; n=3, 4, 2, 0
GSK1265744 10 mg0.1-0.22.72.01.12.12.61.81.71.60.30.51.22.61.83.32.74.04.23.54.04.06.35.53.34.54.75.16.26.26.36.67.34.67.04.3
GSK1265744 30 mg0.00.54.83.93.53.84.83.44.03.12.92.22.74.74.54.03.33.44.73.02.65.16.04.03.54.74.14.85.86.46.05.56.85.16.110.0
GSK1265744 60 mg-0.70.62.02.62.33.13.62.51.53.52.72.1-0.52.22.43.03.63.02.12.52.32.74.82.73.03.23.43.12.15.85.55.46.95.58.020.5

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Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit

Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

InterventionLog10 copies per milliliter (Mean)
Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=59, 56, 57, 55Week 12; n=58, 52, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 47Week 24; n=56, 53, 56, 48Week 26; n=48, 50, 53, 44Week 28; n=51, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 48, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=45, 48, 52, 40
Efavirenz 600 mg-1.875-2.092-2.344-2.533-2.602-2.666-2.694-2.733-2.714-2.672-2.679-2.679-2.676-2.615-2.738-2.739-2.731

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Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit

Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

,,
InterventionLog10 copies per milliliter (Mean)
Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=59, 56, 57, 55Week 12; n=58, 52, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 47Week 24; n=56, 53, 56, 48Week 26; n=48, 50, 53, 44Week 28; n=51, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 48, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=45, 48, 52, 40Week 108; n=43, 46, 49, 0Week 120; n=41, 46, 49, 0Week 132; n=40, 46, 49, 0Week 144; n=37, 45, 47, 0Week 156; n=37, 42, 49, 0Week 168; n=35, 43, 47, 0Week 180; n=36, 41, 47, 0Week 192; n=36, 40, 47, 0Week 204; n=34, 39, 47, 0Week 216; n=33, 39, 47, 0Week 228; n=32, 39, 47, 0Week 240; n=31, 39, 45, 0Week 252; n=31, 38, 47, 0Week 264; n=32, 38, 47, 0Week 276; n=31, 38, 45, 0Week 288; n=30, 38, 45, 0Week 300; n=31, 37, 44, 0Week 312; n=31, 33, 43, 0Week 324; n=3, 4, 3, 0
GSK1265744 10 mg-2.534-2.731-2.733-2.793-2.823-2.823-2.831-2.788-2.784-2.763-2.768-2.760-2.682-2.729-2.745-2.722-2.670-2.723-2.712-2.705-2.690-2.737-2.680-2.747-2.671-2.750-2.787-2.770-2.798-2.787-2.780-2.786-2.768-2.776-2.780-2.488
GSK1265744 30 mg-2.306-2.550-2.611-2.634-2.659-2.665-2.659-2.662-2.663-2.636-2.646-2.638-2.602-2.613-2.514-2.568-2.608-2.632-2.650-2.610-2.555-2.645-2.592-2.628-2.641-2.632-2.636-2.636-2.627-2.601-2.659-2.659-2.659-2.664-2.569-2.215
GSK1265744 60 mg-2.504-2.718-2.741-2.790-2.815-2.834-2.830-2.792-2.791-2.781-2.792-2.790-2.799-2.787-2.783-2.782-2.778-2.743-2.717-2.743-2.703-2.716-2.700-2.767-2.667-2.718-2.718-2.726-2.736-2.758-2.734-2.764-2.775-2.730-2.789-2.438

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Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit

Blood samples were collected for the analysis of total neutrophils, platelet count and WBC count. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

,,
InterventionGiga cells per liter (Mean)
T. neutrophils; Week 2; n=57, 56, 59, 59T. neutrophils; Week 4; n=57, 57, 59, 57T. neutrophils; Week 8; n=58, 56, 56, 55T. neutrophils; Week 12; n=58, 53, 57, 51T. neutrophils; Week 16; n=57, 54, 57, 52T. neutrophils; Week 20; n=56, 54, 55, 49T. neutrophils; Week 24; n=56, 53, 56, 47T. neutrophils; Week 26; n=48, 50, 53, 45T. neutrophils; Week 28; n=50, 52, 52, 45T. neutrophils; Week 32; n=51, 53, 55, 45T. neutrophils; Week 36; n=52, 53, 55, 44T. neutrophils; Week 40; n=51, 53, 55, 45T. neutrophils; Week 48; n=51, 53, 54, 44T. neutrophils; Week 60; n=48, 47, 52, 44T. neutrophils; Week 72; n=47, 48, 52, 42T. neutrophils; Week 84; n=46, 48, 51, 42T. neutrophils; Week 96; n=46, 46, 52, 41T. neutrophils; Week 108; n=43, 46, 49, 0T. neutrophils; Week 120; n=41, 46, 49, 0T. neutrophils; Week 132; n=40, 46, 49, 0T. neutrophils; Week 144; n=37, 45, 46, 0T. neutrophils; Week 156; n=37, 42, 49, 0T. neutrophils; Week 168; n=35, 43, 47, 0T. neutrophils; Week 180; n=36, 41, 47, 0T. neutrophils; Week 192; n=35, 40, 47, 0T. neutrophils; Week 204; n=34, 39, 47, 0T. neutrophils; Week 216; n=32, 39, 43, 0T. neutrophils; Week 228; n=30, 39, 47, 0T. neutrophils; Week 240; n=32, 39, 47, 0T. neutrophils; Week 252; n=31, 36, 45, 0T. neutrophils; Week 264; n=32, 38, 46, 0T. neutrophils; Week 276; n=31, 38, 45, 0T. neutrophils; Week 288; n=30, 38, 44, 0T. neutrophils; Week 300; n=30, 37, 43, 0T. neutrophils; Week 312; n=31, 33, 41, 0T. neutrophils; Week 324; n=3, 4, 2, 0Platelet count; Week 2; n=57, 56, 59, 59Platelet count; Week 4; n=57, 57, 59, 57Platelet count; Week 8; n=58, 56, 56, 55Platelet count; Week 12; n=58, 53, 57, 51Platelet count; Week 16; n=57, 54, 57, 52Platelet count; Week 20; n=56, 54, 55, 49Platelet count; Week 24; n=56, 53, 56, 47Platelet count; Week 26; n=48, 50, 53, 45Platelet count; Week 28; n=50, 52, 52, 45Platelet count; Week 32; n=51, 52, 55, 45Platelet count; Week 36; n=52, 53, 55, 44Platelet count; Week 40; n=51, 53, 54, 45Platelet count; Week 48; n=51, 52, 53, 44Platelet count; Week 60; n=48, 47, 51, 44Platelet count; Week 72; n=47, 48, 52, 42Platelet count; Week 84; n=46, 48, 51, 42Platelet count; Week 96; n=46, 45, 51, 41Platelet count; Week 108; n=43, 46, 49, 0Platelet count; Week 120; n=41, 46, 49, 0Platelet count; Week 132; n=40, 46, 48, 0Platelet count; Week 144; n=37, 45, 44, 0Platelet count; Week 156; n=37, 42, 47, 0Platelet count; Week 168; n=35, 43, 46, 0Platelet count; Week 180; n=36, 41, 46, 0Platelet count; Week 192; n=35, 40, 46, 0Platelet count; Week 204; n=34, 39, 45, 0Platelet count; Week 216; n=32, 39, 44, 0Platelet count; Week 228; n=31, 39, 46, 0Platelet count; Week 240; n=32, 39, 47, 0Platelet count; Week 252; n=31, 36, 44, 0Platelet count; Week 264; n=32, 38, 45, 0Platelet count; Week 276; n=31, 38, 45, 0Platelet count; Week 288; n=30, 38, 43, 0Platelet count; Week 300; n=30, 37, 40, 0Platelet count; Week 312; n=31, 33, 41, 0Platelet count; Week 324; n=3, 4, 2, 0WBC count; Week 2; n=57, 56, 59, 59WBC count; Week 4; n=57, 57, 59, 57WBC count; Week 8; n=58, 56, 56, 55WBC; Week 12; n=58, 53, 57, 51WBC count; Week 16; n=57, 54, 57, 52WBC count; Week 20; n=56, 54, 55, 49WBC count; Week 24; n=56, 53, 56, 47WBC count; Week 26; n=48, 50, 53, 45WBC count; Week 28; n=50, 52, 52, 45WBC count; Week 32; n=51, 53, 55, 45WBC count; Week 36; n=52, 53, 55, 44WBC count; Week 40; n=51, 53, 55, 45WBC count; Week 48; n=51, 53, 54, 44WBC count; Week 60; n=48, 47, 52, 44WBC count; Week 72; n=47, 48, 52, 42WBC count; Week 84; n=46, 48, 51, 42WBC count; Week 96; n=46, 46, 52, 41WBC count; Week 108; n=43, 46, 49, 0WBC count; Week 120; n=41, 46, 49, 0WBC count; Week 132; n=40, 46, 49, 0WBC count; Week 144; n=37, 45, 46, 0WBC count; Week 156; n=37, 42, 49, 0WBC count; Week 168; n=35, 43, 47, 0WBC count; Week 180; n=36, 41, 47, 0WBC count; Week 192; n=35, 40, 47, 0WBC count; Week 204; n=34, 39, 47, 0WBC count; Week 216; n=32, 39, 43, 0WBC count; Week 228; n=31, 39, 47, 0WBC count; Week 240; n=32, 39, 47, 0WBC count; Week 252; n=31, 36, 45, 0WBC count; Week 264; n=32, 38, 46, 0WBC count; Week 276; n=31, 38, 45, 0WBC count; Week 288; n=30, 38, 44, 0WBC count; Week 300; n=30, 37, 43, 0WBC count; Week 312; n=31, 33, 41, 0WBC count; Week 324; n=3, 4, 2, 0
GSK1265744 10 mg0.0420.0380.2510.1380.3880.2700.4620.1200.4960.0710.4200.4300.3860.3740.3830.4100.6310.6230.3720.7770.6720.7620.5880.7690.4900.6180.5430.7800.5080.2680.4750.4000.4560.1390.2430.86011.09.910.313.716.517.212.08.36.67.75.211.112.520.923.713.625.924.523.816.827.126.634.928.434.733.928.128.727.215.927.948.444.128.527.331.70.190.160.370.320.450.360.470.190.670.250.560.570.430.600.630.710.950.890.590.920.911.050.971.070.610.980.880.980.790.660.620.920.920.580.571.97
GSK1265744 30 mg-0.084-0.083-0.0660.040-0.1560.0320.1090.0520.2130.1490.0290.1780.2450.4580.2740.5280.6980.5700.6500.4050.4680.4180.5340.4050.5940.6480.5880.7890.8130.7610.7610.6270.6730.4550.4170.31516.620.125.914.611.314.518.411.215.811.610.88.920.018.722.817.220.824.626.921.023.230.636.427.624.626.425.227.126.215.423.234.535.526.830.98.30.130.020.150.280.020.230.340.260.420.450.300.420.530.760.560.961.010.901.010.710.820.750.970.690.890.951.011.131.151.101.211.041.130.770.700.53
GSK1265744 60 mg0.1040.1550.3410.3590.2030.5250.4060.3750.5020.6920.5350.5750.5340.7110.6661.0060.9971.0060.7690.6710.8311.0951.0110.8400.7220.8210.9140.8191.0830.8121.1761.1060.9130.6990.5640.96014.314.118.417.717.913.719.310.317.815.411.87.817.626.622.721.121.733.120.432.233.541.240.045.427.937.633.529.127.430.832.845.846.745.435.32.00.310.300.480.730.360.770.640.660.690.930.920.810.781.041.091.431.381.351.161.021.221.641.581.331.111.241.371.311.531.171.661.571.321.020.95-0.05

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Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit

Blood samples were collected for the analysis of total neutrophils, platelet count and WBC count. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

InterventionGiga cells per liter (Mean)
T. neutrophils; Week 2; n=57, 56, 59, 59T. neutrophils; Week 4; n=57, 57, 59, 57T. neutrophils; Week 8; n=58, 56, 56, 55T. neutrophils; Week 12; n=58, 53, 57, 51T. neutrophils; Week 16; n=57, 54, 57, 52T. neutrophils; Week 20; n=56, 54, 55, 49T. neutrophils; Week 24; n=56, 53, 56, 47T. neutrophils; Week 26; n=48, 50, 53, 45T. neutrophils; Week 28; n=50, 52, 52, 45T. neutrophils; Week 32; n=51, 53, 55, 45T. neutrophils; Week 36; n=52, 53, 55, 44T. neutrophils; Week 40; n=51, 53, 55, 45T. neutrophils; Week 48; n=51, 53, 54, 44T. neutrophils; Week 60; n=48, 47, 52, 44T. neutrophils; Week 72; n=47, 48, 52, 42T. neutrophils; Week 84; n=46, 48, 51, 42T. neutrophils; Week 96; n=46, 46, 52, 41Platelet count; Week 2; n=57, 56, 59, 59Platelet count; Week 4; n=57, 57, 59, 57Platelet count; Week 8; n=58, 56, 56, 55Platelet count; Week 12; n=58, 53, 57, 51Platelet count; Week 16; n=57, 54, 57, 52Platelet count; Week 20; n=56, 54, 55, 49Platelet count; Week 24; n=56, 53, 56, 47Platelet count; Week 26; n=48, 50, 53, 45Platelet count; Week 28; n=50, 52, 52, 45Platelet count; Week 32; n=51, 52, 55, 45Platelet count; Week 36; n=52, 53, 55, 44Platelet count; Week 40; n=51, 53, 54, 45Platelet count; Week 48; n=51, 52, 53, 44Platelet count; Week 60; n=48, 47, 51, 44Platelet count; Week 72; n=47, 48, 52, 42Platelet count; Week 84; n=46, 48, 51, 42Platelet count; Week 96; n=46, 45, 51, 41WBC count; Week 2; n=57, 56, 59, 59WBC count; Week 4; n=57, 57, 59, 57WBC count; Week 8; n=58, 56, 56, 55WBC; Week 12; n=58, 53, 57, 51WBC count; Week 16; n=57, 54, 57, 52WBC count; Week 20; n=56, 54, 55, 49WBC count; Week 24; n=56, 53, 56, 47WBC count; Week 26; n=48, 50, 53, 45WBC count; Week 28; n=50, 52, 52, 45WBC count; Week 32; n=51, 53, 55, 45WBC count; Week 36; n=52, 53, 55, 44WBC count; Week 40; n=51, 53, 55, 45WBC count; Week 48; n=51, 53, 54, 44WBC count; Week 60; n=48, 47, 52, 44WBC count; Week 72; n=47, 48, 52, 42WBC count; Week 84; n=46, 48, 51, 42WBC count; Week 96; n=46, 46, 52, 41
Efavirenz 600 mg0.7160.3750.2730.5250.3670.7400.6370.4490.4460.7170.4140.7300.6650.8000.8920.7900.83117.115.610.311.29.317.123.917.517.213.812.318.920.630.828.318.917.50.690.290.270.540.360.780.550.350.390.710.360.750.730.951.020.950.92

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Number of Participants With Adherence to Study Treatment

Number of participants with >=90% adherence to study treatment based on pill count is summarized. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312

InterventionParticipants (Count of Participants)
Baseline; n=57, 55, 56, 52Week 4; n=54, 52, 53, 50Week 8; n=53, 50, 56, 48Week 12; n=55, 48, 53, 48Week 16; n=53, 51, 53, 44Week 20; n=51, 49, 55, 44Week 24; n=51, 46, 51, 43Week 28; n=49, 48, 53, 41Week 32; n=47, 48, 55, 41Week 36; n=46, 48, 50, 41Week 40; n=38, 35, 45, 39Week 48; n=33, 37, 45, 35Week 60; n=38, 38, 40, 37Week 72; n=35, 37, 44, 32Week 84; n=36, 39, 42, 33Week 96; n=31, 36, 33, 0Week 108; n=23, 23, 29, 0Week 120; n=30, 38, 41, 0Week 132; n=29, 32, 40, 0Week 144; n=33, 34, 43, 0Week 156; n=31, 28, 39, 0Week 168; n=29, 33, 41, 0Week 180; n=26, 29, 39, 0Week 192; n=30, 30, 39, 0Week 204; n=29, 32, 38, 0Week 216; n=29, 30, 37, 0Week 228; n=27, 34, 40, 0Week 240; n=28, 26, 41, 0Week 252; n=23, 26, 33, 0Week 264; n=15, 18, 24, 0Week 276; n=14, 14, 21, 0Week 288; n=12, 14, 18, 0Week 300; n=12, 13, 20, 0
GSK1265744 60 mg555253465051484852484141374139302739354135353435333135352921181718

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Number of Participants With Adherence to Study Treatment

Number of participants with >=90% adherence to study treatment based on pill count is summarized. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312

,
InterventionParticipants (Count of Participants)
Baseline; n=57, 55, 56, 52Week 4; n=54, 52, 53, 50Week 8; n=53, 50, 56, 48Week 12; n=55, 48, 53, 48Week 16; n=53, 51, 53, 44Week 20; n=51, 49, 55, 44Week 24; n=51, 46, 51, 43Week 28; n=49, 48, 53, 41Week 32; n=47, 48, 55, 41Week 36; n=46, 48, 50, 41Week 40; n=38, 35, 45, 39Week 48; n=33, 37, 45, 35Week 60; n=38, 38, 40, 37Week 72; n=35, 37, 44, 32Week 84; n=36, 39, 42, 33Week 96; n=31, 36, 33, 0Week 108; n=23, 23, 29, 0Week 120; n=30, 38, 41, 0Week 132; n=29, 32, 40, 0Week 144; n=33, 34, 43, 0Week 156; n=31, 28, 39, 0Week 168; n=29, 33, 41, 0Week 180; n=26, 29, 39, 0Week 192; n=30, 30, 39, 0Week 204; n=29, 32, 38, 0Week 216; n=29, 30, 37, 0Week 228; n=27, 34, 40, 0Week 240; n=28, 26, 41, 0Week 252; n=23, 26, 33, 0Week 264; n=15, 18, 24, 0Week 276; n=14, 14, 21, 0Week 288; n=12, 14, 18, 0Week 300; n=12, 13, 20, 0Week 312; n=1, 1, 0, 0
GSK1265744 10 mg5346494444454745464033323732342521282832302924282729252818121312111
GSK1265744 30 mg514945404540414642433033353536322036302925242427262728222116131071

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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase

An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Maintenance Safety Population comprised of all participants randomized to GSK1265744 and who were exposed to investigational products during the maintenance phase of the study with the exception of any participants with documented evidence of not having consumed any amount of investigational product. (NCT01641809)
Timeframe: Week 24 to Week 96

,,,
InterventionParticipants (Count of Participants)
Any AEAny SAE
Efavirenz 600 mg352
GSK1265744 10 mg405
GSK1265744 30 mg505
GSK1265744 60 mg505

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Number of Participants With AEs and SAEs Over Time

An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Safety Population comprised of all randomized participants who were exposed to investigational products with the exception of any participants with documented evidence of not having consumed any amount of investigational product. (NCT01641809)
Timeframe: Up to Week 324

,,,
InterventionParticipants (Count of Participants)
Any AEAny SAE
Efavirenz 600 mg604
GSK1265744 10 mg5713
GSK1265744 30 mg5712
GSK1265744 60 mg6011

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Number of Participants With AEs and SAEs-Induction Phase

An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. (NCT01641809)
Timeframe: Up to Week 24

,,,
InterventionParticipants (Count of Participants)
Any AEAny SAE
Efavirenz 600 mg592
GSK1265744 10 mg542
GSK1265744 30 mg540
GSK1265744 60 mg552

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Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time

Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, cholesterol, CK, creatinine, glucose, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Up to Week 324

,,,
InterventionParticipants (Count of Participants)
ALT; Grade 1ALT; Grade 2ALT; Grade 3ALT; Grade 4Albumin; Grade 1Albumin; Grade 2Albumin; Grade 3Albumin; Grade 4ALP; Grade 1ALP; Grade 2ALP; Grade 3ALP; Grade 4AST; Grade 1AST; Grade 2AST; Grade 3AST; Grade 4CO2/bicarbonate; Grade 1CO2/bicarbonate; Grade 2CO2/bicarbonate; Grade 3CO2/bicarbonate; Grade 4Cholesterol; Grade 1Cholesterol; Grade 2Cholesterol; Grade 3Cholesterol; Grade 4CK; Grade 1CK; Grade 2CK; Grade 3CK; Grade 4Creatinine; Grade 1Creatinine; Grade 2Creatinine; Grade 3Creatinine; Grade 4Glucose; Grade 1Glucose; Grade 2Glucose; Grade 3Glucose; Grade 4LDL cholesterol; Grade 1LDL cholesterol; Grade 2LDL cholesterol; Grade 3LDL cholesterol; Grade 4Lipase; Grade 1Lipase; Grade 2Lipase; Grade 3Lipase; Grade 4Inorganic phosphorus; Grade 1Inorganic phosphorus; Grade 2Inorganic phosphorus; Grade 3Inorganic phosphorus; Grade 4Potassium; Grade 1Potassium; Grade 2Potassium; Grade 3Potassium; Grade 4Sodium; Grade 1Sodium; Grade 2Sodium; Grade 3Sodium; Grade 4Total bilirubin; Grade 1Total bilirubin; Grade 2Total bilirubin; Grade 3Total bilirubin; Grade 4Triglycerides; Grade 1Triglycerides; Grade 2Triglycerides; Grade 3Triglycerides; Grade 4
Efavirenz 600 mg84010000500072328100910605045110012601874010710892041001110000000111
GSK1265744 10 mg960100002000762261001773092371100191400147401195251120140001420072000110
GSK1265744 30 mg1261110001100138011400017120010426100018100017112098203111070001210013100400
GSK1265744 60 mg1950200004000155409000191530124452000211120131470911621065080001600084000331

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Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase

Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, chloride, cholesterol, CK, creatinine, glucose, high density lipoprotein (HDL) cholesterol, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin, triglycerides and urea/blood urea nitrogen (BUN). A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Up to Week 24

,,,
InterventionParticipants (Count of Participants)
ALT; Grade 1ALT; Grade 2ALT; Grade 3ALT; Grade 4Albumin; Grade 1Albumin; Grade 2Albumin; Grade 3Albumin; Grade 4ALP; Grade 1ALP; Grade 2ALP; Grade 3ALP; Grade 4AST; Grade 1AST; Grade 2AST; Grade 3AST; Grade 4CO2/bicarbonate; Grade 1CO2/bicarbonate; Grade 2CO2/bicarbonate; Grade 3CO2/bicarbonate; Grade 4Chloride; Grade 1Chloride; Grade 2Chloride; Grade 3Chloride; Grade 4Cholesterol; Grade 1Cholesterol; Grade 2Cholesterol; Grade 3Cholesterol; Grade 4CK; Grade 1CK; Grade 2CK; Grade 3CK; Grade 4Creatinine; Grade 1Creatinine; Grade 2Creatinine; Grade 3Creatinine; Grade 4Glucose; Grade 1Glucose; Grade 2Glucose; Grade 3Glucose; Grade 4HDL cholesterol; Grade 1HDL cholesterol; Grade 2HDL cholesterol; Grade 3HDL cholesterol; Grade 4LDL cholesterol; Grade 1LDL cholesterol; Grade 2LDL cholesterol; Grade 3LDL cholesterol; Grade 4Lipase; Grade 1Lipase; Grade 2Lipase; Grade 3Lipase; Grade 4Inorganic phosphorus; Grade 1Inorganic phosphorus; Grade 2Inorganic phosphorus; Grade 3Inorganic phosphorus; Grade 4Potassium; Grade 1Potassium; Grade 2Potassium; Grade 3Potassium; Grade 4Sodium; Grade 1Sodium; Grade 2Sodium; Grade 3Sodium; Grade 4Total bilirubin; Grade 1Total bilirubin; Grade 2Total bilirubin; Grade 3Total bilirubin; Grade 4Triglycerides; Grade 1Triglycerides; Grade 2Triglycerides; Grade 3Triglycerides; Grade 4Urea/BUN; Grade 1Urea/BUN; Grade 2Urea/BUN; Grade 3Urea/BUN; Grade 4
Efavirenz 600 mg8400000030006120600000004960412411006501000048206510682021008100000002010000
GSK1265744 10 mg31000000000062101000000073007232010010500000054009620561070007000020000000000
GSK1265744 30 mg4500000011008500500000008200521400008300000091003110221010004000110001000000
GSK1265744 60 mg1300200004000713010000000123206312000013120000085305741722020007000410003100000

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Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit

Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

,,
InterventionLog10 copies per milliliter (Mean)
Baseline; n=60, 60, 61, 62Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=59, 56, 57, 55Week 12; n=58, 52, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 47Week 24; n=56, 53, 56, 48Week 26; n=48, 50, 53, 44Week 28; n=51, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 48, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=45, 48, 52, 40Week 108; n=43, 46, 49, 0Week 120; n=41, 46, 49, 0Week 132; n=40, 46, 49, 0Week 144; n=37, 45, 47, 0Week 156; n=37, 42, 49, 0Week 168; n=35, 43, 47, 0Week 180; n=36, 41, 47, 0Week 192; n=36, 40, 47, 0Week 204; n=34, 39, 47, 0Week 216; n=33, 39, 47, 0Week 228; n=32, 39, 47, 0Week 240; n=31, 39, 45, 0Week 252; n=31, 38, 47, 0Week 264; n=32, 38, 47, 0Week 276; n=31, 38, 45, 0Week 288; n=30, 38, 45, 0Week 300; n=31, 37, 44, 0Week 312; n=31, 33, 43, 0Week 324; n=3, 4, 3, 0
GSK1265744 10 mg4.4241.8831.7061.6951.6431.6191.6231.6151.5951.5911.6091.6041.6121.6861.6481.6251.6451.6811.6341.6381.6461.6821.6341.6651.6131.6891.6281.5911.5911.5961.5911.5911.5911.5911.6011.5971.591
GSK1265744 30 mg4.2701.9841.7311.6661.6181.6021.5961.5971.6021.6071.6201.6101.6181.6541.5981.6971.6431.6031.6091.5911.6311.6981.6031.6421.5911.5911.5951.5921.5911.6011.5991.5911.5911.5921.5911.6001.591
GSK1265744 60 mg4.4281.9391.7251.6661.6411.6161.5991.6031.5941.5911.6181.6061.6081.5981.5941.5911.5921.5961.5911.6181.5911.6301.6191.6031.6001.6991.6341.6341.6251.5911.5931.6171.6181.5911.6251.5911.591

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Maximum Observed Concentration (Cmax) for GSK1265744 at Week 2

Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. (NCT01641809)
Timeframe: pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2

InterventionMicrograms per milliliter (Geometric Mean)
GSK1265744 10 mg2.77
GSK1265744 30 mg7.49
GSK1265744 60 mg13.12

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Concentration at the End of a Dosing Interval (Ctau) for GSK1265744 at Week 2

Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. (NCT01641809)
Timeframe: pre-dose, 1, 2, 3, 4, 8 and 24 hours post dose at Week 2

InterventionMicrograms per milliliter (Geometric Mean)
GSK1265744 10 mg1.45
GSK1265744 30 mg4.34
GSK1265744 60 mg5.83

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Area Under the Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) for GSK1265744 at Week 2

Blood samples for pharmacokinetic (PK) analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. The PK Summary Population comprised of all participants who received GSK1265744 or with Rilpivirine, underwent intensive and/or limited/sparse PK sampling during the study, and provided evaluable GSK1265744 and Rilpivirine plasma concentration data (NCT01641809)
Timeframe: pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2

InterventionHours*micrograms per milliliter (Geometric Mean)
GSK1265744 10 mg45.69
GSK1265744 30 mg133.74
GSK1265744 60 mg227.58

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Change From Baseline in Estimated Creatinine Clearance Over Time by Visit

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264

InterventionMilliliters per minute (Mean)
Week 2; n=1, 1, 0, 3Week 4; n=58, 57, 59, 57Week 8; n=2, 1, 1, 1Week 16; n=55, 53, 56, 49Week 24; n=52, 53, 55, 46Week 26; n=0, 1, 0, 0Week 40; n=0, 1, 0, 0Week 48; n=51, 50, 54, 44Week 96; n=45, 48, 52, 40Week 204; n=0, 1, 0, 0Week 252; n=0, 1, 0, 0
GSK1265744 30 mg-10.0-3.7-1.00.2-6.4-7.0-95.0-1.1-2.4-23.00.0

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Change From Baseline in Estimated Creatinine Clearance Over Time by Visit

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264

InterventionMilliliters per minute (Mean)
Week 4; n=58, 57, 59, 57Week 8; n=2, 1, 1, 1Week 16; n=55, 53, 56, 49Week 24; n=52, 53, 55, 46Week 48; n=51, 50, 54, 44Week 96; n=45, 48, 52, 40Week 264; n=0, 0, 1, 0
GSK1265744 60 mg-4.97.0-2.7-5.8-4.5-9.0-143.0

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Change From Baseline in Estimated Creatinine Clearance Over Time by Visit

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264

InterventionMilliliters per minute (Mean)
Week 2; n=1, 1, 0, 3Week 4; n=58, 57, 59, 57Week 8; n=2, 1, 1, 1Week 16; n=55, 53, 56, 49Week 20; n=2, 0, 0, 1Week 24; n=52, 53, 55, 46Week 48; n=51, 50, 54, 44Week 60; n=0, 0, 0, 1Week 96; n=45, 48, 52, 40
Efavirenz 600 mg-0.7-0.10.03.44.04.80.416.05.1

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Number of Participants With Adherence to Study Treatment

Number of participants with >=90% adherence to study treatment based on pill count is summarized. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312

InterventionParticipants (Count of Participants)
Baseline; n=57, 55, 56, 52Week 4; n=54, 52, 53, 50Week 8; n=53, 50, 56, 48Week 12; n=55, 48, 53, 48Week 16; n=53, 51, 53, 44Week 20; n=51, 49, 55, 44Week 24; n=51, 46, 51, 43Week 28; n=49, 48, 53, 41Week 32; n=47, 48, 55, 41Week 36; n=46, 48, 50, 41Week 40; n=38, 35, 45, 39Week 48; n=33, 37, 45, 35Week 60; n=38, 38, 40, 37Week 72; n=35, 37, 44, 32Week 84; n=36, 39, 42, 33
Efavirenz 600 mg484447434241393537363433352729

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Change From Baseline in ALT, AST and CK Over Time by Visit

Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

,,
InterventionInternational Units per Liter (Mean)
ALT; Week 2; n=58, 56, 58, 58ALT; Week 4; n=58, 57, 59, 57ALT; Week 8; n=58, 55, 57, 54ALT; Week 12; n=58, 53, 57, 51ALT; Week 16; n=57, 54, 57, 52ALT; Week 20; n=56, 54, 55, 49ALT; Week 24; n=56, 53, 56, 47ALT; Week 26; n=48, 50, 53, 45ALT; Week 28; n=51, 52, 52, 45ALT; Week 32; n=52, 53, 55, 45ALT; Week 36; n=52, 52, 55, 45ALT; Week 40; n=52, 53, 55, 44ALT; Week 48; n=51, 53, 54, 44ALT; Week 60; n=48, 47, 53, 44ALT; Week 72; n=47, 47, 52, 42ALT; Week 84; n=46, 48, 52, 42ALT; Week 96; n=45, 48, 52, 40ALT; Week 108; n=43, 46, 48, 0ALT; Week 120; n=40, 45, 48, 0ALT; Week 132; n=40, 46, 49, 0ALT; Week 144; n=37, 45, 47, 0ALT; Week 156; n=37, 42, 49, 0ALT; Week 168; n=35, 43, 47, 0ALT; Week 180; n=36, 41, 47, 0ALT; Week 192; n=36, 39, 47, 0ALT; Week 204; n=34, 39, 47, 0ALT; Week 216; n=33, 39, 46, 0ALT; Week 228; n=32, 39, 47, 0ALT; Week 240; n=30, 39, 46, 0ALT; Week 252; n=31, 38, 46, 0ALT; Week 264; n=32, 38, 47, 0ALT; Week 276; n=31, 38, 45, 0ALT; Week 288; n=31, 38, 45, 0ALT; Week 300; n=30, 37, 44, 0ALT; Week 312; n=31, 34, 43, 0ALT; Week 324; n=3, 4, 3, 0AST; Week 2; n=58, 56, 58, 58AST; Week 4; n=58, 57, 59, 57AST; Week 8; n=58, 55, 57, 54AST; Week 12; n=58, 53, 57, 50AST; Week 16; n=57, 54, 57, 52AST; Week 20; n=56, 54, 55, 49AST; Week 24; n=56, 53, 56, 47AST; Week 26; n=48, 50, 53, 45AST; Week 28; n=51, 52, 52, 45AST; Week 32; n=52, 53, 55, 45AST; Week 36; n=52, 52, 55, 45AST; Week 40; n=52, 53, 55, 44AST; Week 48; n=51, 53, 54, 44AST; Week 60; n=48, 47, 53, 44AST; Week 72; n=47, 47, 52, 42AST; Week 84; n=46, 48, 52, 42AST; Week 96; n=45, 48, 52, 40AST; Week 108; n=43, 46, 48, 0AST; Week 120; n=40, 45, 48, 0AST; Week 132; n=40, 46, 49, 0AST; Week 144; n=37, 45, 47, 0AST; Week 156; n=37, 42, 49, 0AST; Week 168; n=35, 43, 47, 0AST; Week 180; n=36, 41, 47, 0AST; Week 192; n=36, 39, 47, 0AST; Week 204; n=34, 39, 47, 0AST; Week 216; n=33, 39, 46, 0AST; Week 228; n=32, 39, 47, 0AST; Week 240; n=30, 39, 46, 0AST; Week 252; n=31, 38, 46, 0AST; Week 264; n=32, 38, 47, 0AST; Week 276; n=31, 38, 45, 0AST; Week 288; n=31, 38, 45, 0AST; Week 300; n=30, 37, 44, 0AST; Week 312; n=31, 34, 43, 0AST; Week 324; n=3, 4, 3, 0CK; Week 2; n=58, 56, 58, 58CK; Week 4; n=58, 57, 59, 57CK; Week 8; n=58, 55, 57, 54CK; Week 12; n=58, 53, 57, 51CK; Week 16; n=57, 54, 57, 52CK; Week 20; n=56, 54, 55, 49CK; Week 24; n=56, 53, 56, 47CK; Week 26; n=48, 50, 53, 45CK; Week 28; n=51, 52, 52, 45CK; Week 32; n=52, 53, 55, 45CK; Week 36; n=52, 52, 55, 45CK; Week 40; n=52, 53, 55, 44CK; Week 48; n=51, 53, 54, 44CK; Week 60; n=48, 47, 53, 44CK; Week 72; n=47, 47, 52, 42CK; Week 84; n=46, 48, 52, 42CK; Week 96; n=45, 48, 52, 40CK; Week 108; n=43, 46, 48, 0CK; Week 120; n=40, 45, 48, 0CK; Week 132; n=40, 46, 49, 0CK; Week 144; n=37, 45, 47, 0CK; Week 156; n=37, 42, 49, 0CK; Week 168; n=35, 43, 47, 0CK; Week 180; n=36, 41, 47, 0CK; Week 192; n=36, 39, 47, 0CK; Week 204; n=34, 39, 47, 0CK; Week 216; n=33, 39, 46, 0CK; Week 228; n=32, 39, 47, 0CK; Week 240; n=30, 39, 46, 0CK; Week 252; n=31, 38, 46, 0CK; Week 264; n=32, 38, 47, 0CK; Week 276; n=31, 38, 45, 0CK; Week 288; n=31, 38, 45, 0CK; Week 300; n=30, 37, 44, 0CK; Week 312; n=31, 34, 43, 0CK; Week 324; n=3, 4, 3, 0
GSK1265744 10 mg0.1-0.72.21.22.1-0.7-2.11.1-2.3-3.10.80.1-4.1-1.0-2.8-2.4-0.40.54.44.30.1-0.52.31.74.91.91.736.85.32.03.33.36.64.85.517.70.7-1.04.21.3-0.71.3-1.43.3-2.0-2.74.60.1-3.3-0.9-2.7-2.2-0.8-1.00.1-0.2-3.4-3.0-0.8-1.9-1.5-1.7-2.713.5-1.0-2.2-1.6-1.5-1.4-2.011.72.740.0-2.3216.9120.6-2.0144.227.5133.79.83.1325.957.1-1.3115.4-19.8-0.7335.464.211.530.610.6-5.327.722.45.279.143.264.01.224.61.939.921.625.3727.5-1.3
GSK1265744 30 mg-2.1-2.60.52.70.1-3.6-1.2-2.6-2.3-1.7-4.2-4.1-3.8-2.62.71.920.6-2.7-2.6-3.0-3.4-1.8-1.1-2.8-3.3-1.7-3.0-1.1-0.12.80.72.91.2-1.47.61.3-1.3-2.81.51.61.9-3.1-0.3-0.9-0.2-1.0-2.1-2.9-3.2-2.03.72.020.5-4.0-2.5-3.9-4.3-3.2-3.4-4.2-5.3-4.8-4.9-5.9-5.3-2.1-4.3-3.3-3.6-5.3-2.3-5.3-32.2-82.0115.839.8156.3-68.932.4-16.374.1-25.1-33.6-48.6-54.7-80.153.833.6-22.8-88.5-48.9-41.3-72.4-87.9-60.7-16.4-98.5-101.8-74.4-129.0-108.1-110.1-31.3-126.5-98.5-100.7-141.3-195.0
GSK1265744 60 mg-1.51.78.0-0.6-0.33.01.4-1.7-2.9-4.0-3.0-1.4-2.40.5-0.9-2.0-1.7-0.7-3.7-3.8-1.8-2.2-3.6-1.21.3-3.4-2.70.5-0.7-1.62.01.11.9-1.80.01.0-1.60.15.3-1.7-0.64.61.5-1.7-1.9-1.4-0.6-0.5-3.03.0-0.5-1.8-1.00.6-2.40.7-3.9-4.1-3.8-2.90.1-4.5-4.3-2.8-3.4-3.9-2.9-1.4-2.2-4.1-0.3-6.70.4-2.9266.727.128.6298.955.954.496.8122.166.1103.528.6206.267.614.919.6100.361.4649.668.773.374.462.898.648.341.940.492.062.538.9146.443.456.0209.4102.7

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Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96

Blood samples were collected for the analysis of platelet count, total neutrophils (T. neutrophils) and WBC count. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

,,,
InterventionGiga cells per liter (Mean)
T. neutrophils; Baseline; n=60, 60, 61, 62T. neutrophils; Week 2; n=57, 56, 59, 59T. neutrophils; Week 4; n=57, 57, 59, 57T. neutrophils; Week 8; n=58, 56, 56, 55T. neutrophils; Week 12; n=58, 53, 57, 51T. neutrophils; Week 16; n=57, 54, 57, 52T. neutrophils; Week 20; n=56, 54, 55, 49T. neutrophils; Week 24; n=56, 53, 56, 47T. neutrophils; Week 26; n=48, 50, 53, 45T. neutrophils; Week 28; n=50, 52, 52, 45T. neutrophils; Week 32; n=51, 53, 55, 45T. neutrophils; Week 36; n=52, 53, 55, 44T. neutrophils; Week 40; n=51, 53, 55, 45T. neutrophils; Week 48; n=51, 53, 54, 44T. neutrophils; Week 60; n=48, 47, 52, 44T. neutrophils; Week 72; n=47, 48, 52, 42T. neutrophils; Week 84; n=46, 48, 51, 42T. neutrophils; Week 96; n=46, 46, 52, 41Platelet count; Baseline; n=60, 60, 61, 62Platelet count; Week 2; n=57, 56, 59, 59Platelet count; Week 4; n=57, 57, 59, 57Platelet count; Week 8; n=58, 56, 56, 55Platelet count; Week 12; n=58, 53, 57, 51Platelet count; Week 16; n=57, 54, 57, 52Platelet count; Week 20; n=56, 54, 55, 49Platelet count; Week 24; n=56, 53, 56, 47Platelet count; Week 26; n=48, 50, 53, 45Platelet count; Week 28; n=50, 52, 52, 45Platelet count; Week 32; n=51, 52, 55, 45Platelet count; Week 36; n=52, 53, 55, 44Platelet count; Week 40; n=51, 53, 54, 45Platelet count; Week 48; n=51, 52, 53, 44Platelet count; Week 60; n=48, 47, 51, 44Platelet count; Week 72; n=47, 48, 52, 42Platelet count; Week 84; n=46, 48, 51, 42Platelet count; Week 96; n=46, 45, 51, 41WBC count; Baseline; n=60, 60, 61, 62WBC count; Week 2; n=57, 56, 59, 59WBC count; Week 4; n=57, 57, 59, 57WBC count; Week 8; n=58, 56, 56, 55WBC count; Week 12; n=58, 53, 57, 51WBC count; Week 16; n=57, 54, 57, 52WBC count; Week 20; n=56, 54, 55, 49WBC count; Week 24; n=56, 53, 56, 47WBC count; Week 26; n=48, 50, 53, 45WBC count; Week 28; n=50, 52, 52, 45WBC count; Week 32; n=51, 53, 55, 45WBC count; Week 36; n=52, 53, 55, 44WBC count; Week 40; n=51, 53, 55, 45WBC count; Week 48; n=51, 53, 54, 44WBC count; Week 60; n=48, 47, 52, 44WBC count; Week 72; n=47, 48, 52, 42WBC count; Week 84; n=46, 48, 51, 42WBC count; Week 96; n=46, 46, 52, 41
Efavirenz 600 mg2.4413.2072.8482.7462.9792.8583.1873.1422.8862.9163.1742.9143.1873.1343.2693.3613.2593.297200.1216.2216.0209.8213.7211.4214.9220.9214.4215.4212.6209.8217.7220.3230.5225.9216.5214.04.705.455.025.025.275.135.505.345.085.145.485.175.515.535.755.845.785.75
GSK1265744 10 mg2.6432.7232.6852.8992.8123.0782.9583.1512.8853.1832.7973.1623.1553.1383.1643.1973.2453.466212.5225.0225.2224.5227.2230.0231.3226.1224.9223.3220.5220.0224.9225.6232.5234.0224.8237.15.065.325.245.445.415.565.465.575.305.715.305.645.635.515.735.805.916.14
GSK1265744 30 mg2.8912.7762.7712.8022.9332.7162.9042.9962.9583.0053.0362.9163.0653.1323.3333.1313.3853.540202.3222.0222.4228.4216.4212.4215.5219.7215.5217.0214.0212.1210.1221.2219.8224.4218.8221.85.195.305.175.305.505.205.415.535.505.535.635.485.615.725.935.716.116.15
GSK1265744 60 mg2.4872.5982.6492.7382.8222.6652.9892.8842.8302.9893.1673.0103.0503.0043.2003.1633.5123.494190.0204.8204.6211.5209.2209.5205.4210.9199.4209.8207.8204.2199.3209.9212.2212.2210.1210.64.725.025.025.045.344.975.395.285.295.385.575.565.455.415.635.736.056.01

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Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit

Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

InterventionLog10 copies per milliliter (Mean)
Baseline; n=60, 60, 61, 62Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=59, 56, 57, 55Week 12; n=58, 52, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 47Week 24; n=56, 53, 56, 48Week 26; n=48, 50, 53, 44Week 28; n=51, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 48, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=45, 48, 52, 40
Efavirenz 600 mg4.2902.4152.2011.9501.7581.6971.6491.6101.6101.6001.6141.6071.6071.5961.6571.5921.5911.598

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Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96

Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

,,,
InterventionGrams per liter (Mean)
Baseline; n=60, 60, 61, 62Week 2; n=57, 56, 59, 59Week 4; n=57, 57, 59, 57Week 8; n=58, 56, 56, 55Week 12; n=58, 53, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 55, 49Week 24; n=56, 53, 56, 47Week 26; n=48, 50, 53, 45Week 28; n=50, 52, 52, 45Week 32; n=51, 53, 55, 45Week 36; n=52, 53, 55, 44Week 40; n=51, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 47, 52, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 51, 42Week 96; n=46, 46, 52, 41
Efavirenz 600 mg145.4146.4146.6148.1149.2147.6147.2148.5148.2145.9145.9145.0145.1145.4147.6147.7147.0147.0
GSK1265744 10 mg141.9142.0141.9144.9144.3143.5144.3144.8144.4143.7144.6142.3142.2142.9144.5143.9145.6144.9
GSK1265744 30 mg143.2142.8143.5147.7147.4146.5146.9147.8145.8146.8146.1145.9145.2145.7148.3148.1147.7147.1
GSK1265744 60 mg146.6145.9147.3148.6149.1148.7149.8150.4149.8149.3150.5149.8149.2146.5149.8149.6150.3150.8

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Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96

InterventionMilliliters per minute (Mean)
Baseline; n=60, 60, 61, 62Week 2; n=1, 1, 0, 3Week 4; n=58, 57, 59, 57Week 8; n=2, 1, 1, 1Week 16; n=55, 53, 56, 49Week 20; n=2, 0, 0, 1Week 24; n=52, 53, 55, 46Week 48; n=51, 50, 54, 44Week 96; n=45, 48, 52, 40
GSK1265744 10 mg131.096.0129.3125.0132.4137.0127.9127.0130.8

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Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96

InterventionMilliliters per minute (Mean)
Baseline; n=60, 60, 61, 62Week 4; n=58, 57, 59, 57Week 8; n=2, 1, 1, 1Week 16; n=55, 53, 56, 49Week 24; n=52, 53, 55, 46Week 48; n=51, 50, 54, 44Week 96; n=45, 48, 52, 40
GSK1265744 60 mg128.3122.4143.0123.9120.7122.3116.6

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Change From Baseline in Estimated Creatinine Clearance Over Time by Visit

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264

InterventionMilliliters per minute (Mean)
Week 2; n=1, 1, 0, 3Week 4; n=58, 57, 59, 57Week 8; n=2, 1, 1, 1Week 16; n=55, 53, 56, 49Week 20; n=2, 0, 0, 1Week 24; n=52, 53, 55, 46Week 48; n=51, 50, 54, 44Week 96; n=45, 48, 52, 40Week 180; n=1, 0, 0, 0
GSK1265744 10 mg-3.0-1.45.52.28.0-2.7-2.62.21.0

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Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit

Blood samples were collected for the analysis of creatinine and total bilirubin. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

,,
InterventionMicromoles per liter (Mean)
Creatinine; Week 2; n=58, 56, 58, 58Creatinine; Week 4; n=58, 57, 59, 57Creatinine; Week 8; n=58, 55, 57, 54Creatinine; Week 12; n=58, 53, 57, 51Creatinine; Week 16; n=57, 54, 57, 52Creatinine; Week 20; n=56, 54, 55, 49Creatinine; Week 24; n=56, 53, 56, 47Creatinine; Week 26; n=48, 50, 53, 45Creatinine; Week 28; n=51, 52, 52, 45Creatinine; Week 32; n=52, 53, 55, 45Creatinine; Week 36; n=52, 52, 55, 45Creatinine; Week 40; n=52, 53, 55, 44Creatinine; Week 48; n=51, 53, 54, 44Creatinine; Week 60; n=48, 47, 53, 44Creatinine; Week 72; n=47, 47, 52, 42Creatinine; Week 84; n=46, 48, 52, 42Creatinine; Week 96; n=45, 48, 52, 40Creatinine; Week 108; n=43, 46, 48, 0Creatinine; Week 120; n=40, 45, 48, 0Creatinine; Week 132; n=40, 46, 49, 0Creatinine; Week 144; n=37, 45, 47, 0Creatinine; Week 156; n=37, 42, 49, 0Creatinine; Week 168; n=35, 43, 47, 0Creatinine; Week 180; n=36, 41, 47, 0Creatinine; Week 192; n=36, 39, 47, 0Creatinine; Week 204; n=34, 39, 47, 0Creatinine; Week 216; n=33, 39, 46, 0Creatinine; Week 228; n=32, 39, 47, 0Creatinine; Week 240; n=30, 39, 46, 0Creatinine; Week 252; n=31, 38, 46, 0Creatinine; Week 264; n=32, 38, 47, 0Creatinine; Week 276; n=31, 38, 45, 0Creatinine; Week 288; n=31, 38, 45, 0Creatinine; Week 300; n=30, 37, 44, 0Creatinine; Week 312; n=31, 34, 43, 0Creatinine; Week 324; n=3, 4, 3, 0T. Bilirubin; Week 2; n=58, 56, 58, 58T. Bilirubin; Week 4; n=58, 57, 59, 57T. Bilirubin; Week 8; n=58, 55, 57, 54T. Bilirubin; Week 12; n=58, 53, 57, 51T. Bilirubin; Week 16; n=57, 54, 57, 52T. Bilirubin; Week 20; n=56, 54, 55, 49T. Bilirubin; Week 24; n=56, 53, 56, 47T. Bilirubin; Week 26; n=48, 50, 53, 45T. Bilirubin; Week 28; n=51, 52, 52, 45T. Bilirubin; Week 32; n=52, 53, 55, 45T. Bilirubin; Week 36; n=52, 52, 55, 45T. Bilirubin; Week 40; n=52, 53, 55, 44T. Bilirubin; Week 48; n=51, 53, 54, 44T. Bilirubin; Week 60; n=48, 47, 53, 44T. Bilirubin; Week 72; n=47, 47, 52, 42T. Bilirubin; Week 84; n=46, 48, 52, 42T. Bilirubin; Week 96; n=45, 48, 52, 40T. Bilirubin; Week 108; n=43, 46, 48, 0T. Bilirubin; Week 120; n=40, 45, 48, 0T. Bilirubin; Week 132; n=40, 46, 49, 0T. Bilirubin; Week 144; n=37, 45, 47, 0T. Bilirubin; Week 156; n=37, 42, 49, 0T. Bilirubin; Week 168; n=35, 43, 47, 0T. Bilirubin; Week 180; n=36, 41, 47, 0T. Bilirubin; Week 192; n=36, 39, 47, 0T. Bilirubin; Week 204; n=34, 39, 47, 0T. Bilirubin; Week 216; n=33, 39, 46, 0T. Bilirubin; Week 228; n=32, 39, 47, 0T. Bilirubin; Week 240; n=30, 39, 46, 0T. Bilirubin; Week 252; n=31, 38, 46, 0T. Bilirubin; Week 264; n=32, 38, 47, 0T. Bilirubin; Week 276; n=31, 38, 45, 0T. Bilirubin; Week 288; n=31, 38, 45, 0T. Bilirubin; Week 300; n=30, 37, 44, 0T. Bilirubin; Week 312; n=31, 34, 43, 0T. Bilirubin; Week 324; n=3, 4, 3, 0
GSK1265744 10 mg3.362.242.383.392.912.542.522.742.223.363.112.832.753.283.894.581.905.874.413.765.995.286.575.896.906.218.347.168.486.965.977.898.8110.497.9815.900.00.10.00.40.4-0.10.51.11.10.71.21.60.91.91.52.31.00.70.91.00.71.61.11.10.71.10.51.61.21.40.40.70.51.11.45.3
GSK1265744 30 mg2.582.502.061.591.100.852.441.802.801.693.412.362.182.304.713.805.345.184.154.025.806.365.625.087.916.469.317.197.337.527.105.847.849.167.869.75-0.3-0.3-0.5-0.9-1.2-0.70.20.50.70.20.61.70.10.00.10.10.01.41.12.01.11.00.80.00.30.70.80.50.92.02.92.81.91.71.15.5
GSK1265744 60 mg4.154.083.443.792.095.294.456.035.015.006.004.764.474.466.596.537.767.266.784.995.075.166.825.915.905.167.426.617.087.646.996.196.208.197.105.03-0.4-0.8-0.6-0.5-0.2-0.4-0.71.00.50.91.41.5-0.30.90.61.21.70.81.31.10.41.01.41.00.90.60.3-0.3-0.10.2-0.10.90.00.90.80.7

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Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time

Blood samples were collected for the analysis of following hematology parameters: APTT, hemoglobin, INR, platelet count, PT, total neutrophils and WBC count. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Up to Week 324

,,,
InterventionParticipants (Count of Participants)
APTT; Grade 1APTT; Grade 2APTT; Grade 3APTT; Grade 4Hemoglobin; Grade 1Hemoglobin; Grade 2Hemoglobin; Grade 3Hemoglobin; Grade 4INR; Grade 1INR; Grade 2INR; Grade 3INR; Grade 4Platelet count; Grade 1Platelet count; Grade 2Platelet count; Grade 3Platelet count; Grade 4PT; Grade 1PT; Grade 2PT; Grade 3PT; Grade 4Total neutrophils; Grade 1Total neutrophils; Grade 2Total neutrophils; Grade 3Total neutrophils; Grade 4WBC count; Grade 1WBC count; Grade 2WBC count; Grade 3WBC count; Grade 4
Efavirenz 600 mg5001000031001000310023113000
GSK1265744 10 mg5001010020104000100075112100
GSK1265744 30 mg5101000041010000301192015100
GSK1265744 60 mg50010000010041110010103132110

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Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase

Blood samples were collected for the analysis of following hematology parameters: APTT, basophils, eosinophils, hematocrit, hemoglobin, INR, lymphocytes, mean corpuscle volume (MCV), monocytes, platelet count, PT, red blood cell (RBC) count, total neutrophils and WBC count. A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Up to Week 24

,,,
InterventionParticipants (Count of Participants)
APTT; Grade 1APTT; Grade 2APTT; Grade 3APTT; Grade 4Basophils; Grade 1Basophils; Grade 2Basophils; Grade 3Basophils; Grade 4Eosinophils; Grade 1Eosinophils; Grade 2Eosinophils; Grade 3Eosinophils; Grade 4Hematocrit; Grade 1Hematocrit; Grade 2Hematocrit; Grade 3Hematocrit; Grade 4Hemoglobin; Grade 1Hemoglobin; Grade 2Hemoglobin; Grade 3Hemoglobin; Grade 4INR; Grade 1INR; Grade 2INR; Grade 3INR; Grade 4Lymphocytes; Grade 1Lymphocytes; Grade 2Lymphocytes; Grade 3Lymphocytes; Grade 4MCV; Grade 1MCV; Grade 2MCV; Grade 3MCV; Grade 4Monocytes; Grade 1Monocytes; Grade 2Monocytes; Grade 3Monocytes; Grade 4Platelet count; Grade 1Platelet count; Grade 2Platelet count; Grade 3Platelet count; Grade 4PT; Grade 1PT; Grade 2PT; Grade 3PT; Grade 4RBC; Grade 1RBC; Grade 2RBC; Grade 3RBC; Grade 4Total neutrophils; Grade 1Total neutrophils; Grade 2Total neutrophils; Grade 3Total neutrophils; Grade 4WBC count; Grade 1WBC count; Grade 2WBC count; Grade 3WBC count; Grade 4
Efavirenz 600 mg30000000000000000000100000000000000010001000000022111000
GSK1265744 10 mg10000000000000000100000000000000000020000000000083000000
GSK1265744 30 mg00010000000000000000200100000000000000001001000062002100
GSK1265744 60 mg10010000000000000000000000000000000020000000000083012000

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Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase

Blood samples were collected for the analysis of following hematology parameters: Activated Partial Thromboplastin Time (APTT), hemoglobin, international normalized ratio (INR), platelet count, prothrombin time (PT), total neutrophils and white blood cell (WBC) count. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Week 24 to Week 96

,,,
InterventionParticipants (Count of Participants)
APTT; Grade 1APTT; Grade 2APTT; Grade 3APTT; Grade 4Hemoglobin; Grade 1Hemoglobin; Grade 2Hemoglobin; Grade 3Hemoglobin; Grade 4INR; Grade 1INR; Grade 2INR; Grade 3INR; Grade 4Platelet count; Grade 1Platelet count; Grade 2Platelet count; Grade 3Platelet count; Grade 4PT; Grade 1PT; Grade 2PT; Grade 3PT; Grade 4Total neutrophils; Grade 1Total neutrophils; Grade 2Total neutrophils; Grade 3Total neutrophils; Grade 4WBC count; Grade 1WBC count; Grade 2WBC count; Grade 3WBC count; Grade 4
Efavirenz 600 mg5001000031001000310023113000
GSK1265744 10 mg5001010020104000100075112100
GSK1265744 30 mg5101000041010000301192015100
GSK1265744 60 mg50010000010041110010103132110

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Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease

HIV-1 associated conditions were assessed according to the 1993 Centers for Disease Control and Prevention (CDC) Revised Classification System for HIV Infection in Adults. The clinical categories of HIV infection as per CDC system are class A=Asymptomatic HIV infection or lymphadenopathy or acute HIV infection; class B=symptomatic non-acquired immunodeficiency syndrome (AIDS) conditions and class C=AIDS indicator conditions. Number of participants experiencing disease progression is presented, where disease progression is defined as the progression from Baseline HIV disease status as follows: CDC class A at Baseline to CDC class C event; CDC Class B at Baseline to CDC Class C event; CDC Class C at Baseline to new CDC Class C event; and CDC class A, B or C at Baseline to death. (NCT01641809)
Timeframe: Up to Week 324

,,,
InterventionParticipants (Count of Participants)
CDC Class A to CDC Class CCDC Class B to CDC Class CCDC Class C to new CDC Class CCDC Class A, B or C to Death
Efavirenz 600 mg0000
GSK1265744 10 mg1000
GSK1265744 30 mg1001
GSK1265744 60 mg0001

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Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance

Plasma samples were collected for drug resistance testing. The treatment emergent INI mutations associated with development of resistance to RAL, ELV, dolutegravir (DTG) or GSK1265744 and major resistance mutations to other classes (NRTI, NNRTI, PI) as defined by International AIDS society (IAS)-United States of America (USA) are presented. On-treatment Genotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment genotypic resistance data, excluding participants who are not protocol-defined virologic failures. (NCT01641809)
Timeframe: Up to Week 324

,,,
InterventionParticipants (Count of Participants)
Any INI mutationAny mutation to other classes
Efavirenz 600 mg00
GSK1265744 10 mg34
GSK1265744 30 mg00
GSK1265744 60 mg11

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Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96

InterventionMilliliters per minute (Mean)
Baseline; n=60, 60, 61, 62Week 2; n=1, 1, 0, 3Week 4; n=58, 57, 59, 57Week 8; n=2, 1, 1, 1Week 16; n=55, 53, 56, 49Week 24; n=52, 53, 55, 46Week 26; n=0, 1, 0, 0Week 40; n=0, 1, 0, 0Week 48; n=51, 50, 54, 44Week 96; n=45, 48, 52, 40
GSK1265744 30 mg135.2106.0132.5124.0139.4132.8147.0180.0139.2137.7

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Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96

InterventionMilliliters per minute (Mean)
Baseline; n=60, 60, 61, 62Week 2; n=1, 1, 0, 3Week 4; n=58, 57, 59, 57Week 8; n=2, 1, 1, 1Week 16; n=55, 53, 56, 49Week 20; n=2, 0, 0, 1Week 24; n=52, 53, 55, 46Week 48; n=51, 50, 54, 44Week 60; n=0, 0, 0, 1Week 96; n=45, 48, 52, 40
Efavirenz 600 mg125.699.0127.0101.0132.3122.0135.1131.0144.0134.8

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Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96

Blood samples were collected for the analysis of creatinine and total bilirubin (T. bilirubin). Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

,,,
InterventionMicromoles per liter (Mean)
Creatinine; Baseline; n=60, 60, 61, 62Creatinine; Week 2; n=58, 56, 58, 58Creatinine; Week 4; n=58, 57, 59, 57Creatinine; Week 8; n=58, 55, 57, 54Creatinine; Week 12; n=58, 53, 57, 51Creatinine; Week 16; n=57, 54, 57, 52Creatinine; Week 20; n=56, 54, 55, 49Creatinine; Week 24; n=56, 53, 56, 47Creatinine; Week 26; n=48, 50, 53, 45Creatinine; Week 28; n=51, 52, 52, 45Creatinine; Week 32; n=52, 53, 55, 45Creatinine; Week 36; n=52, 52, 55, 45Creatinine; Week 40; n=52, 53, 55, 44Creatinine; Week 48; n=51, 53, 54, 44Creatinine; Week 60; n=48, 47, 53, 44Creatinine; Week 72; n=47, 47, 52, 42Creatinine; Week 84; n=46, 48, 52, 42Creatinine; Week 96; n=45, 48, 52, 40T. Bilirubin; Baseline; n=60, 60, 61, 62T. Bilirubin; Week 2; n=58, 56, 58, 58T. Bilirubin; Week 4; n=58, 57, 59, 57T. Bilirubin; Week 8; n=58, 55, 57, 54T. Bilirubin; Week 12; n=58, 53, 57, 51T. Bilirubin; Week 16; n=57, 54, 57, 52T. Bilirubin; Week 20; n=56, 54, 55, 49T. Bilirubin; Week 24; n=56, 53, 56, 47T. Bilirubin; Week 26; n=48, 50, 53, 45T. Bilirubin; Week 28; n=51, 52, 52, 45T. Bilirubin; Week 32; n=52, 53, 55, 45T. Bilirubin; Week 36; n=52, 52, 55, 45T. Bilirubin; Week 40; n=52, 53, 55, 44T. Bilirubin; Week 48; n=51, 53, 54, 44T. Bilirubin; Week 60; n=48, 47, 53, 44T. Bilirubin; Week 72; n=47, 47, 52, 42T. Bilirubin; Week 84; n=46, 48, 52, 42T. Bilirubin; Week 96; n=45, 48, 52, 40
Efavirenz 600 mg83.183.883.182.481.179.679.580.078.678.578.178.479.279.077.977.779.781.09.76.86.46.37.07.06.86.66.86.46.66.56.36.67.06.56.66.8
GSK1265744 10 mg80.483.882.982.983.883.483.283.283.483.083.883.583.383.483.984.585.082.09.29.29.49.39.59.69.09.610.610.39.810.310.810.011.210.811.710.3
GSK1265744 30 mg80.583.383.082.282.782.382.083.382.683.882.684.683.283.183.086.184.886.49.49.19.39.08.98.59.09.89.910.29.810.111.29.69.810.09.99.9
GSK1265744 60 mg79.984.684.283.584.182.486.185.287.085.685.786.785.485.085.287.387.388.510.510.09.810.110.210.410.410.012.011.411.712.212.310.411.611.412.012.5

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Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96

CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

,,,
InterventionCells per cubic millimeter (Mean)
Baseline; n=60, 60, 61, 62Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=58, 56, 57, 55Week 12; n=58, 53, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 49Week 24; n=56, 53, 56, 47Week 26; n=48, 50, 53, 45Week 28; n=49, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 47, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=46, 46, 52, 41
Efavirenz 600 mg456.5487.0509.9531.4564.3594.4607.7599.5625.7635.7663.8651.5687.9732.6733.9722.5744.7747.8
GSK1265744 10 mg445.5544.0580.5576.6588.4608.3607.3614.6632.8652.2638.1638.7650.2677.3668.1683.2718.3726.2
GSK1265744 30 mg444.9525.1522.0555.2599.0595.8607.4626.5629.5635.9650.8658.6658.5687.2720.9651.3736.9722.9
GSK1265744 60 mg459.0549.3545.8544.3596.6599.7636.6658.0645.8653.3665.2720.3667.6713.8719.8710.9735.0743.1

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Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96

Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

,,,
InterventionInternational Units per Liter (Mean)
ALT; Baseline; n=60, 60, 61, 62ALT; Week 2; n=58, 56, 58, 58ALT; Week 4; n=58, 57, 59, 57ALT; Week 8; n=58, 55, 57, 54ALT; Week 12; n=58, 53, 57, 51ALT; Week 16; n=57, 54, 57, 52ALT; Week 20; n=56, 54, 55, 49ALT; Week 24; n=56, 53, 56, 47ALT; Week 26; n=48, 50, 53, 45ALT; Week 28; n=51, 52, 52, 45ALT; Week 32; n=52, 53, 55, 45ALT; Week 36; n=52, 52, 55, 45ALT; Week 40; n=52, 53, 55, 44ALT; Week 48; n=51, 53, 54, 44ALT; Week 60; n=48, 47, 53, 44ALT; Week 72; n=47, 47, 52, 42ALT; Week 84; n=46, 48, 52, 42ALT; Week 96; n=45, 48, 52, 40AST; Baseline; n=60, 60, 61, 62AST; Week 2; n=58, 56, 58, 58AST; Week 4; n=58, 57, 59, 57AST; Week 8; n=58, 55, 57, 54AST; Week 12; n=58, 53, 57, 51AST; Week 16; n=57, 54, 57, 52AST; Week 20; n=56, 54, 55, 49AST; Week 24; n=56, 53, 56, 47AST; Week 26; n=48, 50, 53, 45AST; Week 28; n=51, 52, 52, 45AST; Week 32; n=52, 53, 55, 45AST; Week 36; n=52, 52, 55, 45AST; Week 40; n=52, 53, 55, 44AST; Week 48; n=51, 53, 54, 44AST; Week 60; n=48, 47, 53, 44AST; Week 72; n=47, 47, 52, 42AST; Week 84; n=46, 48, 52, 42AST; Week 96; n=45, 48, 52, 40CK; Baseline; n=60, 60, 61, 62CK; Week 2; n=58, 56, 58, 58CK; Week 4; n=58, 57, 59, 57CK; Week 8; n=58, 55, 57, 54CK; Week 12; n=58, 53, 57, 51CK; Week 16; n=57, 54, 57, 52CK; Week 20; n=56, 54, 55, 49CK; Week 24; n=56, 53, 56, 47CK; Week 26; n=48, 50, 53, 45CK; Week 28; n=51, 52, 52, 45CK; Week 32; n=52, 53, 55, 45CK; Week 36; n=52, 52, 55, 45CK; Week 40; n=52, 53, 55, 44CK; Week 48; n=51, 53, 54, 44CK; Week 60; n=48, 47, 53, 44CK; Week 72; n=47, 47, 52, 42CK; Week 84; n=46, 48, 52, 42CK; Week 96; n=45, 48, 52, 40
Efavirenz 600 mg30.530.031.425.025.730.427.025.728.324.223.123.523.422.624.922.727.124.331.532.829.024.424.436.728.726.125.823.725.426.323.023.724.922.929.927.7349.8512.1236.2152.9161.2646.5528.2247.4163.5154.7254.7303.1150.2146.3168.0120.5258.6281.1
GSK1265744 10 mg23.924.023.125.425.026.022.320.924.220.419.523.422.718.421.419.920.122.025.025.624.028.726.324.226.023.328.422.621.929.224.721.423.421.822.323.6197.3237.9196.7413.3316.1195.1342.7226.0344.1213.4205.6528.4259.5203.5315.7182.5204.3542.7
GSK1265744 30 mg28.126.325.629.331.428.524.927.526.626.526.924.724.624.825.930.729.948.727.526.625.029.529.029.224.227.226.926.726.525.424.524.325.331.029.247.7295.9276.1221.8427.2314.7427.3202.1306.3267.7276.8248.8242.9225.4219.3215.5354.0329.2272.8
GSK1265744 60 mg28.527.230.335.926.626.930.328.623.524.823.224.225.824.828.126.325.325.528.126.828.332.825.526.531.728.624.525.525.626.426.524.230.426.425.225.9181.2184.8180.5451.7211.8213.3485.3243.0242.5290.4311.3255.2292.6219.8399.6247.7195.0199.7

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Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 was determined using the MSDF algorithm based on the current US Food and Drug Administration (FDA) definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-E Population comprised of all randomized participants who received at least one dose of investigational product. (NCT01641809)
Timeframe: Week 48

InterventionPercentage of participants (Number)
GSK1265744 10 mg80
GSK1265744 30 mg80
GSK1265744 60 mg87
Efavirenz 600 mg71

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Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase

AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented. (NCT01641809)
Timeframe: Week 24 to Week 96

InterventionPercentage of participants (Number)
GSK1265744 10 mg2
GSK1265744 30 mg4
GSK1265744 60 mg2
Efavirenz 600 mg2

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Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Induction Phase

AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented. (NCT01641809)
Timeframe: Up to Week 24

InterventionPercentage of participants (Number)
GSK1265744 10 mg0
GSK1265744 30 mg2
GSK1265744 60 mg5
Efavirenz 600 mg13

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Percentage of Participants Who Discontinued Investigational Product Due to Adverse Events

AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented. (NCT01641809)
Timeframe: Up to Week 324

InterventionPercentage of participants (Number)
GSK1265744 10 mg7
GSK1265744 30 mg7
GSK1265744 60 mg7
Efavirenz 600 mg15

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Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase

Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotranferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), carbon dioxide(CO2)/bicarbonate, cholesterol, creatine kinase (CK), creatinine, glucose, low density lipoprotein (LDL) cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Week 24 to Week 96

,,,
InterventionParticipants (Count of Participants)
ALT; Grade 1ALT; Grade 2ALT; Grade 3ALT; Grade 4Albumin; Grade 1Albumin; Grade 2Albumin; Grade 3Albumin; Grade 4ALP; Grade 1ALP; Grade 2ALP; Grade 3ALP; Grade 4AST; Grade 1AST; Grade 2AST; Grade 3AST; Grade 4CO2/bicarbonate; Grade 1CO2/bicarbonate; Grade 2CO2/bicarbonate; Grade 3CO2/bicarbonate; Grade 4Cholesterol; Grade 1Cholesterol; Grade 2Cholesterol; Grade 3Cholesterol; Grade 4CK; Grade 1CK; Grade 2CK; Grade 3CK; Grade 4Creatinine; Grade 1Creatinine; Grade 2Creatinine; Grade 3Creatinine; Grade 4Glucose; Grade 1Glucose; Grade 2Glucose; Grade 3Glucose; Grade 4LDL cholesterol; Grade 1LDL cholesterol; Grade 2LDL cholesterol; Grade 3LDL cholesterol; Grade 4Lipase; Grade 1Lipase; Grade 2Lipase; Grade 3Lipase; Grade 4Inorganic phosphorus; Grade 1Inorganic phosphorus; Grade 2Inorganic phosphorus; Grade 3Inorganic phosphorus; Grade 4Potassium; Grade 1Potassium; Grade 2Potassium; Grade 3Potassium; Grade 4Sodium; Grade 1Sodium; Grade 2Sodium; Grade 3Sodium; Grade 4Total bilirubin; Grade 1Total bilirubin; Grade 2Total bilirubin; Grade 3Total bilirubin; Grade 4Triglycerides; Grade 1Triglycerides; Grade 2Triglycerides; Grade 3Triglycerides; Grade 4
Efavirenz 600 mg630100004000523281009104050351000115008640970079204100710000000110
GSK1265744 10 mg96010000200055226100176308236110017140014640995251020120001420072000110
GSK1265744 30 mg126111000110013801140001712009426100017100016112098103111070001210013100400
GSK1265744 60 mg175000000400013520900019153011445200020112013147081162955080001600084000331

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Number of Participants With Treatment Emergent Phenotypic Resistance

Plasma samples were collected for drug resistance testing. Phenotypic resistance data for the following drugs under integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), NRTI and proteasome inhibitor drug classes is presented for participants with confirmed virologic failure: GSK1265744, Raltegravir [RAL], Delavirdine [DLV], Efavirenz [EFV], Etravirine [ETR], Nevirapine (NVP), RPV, 3TC, ABC, FTC, TDF, Zidovudine [ZDV], Stavudine [d4T], Didanosine [ddI], Atazanavir/ritonavir [ATV/r], Darunavir (DRV)/r, Fosamprenavir/r [FPV/r], Indinavir/r [IDV/r], Lopinavir/r [LPV/r], Nelfinavir [NFV], Ritonavir [RTV], Saquinavir/r [SQV/r], Tipranavir/r [TPV/r]. On-treatment Phenotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment phenotypic resistance data, excluding participants who are not protocol-defined virologic failures. (NCT01641809)
Timeframe: Up to Week 324

,,,
InterventionParticipants (Count of Participants)
INI, GSK1265744; Resistant; n=5, 1, 2, 2INI, GSK1265744; Sensitive; n=5, 1, 2, 2INI, RAL; Resistant; n=5, 1, 2, 2INI, RAL; Sensitive; n=5, 1, 2, 2NNRTI, DLV; Resistant; n=6, 2, 2, 5NNRTI, DLV; Sensitive; n=6, 2, 2, 5NNRTI, EFV; Resistant; n=6, 2, 2, 5NNRTI, EFV; Sensitive; n=6, 2, 2, 5NNRTI, ETR; Resistant; n=6, 2, 2, 5NNRTI, ETR; Partially sensitive; n=6, 2, 2, 5NNRTI, ETR; Sensitive; n=6, 2, 2, 5NNRTI, NVP; Resistant; n=6, 2, 2, 5NNRTI, NVP; Sensitive; n=6, 2, 2, 5NNRTI, RPV; Resistant; n=6, 2, 2, 5NNRTI, RPV; Sensitive; n=6, 2, 2, 5NRTI, 3TC; Resistant; n=6, 2, 2, 5NRTI, 3TC; Sensitive; n=6, 2, 2, 5NRTI, ABC; Resistant; n=6, 2, 2, 5NRTI, ABC; Partially sensitive; n=6, 2, 2, 5NRTI, ABC; Sensitive; n=6, 2, 2, 5NRTI, FTC; Resistant; n=6, 2, 2, 5NRTI, FTC; Sensitive; n=6, 2, 2, 5NRTI, TDF; Resistant; n=6, 2, 2, 5NRTI, TDF; Partially sensitive; n=6, 2, 2, 5NRTI, TDF; Sensitive; n=6, 2, 2, 5NRTI, ZDV; Resistant; n=6, 2, 2, 5NRTI, ZDV; Sensitive; n=6, 2, 2, 5NRTI, d4T; Resistant; n=6, 2, 2, 5NRTI, d4T; Sensitive; n=6, 2, 2, 5NRTI, ddI; Resistant; n=6, 2, 2, 5NRTI, ddI; Partially sensitive; n=6, 2, 2, 5NRTI, ddI; Sensitive; n=6, 2, 2, 5PI, ATV/r; Resistant; n=6, 2, 2, 5PI, ATV/r; Sensitive; n=6, 2, 2, 5PI, DRV/r; Resistant; n=6, 2, 2, 5PI, DRV/r; Partially sensitive; n=6, 2, 2, 5PI, DRV/r; Sensitive; n=6, 2, 2, 5PI, FPV/r; Resistant; n=6, 2, 2, 5PI, FPV/r; Partially sensitive; n=6, 2, 2, 5PI, FPV/r; Sensitive; n=6, 2, 2, 5PI, IDV/r; Resistant; n=6, 2, 2, 5PI, IDV/r; Sensitive; n=6, 2, 2, 5PI, LPV/r; Resistant; n=6, 2, 2, 5PI, LPV/r; Partially sensitive; n=6, 2, 2, 5PI, LPV/r; Sensitive; n=6, 2, 2, 5PI, NFV; Resistant; n=6, 2, 2, 5PI, NFV; Sensitive; n=6, 2, 2, 5PI, RTV; Resistant; n=6, 2, 2, 5PI, RTV; Sensitive; n=6, 2, 2, 5PI, SQV/r; Resistant; n=6, 2, 2, 5PI, SQV/r; Partially sensitive; n=6, 2, 2, 5PI, SQV/r; Sensitive; n=6, 2, 2, 5PI, TPV/r; Resistant; n=6, 2, 2, 5PI, TPV/r; Partially sensitive; n=6, 2, 2, 5PI, TPV/r; Sensitive; n=6, 2, 2, 5
Efavirenz 600 mg0202050500505050500505005050500505005005050050505005005
GSK1265744 10 mg2332333330333330600606015240600606006006060060606006006
GSK1265744 30 mg0101020200202020200202002020200202002002020020202002002
GSK1265744 60 mg1111020200202020200202002020200202002002020020202002002

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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. (NCT01641809)
Timeframe: Week 16 and Week 24

,,,
InterventionPercentage of participants (Number)
Week 16Week 24
Efavirenz 600 mg7474
GSK1265744 10 mg9087
GSK1265744 30 mg8385
GSK1265744 60 mg8787

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Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase

Plasma samples were collected for quantitative analysis of HIV-1 RNA. The end point was determined using MSDF algorithm based on the current US FDA definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-Maintenance Exposed (ME) Population comprised of all participants randomized to GSK1265744 and who received at least one dose of investigational product during maintenance phase of the study. (NCT01641809)
Timeframe: Weeks 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

,,,
InterventionPercentage of participants (Number)
Week 24Week 26Week 28Week 32Week 36Week 40Week 48Week 60Week 72Week 84Week 96
Efavirenz 600 mg9687919194899489898983
GSK1265744 10 mg9690989698969290838379
GSK1265744 30 mg9485899192929183838585
GSK1265744 60 mg9695959695959695959593

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Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm

Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with HIV-1 RNA <400 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

,,,
InterventionPercentage of participants (Number)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 24Week 26Week 28Week 32Week 36Week 40Week 48Week 60Week 72Week 84Week 96
Efavirenz 600 mg068687973817971737373737371686865
GSK1265744 10 mg087939390939380858787878380777775
GSK1265744 30 mg080939285878780838585858577757777
GSK1265744 60 mg084939289939287858990908987858585

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Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <400 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on randomized therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

,,,
InterventionPercentage of participants (Number)
Baseline; n=60, 60, 61, 62Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=59, 56, 57, 55Week 12; n=58, 52, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 47Week 24; n=56, 53, 56, 48Week 26; n=48, 50, 53, 44Week 28; n=51, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 48, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=45, 48, 52, 40
Efavirenz 600 mg0717491929610010010010010010010010098100100100
GSK1265744 10 mg0919795979810010010010010010010098969810096
GSK1265744 30 mg0869898100100100100100100100100100981009698100
GSK1265744 60 mg08697989810010010010010098100100100100100100100

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Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period or open-label phase. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

InterventionPercentage of participants (Number)
Baseline; n=60, 60, 61, 62Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=59, 56, 57, 55Week 12; n=58, 52, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 47Week 24; n=56, 53, 56, 48Week 26; n=48, 50, 53, 44Week 28; n=51, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 48, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=45, 48, 52, 40
Efavirenz 600 mg0142655768791969396969893989510010098

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Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period or open-label phase. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

,,
InterventionPercentage of participants (Number)
Baseline; n=60, 60, 61, 62Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=59, 56, 57, 55Week 12; n=58, 52, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 47Week 24; n=56, 53, 56, 48Week 26; n=48, 50, 53, 44Week 28; n=51, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 48, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=45, 48, 52, 40Week 108; n=43, 46, 49, 0Week 120; n=41, 46, 49, 0Week 132; n=40, 46, 49, 0Week 144; n=37, 45, 47, 0Week 156; n=37, 42, 49, 0Week 168; n=35, 43, 47, 0Week 180; n=36, 41, 47, 0Week 192; n=36, 40, 47, 0Week 204; n=34, 39, 47, 0Week 216; n=33, 39, 47, 0Week 228; n=32, 39, 47, 0Week 240; n=31, 39, 45, 0Week 252; n=31, 38, 47, 0Week 264; n=32, 38, 47, 0Week 276; n=31, 38, 45, 0Week 288; n=30, 38, 45, 0Week 300; n=31, 37, 44, 0Week 312; n=31, 33, 43, 0Week 324; n=3, 4, 3, 0
GSK1265744 10 mg0518392959591939810096989692949191899595959295949794971001009710010010010097100100
GSK1265744 30 mg05482898894989894949496969296929498961009693959510010097100100979710010010010097100
GSK1265744 60 mg0537393919398959810096959598981001009810098100989898989698989810098989610095100100

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Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312

,,,
InterventionPercentage of participants (Number)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 24Week 26Week 28Week 32Week 36Week 40Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312
Efavirenz 600 mg013244861747466696971687168686863000000000000000000
GSK1265744 10 mg048809088908778858385838078727268686562585857585755555350525352505252
GSK1265744 30 mg050788375838575788082828073737575727370676365676562636362626262626052
GSK1265744 60 mg051708782878785858785858785858584808080778075757475777574757570747070

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Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit

Blood samples were collected for the analysis of creatinine and total bilirubin. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

InterventionMicromoles per liter (Mean)
Creatinine; Week 2; n=58, 56, 58, 58Creatinine; Week 4; n=58, 57, 59, 57Creatinine; Week 8; n=58, 55, 57, 54Creatinine; Week 12; n=58, 53, 57, 51Creatinine; Week 16; n=57, 54, 57, 52Creatinine; Week 20; n=56, 54, 55, 49Creatinine; Week 24; n=56, 53, 56, 47Creatinine; Week 26; n=48, 50, 53, 45Creatinine; Week 28; n=51, 52, 52, 45Creatinine; Week 32; n=52, 53, 55, 45Creatinine; Week 36; n=52, 52, 55, 45Creatinine; Week 40; n=52, 53, 55, 44Creatinine; Week 48; n=51, 53, 54, 44Creatinine; Week 60; n=48, 47, 53, 44Creatinine; Week 72; n=47, 47, 52, 42Creatinine; Week 84; n=46, 48, 52, 42Creatinine; Week 96; n=45, 48, 52, 40T. Bilirubin; Week 2; n=58, 56, 58, 58T. Bilirubin; Week 4; n=58, 57, 59, 57T. Bilirubin; Week 8; n=58, 55, 57, 54T. Bilirubin; Week 12; n=58, 53, 57, 51T. Bilirubin; Week 16; n=57, 54, 57, 52T. Bilirubin; Week 20; n=56, 54, 55, 49T. Bilirubin; Week 24; n=56, 53, 56, 47T. Bilirubin; Week 26; n=48, 50, 53, 45T. Bilirubin; Week 28; n=51, 52, 52, 45T. Bilirubin; Week 32; n=52, 53, 55, 45T. Bilirubin; Week 36; n=52, 52, 55, 45T. Bilirubin; Week 40; n=52, 53, 55, 44T. Bilirubin; Week 48; n=51, 53, 54, 44T. Bilirubin; Week 60; n=48, 47, 53, 44T. Bilirubin; Week 72; n=47, 47, 52, 42T. Bilirubin; Week 84; n=46, 48, 52, 42T. Bilirubin; Week 96; n=45, 48, 52, 40
Efavirenz 600 mg0.65-0.32-0.92-1.42-2.92-3.26-2.03-2.67-3.42-3.50-3.26-2.83-2.73-3.87-4.48-2.48-2.28-3.0-3.4-3.4-2.4-2.4-2.6-2.9-2.7-2.8-2.6-2.7-2.9-2.6-2.2-2.7-2.6-2.5

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Change From Baseline in CD4+ Cell Count Over Time by Visit

CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

,,
InterventionCells per cubic millimeter (Mean)
Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=58, 56, 57, 55Week 12; n=58, 53, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 49Week 24; n=56, 53, 56, 47Week 26; n=48, 50, 53, 45Week 28; n=49, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 47, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=46, 46, 52, 41Week 108; n=43, 46, 49, 0Week 120; n=41, 46, 49, 0Week 132; n=40, 46, 49, 0Week 144; n=37, 45, 46, 0Week 156; n=37, 42, 49, 0Week 168; n=35, 43, 47, 0Week 180; n=36, 41, 47, 0Week 192; n=35, 40, 47, 0Week 204; n=34, 39, 47, 0Week 216; n=33, 39, 47, 0Week 228; n=32, 39, 47, 0Week 240; n=32, 39, 47, 0Week 252; n=31, 38, 47, 0Week 264; n=32, 38, 47, 0Week 276; n=31, 38, 46, 0Week 288; n=30, 38, 45, 0Week 300; n=30, 37, 44, 0Week 312; n=30, 34, 43, 0Week 324; n=3, 4, 3, 0
GSK1265744 10 mg92.6136.4129.9140.5159.3165.2172.5186.4205.0191.4192.0203.6235.1217.7232.0261.5269.4296.2266.1297.1330.7334.5338.1338.0300.8369.5397.0331.8356.5400.3344.4398.3411.0437.7335.0402.0
GSK1265744 30 mg79.576.9117.8140.8142.2153.8180.9177.7188.1205.2213.0212.8241.6269.4201.4287.0267.5304.3279.3305.2308.9319.2332.4348.6351.0332.9373.4366.5395.9343.7365.0350.3383.5404.4433.0276.0
GSK1265744 60 mg91.788.290.5145.2148.3182.6204.0194.7193.3209.9265.0212.3259.0266.1254.0278.1286.2288.4307.2313.2322.4320.4361.3384.2342.3340.0357.8383.7408.4383.1391.8362.2337.1353.5407.0272.0

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Change From Baseline in CD4+ Cell Count Over Time by Visit

CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

InterventionCells per cubic millimeter (Mean)
Week 2; n=57, 56, 59, 59Week 4; n=58, 57, 59, 57Week 8; n=58, 56, 57, 55Week 12; n=58, 53, 57, 51Week 16; n=57, 54, 57, 52Week 20; n=56, 54, 56, 49Week 24; n=56, 53, 56, 47Week 26; n=48, 50, 53, 45Week 28; n=49, 52, 52, 45Week 32; n=52, 53, 55, 45Week 36; n=52, 53, 55, 45Week 40; n=52, 53, 55, 45Week 48; n=51, 53, 54, 44Week 60; n=48, 47, 53, 44Week 72; n=47, 48, 52, 42Week 84; n=46, 48, 52, 42Week 96; n=46, 46, 52, 41
Efavirenz 600 mg24.846.065.6103.4135.5149.0143.4166.4178.2197.4185.2221.5262.5263.8257.1279.4281.7

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Change From Baseline in ALT, AST and CK Over Time by Visit

Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

InterventionInternational Units per Liter (Mean)
ALT; Week 2; n=58, 56, 58, 58ALT; Week 4; n=58, 57, 59, 57ALT; Week 8; n=58, 55, 57, 54ALT; Week 12; n=58, 53, 57, 51ALT; Week 16; n=57, 54, 57, 52ALT; Week 20; n=56, 54, 55, 49ALT; Week 24; n=56, 53, 56, 47ALT; Week 26; n=48, 50, 53, 45ALT; Week 28; n=51, 52, 52, 45ALT; Week 32; n=52, 53, 55, 45ALT; Week 36; n=52, 52, 55, 45ALT; Week 40; n=52, 53, 55, 44ALT; Week 48; n=51, 53, 54, 44ALT; Week 60; n=48, 47, 53, 44ALT; Week 72; n=47, 47, 52, 42ALT; Week 84; n=46, 48, 52, 42ALT; Week 96; n=45, 48, 52, 40AST; Week 2; n=58, 56, 58, 58AST; Week 4; n=58, 57, 59, 57AST; Week 8; n=58, 55, 57, 54AST; Week 12; n=58, 53, 57, 50AST; Week 16; n=57, 54, 57, 52AST; Week 20; n=56, 54, 55, 49AST; Week 24; n=56, 53, 56, 47AST; Week 26; n=48, 50, 53, 45AST; Week 28; n=51, 52, 52, 45AST; Week 32; n=52, 53, 55, 45AST; Week 36; n=52, 52, 55, 45AST; Week 40; n=52, 53, 55, 44AST; Week 48; n=51, 53, 54, 44AST; Week 60; n=48, 47, 53, 44AST; Week 72; n=47, 47, 52, 42AST; Week 84; n=46, 48, 52, 42AST; Week 96; n=45, 48, 52, 40CK; Week 2; n=58, 56, 58, 58CK; Week 4; n=58, 57, 59, 57CK; Week 8; n=58, 55, 57, 54CK; Week 12; n=58, 53, 57, 51CK; Week 16; n=57, 54, 57, 52CK; Week 20; n=56, 54, 55, 49CK; Week 24; n=56, 53, 56, 47CK; Week 26; n=48, 50, 53, 45CK; Week 28; n=51, 52, 52, 45CK; Week 32; n=52, 53, 55, 45CK; Week 36; n=52, 52, 55, 45CK; Week 40; n=52, 53, 55, 44CK; Week 48; n=51, 53, 54, 44CK; Week 60; n=48, 47, 53, 44CK; Week 72; n=47, 47, 52, 42CK; Week 84; n=46, 48, 52, 42CK; Week 96; n=45, 48, 52, 40
Efavirenz 600 mg-1.30.1-6.3-6.3-1.6-4.8-6.0-3.7-8.1-8.6-8.2-8.0-8.6-6.3-8.5-4.0-7.60.9-2.9-7.3-7.94.4-3.6-2.1-2.6-5.1-2.8-1.9-5.1-4.4-3.2-4.62.3-0.3159.8-120.3-212.8-220.1269.7135.3103.921.24.1110.3158.73.82.824.5-14.3123.9143.9

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Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings

Twelve lead ECG was performed after the participants had rested in a semi-supine position for at least 5 minutes using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst case results at any time on-treatment is presented. (NCT01641809)
Timeframe: Up to Week 324

InterventionParticipants (Count of Participants)
GSK1265744 10 mg25
GSK1265744 30 mg19
GSK1265744 60 mg15
Efavirenz 600 mg10

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Plasma Clearance of Lamivudine

Steady-state plasma clearance (CL/F) of Lamivudine (3TC) (NCT01818258)
Timeframe: 0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entry

,
InterventionL/hours (Geometric Mean)
3TC CL/F at Week 13TC CL/F at Week 123TC CL/F at Week 24
Normal Nutrition/Mild Malnutrition Cohort8.46.88.8
Severe Malnutrition Cohort8.79.57.5

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Minimum Trough Concentration (Ctrough) of Lopinavir

Count (%) of participants with minimum trough concentration (Ctrough) of steady-state Lopinavir >= 1 ug/mL (NCT01818258)
Timeframe: Measured 0, 1, 2, 4, 8, and 12 hours post-dose on 1, 4, 8, 12, 16, 24, 36 and 48 weeks following study entry

,
InterventionParticipants (Count of Participants)
Week 1Week 4Week 8Week 12Week 16Week 24Week 36Week 48
Normal Nutrition/Mild Malnutrition Cohort2118181815191918
Severe Malnutrition Cohort1214131711141616

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HIV Viral Load <400 Copies/mL

Count (%) of participants with plasma HIV RNA viral load <400 copies/mL (NCT01818258)
Timeframe: Baseline and weeks 12, 24, and 48

,
InterventionParticipants (Count of Participants)
BaselineWeek 12Week 24Week 48
Normal Nutrition/Mild Malnutrition Cohort2141818
Severe Malnutrition Cohort281111

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Free Fraction of LPV at Hour 2 Post Dose

Free fraction of steady-state lopinavir at 2 hours post dose (NCT01818258)
Timeframe: Weeks 1, 12 and 24

,
InterventionPercent of Unbound LPV (Mean)
Week 1Week 12Week 24
Normal Nutrition/Mild Malnutrition Cohort3.26.02.1
Severe Malnutrition Cohort0.82.23.1

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Change in WHO Weight-for-height Z-score

Change in WHO weight-for-height Z-score from entry. A Z-score indicates the number of standard deviations the measurement is away from the mean. A Z-score of 0 is equal to the mean of the reference population. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population. The reference population was determined by the World Health Organization for children from 0 up to 5 years. (NCT01818258)
Timeframe: Weeks 0, 24, and 48

,
InterventionZ-Score (Mean)
Week 24Week 48
Normal Nutrition/Mild Malnutrition Cohort0.10.4
Severe Malnutrition Cohort2.32.7

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Change in Mid-upper Arm Circumference

Change in mid-upper arm circumference (MUAC) from entry (NCT01818258)
Timeframe: Weeks 0, 24, and 48

,
Interventioncentimeters (Mean)
Week 24Week 48
Normal Nutrition/Mild Malnutrition Cohort1.21.6
Severe Malnutrition Cohort2.63.5

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Change in HIV Viral Load From Baseline

Change from baseline in plasma HIV RNA viral load (NCT01818258)
Timeframe: Weeks 0, 12, 24, 36 and 48

,
Interventionlog10 copies/mL (Mean)
Change in Log10 Viral Load between Baseline and Week 12Change in Log10 Viral Load between Baseline and Week 24Change in Log10 Viral Load between Baseline and Week 36Change in Log10 Viral Load between Baseline and Week 48
Normal Nutrition/Mild Malnutrition Cohort-2.1-2.5-2.5-2.6
Severe Malnutrition Cohort-1.4-1.7-1.8-1.8

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Change in CD4 Percent

Change in CD4 percent from baseline (NCT01818258)
Timeframe: Weeks 0, 12, 24, 36 and 48

,
Interventionpercent (Mean)
Change in CD4 Percent at Week 12Change in CD4 Percent at Week 24Change in CD4 Percent at Week 36Change in CD4 Percent at Week 48
Normal Nutrition/Mild Malnutrition Cohort3.06.87.16.7
Severe Malnutrition Cohort3.39.310.312.7

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Grade 3 or Higher Adverse Events Through 24 Weeks

Number (percent) of participants with at least one grade 3 or higher adverse event (AE) regardless of the relationship to study drugs. (NCT01818258)
Timeframe: From week 0 to week 24

InterventionParticipants (Count of Participants)
Severe Malnutrition Cohort13
Normal Nutrition/Mild Malnutrition Cohort10

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Plasma Clearance of Ritonavir

Steady-state plasma clearance (CL/F) of RTV (NCT01818258)
Timeframe: 0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entry

,
InterventionL/hours (Geometric Mean)
RTV CL/F at Week 1RTV CL/F at Week 12RTV CL/F at Week 24
Normal Nutrition/Mild Malnutrition Cohort15.811.211.5
Severe Malnutrition Cohort16.917.314.8

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Steady-state Zidovudine Area Under the Curve

Steady-state area under the curve (AUC) of zidovudine (ZDV) (NCT01818258)
Timeframe: 0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entry

,
Interventionng*hours/mL (Geometric Mean)
ZDV AUC at Week 1ZDV AUC at Week 12ZDV AUC at Week 24
Normal Nutrition/Mild Malnutrition Cohort1,774.01,335.71,609.3
Severe Malnutrition Cohort2,261.01,826.02,449.7

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Steady-state Ritonavir Area Under the Curve

Steady-state area under the curve (AUC) for Ritonavir (RTV) (NCT01818258)
Timeframe: 0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entry

,
Interventionug*hours/mL (Geometric Mean)
RTV AUC Week 1RTV AUC Week 12RTV AUC Week 24
Normal Nutrition/Mild Malnutrition Cohort2.13.03.0
Severe Malnutrition Cohort1.61.82.3

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Steady-state Lopinavir Area Under the Curve

Steady-state area under the curve (AUC) for Lopinavir (LPV) (NCT01818258)
Timeframe: 0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entry

,
Interventionug*hours/mL (Geometric Mean)
Week 1Week 12Week 24
Normal Nutrition/Mild Malnutrition Cohort64.883.479.4
Severe Malnutrition Cohort49.853.064.6

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Steady-state Lamivudine Area Under the Curve

Steady-state area under the curve (AUC) of Lamivudine (3TC) (NCT01818258)
Timeframe: 0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entry

,
Interventionng*hours/mL (Geometric Mean)
3TC AUC at Week 13TC AUC at Week 123TC AUC at Week 24
Normal Nutrition/Mild Malnutrition Cohort5,520.27,233.05,849.2
Severe Malnutrition Cohort4,245.04,365.56,359.0

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Plasma Clearance of Zidovudine

Steady-state plasma clearance (CL/F) of Zidovudine (ZDV) (NCT01818258)
Timeframe: 0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entry

,
InterventionL/hours (Geometric Mean)
ZDV CL/F at Week 1ZDV CL/F at Week 12ZDV CL/F at Week 24
Normal Nutrition/Mild Malnutrition Cohort58.381.864.0
Severe Malnutrition Cohort34.848.840.8

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Plasma Clearance of Lopinavir

Steady-state plasma clearance (CL/F) of LPV (NCT01818258)
Timeframe: 0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entry

,
InterventionL/hours (Geometric Mean)
LPV CL/F at Week 1LPV CL/F at Week 12LPV CL/F at Week 24
Normal Nutrition/Mild Malnutrition Cohort2.01.61.7
Severe Malnutrition Cohort2.22.32.1

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Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups

Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA [BPHR], Baseline CD4+ cell count [BCCC], Baseline Centers for Disease Control and Prevention [CDC] category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =100,000 c/mL) and CD4+ cell count (=<350 cells/mm^3 or >350 cells/mm^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. Percentage values are rounded off. (NCT01910402)
Timeframe: Week 48

InterventionPercentage of participants (Number)
Age, <50 Years, n=212, 212Age, >=50 Years, n=36, 35Race, White, n=115, 107Race, Non-White, n=133,140Race, African-American/African Heritage, n=102,108Non-African-American/African Heritage, n=146, 139BPHR, <1000, n=5, 10BPHR, 1000 to <10,000, n=66, 62BPHR, 10,000 to <50,000, n=83, 81BPHR, 50,000 to <=100,000, n=25, 28BPHR, >100,000, n=69, 66BCCC, <200, n=64, 49BCCC, >=200, n=184, 198BCCC, <50, n=9, 15BCCC, 50 to <200, n=55, 34BCCC, 200 to <350, n=66, 74BCCC, 350 to <500, n=56, 65BCCC, >=500, n=62, 59CDC category, A, n=210, 208CDC category, B, n=27, 30CDC category, C, n=11, 9HIV-1 subtype: B vs Non-B, B, n=95, 111HIV-1 subtype: B vs Non-B, non-B, n=140, 131Argentina, n=24, 20Canada, n=11, 9France, n=7, 8Italy, n=17, 11Mexico, n=6, 5Portugal, n=4, 5Russia, n=28, 22South Africa, n=33, 33Spain, n=23, 31Thailand, n=19, 21USA, n=62, 69United Kingdom, n=14, 11
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase809286787488608384808081826784897977818191808492911008810075896770957493

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Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups

Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA [BPHR], Baseline CD4+ cell count [BCCC], Baseline Centers for Disease Control and Prevention [CDC] category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =100,000 c/mL) and CD4+ cell count (=<350 cells/mm^3 or >350 cells/mm^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. Percentage values are rounded off. (NCT01910402)
Timeframe: Week 48

InterventionPercentage of participants (Number)
Age, <50 Years, n=212, 212Age, >=50 Years, n=36, 35Race, White, n=115, 107Race, Non-White, n=133,140Race, African-American/African Heritage, n=102,108Non-African-American/African Heritage, n=146, 139BPHR, <1000, n=5, 10BPHR, 1000 to <10,000, n=66, 62BPHR, 10,000 to <50,000, n=83, 81BPHR, 50,000 to <=100,000, n=25, 28BPHR, >100,000, n=69, 66BCCC, <200, n=64, 49BCCC, >=200, n=184, 198BCCC, <50, n=9, 15BCCC, 50 to <200, n=55, 34BCCC, 200 to <350, n=66, 74BCCC, 350 to <500, n=56, 65BCCC, >=500, n=62, 59CDC category, A, n=210, 208CDC category, B, n=27, 30CDC category, C, n=11, 9HIV-1 subtype: B vs Non-B, B, n=95, 111HIV-1 subtype: B vs Non-B, non-B, n=140, 131Argentina, n=24, 20Canada, n=11, 9France, n=7, 8Italy, n=17, 11Mexico, n=6, 5Portugal, n=4, 5Puerto Rico, n=0, 2Russia, n=28, 22South Africa, n=33, 33Spain, n=23, 31Thailand, n=19, 21USA, n=62, 69United Kingdom, n=14, 11
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase7174806467758077746464697260747374687177566973808975646060100827677526764

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Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase

Percentage of participants with plasma HIV-1 RNA <50 and <400 c/mL were assessed at Baseline, Weeks 4, 12, 24 , 36 and 48 using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Percentage values are rounded off. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionPercentage of participants (Number)
HIV-1 RNA <50 c/mL, Baseline (Day 1)HIV-1 RNA <50 c/mL, Week 4HIV-1 RNA <50 c/mL, Week 12HIV-1 RNA <50 c/mL, Week 24HIV-1 RNA <50 c/mL, Week 36HIV-1 RNA <50 c/mL, Week 48HIV-1 RNA <400 c/mL, Baseline (Day 1)HIV-1 RNA <400 c/mL, Week 4HIV-1 RNA <400 c/mL, Week 12HIV-1 RNA <400 c/mL, Week 24HIV-1 RNA <400 c/mL, Week 36HIV-1 RNA <400 c/mL, Week 48
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase0134977777115484828176
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase0648185858219091888683

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Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase

Change from the Baseline in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionLog10 copies/mL (Mean)
Week 4, n=245, 238Week 12, n=236, 226Week 24, n=225, 212Week 36, n=221, 204Week 48, n=207, 192
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase-1.923-2.541-2.726-2.772-2.752
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase-2.591-2.756-2.789-2.838-2.874

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Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints

Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in Total CHLS/HDL CHLS ratio is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionRatio (Mean)
Week 4, n= 1, 4Week 12, n= 233, 223Week 24, n= 224, 209Week 36, n= 212, 198Week 48, n= 207, 186
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase0.2159-0.1092-0.1922-0.1433-0.1444
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase0.1264-0.2736-0.3098-0.3286-0.2886

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Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints

Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in Type I collagen C-telopeptides (T-1 CCT) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Weeks 24 and 48

,
InterventionNanograms per liter (Mean)
Week 24, n=221, 207Week 48, n=202, 185
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase272.4267.9
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase89.875.9

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Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points

Change from Baseline in urine albumin creatinine ratio at Week 24 and Week 48 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 24 and Week 48

,
Interventionmilligrams per millimole (Mean)
Week 24, n= 179, 186Week 48, n= 170, 164
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase-1.03-0.10
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase-1.15-0.68

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Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48

Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in vitamin D, vitamin D2 and vitamin D3 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Weeks 24 and 48

,
InterventionNanomoles per liter (Mean)
Vitamin D, Week 24, n=223, 208Vitamin D, Week 48, n=206, 186Vitamin D2, Week 24, n=223, 208Vitamin D2, Week 48, n=206, 186Vitamin D3, Week 24, n=223, 208Vitamin D3, Week 48, n=206, 186
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase16.38.91.00.915.27.9
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase1.8-1.90.30.11.5-1.9

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HIVTSQs Total Score at Indicated Timepoints

The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction total score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Statistical analysis was performed based on Wilcoxon rank sum test. (NCT01910402)
Timeframe: Weeks 4, 12, 24 and 48

,
InterventionScore on a scale (Mean)
Week 4, n=243, 239Week 12, n=236, 226Week 24, n=225, 211Week 48, n=206, 191
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase51.953.654.355.4
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase54.056.156.857.0

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Number of Participants With AEs by Maximum Toxicity-Randomized Phase

Number of participants with Grade 1-4 AEs by maximum toxicity were assessed from the start of study treatment and until end of the Randomization phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. (NCT01910402)
Timeframe: Up to Week 48

,
InterventionParticipants (Count of Participants)
Grade 1Grade 2Grade 3Grade 4
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase6091379
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase7994183

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Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)-Randomized Phase

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented. (NCT01910402)
Timeframe: Up to Week 48

,
InterventionParticipants (Count of Participants)
Any AEsAny SAEs
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase19720
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase19512

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Number of Participants With Any AEs, and SAEs in Continuation Phase

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented. (NCT01910402)
Timeframe: From Weeks 48 to 432

InterventionParticipants (Count of Participants)
Any AEsAny SAEs
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase9313

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Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase

Number of participants with grades 1-4 emergent chemistry toxicities were assessed in Continuation Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose. (NCT01910402)
Timeframe: From Weeks 48 to 432

InterventionParticipants (Count of Participants)
Hyperglycaemia, Grade 1, n=143Hyperglycaemia, Grade 2, n=143Hyperglycaemia, Grade 3, n=143Hyperglycaemia, Grade 4, n=143Hypernatremia, Grade 1, n=146Hypernatremia, Grade 2, n=146Hypernatremia, Grade 3, n=146Hypernatremia, Grade 4, n=146Hypoglycaemia, Grade 1, n=143Hypoglycaemia, Grade 2, n=143Hypoglycaemia, Grade 3, n=143Hypoglycaemia, Grade 4, n=143Hypokalemia, Grade 1, n=146Hypokalemia, Grade 2, n=146Hypokalemia, Grade 3, n=146Hypokalemia, Grade 4, n=146Hyponatremia, Grade 1, n=146Hyponatremia, Grade 2, n=146Hyponatremia, Grade 3, n=146Hyponatremia, Grade 4, n=146Alanine aminotransferase, Grade 1, n=146Alanine aminotransferase, Grade 2, n=146Alanine aminotransferase, Grade 3, n=146Alanine aminotransferase, Grade 4, n=146Alkaline phosphatase, Grade 1, n=146Alkaline phosphatase, Grade 2, n=146Alkaline phosphatase, Grade 3, n=146Alkaline phosphatase, Grade 4, n=146Aspartate aminotransferase, Grade 1, n=146Aspartate aminotransferase, Grade 2, n=146Aspartate aminotransferase, Grade 3, n=146Aspartate aminotransferase, Grade 4, n=146Bilirubin, Grade 1, n=146Bilirubin, Grade 2, n=146Bilirubin, Grade 3, n=146Bilirubin, Grade 4, n=146Carbon dioxide, Grade 1, n=146Carbon dioxide, Grade 2, n=146Carbon dioxide, Grade 3, n=146Carbon dioxide, Grade 4, n=146Cholesterol, Grade 1, n=71Cholesterol, Grade 2, n=71Cholesterol, Grade 3, n=71Cholesterol, Grade 4, n=71Creatine kinase, Grade 1, n=146Creatine kinase, Grade 2, n=146Creatine kinase, Grade 3, n=146Creatine kinase, Grade 4, n=146Creatinine, Grade 1, n=146Creatinine, Grade 2, n=146Creatinine, Grade 3, n=146Creatinine, Grade 4, n=146LDL cholesterol calculation, Grade 1, n=70LDL cholesterol calculation, Grade 2, n=70LDL cholesterol calculation, Grade 3, n=70LDL cholesterol calculation, Grade 4, n=70LDL cholesterol direct, Grade 1, n=2LDL cholesterol direct, Grade 2, n=2LDL cholesterol direct, Grade 3, n=2LDL cholesterol direct, Grade 4, n=2Lipase, Grade 1, n=146Lipase, Grade 2, n=146Lipase, Grade 3, n=146Lipase, Grade 4, n=146Phosphate, Grade 1, n=146Phosphate, Grade 2, n=146Phosphate, Grade 3, n=146Phosphate, Grade 4, n=146Potassium, Grade 1, n=146Potassium, Grade 2, n=146Potassium, Grade 3, n=146Potassium, Grade 4, n=146Sodium, Grade 1, n=146Sodium, Grade 2, n=146Sodium, Grade 3, n=146Sodium, Grade 4, n=146Triglycerides, Grade 1, n=71Triglycerides, Grade 2, n=71Triglycerides, Grade 3, n=71Triglycerides, Grade 4, n=71Glucose, Grade 1, n=143Glucose, Grade 2, n=143Glucose, Grade 3, n=143Glucose, Grade 4, n=143
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase249302000100113000360007302500010202413058700993061115001582010009611215201300037000010024931

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Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase

Number of participants with Grade 1-4 emergent chemistry toxicities were assessed from the start of study treatment and end of Randomized Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hyperkalemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose. (NCT01910402)
Timeframe: Up to Week 48

,
InterventionParticipants (Count of Participants)
Hyperglycaemia, Grade 1Hyperglycaemia, Grade 2Hyperglycaemia, Grade 3Hyperglycaemia, Grade 4Hyperkalemia, Grade 1Hyperkalemia, Grade 2Hyperkalemia, Grade 3Hyperkalemia, Grade 4Hypernatremia, Grade 1Hypernatremia, Grade 2Hypernatremia, Grade 3Hypernatremia, Grade 4Hypoglycaemia, Grade 1Hypoglycaemia, Grade 2Hypoglycaemia, Grade 3Hypoglycaemia, Grade 4Hypokalemia, Grade 1Hypokalemia, Grade 2Hypokalemia, Grade 3Hypokalemia, Grade 4Hyponatremia, Grade 1Hyponatremia, Grade 2Hyponatremia, Grade 3Hyponatremia, Grade 4Alanine aminotransferase, Grade 1Alanine aminotransferase, Grade 2Alanine aminotransferase, Grade 3Alanine aminotransferase, Grade 4Albumin, Grade 1Albumin, Grade 2Albumin, Grade 3Albumin, Grade 4Alkaline phosphatase, Grade 1Alkaline phosphatase, Grade 2Alkaline phosphatase, Grade 3Alkaline phosphatase, Grade 4Aspartate aminotransferase, Grade 1Aspartate aminotransferase, Grade 2Aspartate aminotransferase, Grade 3Aspartate aminotransferase, Grade 4Bilirubin, Grade 1Bilirubin, Grade 2Bilirubin, Grade 3Bilirubin, Grade 4Carbon dioxide, Grade 1Carbon dioxide, Grade 2Carbon dioxide, Grade 3Carbon dioxide, Grade 4Cholesterol, Grade 1Cholesterol, Grade 2Cholesterol, Grade 3Cholesterol, Grade 4Creatine kinase, Grade 1Creatine kinase, Grade 2Creatine kinase, Grade 3Creatine kinase, Grade 4Creatinine, Grade 1Creatinine, Grade 2Creatinine, Grade 3Creatinine, Grade 4LDL cholesterol calculation, Grade 1LDL cholesterol calculation, Grade 2LDL cholesterol calculation, Grade 3LDL cholesterol calculation, Grade 4LDL cholesterol direct, Grade 1LDL cholesterol direct, Grade 2LDL cholesterol direct, Grade 3LDL cholesterol direct, Grade 4Lipase, Grade 1Lipase, Grade 2Lipase, Grade 3Lipase, Grade 4Phosphate, Grade 1Phosphate, Grade 2Phosphate, Grade 3Phosphate, Grade 4Potassium, Grade 1Potassium, Grade 2Potassium, Grade 3Potassium, Grade 4Sodium, Grade 1Sodium, Grade 2Sodium, Grade 3Sodium, Grade 4Triglycerides, Grade 1Triglycerides, Grade 2Triglycerides, Grade 3Triglycerides, Grade 4Glucose, Grade 1Glucose, Grade 2Glucose, Grade 3Glucose, Grade 4
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase11930010000005100190005700074202200141007420528657554300319205101730021920100073211192019100570000200151030
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase17164110001000631017100441005611300032001241120006540052284031303010381370310012530571018100451000520221941

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Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase

Number of participants with Grade 1-4 emergent hematology toxicities were assessed in Continuation Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets. (NCT01910402)
Timeframe: From Weeks 48 to 432

InterventionParticipants (Count of Participants)
Hemoglobin, Grade 1Hemoglobin, Grade 2Hemoglobin, Grade 3Hemoglobin, Grade 4Leukocytes, Grade 1Leukocytes, Grade 2Leukocytes, Grade 3Leukocytes, Grade 4Neutrophils, Grade 1Neutrophils, Grade 2Neutrophils, Grade 3Neutrophils, Grade 4Platelets, Grade 1Platelets, Grade 2Platelets, Grade 3Platelets, Grade 4
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase51002010102113100

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Number of Participants With AEs by Maximum Toxicity-Continuation Phase

Number of participants with Grade 1-4 AEs were assessed in Continuation Phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. (NCT01910402)
Timeframe: From Weeks 48 to 432

InterventionParticipants (Count of Participants)
Grade 1Grade 2Grade 3Grade 4
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase324876

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Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase

Number of participants with Grade 1-4 emergent hematology toxicities were assessed from the start of study treatment and end of Randomized Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets. (NCT01910402)
Timeframe: Up to Week 48

,
InterventionParticipants (Count of Participants)
Hemoglobin, Grade 1Hemoglobin, Grade 2Hemoglobin, Grade 3Hemoglobin, Grade 4Leukocytes, Grade 1Leukocytes, Grade 2Leukocytes, Grade 3Leukocytes, Grade 4Neutrophils, Grade 1Neutrophils, Grade 2Neutrophils, Grade 3Neutrophils, Grade 4Platelets, Grade 1Platelets, Grade 2Platelets, Grade 3Platelets, Grade 4
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase213106200129211200
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase72105100157016010

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Number of Participants With Post-Baseline HIV-1 Disease Progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)

Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. (NCT01910402)
Timeframe: Up to week 432

InterventionParticipants (Count of Participants)
CDC Class A to CDC Class CCDC Class B to CDC Class CCDC Class C to new CDC Class CCDC Class A, B or C to Death
DTG 50 mg/ABC 600 mg/3TC 300 mg QD6102

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Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase

Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. (NCT01910402)
Timeframe: Up to week 48

,
InterventionParticipants (Count of Participants)
CDC Class A to CDC Class CCDC Class B to CDC Class CCDC Class C to new CDC Class CCDC Class A, B or C to Death
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase4201
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase5101

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Number of Participants With Treatment Emergent Resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase)

Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to integrase strand transfer inhibitor (INSTI), Non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitors (PI) will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITTE population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met. (NCT01910402)
Timeframe: Up to week 48

InterventionParticipants (Count of Participants)
INSTI; n= 3NNRTI; n=4NRTI; n=4PI; n=4
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD-Randomized Phase1010

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Number of Participants With Treatment Emergent Resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)

Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to integrase strand transfer inhibitor (INSTI), Non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitors (PI) will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITTE population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met. (NCT01910402)
Timeframe: Up to week 432

InterventionParticipants (Count of Participants)
INSTI; n= 6NNRTI; n=8NRTI; n=8PI; n=8
DTG 50 mg/ABC 600 mg/3TC 300 mg QD0110

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Absolute Values in CD4+ Cell Count at Indicated Timepoints-Continuation Phase

Absolute values in CD4+ cell count were assessed at indicated time points. (NCT01910402)
Timeframe: Week 96 and Week 432

InterventionCells per cubic millimeter (Mean)
Week 96, n=99Week 432, n=3
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase635.3553.0

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Change From Baseline in TC/HDL Ratio at Week 48

Change from Baseline in mean total cholesterol (TC)/HDL ratio is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted TC/HDL at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides/HDL at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36. (NCT01910402)
Timeframe: Baseline (Day 1) and Week 48

InterventionRatio (Least Squares Mean)
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase-0.264
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase-0.158

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Change From Baseline in Triglycerides at Week 48

Change from Baseline in mean triglycerides is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted triglycerides at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36. (NCT01910402)
Timeframe: Baseline (Day 1) and Week 48

InterventionMillimoles per liter (Least Squares Mean)
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase0.045
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase0.070

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Number of Participants Who Withdrew From Treatment Due to AEs-Continuation Phase

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. (NCT01910402)
Timeframe: From Weeks 48 to 432

InterventionParticipants (Count of Participants)
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase4

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Number of Participants Who Withdrew From Treatment Due to AEs-Randomized Phase

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. (NCT01910402)
Timeframe: Up to Week 48

InterventionParticipants (Count of Participants)
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase10
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase17

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Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48

Percentage of participants with plasma human immunodeficiency virus type 1(HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL) were assessed at Week 48 using the Snapshot algorithm. Analysis was performed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights, adjusting for Baseline plasma HIV-1 RNA ( =100,000 c/mL) and CD4+ cell count (=<350 cells per millimeter cube (cells/mm^3) or >350 cells/mm^3). Intent-to-Treat Exposed (ITT-E) Population comprised of all randomized participants who received at least one dose of study medication. Percentage values are rounded off. (NCT01910402)
Timeframe: Week 48

InterventionPercentage of participants (Number)
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase82
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase71

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Percentage of Participants With Plasma HIV-1 RNA <50 c/mL in Continuation Phase

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA <50 c/mL were reported. Percentage values are rounded off. (NCT01910402)
Timeframe: Week 96 and Week 432

InterventionPercentage of participants (Number)
Week 96, n=99Week 432, n=3
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase100100

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Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase

Change from the Baseline in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 96 and Week 432

InterventionLog10 copies/mL (Mean)
Week 96, n=99Week 432, n=3
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase-2.911-3.107

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Change From Baseline in Lipase at Indicated Timepoints

Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in lipase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionUnits per liter (Mean)
Week 4, n= 245, 237Week 12, n= 236, 226Week 24, n= 225, 212Week 36, n= 219, 204Week 48, n= 208, 192
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase-1.3-2.1-6-6.3-7.8
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase-1.2-2.2-6-6.3-6.5

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Change From Baseline in Hematocrit Count at Indicated Time Points

Hematology parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in hematocrit is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionProportion of red blood cells in blood (Mean)
Week 4, n= 243, 234Week 12, n= 233, 220Week 24, n= 225, 211Week 36, n= 218, 203Week 48, n= 207, 190
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase-0.00420.00000.00510.00620.0107
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase0.00030.00810.01570.01670.0212

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Change From Baseline in Erythrocytes at Indicated Time Points

Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
Intervention10^12 cells per liter (Mean)
Week 4, n= 243, 234Week 12, n= 233, 220Week 24, n= 225, 211Week 36, n= 218, 203Week 48, n= 207, 190
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase-0.07-0.09-0.09-0.08-0.05
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase-0.04-0.07-0.08-0.10-0.10

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Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points

Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocyte mean corpuscular volume (EMCV) is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionFemtoliter (Mean)
Week 4, n= 243, 234Week 12, n= 233, 220Week 24, n= 225, 211Week 36, n= 218, 203Week 48, n= 207, 190
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase0.51.93.13.13.7
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase0.93.45.56.07.1

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Change From Baseline in Creatinine Clearance at Indicated Time Points

Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in creatinine clearance is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionMilliliter per minute (Mean)
Week 4, n= 245, 237Week 12, n= 236, 226Week 24, n= 225, 212Week 36, n= 219, 204Week 48, n= 208, 192
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase-7.5-7-9.1-7.5-7.7
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase-16.3-17.3-16.2-16.8-15.9

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Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase

Absolute values in CD4+ cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionCells per cubic millimeter (Mean)
Baseline (Day 1), n=248, 247Week 4, n=245, 237Week 12, n=236, 224Week 24, n=226, 210Week 36, n=219, 204Week 48, n=208, 191
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase380.3455.1506.2542.5569.2608.5
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase369.7465.0509.5563.8592.8608.8

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Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase

Change from Baseline in cluster of differentiation 4 (CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionCells per cubic millimeter (Mean)
Week 4, n=245, 237Week 12, n=236, 224Week 24, n=226, 210Week 36, n=219, 204Week 48, n=208, 191
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase73.7124.4163.0191.4230.7
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase94.9143.8200.6230.7248.8

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Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Continuation Phase

Change from Baseline in cluster of differentiation 4(CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 96, Week 432

InterventionCells per cubic millimeter (Mean)
Week 96, n=99Week 432, n=3
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase286.5254.7

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Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points

Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol [CHLS], high density lipoprotein [HDL] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

InterventionMillimoles per liter (Mean)
Carbon Dioxide, Week 4, n= 244, 237Carbon Dioxide, Week 12, n= 236, 226Carbon Dioxide, Week 24, n= 224, 212Carbon Dioxide, Week 36, n= 219, 204Carbon Dioxide, Week 48, n= 208, 192Chloride, Week 4, n= 245, 237Chloride, Week 12, n= 236, 226Chloride, Week 24, n= 225, 212Chloride, Week 36, n= 219, 204Chloride, Week 48, n= 208, 192CHLS, Week 4, n= 1, 3CHLS, Week 12, n= 224, 221CHLS, Week 24, n= 218, 201CHLS, Week 36, n= 205, 191CHLS, Week 48, n= 195, 175Glucose, Week 12, n= 226, 224Glucose, Week 24, n= 219, 204Glucose, Week 36, n= 211, 196Glucose, Week 48, n= 197, 180HDL CHLS, Direct, Week 4, n= 1, 3HDL CHLS, Direct, Week 12, n= 224, 221HDL CHLS, Direct, Week 24, n= 218, 201HDL CHLS, Direct, Week 36, n= 205, 191HDL CHLS, Direct, Week 48, n= 195, 175Hyperglycaemia, Week 12, n= 226, 224Hyperglycaemia, Week 24, n= 219, 204Hyperglycaemia, Week 36, n= 211, 196Hyperglycaemia, Week 48, n= 197, 180Hyperkalemia, Week 4, n= 244, 237Hyperkalemia, Week 12, n= 236, 226Hyperkalemia, Week 24, n= 224, 212Hyperkalemia, Week 36, n= 219, 204Hyperkalemia, Week 48, n= 208, 192Hypernatremia, Week 4, n= 245, 237Hypernatremia, Week 12, n= 236, 226Hypernatremia, Week 24, n= 225, 212Hypernatremia, Week 36, n= 219, 204Hypernatremia, Week 48, n= 208, 192Hypoglycaemia, Week 12, n= 226, 224Hypoglycaemia, Week 24, n= 219, 204Hypoglycaemia, Week 36, n= 211, 196Hypoglycaemia, Week 48, n= 197, 180Hypokalemia, Week 4, n= 244, 237Hypokalemia, Week 12, n= 236, 226Hypokalemia, Week 24, n= 224, 212Hypokalemia, Week 36, n= 219, 204Hypokalemia, Week 48, n= 208, 192Hyponatremia, Week 4, n= 245, 237Hyponatremia, Week 12, n= 236, 226Hyponatremia, Week 24, n= 225, 212Hyponatremia, Week 36, n= 219, 204Hyponatremia, Week 48, n= 208, 192LDL CHLS Calculation, Week 4, n= 1, 3LDL CHLS Calculation, Week 12, n= 221, 219LDL CHLS Calculation, Week 24, n= 213, 201LDL CHLS Calculation, Week 36, n= 201, 188LDL CHLS Calculation, Week 48, n= 190, 175LDL CHLS, Direct, Week 24, n= 1, 0LDL CHLS, Direct, Week 36, n= 1, 0Phosphate, Week 4, n= 245, 237Phosphate, Week 12, n= 236, 226Phosphate, Week 24, n= 225, 212Phosphate, Week 36, n= 219, 204Phosphate, Week 48, n= 208, 192Potassium, Week 4, n= 244, 237Potassium, Week 12, n= 236, 226Potassium, Week 24, n= 224, 212Potassium, Week 36, n= 219, 204Potassium, Week 48, n= 208, 192Sodium, Week 4, n= 245, 237Sodium, Week 12, n= 236, 226Sodium, Week 24, n= 225, 212Sodium, Week 36, n= 219, 204Sodium, Week 48, n= 208, 192Triglycerides, Week 4, n= 1, 3Triglycerides, Week 12, n= 224, 221Triglycerides, Week 24, n= 218, 201Triglycerides, Week 36, n= 205, 191Triglycerides, Week 48, n= 195, 175Urea, Week 4, n= 245, 237Urea, Week 12, n= 236, 226Urea, Week 24, n= 225, 212Urea, Week 36, n= 219, 204Urea, Week 48, n= 208, 192
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase-0.4-0.2-0.50-0.60.610.70.90.7-0.10.2980.3170.330.4470.30.170.170.18-0.10.1820.2010.2040.2310.30.170.170.18-0.010.03-0.040.03-0.0400.70.60.90.60.30.170.170.18-0.010.03-0.040.03-0.0400.70.60.90.60.080.1250.1110.1120.213-0.64-0.2300.020.0210.0290.016-0.010.03-0.040.03-0.0400.70.60.90.6-0.18-0.040.0360.0370.018-0.040.080.030.080.1

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Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points

Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol [CHLS], high density lipoprotein [HDL] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

InterventionMillimoles per liter (Mean)
Carbon Dioxide, Week 4, n= 244, 237Carbon Dioxide, Week 12, n= 236, 226Carbon Dioxide, Week 24, n= 224, 212Carbon Dioxide, Week 36, n= 219, 204Carbon Dioxide, Week 48, n= 208, 192Chloride, Week 4, n= 245, 237Chloride, Week 12, n= 236, 226Chloride, Week 24, n= 225, 212Chloride, Week 36, n= 219, 204Chloride, Week 48, n= 208, 192CHLS, Week 4, n= 1, 3CHLS, Week 12, n= 224, 221CHLS, Week 24, n= 218, 201CHLS, Week 36, n= 205, 191CHLS, Week 48, n= 195, 175Glucose, Week 12, n= 226, 224Glucose, Week 24, n= 219, 204Glucose, Week 36, n= 211, 196Glucose, Week 48, n= 197, 180HDL CHLS, Direct, Week 4, n= 1, 3HDL CHLS, Direct, Week 12, n= 224, 221HDL CHLS, Direct, Week 24, n= 218, 201HDL CHLS, Direct, Week 36, n= 205, 191HDL CHLS, Direct, Week 48, n= 195, 175Hyperglycaemia, Week 12, n= 226, 224Hyperglycaemia, Week 24, n= 219, 204Hyperglycaemia, Week 36, n= 211, 196Hyperglycaemia, Week 48, n= 197, 180Hyperkalemia, Week 4, n= 244, 237Hyperkalemia, Week 12, n= 236, 226Hyperkalemia, Week 24, n= 224, 212Hyperkalemia, Week 36, n= 219, 204Hyperkalemia, Week 48, n= 208, 192Hypernatremia, Week 4, n= 245, 237Hypernatremia, Week 12, n= 236, 226Hypernatremia, Week 24, n= 225, 212Hypernatremia, Week 36, n= 219, 204Hypernatremia, Week 48, n= 208, 192Hypoglycaemia, Week 12, n= 226, 224Hypoglycaemia, Week 24, n= 219, 204Hypoglycaemia, Week 36, n= 211, 196Hypoglycaemia, Week 48, n= 197, 180Hypokalemia, Week 4, n= 244, 237Hypokalemia, Week 12, n= 236, 226Hypokalemia, Week 24, n= 224, 212Hypokalemia, Week 36, n= 219, 204Hypokalemia, Week 48, n= 208, 192Hyponatremia, Week 4, n= 245, 237Hyponatremia, Week 12, n= 236, 226Hyponatremia, Week 24, n= 225, 212Hyponatremia, Week 36, n= 219, 204Hyponatremia, Week 48, n= 208, 192LDL CHLS Calculation, Week 4, n= 1, 3LDL CHLS Calculation, Week 12, n= 221, 219LDL CHLS Calculation, Week 24, n= 213, 201LDL CHLS Calculation, Week 36, n= 201, 188LDL CHLS Calculation, Week 48, n= 190, 175LDL CHLS, Direct, Week 12, n= 0, 1Phosphate, Week 4, n= 245, 237Phosphate, Week 12, n= 236, 226Phosphate, Week 24, n= 225, 212Phosphate, Week 36, n= 219, 204Phosphate, Week 48, n= 208, 192Potassium, Week 4, n= 244, 237Potassium, Week 12, n= 236, 226Potassium, Week 24, n= 224, 212Potassium, Week 36, n= 219, 204Potassium, Week 48, n= 208, 192Sodium, Week 4, n= 245, 237Sodium, Week 12, n= 236, 226Sodium, Week 24, n= 225, 212Sodium, Week 36, n= 219, 204Sodium, Week 48, n= 208, 192Triglycerides, Week 4, n= 1, 3Triglycerides, Week 12, n= 224, 221Triglycerides, Week 24, n= 218, 201Triglycerides, Week 36, n= 205, 191Triglycerides, Week 48, n= 195, 175Urea, Week 4, n= 245, 237Urea, Week 12, n= 236, 226Urea, Week 24, n= 225, 212Urea, Week 36, n= 219, 204Urea, Week 48, n= 208, 192
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase0.60.80.30.60.4-0.50.2-0.100-0.017-0.058-0.00100.1090.220.260.340.2400.0050.0530.0360.0810.220.260.340.240.120.10.060.130.04-0.50.10.20.20.50.220.260.340.240.120.10.060.130.04-0.50.10.20.20.5-0.123-0.14-0.111-0.099-0.021-0.44-0.0320.0260.0260.00900.120.10.060.130.04-0.50.10.20.20.50.2370.1670.1250.1570.1070.10.160.12-0.030.02

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Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints

Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Weeks 24 and 48

,
InterventionMicrograms per liter (Mean)
BSAP, Week 24, n=219, 207BSAP, Week 48, n=202, 184Osteocalcin, Week 24, n=209, 197Osteocalcin, Week 48, n=194, 178PTP, Week 24, n=223, 206PTP, Week 48, n=205, 186
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase6.007.6014.3816.3032.034.1
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase1.332.643.735.1510.111.2

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Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints

Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in bilirubin and creatinine are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionMicromoles per liter (Mean)
Bilirubin, Week 4, n= 244, 237Bilirubin, Week 12, n= 236, 226Bilirubin, Week 24, n= 225, 212Bilirubin, Week 36, n= 219, 204Bilirubin, Week 48, n= 208, 192Creatinine, Week 4, n= 245, 237Creatinine, Week 12, n= 236, 226Creatinine, Week 24, n= 225, 212Creatinine, Week 36, n= 219, 204Creatinine, Week 48, n= 208, 192
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase27.222.82523.823.74.895.835.85.375.86
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase-0.8-0.6-0.2-0.2-0.38.49.29.1610.089.29

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Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points

Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
Intervention10^9 cells per liter (Mean)
Basophils, Week 4, n= 241, 234Basophils, Week 12, n= 228, 216Basophils, Week 24, n= 221, 208Basophils, Week 36, n= 214, 203Basophils, Week 48, n= 206, 189Eosinophils, Week 4, n= 241, 234Eosinophils, Week 12, n= 228, 216Eosinophils, Week 24, n= 221, 208Eosinophils, Week 36, n= 214, 203Eosinophils, Week 48, n= 206, 189Lymphocytes, Week 4, n= 241, 234Lymphocytes, Week 12, n= 228, 216Lymphocytes, Week 24, n= 221, 208Lymphocytes, Week 36, n= 214, 203Lymphocytes, Week 48, n= 206, 189Monocytes, Week 4, n= 241, 234Monocytes, Week 12, n= 228, 216Monocytes, Week 24, n= 221, 208Monocytes, Week 36, n= 214, 203Monocytes, Week 48, n= 206, 189
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase0.0030.0030.0030.0030.0060.021-0.0010.0050.0140.0070.1190.1560.1920.1780.261-0.015-0.031-0.015-0.028-0.024
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase0.0030.0020.0040.0040.0050.0400.0370.0280.0480.0300.2080.2570.3170.3620.359-0.001-0.0100.008-0.0060.001

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Change From Baseline in Albumin at Indicated Timepoints

Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in albumin is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionGrams per liter (Mean)
Week 4, n= 245, 237Week 12, n= 236, 226Week 24, n= 225, 212Week 36, n= 219, 204Week 48, n= 208, 192
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase-0.50.10.80.61.3
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase0.10.51.41.41.7

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Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points

Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionInternational units per liter (Mean)
Alanine aminotransferase, Week 4, n= 245, 237Alanine aminotransferase, Week 12, n= 236, 226Alanine aminotransferase, Week 24, n= 225, 212Alanine aminotransferase, Week 36, n= 219, 204Alanine aminotransferase, Week 48, n= 208, 192Alkaline phosphatase, Week 4, n= 245, 237Alkaline phosphatase, Week 12, n= 236, 226Alkaline phosphatase, Week 24, n= 225, 212Alkaline phosphatase, Week 36, n= 219, 204Alkaline phosphatase, Week 48, n= 208, 192Aspartate aminotransferase, Week 4, n= 244, 237Aspartate aminotransferase, Week 12, n= 236, 226Aspartate aminotransferase, Week 24, n= 224, 212Aspartate aminotransferase, Week 36, n= 219, 204Aspartate aminotransferase, Week 48, n= 208, 192Creatine Kinase, Week 4, n= 245, 237Creatine Kinase, Week 12, n= 236, 226Creatine Kinase, Week 24, n= 225, 212Creatine Kinase, Week 36, n= 219, 204Creatine Kinase, Week 48, n= 208, 192
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase-3.4-2.3-3.7-5.3-1.59.415.122.420.421.9-3.6-4-5.1-6.5-3.735.67.35.87.23.8
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase-3.3-5.2-5.4-4.9-5.7-1.5-2.10.50.62.9-3.3-6.2-6.3-6.4-7.5-0.36.910.311.923.8

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Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS

The 12-Item Short Form Health Survey (SF-12) is 12 item abbreviated form of SF-36 survey. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health. SF-12 is a self-reported outcome measure assessing psychological wellness and the impact of health on an individual's everyday life. SF-12 total score ranges from 20 to 60 and higher score indicate a higher level of functioning. SF-12 total score was calculated by a clinician scoring 12-question survey filled by participants. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1) and Week 48

,
InterventionScore on a scale (Mean)
Total Score, Week 48, n=205, 192MCS, Week 48, n=205, 192PCS, Week 48, n=205, 192
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase0.12.3291.444
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase0.02.3971.905

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Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline

Bone markers were assessed at indicated timepoints. Bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP), Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline is calculated. Bone biomarkers were analyzed based on log transformed data. Estimates of adjusted mean and difference were calculated from an Analysis of covariance (ANCOVA) model adjusting for age, baseline viral load Baseline CD4+ cell count, Baseline biomarker level, body mass index category, smoking status and baseline Vitamin D use. Adjusted mean of log-transformed change from Baseline are transformed back to Week 48/Baseline ratio for each treatment group. Adjusted difference of log-transformed change from Baseline between treatment groups is transformed back to the ratio of Week 48/Baseline ratio in DTG/ABC/3TC FDC to ATV+RTV+TDF/FTC FDC. (NCT01910402)
Timeframe: Baseline (Day 1) and Week 48

,
InterventionRatio (Number)
BSAP, n=202, 183PTP, n=202, 184Osteocalcin, n=194, 178Type 1 Collagen C-Telopeptide, n=202, 184Vitamin D, n=206, 186
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase1.6291.7522.0391.9181.158
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase1.1881.2141.2821.2570.987

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Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase

Absolute Values in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

,
InterventionLog10 copies/mL (Mean)
Baseline (Day 1), n=248, 247Week 4, n=245, 238Week 12, n=236, 226Week 24, n=225, 212Week 36, n=221, 204Week 48, n=207, 192
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase4.4412.5161.9081.7101.6581.657
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase4.4811.8951.7481.7241.6661.619

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Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase

Absolute Values in plasma HIV-1 RNA were assessed at indicated time points. (NCT01910402)
Timeframe: Week 96 and Week 432

InterventionLog10 copies/mL (Mean)
Week 96, n=99Week 432, n=3
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase1.5911.590

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Cotrimoxazole: Change From Baseline in CD4% to Week 72

(NCT02028676)
Timeframe: Baseline, week 72

Interventionpercentage of total lymphocytes (Mean)
Continued Cotrimoxazole Prophylaxis1.7
Stopped Cotrimoxazole Prophylaxis1.1

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Cotrimoxazole: Change From Baseline in Absolute CD4 to Week 72

Estimated in those >5 years at randomization to stop vs continue, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.) (NCT02028676)
Timeframe: Baseline, week 72

Interventioncells per mm3 (Mean)
Continued Cotrimoxazole Prophylaxis7
Stopped Cotrimoxazole Prophylaxis-2

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Cotrimoxazole: Body Mass Index-for-age Z-score

Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Interventionage-adjusted z-score (Mean)
Continued Cotrimoxazole Prophylaxis-0.24
Stopped Cotrimoxazole Prophylaxis-0.28

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Cotrimoxazole: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)

Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks. (NCT02028676)
Timeframe: Mean over median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Intervention% of visits reporting missed pills (Mean)
Continued Cotrimoxazole Prophylaxis9
Stopped Cotrimoxazole Prophylaxis8

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CDM vs LCM, Induction ART: Suppression of HIV RNA Viral Load 72 Weeks After Baseline

Number of participants with HIV RNA viral load <80 copies/ml 72 weeks after baseline. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes. (NCT02028676)
Timeframe: 72 weeks

Interventionparticipants (Number)
Clinically Driven Monitoring (CDM)76
Laboratory Plus Clinical Monitoring (LCM)78
Arm A: ABC+3TC+NNRTI56
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance72
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance26

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CDM vs LCM, Induction ART: Suppression of HIV RNA Viral Load 144 Weeks After Baseline

Number of participants with HIV RNA viral load <80 copies/ml 144 weeks after baseline. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes. (NCT02028676)
Timeframe: 144 weeks

Interventionparticipants (Number)
Clinically Driven Monitoring (CDM)192
Laboratory Plus Clinical Monitoring (LCM)193
Arm A: ABC+3TC+NNRTI127
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance135
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance124

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LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 72

Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.) (NCT02028676)
Timeframe: Baseline, week 72

Interventionabsolute cells per mm3 (Mean)
Clinically Driven Monitoring (CDM)408
Laboratory Plus Clinical Monitoring (LCM)385
Arm A: ABC+3TC+NNRTI402
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance447
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance336

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LCM vs CDM, Induction ART: Height-for-age Z-score

Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 4 years (maximum 5 years)

Interventionage-adjusted z-score (Mean)
Clinically Driven Monitoring (CDM)0.36
Laboratory Plus Clinical Monitoring (LCM)0.43
Arm A: ABC+3TC+NNRTI0.40
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance0.40
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance0.38

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LCM vs CDM, Induction ART: New ART-modifying Adverse Event

Number of participants with a new ART-modifying adverse event, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)

Interventionparticipants (Number)
Clinically Driven Monitoring (CDM)31
Laboratory Plus Clinical Monitoring (LCM)32
Arm A: ABC+3TC+NNRTI8
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance30
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance25

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Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks) at 96 Weeks

Number of participants reporting missing any doses of ART in the last 4 weeks by self-report at 96 weeks. (NCT02028676)
Timeframe: 96 weeks after randomization to once- versus twice-daily

Interventionparticipants (Number)
Once-daily ABC+3TC26
Twice-daily ABC+3TC25

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LCM vs CDM, Induction ART: New or Recurrent WHO Stage 3 or 4 Event or Death

Number of participants with a new or recurrent WHO stage 3 or 4 event or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)

Interventionparticipants (Number)
Clinically Driven Monitoring (CDM)91
Laboratory Plus Clinical Monitoring (LCM)79
Arm A: ABC+3TC+NNRTI64
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance53
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance53

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LCM vs CDM, Induction ART: New WHO Stage 3 or 4 Event or Death

Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)

Interventionparticipants (Number)
Clinically Driven Monitoring (CDM)77
Laboratory Plus Clinical Monitoring (LCM)73
Arm A: ABC+3TC+NNRTI73
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance61
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance54

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LCM vs CDM, Induction ART: Weight-for-age Z-score

Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 4 years (maximum 5 years)

Interventionage-adjusted z-score (Mean)
Clinically Driven Monitoring (CDM)0.76
Laboratory Plus Clinical Monitoring (LCM)0.78
Arm A: ABC+3TC+NNRTI0.72
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance0.79
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance0.80

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LCM vs CDM, Induction ART: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)

Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks. (NCT02028676)
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)

Intervention% of visits reporting missed pills (Mean)
Clinically Driven Monitoring (CDM)8.5
Laboratory Plus Clinical Monitoring (LCM)9.4
Arm A: ABC+3TC+NNRTI8.3
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance9.5
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance9.1

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Cotrimoxazole: All-cause Mortality

Number of participants who died, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Interventionparticipants (Number)
Continued Cotrimoxazole Prophylaxis3
Stopped Cotrimoxazole Prophylaxis2

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Once Versus Twice Daily Abacavir+Lamivudine: Suppressed HIV RNA Viral Load 48 Weeks After Randomisation

Number of participants with HIV RNA viral load <80 copies/ml at 48 weeks. Measured retrospectively on stored plasma specimens: due to low stored volumes from some children, samples had to be diluted and therefore a threshold of <80 copies/ml was used to indicate suppression. (NCT02028676)
Timeframe: 48 weeks

Interventionparticipants (Number)
Once-daily ABC+3TC236
Twice-daily ABC+3TC242

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Once Versus Twice Daily Abacavir+Lamivudine: Suppression of HIV RNA Viral Load 96 Weeks After Randomisation

Number of participants with HIV RNA viral load <80 copies/ml at 96 weeks. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes. (NCT02028676)
Timeframe: 96 weeks

Interventionparticipants (Number)
Once-daily ABC+3TC230
Twice-daily ABC+3TC234

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Once Versus Twice Daily Abacavir+Lamivudine: Weight-for-age Z-score

Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)

Interventionage-adjusted z-score (Mean)
Once-daily ABC+3TC0.01
Twice-daily ABC+3TC-0.00

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LCM vs CDM, Induction ART: Cessation of First-line Regimen for Clinical/Immunological Failure

Number of participants stopping their first-line regimen for clinical/immunological failure, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)

Interventionparticipants (Number)
Clinically Driven Monitoring (CDM)28
Laboratory Plus Clinical Monitoring (LCM)35

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LCM vs CDM, Induction ART: Body Mass Index-for-age Z-score

Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 4 years (maximum 5 years)

Interventionage-adjusted z-score (Mean)
Clinically Driven Monitoring (CDM)0.65
Laboratory Plus Clinical Monitoring (LCM)0.61
Arm A: ABC+3TC+NNRTI0.56
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance0.64
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance0.69

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LCM vs CDM, Induction ART: All-cause Mortality

Number of participants who died from any cause, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)

Interventionparticipants (Number)
Clinically Driven Monitoring (CDM)25
Laboratory Plus Clinical Monitoring (LCM)29
Arm A: ABC+3TC+NNRTI20
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance14
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance20

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LCM vs CDM: Change From Baseline in CD4% to Week 144

(NCT02028676)
Timeframe: Baseline, week 144

Interventionpercentage of total lymphocytes (Mean)
Clinically Driven Monitoring (CDM)19.7
Laboratory Plus Clinical Monitoring (LCM)19.4

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LCM vs CDM: Change From Baseline in CD4% to Week 72

(NCT02028676)
Timeframe: Baseline, week 72

Interventionpercentage of total lymphocytes (Mean)
Clinically Driven Monitoring (CDM)17.2
Laboratory Plus Clinical Monitoring (LCM)16.7

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LCM vs CDM: Disease Progression to a New WHO Stage 4 Event or Death

Number of participants with disease progression to a new WHO stage 4 event or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)

Interventionparticipants (Number)
Clinically Driven Monitoring (CDM)47
Laboratory Plus Clinical Monitoring (LCM)39

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Induction ART: New WHO Stage 4 Event or Death

Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 4 years (from randomization to 16 March 2012; maximum 5 years)

Interventionparticipants (Number)
Arm A: ABC+3TC+NNRTI30
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance28
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance28

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Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks) at 48 Weeks

Number of participants reporting missing any doses of ART in the last 4 weeks by self-report at 48 weeks. (NCT02028676)
Timeframe: 48 weeks after randomization to once- versus twice-daily

Interventionparticipants (Number)
Once-daily ABC+3TC32
Twice-daily ABC+3TC29

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Once Versus Twice Daily Abacavir+Lamivudine: All-cause Mortality

Number of participants who died, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)

Interventionparticipants (Number)
Once-daily ABC+3TC1
Twice-daily ABC+3TC4

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Once Versus Twice Daily Abacavir+Lamivudine: Body Mass Index-for-age Z-score

Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)

Interventionage-adjusted z-score (Mean)
Once-daily ABC+3TC-0.29
Twice-daily ABC+3TC-0.35

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Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 48

Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.) (NCT02028676)
Timeframe: Randomisation to once vs twice daily, week 48

Interventioncells per mm3 (Mean)
Once-daily ABC+3TC3
Twice-daily ABC+3TC-3

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LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 144

Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.) (NCT02028676)
Timeframe: Baseline, week 144

Interventionabsolute cells per mm3 (Mean)
Clinically Driven Monitoring (CDM)418
Laboratory Plus Clinical Monitoring (LCM)420
Arm A: ABC+3TC+NNRTI446
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance450
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance360

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Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 72

All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured (NCT02028676)
Timeframe: Baseline, week 72

Interventioncells per mm3 (Mean)
Once-daily ABC+3TC-6
Twice-daily ABC+3TC27

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Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 96

All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured (NCT02028676)
Timeframe: Randomisation to once vs twice daily, week 96

Interventioncells per mm3 (Mean)
Once-daily ABC+3TC-26
Twice-daily ABC+3TC60

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Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 48

(NCT02028676)
Timeframe: Randomisation to once vs twice daily, week 48

Interventionpercentage of total lymphocytes (Mean)
Once-daily ABC+3TC0.9
Twice-daily ABC+3TC1.3

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Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 72

(NCT02028676)
Timeframe: Baseline, week 72

Interventionpercentage of total lymphocytes (Mean)
Once-daily ABC+3TC1.9
Twice-daily ABC+3TC1.9

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Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 96

(NCT02028676)
Timeframe: Randomisation to once vs twice daily, week 96

Interventionpercentage of lymphocytes (Mean)
Once-daily ABC+3TC1.6
Twice-daily ABC+3TC2.5

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Once Versus Twice Daily Abacavir+Lamivudine: Height-for-age Z-score

Age-adjusted change in height-for-age Z-score over all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)

Interventionage-adjusted z-score (Mean)
Once-daily ABC+3TC0.28
Twice-daily ABC+3TC0.32

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Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)

Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks. (NCT02028676)
Timeframe: Mean over median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)

Intervention% of visits reporting missed pills (Mean)
Once-daily ABC+3TC8
Twice-daily ABC+3TC8

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Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 4 Event or Death

Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)

Interventionparticipants (Number)
Once-daily ABC+3TC3
Twice-daily ABC+3TC7

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Induction ART: Change From Baseline in CD4% to 144 Weeks From ART Initiation

(NCT02028676)
Timeframe: Baseline, 144 weeks

Interventionpercentage of total lymphocytes (Mean)
Arm A: ABC+3TC+NNRTI19.8
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance19.6
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance19.2

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Induction ART: Change From Baseline in CD4% 72 Weeks After ART Initiation

(NCT02028676)
Timeframe: Baseline, 72 weeks

Interventionpercentage of total lymphocytes (Mean)
Arm A: ABC+3TC+NNRTI16.4
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance17.1
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance17.3

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Cotrimoxazole: Weight-for-age Z-score

Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Interventionage-adjusted z-score (Mean)
Continued Cotrimoxazole Prophylaxis-0.01
Stopped Cotrimoxazole Prophylaxis-0.05

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Cotrimoxazole: New WHO Stage 4 Event or Death

Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from randomization to 16 March 2012; maximum 2.5 years)

Interventionparticipants (Number)
Continued Cotrimoxazole Prophylaxis4
Stopped Cotrimoxazole Prophylaxis7

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Cotrimoxazole: New WHO Stage 3 Severe Recurrent Pneumonia or Diarrhoea

Number of participants with a new WHO stage 3 severe recurrent pneumonia or diarrhoea, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Interventionparticipants (Number)
Continued Cotrimoxazole Prophylaxis1
Stopped Cotrimoxazole Prophylaxis4

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Cotrimoxazole: New WHO Stage 3 or 4 Event or Death

Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from randomization to 16 March 2012; maximum 2.5 years)

Interventionparticipants (Number)
Continued Cotrimoxazole Prophylaxis8
Stopped Cotrimoxazole Prophylaxis19

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Cotrimoxazole: New Severe Pneumonia

Number of participants with a new severe pneumonia, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Interventionparticipants (Number)
Continued Cotrimoxazole Prophylaxis7
Stopped Cotrimoxazole Prophylaxis10

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Cotrimoxazole: New Hospitalisation or Death

Number of participants with a new hospitalisation or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Interventionparticipants (Number)
Continued Cotrimoxazole Prophylaxis48
Stopped Cotrimoxazole Prophylaxis72

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Cotrimoxazole: New Clinical and Diagnostic Positive Malaria

Number of participants with a new clinical and diagnostic positive malaria, to be analysed using time-to-event methods. Diagnostic positive by either microscopy (thick film) or rapid diagnostic test (RDT) (NCT02028676)
Timeframe: Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Interventionparticipants (Number)
Continued Cotrimoxazole Prophylaxis39
Stopped Cotrimoxazole Prophylaxis77

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Cotrimoxazole: Height-for-age Z-score

Age-adjusted change in height-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29). (NCT02028676)
Timeframe: Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)

Interventionage-adjusted z-score (Mean)
Continued Cotrimoxazole Prophylaxis0.22
Stopped Cotrimoxazole Prophylaxis0.19

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Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 3 or 4 Event or Death

Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods (NCT02028676)
Timeframe: Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)

Interventionparticipants (Number)
Once-daily ABC+3TC9
Twice-daily ABC+3TC12

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Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)

Glomerular Filtration Rate (eGFR) was estimated from the Modification of Diet in Renal Disease (MDRD)-6 equation. The MDRD-6 equation = 198 × [serum creatinine(mg/dL)]^-0.858 × [age]-0.167 × [0.822 if patient is female] × [1.178 if patient is black] × [serum urea nitrogen concentration (mg/dL)]^-0.293 × [urine urea nitrogen excretion (g/d)]^0.249. (NCT02116660)
Timeframe: Baseline and Week 48

InterventionmL/min (Mean)
Raltegravir Plus Nevirapine Plus Lamivudine-1.1
Protease Inhibitor/Ritonavir Plus Tenofovir/Emtricitabine-5.5

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Percentage of Participants With Loss of Hepatitis B Virus Envelope Antigen (HBeAg)

This endpoint is defined as loss of HBeAg at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80) and at 1 year post-end of treatment in the treated group. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. (NCT02263079)
Timeframe: 24 weeks post-treatment /end of untreated observation (Week 80), and 1 year post-end of treatment (End of treatment = Week 56)

InterventionPercentage of Participants (Number)
24 Weeks post-treatment/Week 80
Untreated Control Participants12.1

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Percentage of Participants With Seroconversion to Hepatitis B Surface Antibody (Anti-HBs), Defined as Loss of HBsAg and Presence of Anti-HBs

This endpoint measures the seroconversion to anti-HBs defined as loss of HBsAg and presence of anti-HBs at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80) and at 1 year post-end of treatment in the treated group. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. (NCT02263079)
Timeframe: 24 weeks post-treatment /end of untreated observation (Week 80), and 1 year post-end of treatment (End of treatment = Week 56)

InterventionPercentage of Participants (Number)
24 Weeks post-treatment/Week 801 year post-end of treatment
Peg-IFN-Alfa-2A + Lamivudine or Entecavir3.83.8

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Percentage of Participants With Seroconversion to Hepatitis B Surface Antibody (Anti-HBs), Defined as Loss of HBsAg and Presence of Anti-HBs

This endpoint measures the seroconversion to anti-HBs defined as loss of HBsAg and presence of anti-HBs at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80) and at 1 year post-end of treatment in the treated group. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. (NCT02263079)
Timeframe: 24 weeks post-treatment /end of untreated observation (Week 80), and 1 year post-end of treatment (End of treatment = Week 56)

InterventionPercentage of Participants (Number)
24 Weeks post-treatment/Week 80
Untreated Control Participants0.0

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Percentage of Participants With Seroconversion to Hepatitis B Envelope Antibody (Anti-HBe), Defined as Loss of HBeAg and Presence of Anti-HBe

This endpoint measures the seroconversion to anti-HBe defined as loss of HBeAg and presence of anti-HBe at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80) and at 1 year post-end of treatment in the treated group. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. (NCT02263079)
Timeframe: 24 weeks post-treatment /end of untreated observation (Week 80), and 1 year post-end of treatment (End of treatment = Week 56)

InterventionPercentage of Participants (Number)
24 Weeks post-treatment/Week 801 year post-end of treatment
Peg-IFN-Alfa-2A + Lamivudine or Entecavir0.07.7

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Percentage of Participants With Seroconversion to Hepatitis B Envelope Antibody (Anti-HBe), Defined as Loss of HBeAg and Presence of Anti-HBe

This endpoint measures the seroconversion to anti-HBe defined as loss of HBeAg and presence of anti-HBe at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80) and at 1 year post-end of treatment in the treated group. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. (NCT02263079)
Timeframe: 24 weeks post-treatment /end of untreated observation (Week 80), and 1 year post-end of treatment (End of treatment = Week 56)

InterventionPercentage of Participants (Number)
24 Weeks post-treatment/Week 80
Untreated Control Participants9.1

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Percentage of Participants With Loss of Hepatitis B Virus Envelope Antigen (HBeAg)

This endpoint is defined as loss of HBeAg at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80) and at 1 year post-end of treatment in the treated group. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. (NCT02263079)
Timeframe: 24 weeks post-treatment /end of untreated observation (Week 80), and 1 year post-end of treatment (End of treatment = Week 56)

InterventionPercentage of Participants (Number)
24 Weeks post-treatment/Week 801 year post-end of treatment
Peg-IFN-Alfa-2A + Lamivudine or Entecavir3.811.5

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Percentage of Participants With Different Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels (Less Than [<] 20,000 International Units Per Milliliter [IU/mL], < 2000 IU/mL, or Undetectable HBV DNA)

This endpoint measures different HBV DNA levels (<20000 IU/mL, <2000 IU/mL and undetectable) measured by PCR or hybridization at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80) and at 1 year post-treatment in the treated group. HBV-DNA undetectable is defined as <29 IU/mL. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. (NCT02263079)
Timeframe: 24 weeks post-treatment /end of untreated observation (Week 80), and 1 year post-end of treatment (End of treatment = Week 56)

InterventionPercentage of Participants (Number)
HBV-DNA <20000 IU/mL at follow up Week 24/Week 80HBV-DNA <2000 IU/mL at follow up Week 24/Week 80HBV-DNA Undetectable at follow up Week 24/Week 80HBV-DNA <20000 IU/mL 1 year post-end of treatmentHBV-DNA <2000 IU/mL 1 year post-end of treatmentHBV-DNA Undetectable 1 year post-end of treatment
Peg-IFN-Alfa-2A + Lamivudine or Entecavir7.77.70.015.47.70.0

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Percentage of Participants With Different Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels (Less Than [<] 20,000 International Units Per Milliliter [IU/mL], < 2000 IU/mL, or Undetectable HBV DNA)

This endpoint measures different HBV DNA levels (<20000 IU/mL, <2000 IU/mL and undetectable) measured by PCR or hybridization at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80) and at 1 year post-treatment in the treated group. HBV-DNA undetectable is defined as <29 IU/mL. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. (NCT02263079)
Timeframe: 24 weeks post-treatment /end of untreated observation (Week 80), and 1 year post-end of treatment (End of treatment = Week 56)

InterventionPercentage of Participants (Number)
HBV-DNA <20000 IU/mL at follow up Week 24/Week 80HBV-DNA <2000 IU/mL at follow up Week 24/Week 80HBV-DNA Undetectable at follow up Week 24/Week 80
Untreated Control Participants12.112.16.1

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Percentage of Participants With Combined Response for HBeAg Seroconversion (Defined as Loss of HBeAg and Presence of Anti-HBe) and HBV DNA Levels <2000 IU/mL

This endpoint measures the combined response for HBeAg Seroconversion and HBV DNA Levels <2000 IU/mL at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80) and at 1 year post-end of treatment in the treated group. The HBeAg is defined as loss of HBeAg and presence of anti-HBe. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. (NCT02263079)
Timeframe: 24 weeks post-treatment /end of untreated observation (Week 80), and 1 year post-end of treatment (End of treatment = Week 56)

InterventionPercentage of Participants (Number)
24 Weeks post-treatment/Week 801 year post-end of treatment
Peg-IFN-Alfa-2A + Lamivudine or Entecavir0.07.7

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Percentage of Participants With Combined Response for HBeAg Seroconversion (Defined as Loss of HBeAg and Presence of Anti-HBe) and HBV DNA Levels <2000 IU/mL

This endpoint measures the combined response for HBeAg Seroconversion and HBV DNA Levels <2000 IU/mL at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80) and at 1 year post-end of treatment in the treated group. The HBeAg is defined as loss of HBeAg and presence of anti-HBe. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. (NCT02263079)
Timeframe: 24 weeks post-treatment /end of untreated observation (Week 80), and 1 year post-end of treatment (End of treatment = Week 56)

InterventionPercentage of Participants (Number)
24 Weeks post-treatment/Week 80
Untreated Control Participants9.1

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Percentage of Participants With Combined Response for HBeAg Seroconversion (Defined as Loss of HBeAg and Presence of Anti-HBe) and HBV DNA Levels <20,000 IU/mL

This endpoint measures the combined response for HBeAg Seroconversion and HBV DNA Levels <20,000 IU/mL at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80) and at 1 year post-end of treatment in the treated group. The HBeAg is defined as loss of HBeAg and presence of anti-HBe. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. (NCT02263079)
Timeframe: 24 weeks post-treatment /end of untreated observation (Week 80), and 1 year post-end of treatment (End of treatment = Week 56)

InterventionPercentage of Participants (Number)
24 Weeks post-treatment/Week 801 year post-end of treatment
Peg-IFN-Alfa-2A + Lamivudine or Entecavir0.07.7

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Percentage of Participants With Combined Response for HBeAg Seroconversion (Defined as Loss of HBeAg and Presence of Anti-HBe) and HBV DNA Levels <20,000 IU/mL

This endpoint measures the combined response for HBeAg Seroconversion and HBV DNA Levels <20,000 IU/mL at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80) and at 1 year post-end of treatment in the treated group. The HBeAg is defined as loss of HBeAg and presence of anti-HBe. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. (NCT02263079)
Timeframe: 24 weeks post-treatment /end of untreated observation (Week 80), and 1 year post-end of treatment (End of treatment = Week 56)

InterventionPercentage of Participants (Number)
24 Weeks post-treatment/Week 80
Untreated Control Participants9.1

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Percentage of Participants With Adverse Events (AEs)

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. (NCT02263079)
Timeframe: Baseline up to 24 weeks post-treatment/end of untreated observation (Week 80)

,
InterventionPercentage of Participants (Number)
With at least one Non-Serious AEWith at least one Serious Adverse Event (SAE)
Peg-IFN-Alfa-2A + Lamivudine or Entecavir92.30
Untreated Control Participants45.53.0

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Change From Baseline in HBV DNA Levels in the Untreated Control Participants

This outcome measure presents HBV DNA levels measured at defined time points from baseline in the Untreated Control arm. (NCT02263079)
Timeframe: Baseline, Week 32, 56 and end of untreated observation (Week 80)

Interventionlog10 IU/mL (Mean)
BaselineWeek 32Week 56Week 80
Untreated Control Participants8.228.297.577.24

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Change From Baseline in HBV DNA Levels in the Peg-INF-Alfa-2A (Treated) Arm

This outcome measure presents HBV DNA levels measured at defined time points from baseline in the Peg-INF-Alfa-2A + Lamivudine or Entecavir arm. (NCT02263079)
Timeframe: Baseline, Week 8, 20, 32, 44, 56, Follow up Week 4 and 24

Interventionlog10 IU/mL (Mean)
BaselineWeek 8Week 20Week 32Week 44Week 56Fu Week 4Fu Week 24
Peg-IFN-Alfa-2A + Lamivudine or Entecavir8.024.743.542.562.152.214.347.31

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Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) at 24 Weeks Post-End of Treatment/End of Untreated Observation

This endpoint is defined as loss of HBsAg at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80). The percentage of responders (response rate) and 95% CI (using the Clopper-Pearson method) for the response rate are presented for each group. (NCT02263079)
Timeframe: 24 weeks post-treatment/at the end of untreated observation (Week 80)

InterventionPercentage of Participants (Number)
Peg-IFN-Alfa-2A + Lamivudine or Entecavir3.8
Untreated Control Participants0

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Percentage of Participants With Loss of HBsAg

This endpoint is defined as loss of HBsAg at 1 year post-treatment in the treated group. The 95% Confidence Interval of response rate is calculated by Clopper-Pearson method. (NCT02263079)
Timeframe: 1 year post-end of treatment (End of treatment = Week 56)

InterventionPercentage of Participants (Number)
Peg-IFN-Alfa-2A + Lamivudine or Entecavir3.8

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Percentage of Participants With AEs Leading to Dose Modification or Interruption

This endpoint measures AEs and lab abnormalities leading to dose interruption or dose modification. Does modification included dose reduced, dose increased or drug interrupted. Adverse events included laboratory abnormalities reported as adverse events. (NCT02263079)
Timeframe: Baseline up to 24 weeks post-end of treatment

InterventionPercentage of Participants (Number)
Peg-IFN-Alfa-2A + Lamivudine or Entecavir23.0

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Serum Concentration of Peg-INF-Alfa-2A

The serum concentration of Peg-INF-Alfa-2A was measured in picogram/milliliter. (NCT02263079)
Timeframe: At Weeks 12, 16, 20, 32, 44, 56

Interventionpg/mL (Mean)
Week 12 PredoseWeek 16 PredoseWeek 20 PredoseWeek 32 PredoseWeek 32 24-48h Post-doseWeek 32 72-96h Post-doseWeek 32 168h Post-doseWeek 44 PredoseWeek 56 Predose
Peg-IFN-Alfa-2A + Lamivudine or Entecavir84301630013800149002270023000193002190025400

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Change in LDL Cholesterol From Baseline to Week 48

Change in Low-density lipoprotein (LDL) cholesterol between arms will be presented in the attached statistical analysis table (NCT02263326)
Timeframe: Baseline and Week 48

Interventionmg/dL (Median)
Dolutegravir Plus Lamivudine2
Continue Current ART Regimen-3

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Change in Total Cholesterol From Baseline to Week 48

Change in Total Cholesterol between arms will be presented in the attached statistical analysis table (NCT02263326)
Timeframe: Baseline and 48 weeks

Interventionmg/dL (Median)
Dolutegravir Plus Lamivudine0
Continue Current ART Regimen-1

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Drug Resistance Associated Mutations

Drug resistance mutations measured by HIV genotyping in patients with confirmed virologic failure (NCT02263326)
Timeframe: 48 weeks

InterventionParticipants (Count of Participants)
Dolutegravir Plus Lamivudine0
Continue Current ART Regimen0

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Proportion of Participants With Virologic Success

Proportion of participants with virologic success (<50 copies/mL) based on FDA snapshot definition (NCT02263326)
Timeframe: 48 weeks

Interventionproportion of participants (Number)
Dolutegravir Plus Lamivudine0.9091
Continue Current ART Regimen0.8889

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Residual Viremia by HIV-1 Single-copy Assay

Difference in HIV-1 detection by the HIV-1 single copy assay between arms will be presented in statistical analysis (NCT02263326)
Timeframe: 48 weeks

Interventioncopies/mL (Mean)
Dolutegravir Plus Lamivudine4.7
Continue Current ART Regimen4.2

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Proportion of Participants With Treatment Failure

Proportion of participants with treatment failure (defined as virologic failure (HIV RNA >50 copies/mL), loss to follow-up, or treatment discontinuation) between those who switch to DTG + lamivudine and those who continue their current ART regimen (NCT02263326)
Timeframe: 24 weeks

Interventionproportion of participants (Number)
Dolutegravir Plus Lamivudine0.0682
Continue Current ART Regimen0.0667

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Change in CD4 Count From Baseline to Week 48

Change in CD4 count between arms will be presented in the attached statistical analysis table (NCT02263326)
Timeframe: Baseline and 48 weeks

Interventioncells/mm^3 (Median)
Dolutegravir Plus Lamivudine39
Continue Current ART Regimen28

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Change in Creatinine Clearance From Baseline to Week 48

Change in Creatinine Clearance between arms will be presented in the attached statistical analysis table (NCT02263326)
Timeframe: Baseline and Week 48

Interventionml/min (Median)
Dolutegravir Plus Lamivudine-4
Continue Current ART Regimen0

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Number of Participants With Grade 3 or Higher Adverse Event (AE)

Sign/symptom, lab toxicity, or clinical events, or Grade 3 or higher AE that is definitely, probably, or possibly related to study treatment (NCT02384395)
Timeframe: Baseline through Week 96

InterventionParticipants (Count of Participants)
DTG/3TC/ABC FDC1

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Median Change HIV-1 RNA Level Among Participants Completing Week 24 Visit

(NCT02384395)
Timeframe: Baseline, Week 24

Interventioncopies/mL (Median)
DTG/3TC/ABC FDC-590211

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Number of Participants With Viral Load Measurement <200 Copies/mL at Week 24

Total number of participants on study at Week 24 with an HIV-1 RNA level less than 200 copies/mL (NCT02384395)
Timeframe: Week 24

InterventionParticipants (Count of Participants)
DTG/3TC/ABC FDC34

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Proportion of Treated Participants With HIV-1 RNA to <50 Copies/mL at Week 48

Proportion of participants completing Week 48 with an HIV-1 RNA level less than 50 copies/mL (NCT02384395)
Timeframe: Week 48

Interventionproportion of participants (Number)
DTG/3TC/ABC FDC0.88

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Percentage of Participants Maintaining HIV-1 RNA <50 Copies/mL

"The percentage of participants in each arm achieving HIV-1 RNA levels <50 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach and all missing data were considered treatment failures, regardless of the reason." (NCT02397096)
Timeframe: Week 24

InterventionPercentage of Participants (Number)
Immediate Switch Group (ISG)93.7
Delayed Switch Group (DSG)94.6

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Percentage of Participants Maintaining Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL

"The percentage of participants in each arm achieving HIV-1 RNA levels <50 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach and all missing data were considered treatment failures, regardless of the reason." (NCT02397096)
Timeframe: Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24

InterventionPercentage of Participants (Number)
Immediate Switch Group (ISG)90.8
Delayed Switch Group (DSG)94.6

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Percentage of Participants With HIV-1 RNA >=50 Copies/mL

"The percentage of participants in each arm achieving HIV-1 RNA levels >=50 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach." (NCT02397096)
Timeframe: Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24

InterventionPercentage of Participants (Number)
Immediate Switch Group (ISG)1.6
Delayed Switch Group (DSG)1.8

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Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts

The mean change from baseline in CD4 cell counts at Week 48 was assessed using the Observed Failure (OF) approach. With the OF approach, baseline values were carried forward for participants who discontinued due to lack of efficacy. Cell counts were measured and expressed as cells/mm^3, and percent change was then calculated. CD4 cell counts were quantified by a central laboratory using a commercially available assay. (NCT02397096)
Timeframe: Baseline and Week 24

,
Interventioncells/mm^3 (Geometric Mean)
BaselineChange from Baseline
Delayed Switch Group (DSG)655.618.0
Immediate Switch Group (ISG)664.55.1

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Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts

The mean change from baseline in CD4 cell counts was assessed using the Observed Failure (OF) approach. With the OF approach, baseline values were carried forward for participants who discontinued due to lack of efficacy. Cell counts were measured and expressed as cells/mm^3, and percent change was then calculated. CD4 cell counts were quantified by a central laboratory using a commercially available assay. (NCT02397096)
Timeframe: Immediate Switch to MK-1439A arm: Baseline and Week 48; Delayed Switch to MK-1439A arm: Baseline and Week 24

,
Interventioncells/mm^3 (Mean)
BaselineChange from Baseline
Delayed Switch Group (DSG)655.618.0
Immediate Switch Group (ISG)660.513.9

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Mean Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C)

To evaluate the effect on fasting LDL-C of an immediate switch to DOR/3TC/TDF on Study Day 1 compared with continuation of a ritonavir-boosted, PI-based regimen, as measured by mean change from baseline in each treatment group. The Last Observation Carry Forward (LOCF) approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy. (NCT02397096)
Timeframe: Baseline and Week 24

,
Interventionmg/dL (Mean)
BaselineChange from Baseline
Delayed Switch (Ritonavir-boosted, PI-based) Group (DSG)109.00-1.94
Immediate Switch (Ritonavir--boosted, PI-based) Group (ISG)108.82-16.54

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Mean Change From Baseline in Fasting Non-high-density Lipoprotein Cholesterol (Non-HDL-C)

Serum non-HDL-C was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The Last Observation Carry Forward (LOCF) approach was applied for missing data or data collected after modifying lipid lowering therapy. (NCT02397096)
Timeframe: Baseline and Week 24

,
Interventionmg/dL (Mean)
BaselineChange from Baseline
Delayed Switch (Ritonavir-boosted, PI-based) Group (DSG)137.99-1.31
Immediate Switch (Ritonavir--boosted, PI-based) Group (ISG)139.14-24.74

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Percentage of Participants Experiencing ≥1 Adverse Event (AE)

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02397096)
Timeframe: Up to week 24

InterventionPercentage of Participants (Number)
Immediate Switch Group (ISG)68.9
Delayed Switch Group (DSG)52.5

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Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL

To evaluate the immunological effect of an immediate switch to MK -1439A on Study Day 1 compared with continuation of a ritonavir boosted, PI-based regimen, as measured by the proportion of subjects maintaining HIV-1 RNA below the limit of quantification (BLoQ) by the Abbott RealTime HIV-1 Assay (<40 copies/mL) in both treatment groups. (NCT02397096)
Timeframe: Immediate Switch to MK-1439A arm: Week 24; Delayed Switch to MK-1439A arm: Week 24

InterventionPercentage of Participants (Number)
Immediate Switch Group (ISG)92.8
Delayed Switch Group (DSG)93.3

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Percentage of Participants Discontinuing From Study Medication Due to an AE(s)

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02397096)
Timeframe: Up to Week 24

InterventionPercentage of Participants (Number)
Immediate Switch Group (ISG)2.5
Delayed Switch Group (DSG)0.4

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Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL

"The percentage of participants in each arm achieving HIV-1 RNA levels <40 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach and all missing data were considered treatment failures, regardless of the reason." (NCT02397096)
Timeframe: Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24

InterventionPercentage of Participants (Number)
Immediate Switch Group (ISG)89.7
Delayed Switch Group (DSG)93.3

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Percentage of Participants Experiencing ≥1 Serious Adverse Event (SAE)

A serious adverse event is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose, or is another important medical event. The percentage of participants with any SAE was assessed. (NCT02397096)
Timeframe: Up to 24 weeks

InterventionPercentage of Participants (Number)
Immediate Switch Group (ISG)2.9
Delayed Switch Group (DSG)3.6

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Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48

"The percentage of participants in each arm with HIV-1 RNA levels <40 copies/mL (including target detected and target not detected) at Week 48 was determined. Plasma HIV RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach in which all missing data are considered treatment failures, regardless of the reason." (NCT02403674)
Timeframe: Week 48

InterventionPercentage of Participants (Number)
MK-1439A83.8
ATRIPLA™79.7

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Percentage of Participants Experiencing ≥1 AE

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02403674)
Timeframe: Up to Week 48

InterventionPercentage of participants (Number)
MK-1439A82.7
ATRIPLA™90.7

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Percentage of Participants Discontinuing From Study Medication Due to an AE(s)

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02403674)
Timeframe: Up to Week 48

InterventionPercentage of participants (Number)
MK-1439A3.0
ATRIPLA™6.6

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Change From Baseline in Fasting Triglycerides at Week 48

The mean percent change from baseline in fasting (fast duration of ≥8 hours) triglycerides levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy. (NCT02403674)
Timeframe: Baseline (Day 1) and Week 48

InterventionPercent Change from Baseline (Mean)
MK-1439A-12.40
ATRIPLA™22.01

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Change From Baseline in Fasting Non-HDL-C at Week 48

The mean percent change from baseline in fasting (fast duration of ≥8 hours) non-HDL-C levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy. (NCT02403674)
Timeframe: Baseline (Day 1) and Week 48

InterventionPercent Change from Baseline (Mean)
MK-1439A-3.83
ATRIPLA™13.26

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Change From Baseline in Fasting LDL-C at Week 48

The mean percent change from baseline in fasting (fast duration of ≥8 hours) LDL-C levels at Week 48 was determined for each arm. The Last Observation Carry Forward (LOCF) approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy. (NCT02403674)
Timeframe: Baseline (Day 1) and Week 48

InterventionPercent Change from Baseline (Mean)
MK-1439A-1.58
ATRIPLA™8.74

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Change From Baseline in Fasting HDL-C at Week 48

The mean percent change from baseline in fasting (fast duration of ≥8 hours) HDL-C levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy. (NCT02403674)
Timeframe: Baseline (Day 1) and Week 48

InterventionPercent Change from Baseline (Mean)
MK-1439A1.86
ATRIPLA™8.51

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Change From Baseline in Fasting Cholesterol at Week 48

The mean percent change from baseline in fasting (fast duration of ≥8 hours) cholesterol levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy. (NCT02403674)
Timeframe: Baseline (Day 1) and Week 48

InterventionPercent Change from Baseline (Mean)
MK-1439A-1.97
ATRIPLA™21.77

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Percentage of Participants With HIV-1 RNA Below the Limit of Quantification (BLoQ) at Week 48

The percentage of participants in each arm with HIV-1 RNA levels BLoQ of 40 copies/mL and target not detected at Week 48 was determined. Plasma HIV RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled as observed. (NCT02403674)
Timeframe: Week 48

InterventionPercentage of Participants (Number)
MK-1439A59.6
ATRIPLA™55.5

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Percentage of Participants With Tier-2 Neuropsychiatric AEs

"The percentage of participants in each arm experiencing ≥1 pre-specified Tier-2 neuropsychiatric AEs was determined. The list of Tier-2 neuropsychiatric AE categories included depression and suicide/self-injury and psychosis and psychotic disorders." (NCT02403674)
Timeframe: Up to Week 48

,
InterventionPercentage of Participants (Number)
Depression and suicide/self-injuryPsychosis and psychotic disorders
ATRIPLA™6.61.1
MK-1439A4.10.3

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Plasma Concentration of Doravirine at Week 48

Plasma samples were collected for analysis of doravirine concentration at Week 48. A total of 2 samples were collected: 1 prior to dosing and 1 collected between 0.5 and 2 hours post-dose. (NCT02403674)
Timeframe: 0 hours post-dose and 2 hours post-dose on Week 48

InterventionnM (Mean)
Pre-dose0.5 to 2 hours post-dose
MK-1439A12902330

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Percentage of Participants With Tier-1 Neuropsychiatric Adverse Events (AEs)

"The percentage of participants in each arm experiencing ≥1 pre-specified Tier-1 neuropsychiatric AEs was determined. The list of Tier-1 neuropsychiatric AE categories included dizziness, sleep disorders and disturbances, and altered sensorium (including disturbance in attention)." (NCT02403674)
Timeframe: Up to Week 48

,
InterventionPercentage of Participants (Number)
DizzinessSleep disorders and disturbancesAltered sensorium
ATRIPLA™37.125.58.2
MK-1439A8.812.14.4

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Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48

"The percentage of participants in each arm with HIV-1 RNA levels <50 copies/mL at Week 48 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach in which all missing data are considered treatment failures, regardless of the reason." (NCT02403674)
Timeframe: Week 48

InterventionPercentage of Participants (Number)
MK-1439A84.3
ATRIPLA™80.8

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Change From Baseline in CD4 Cell Counts at Week 48

The mean change from baseline in CD4 cell counts at Week 48 was assessed using the Observed Failure (OF) approach. With the OF approach, baseline values were carried forward for participants who discontinued prior to Week 48 due to lack of efficacy. Cell counts at Baseline and Week 48 were measured and expressed as cells/mm^3, and percent change was then calculated as [(Baseline counts - Week 48 counts)*100]. CD4 cell counts were quantified by a central laboratory using a commercially available assay. (NCT02403674)
Timeframe: Baseline (Day 1) and Week 48

InterventionPercent Change from Baseline (Mean)
MK-1439A198.4
ATRIPLA™188.4

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Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm

The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02469246)
Timeframe: Week 96

Interventionpercentage of participants (Number)
F/TAF2.5
ABC/3TC1.1

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Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48

(NCT02469246)
Timeframe: Baseline; Week 48

Interventionpercent change (Mean)
F/TAF0.246
ABC/3TC0.086

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Percent Change From Baseline in Spine BMD at Week 48

(NCT02469246)
Timeframe: Baseline; Week 48

Interventionpercent change (Mean)
F/TAF0.081
ABC/3TC-0.052

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Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm

The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02469246)
Timeframe: Week 48

Interventionpercentage of participants (Number)
F/TAF1.8
ABC/3TC0.7

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Percent Change From Baseline in Spine BMD at Week 96

(NCT02469246)
Timeframe: Baseline; Week 96

Interventionpercent change (Mean)
F/TAF0.178
ABC/3TC0.235

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Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02469246)
Timeframe: Week 48

Interventionpercentage of participants (Number)
F/TAF85.7
ABC/3TC87.3

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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02469246)
Timeframe: Week 48

Interventionpercentage of participants (Number)
F/TAF88.6
ABC/3TC92.4

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Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02469246)
Timeframe: Week 96

Interventionpercentage of participants (Number)
F/TAF80.4
ABC/3TC86.2

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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02469246)
Timeframe: Week 96

Interventionpercentage of participants (Number)
F/TAF82.1
ABC/3TC88.4

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Percent Change From Baseline in Hip BMD at Week 96

(NCT02469246)
Timeframe: Baseline; Week 96

Interventionpercent change (Mean)
F/TAF0.169
ABC/3TC0.021

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Change From Baseline in CD4 Cell Count at Week 96

(NCT02469246)
Timeframe: Baseline; Week 96

Interventioncells/μL (Mean)
F/TAF-29
ABC/3TC10

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Change From Baseline in CD4 Cell Count at Week 48

(NCT02469246)
Timeframe: Baseline; Week 48

Interventioncells/µL (Mean)
F/TAF-30
ABC/3TC2

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Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 24

(NCT02581202)
Timeframe: Week 24

Interventionpercentage of participants (Number)
HIV-1 Infected Participants99.5

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Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 48

(NCT02581202)
Timeframe: Week 48

Interventionpercentage of participants (Number)
HIV-1 Infected Participants100

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Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Base-10 Logarithm Transformed Data)

(NCT02581202)
Timeframe: Baseline, Week 24

Interventionlog10 copies/mL (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants3.220.01

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Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Untransformed Data)

(NCT02581202)
Timeframe: Baseline, Week 24

Interventioncopies/mL (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants25.220.22

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Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24

(NCT02581202)
Timeframe: Baseline, Week 24

Interventioncm (Mean)
Absolute values: arm circumferenceChange from BL: arm circumferenceAbsolute values: hip circumferenceChange from BL: hip circumferenceAbsolute values: waist circumferenceChange from BL: waist circumference
HIV-1 Infected Participants29.82-0.3854.620.5783.290.31

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Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 24

(NCT02581202)
Timeframe: Baseline, Week 24

Interventionpercentage of lymphocytes that are CD4+ (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants32.500.96

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Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 48

(NCT02581202)
Timeframe: Baseline, Week 48

Interventionpercentage of lymphocytes that are CD4+ (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants33.111.43

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Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 24

(NCT02581202)
Timeframe: Baseline, Week 24

Interventioncells/mm^3 (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants703.4364.70

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Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 48

(NCT02581202)
Timeframe: Baseline, Week 48

Interventioncells/mm^3 (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants752.44111.75

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Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Base-10 Logarithm Transformed Data)

(NCT02581202)
Timeframe: Baseline, Week 48

Interventionlog10 copies/mL (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants3.220.000

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Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Untransformed Data)

Statistics for absolute HIV-1 RNA viral load, where all participants with undetectable HIV-1-RNA viral load data were included into calculations with half of the lower indication limit (50/2 copies/mL, or 25.00 copies/mL). (NCT02581202)
Timeframe: Baseline, Week 48

Interventioncopies/mL (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants25.000.00

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Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (U/L)

(NCT02581202)
Timeframe: Baseline, Week 24

InterventionU/L (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants29.37-1.31

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Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (µmol/L)

(NCT02581202)
Timeframe: Baseline, Week 24

Interventionµmol/L (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants39.8119.06

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Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (U/L)

(NCT02581202)
Timeframe: Baseline, Week 48

InterventionU/L (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants26.92-0.49

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Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (µmol/L)

(NCT02581202)
Timeframe: Baseline, Week 48

Interventionµmol/L (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants27.195.63

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Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Glucose

(NCT02581202)
Timeframe: Baseline, Week 48

Interventionmmol/L (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants4.83-0.16

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Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: HDL

(NCT02581202)
Timeframe: Baseline, Week 48

Interventionmmol/L (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants1.43-0.00

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Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Insulin

(NCT02581202)
Timeframe: Baseline, Week 48

InterventionµEq/mL (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants10.000.69

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Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: LDL

(NCT02581202)
Timeframe: Baseline, Week 48

Interventionmmol/L (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants2.920.14

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Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Serum Creatinine

(NCT02581202)
Timeframe: Baseline, Week 48

Interventionµmol/L (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants82.132.75

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Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Total Cholesterol

(NCT02581202)
Timeframe: Baseline, Week 48

Interventionmmol/L (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants5.120.11

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Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Triglycerides

(NCT02581202)
Timeframe: Baseline, Week 48

Interventionmmol/L (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants1.61-0.06

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Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: LDL

(NCT02581202)
Timeframe: Baseline, Week 24

Interventionmmol/L (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants2.66-0.07

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Number of Participants Who Developed Resistance to Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs), and Protease Inhibitors (PIs)

(NCT02581202)
Timeframe: Week 48

InterventionParticipants (Count of Participants)
NRTINNRTIPI
HIV-1 Infected Participants110

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Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Serum Creatinine

(NCT02581202)
Timeframe: Baseline, Week 24

Interventionµmol/L (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants81.502.36

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Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Total Cholesterol

(NCT02581202)
Timeframe: Baseline, Week 24

Interventionmmol/L (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants5.110.07

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Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Triglycerides

(NCT02581202)
Timeframe: Baseline, Week 24

Interventionmmol/L (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants1.72-0.70

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Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: HDL

(NCT02581202)
Timeframe: Baseline, Week 24

Interventionmmol/L (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants1.530.07

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Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (U/L)

(NCT02581202)
Timeframe: Baseline, Week 48

InterventionU/L (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants28.35-2.14

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Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (µmol/L)

(NCT02581202)
Timeframe: Baseline, Week 48

Interventionµmol/L (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants27.566.81

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Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (U/L)

(NCT02581202)
Timeframe: Baseline, Week 24

InterventionU/L (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants26.90-0.38

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Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48

(NCT02581202)
Timeframe: Baseline, Week 48

Interventioncm (Mean)
Absolute values: arm circumferenceChange from BL: arm circumferenceAbsolute values: hip circumferenceChange from BL: hip circumferenceAbsolute values: waist circumferenceChange from BL: waist circumference
HIV-1 Infected Participants30.05-0.2055.251.1483.640.63

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Number of Participants With Adverse Events

Adverse events were not recorded in a solicited manner as in an interventional trial, but were recorded by spontaneous reporting in line with the requirements described in European Medicines Agency (EMA) Guideline on Good Pharmacovigilance Practices (GVP) module VI and local pharmacovigilance practice of the Russian Federation. (NCT02581202)
Timeframe: up to Week 48

InterventionParticipants (Count of Participants)
HIV-1 Infected Participants3

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Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Glucose

(NCT02581202)
Timeframe: Baseline, Week 24

Interventionmmol/L (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants4.88-0.10

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Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Insulin

(NCT02581202)
Timeframe: Baseline, Week 24

InterventionµEq/mL (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants10.000.68

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Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (µmol/L)

(NCT02581202)
Timeframe: Baseline, Week 24

Interventionµmol/L (Mean)
Absolute valuesChange from BL
HIV-1 Infected Participants46.5625.00

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Fasting Lipids and Glucose

Fasting lipids include: total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, and glucose. Fasting was set to be 8 hours prior to the sample collection. (NCT02582684)
Timeframe: Baseline and week 48

Interventionmg/dL (Median)
Baseline Total CholesterolWeek 48 Total CholesterolBaseline LDL CholesterolWeek 48 LDL CholesterolBaseline HDL CholesterolWeek 48 HDL CholesterolBaseline TriglyceridesWeek 48 TriglyceridesBaseline GlucoseWeek 48 Glucose
Arm 1: DTG 50 MG + 3TC 300 mg1511548586394691988486

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Creatinine Clearance

Creatinine clearance was estimated by the Cockcroft-Gault equation. (NCT02582684)
Timeframe: Baseline, weeks 4, 12, 24, 32, 40 and 48

InterventionmL/min (Median)
Week 0Week 4Week 12Week 24Week 32Week 40Week 48
Arm 1: DTG 50 MG + 3TC 300 mg126.0112.9112.0114.7115.5112.7114.4

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Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- ITT Missing = Ignored

Proportion of participants with HIV-1 RNA < 200 copies/mL by week, ITT (missing = ignored) population. (NCT02582684)
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48

Interventionproportion of participants (Number)
Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 32Week 40Week 48
Arm 1: DTG 50 MG + 3TC 300 mg0.710.940.980.980.980.990.970.950.960.96

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Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL - Missing = Ignored

Proportion of participants with HIV-1 RNA < 50 copies/mL by week, ITT (missing = ignored) population. (NCT02582684)
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48

Interventionproportion of participants (Number)
Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 32Week 40Week 48
Arm 1: DTG 50 MG + 3TC 300 mg0.410.700.880.940.940.940.960.930.950.94

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Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL- As Treated

Proportion of participants with HIV-1 RNA < 50 copies/mL by week, as treated population. (NCT02582684)
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48

Interventionproportion of participants (Number)
Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 32Week 40Week 48
Arm 1: DTG 50 MG + 3TC 300 mg0.410.700.880.940.940.940.960.950.970.97

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Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- As Treated

Proportion of participants with HIV-1 RNA < 200 copies/mL by week, as treated population. (NCT02582684)
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48

Interventionproportion of participants (Number)
Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 32Week 40Week 48
Arm 1: DTG 50 MG + 3TC 300 mg0.710.940.980.980.980.990.980.970.991.00

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Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/mL - Missing = Failure

Proportion of participants with HIV-1 RNA < 50 copies/mL by week, ITT (Intention To Treat; missing/off study/off treatment = failure) population. (NCT02582684)
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48

Interventionproportion of participants (Number)
Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 32Week 40Week 48
Arm 1: DTG 50 MG + 3TC 300 mg0.400.680.850.890.880.900.900.880.890.84

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Number of Participants With Grade 3 of Higher Adverse Events

Number of participants who experienced an AE (sign/symptom or laboratory abnormality) of Grade 3 or higher. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see reference in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening. (NCT02582684)
Timeframe: from study treatment dispensation through up to week 52 or until study discontinuation

InterventionParticipants (Count of Participants)
Arm 1: DTG 50 MG + 3TC 300 mg16

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CD4+ Cell Count

CD4+ cell counts by study week. (NCT02582684)
Timeframe: Baseline, weeks 4, 12, 24, and 48

Interventioncells/mm^3 (Median)
Week 0Week 4Week 12Week 24Week 48
Arm 1: DTG 50 MG + 3TC 300 mg387473520582579

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Change in CD4+ Cell Count

Change in CD4+ cell counts by study week. Change was calculated as value at the later visit minus the value at baseline. (NCT02582684)
Timeframe: Baseline, weeks 4, 12, 24, and 48

Interventioncells/mm^3 (Median)
Change from Baseline to Week 4Change from Baseline to Week 12Change from Baseline to Week 24Change from Baseline to Week 48
Arm 1: DTG 50 MG + 3TC 300 mg78122167182

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Proportion of Participants With Plasma HIV-1 RNA < 200 Copies/mL - Missing = Failure

Proportion of participants with HIV-1 RNA < 200 copies/mL by week, ITT (missing/off study/off treatment = failure) population. (NCT02582684)
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48

Interventionproportion of participants (Number)
Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 32Week 40Week 48
Arm 1: DTG 50 MG + 3TC 300 mg0.680.900.950.930.920.950.920.890.910.87

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Number of HIV-1 Drug Resistance Mutation Occurrences in Participants

Number of HIV-1 drug resistance mutation occurrences participants with virologic failure and FDA snapshot non-successes. Participants that had one drug class resistance mutation may have one or more mutations. (NCT02582684)
Timeframe: at the time of virologic failure

Interventionnumber of mutation occurrences (Number)
NRTI mutationNNRTI mutationINI mutation
Arm 1: DTG 50 MG + 3TC 300 mg111

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Hip Bone Mineral Density at Baseline

(NCT02603120)
Timeframe: Baseline

Interventiong/cm^2 (Mean)
B/F/TAF1.006
ABC/DTG/3TC0.996

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Percentage Change From Baseline in Hip BMD at Week 48

(NCT02603120)
Timeframe: Baseline; Week 48

Interventionpercentage change (Mean)
B/F/TAF0.156
ABC/DTG/3TC0.299

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Percentage Change From Baseline in Spine BMD at Week 48

(NCT02603120)
Timeframe: Baseline; Week 48

Interventionpercentage change (Mean)
B/F/TAF0.692
ABC/DTG/3TC0.416

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Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Defined by the US FDA-defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02603120)
Timeframe: Week 48

Interventionpercentage of participants (Number)
B/F/TAF93.6
ABC/DTG/3TC95.0

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Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02603120)
Timeframe: Week 48

Interventionpercentage of participants (Number)
B/F/TAF1.1
ABC/DTG/3TC0.4

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Spine Bone Mineral Density (BMD) at Baseline

(NCT02603120)
Timeframe: Baseline

Interventiong/cm^2 (Mean)
B/F/TAF1.124
ABC/DTG/3TC1.103

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Change From Baseline in CD4+ Cell Count at Week 48

(NCT02603120)
Timeframe: Baseline; Week 48

Interventioncells/µL (Mean)
B/F/TAF-31
ABC/DTG/3TC4

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Change From Baseline in log10 HIV-1 RNA at Week 144

(NCT02607930)
Timeframe: Baseline, Week 144

Interventionlog10 copies/mL (Mean)
B/F/TAF-3.11
ABC/DTG/3TC-3.10

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Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm

The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set. (NCT02607930)
Timeframe: Baseline, open-label Week 96

Interventionpercentage of participants (Number)
All B/F/TAF66.2
ABC/DTG/3TC to B/F/TAF85.4

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Change From Baseline in log10 HIV-1 RNA at Week 48

(NCT02607930)
Timeframe: Baseline, Week 48

Interventionlog10 copies/mL (Mean)
B/F/TAF-3.11
ABC/DTG/3TC-3.07

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Change From Baseline in log10 HIV-1 RNA at Week 96

(NCT02607930)
Timeframe: Baseline, Week 96

Interventionlog10 copies/mL (Mean)
B/F/TAF-3.09
ABC/DTG/3TC-3.10

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Percentage Change From Baseline in Hip BMD at Week 144

(NCT02607930)
Timeframe: Baseline, Week 144

Interventionpercentage change (Mean)
B/F/TAF-1.020
ABC/DTG/3TC-1.291

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Percentage Change From Baseline in Hip BMD at Week 48

(NCT02607930)
Timeframe: Baseline, Week 48

Interventionpercentage change (Mean)
B/F/TAF-0.802
ABC/DTG/3TC-1.148

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Percentage Change From Baseline in Hip BMD at Week 96

(NCT02607930)
Timeframe: Baseline, Week 96

Interventionpercentage change (Mean)
B/F/TAF-1.128
ABC/DTG/3TC-1.262

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Percentage Change From Baseline in Spine BMD at Week 144

(NCT02607930)
Timeframe: Baseline, Week 144

Interventionpercentage change (Mean)
B/F/TAF-0.371
ABC/DTG/3TC0.035

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Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02607930)
Timeframe: Week 96

Interventionpercentage of participants (Number)
B/F/TAF87.9
ABC/DTG/3TC89.8

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Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm

The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set. (NCT02607930)
Timeframe: Baseline, open-label Week 48

Interventionpercentage of participants (Number)
All B/F/TAF74.8
ABC/DTG/3TC to B/F/TAF83.5

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Change From Baseline in CD4+ Cell Count at Week 144

(NCT02607930)
Timeframe: Baseline, Week 144

Interventioncells/µL (Mean)
B/F/TAF299
ABC/DTG/3TC317

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Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm

The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with non-missing HIV-1 RNA value at that visit. (NCT02607930)
Timeframe: Baseline, open-label Week 48

Interventionpercentage of participants (Number)
All B/F/TAF99.2
ABC/DTG/3TC to B/F/TAF100

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Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02607930)
Timeframe: Week 144

Interventionpercentage of participants (Number)
B/F/TAF81.5
ABC/DTG/3TC84.1

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Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02607930)
Timeframe: Week 96

Interventionpercentage of participants (Number)
B/F/TAF83.4
ABC/DTG/3TC84.8

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Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02607930)
Timeframe: Week 48

Interventionpercentage of participants (Number)
B/F/TAF87.6
ABC/DTG/3TC87.3

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Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02607930)
Timeframe: Week 144

Interventionpercentage of participants (Number)
B/F/TAF78.0
ABC/DTG/3TC82.2

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Percentage Change From Baseline in Spine BMD at Week 96

(NCT02607930)
Timeframe: Baseline, Week 96

Interventionpercentage change (Mean)
B/F/TAF-0.705
ABC/DTG/3TC-0.219

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Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm

The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with non-missing HIV-1 RNA value at that visit. (NCT02607930)
Timeframe: Baseline, open-label Week 96

Interventionpercentage of participants (Number)
All B/F/TAF97.7
ABC/DTG/3TC to B/F/TAF99.5

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Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02607930)
Timeframe: Week 48

Interventionpercentage of participants (Number)
B/F/TAF92.4
ABC/DTG/3TC93.0

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Change From Baseline in CD4+ Cell Count at Week 48

(NCT02607930)
Timeframe: Baseline, Week 48

Interventioncells/µL (Mean)
B/F/TAF235
ABC/DTG/3TC228

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Change From Baseline in CD4+ Cell Count at Week 48 Open-Label

(NCT02607930)
Timeframe: Baseline, open-label Week 48

Interventioncells/µL (Mean)
All B/F/TAF330
ABC/DTG/3TC to B/F/TAF-4

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Percentage Change From Baseline in Spine BMD at Week 48

(NCT02607930)
Timeframe: Baseline, Week 48

Interventionpercentage change (Mean)
B/F/TAF-0.772
ABC/DTG/3TC-0.552

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Change From Baseline in CD4+ Cell Count at Week 96

(NCT02607930)
Timeframe: Baseline, Week 96

Interventioncells/µL (Mean)
B/F/TAF287
ABC/DTG/3TC288

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Change From Baseline in CD4+ Cell Count at Week 96 Open-Label

(NCT02607930)
Timeframe: Baseline, open-label Week 96

Interventioncell/µL (Mean)
All B/F/TAF339
ABC/DTG/3TC to B/F/TAF-15

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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02616783)
Timeframe: Week 48

InterventionPercentage of participants (Number)
E/C/F/TAF93.6
Stay on Baseline Regimen94.5

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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02616783)
Timeframe: Week 24

InterventionPercentage of participants (Number)
E/C/F/TAF94.5
Stay on Baseline Regimen100.0

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Percent Change From Baseline to Week 48 in Hip BMD

(NCT02616783)
Timeframe: Baseline; Week 48

InterventionPercent change (Mean)
E/C/F/TAF1.330
Stay on Baseline Regimen-0.726

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Percent Change From Baseline to Week 24 in Spine BMD

(NCT02616783)
Timeframe: Baseline; Week 24

InterventionPercent change (Mean)
E/C/F/TAF1.625
Stay on Baseline Regimen-0.027

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Percent Change From Baseline to Week 24 in Hip BMD

(NCT02616783)
Timeframe: Baseline; Week 24

InterventionPercent change (Mean)
E/C/F/TAF0.808
Stay on Baseline Regimen-0.537

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Change in Baseline in CD4+ Cell Count at Week 48

(NCT02616783)
Timeframe: Baseline; Week 48

Interventioncells/μL (Mean)
E/C/F/TAF56
Stay on Baseline Regimen-1

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Change From Baseline in CD4+ Cell Count at Week 24

(NCT02616783)
Timeframe: Baseline; Week 24

Interventioncells/μL (Mean)
E/C/F/TAF48
Stay on Baseline Regimen-4

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Percent Change From Baseline to Week 48 in Spine BMD

(NCT02616783)
Timeframe: Baseline; Week 48

InterventionPercent change (Mean)
E/C/F/TAF2.237
Stay on Baseline Regimen-0.104

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Change From Baseline in CD4 Cell Count at Week 96

The change from baseline in CD4 cell count at Week 96 was calculated. (NCT02629822)
Timeframe: Baseline (Day 1) and Week 96

InterventionCells/mm^3 (Mean)
Baseline for the Week 96 PopulationChange from Baseline at Week 96
DOR/3TC/TDF437153

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Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 48

The percentage of participants experiencing ≥1 AE up to Week 48 was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. (NCT02629822)
Timeframe: Up to Week 48

InterventionPercentage of Participants (Number)
DOR/3TC/TDF90.0

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Change From Baseline in CD4 Cell Count at Week 48

The change from baseline in CD4 cell count at Week 48 was calculated. (NCT02629822)
Timeframe: Baseline (Day 1) and Week 48

InterventionCells/mm^3 (Mean)
Baseline for the Week 48 PopulationChange from Baseline at Week 48
DOR/3TC/TDF409132

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Change From Baseline in CD4 Cell Count at Week 192

The change from baseline in CD4 cell count at Week 192 was calculated. (NCT02629822)
Timeframe: Baseline (Day 1) and Week 192

InterventionCells/mm^3 (Mean)
Baseline for the Week 192 PopulationChange from Baseline at Week 192
DOR/3TC/TDF479196

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Time to Loss of Virologic Response

The time to loss of virologic response (TLOVR) was reported. For participants who achieved HIV-1 RNA <50 copies/mL of plasma and subsequently had two consecutive HIV-1 RNA values of ≥50 copies/mL measured at least 1 week apart, TLOVR was the time between Day 1 and the date of the first of the two consecutive values ≥50 copies/mL. For participants who achieved and sustained HIV-1 RNA <50 copies/mL, time to loss of virologic response was censored at the time of the last available measurement. (NCT02629822)
Timeframe: Up to Week 96

InterventionDays (Mean)
DOR/3TC/TDF166

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Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 96

The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. (NCT02629822)
Timeframe: Up to Week 96

InterventionPercentage of Participants (Number)
DOR/3TC/TDF0.0

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Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 48.

The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. (NCT02629822)
Timeframe: Up to Week 48

InterventionPercentage of Participants (Number)
DOR/3TC/TDF0.0

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Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 96

The percentage of participants experiencing ≥1 AE up to Week 96 was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. (NCT02629822)
Timeframe: Up to Week 96

InterventionPercentage of Participants (Number)
DOR/3TC/TDF90.0

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Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 48

The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 48 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 48 visit. (NCT02629822)
Timeframe: Week 48

InterventionPercentage of Participants (Number)
DOR/3TC/TDF100.0

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Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 192

The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 192 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 192 visit. (NCT02629822)
Timeframe: Week 192

InterventionPercentage of Participants (Number)
DOR/3TC/TDF100.0

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Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 96

The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 96 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 96 visit. Participants with reading below the LoQ were considered to have <40 copies/mL. (NCT02629822)
Timeframe: Week 96

InterventionPercentage of Participants (Number)
DOR/3TC/TDF100.0

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Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 48

The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 48 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 48 visit. Participants with reading below the LoQ were considered to have <40 copies/mL. (NCT02629822)
Timeframe: Week 48

InterventionPercentage of Participants (Number)
DOR/3TC/TDF100.0

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Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 192

The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 192 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 192 visit. Participants with reading below the LoQ were considered to have <40 copies/mL. (NCT02629822)
Timeframe: Week 192

InterventionPercentage of Participants (Number)
DOR/3TC/TDF100.0

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Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 96

The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 96 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 96 visit. (NCT02629822)
Timeframe: Week 96

InterventionPercentage of Participants (Number)
DOR/3TC/TDF100.0

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Time to Observed Maximum Lamivudine Plasma Concentration (Tmax), Time of Last Measurable Plasma Concentration (Tlast) and Absorption Lag Time in Plasma (Tlag)

Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. (NCT02634073)
Timeframe: Day 1 to Day 3 in each treatment period

,,,
InterventionHr (Median)
tmaxtlasttlag
A: Lamivudine 300 mg0.7548.000.000
B: Lamivudine 300 mg + Sorbitol 3.2 g1.00048.000.000
C: Lamivudine 300 mg + Sorbitol 10.2 g1.0048.000.000
D: Lamivudine 300 mg + Sorbitol 13.4 g1.2648.000.000

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Plasma Lamivudine Maximum Observed Concentration (Cmax), Concentration at 24 Hour (h) Post-dose (C24) and Last Measurable Concentration (Ct)

Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. Time of the last measurable concentration (t) was 48 hours for all participants and all treatments. ANOVA, considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine PK parameters. (NCT02634073)
Timeframe: Day 1 to Day 3 in each treatment period

,,,
Interventionmcg/mL (Geometric Mean)
C24CtCmax
A: Lamivudine 300 mg0.0360.0133.34
B: Lamivudine 300 mg + Sorbitol 3.2 g0.0360.0172.42
C: Lamivudine 300 mg + Sorbitol 10.2 g0.0410.0191.60
D: Lamivudine 300 mg + Sorbitol 13.4 g0.0390.0181.52

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Plasma Lamivudine Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point (AUC[0-t]), AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) and AUC From Time Zero to 24 Hours (AUC[0-24])

Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. AUC was determined using the trapezoidal rule. Analysis of variance (ANOVA), considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine Pharmacokinetic (PK) parameters. (NCT02634073)
Timeframe: Day 1 to Day 3 in each treatment period

,,,
Interventionhour (h)*microgram (mcg)/milliliter (mL) (Geometric Mean)
AUC (0-inf); n=16, 14, 16, 13AUC (0-24) ; n=16, 16, 16, 16AUC (0-t) ; n=16, 16, 16, 16
A: Lamivudine 300 mg13.212.412.9
B: Lamivudine 300 mg + Sorbitol 3.2 g11.39.9610.6
C: Lamivudine 300 mg + Sorbitol 10.2 g8.937.548.21
D: Lamivudine 300 mg + Sorbitol 13.4 g8.606.917.55

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Number of Participants With Treatment Emergent Laboratory Abnormality Grade

Division of Acquired immune deficiency syndrome (DAIDS) Table AE grades 1, 2, 3, and 4 of laboratory abnormalities were applied and grade were summarized by treatment and day and were listed by participant, treatment, day, and actual date and time. Treatment emergent grades are defined as any new toxicity grades or the worsened grades compared to Baseline grade. Treatment emergent lab abnormality Grade 1 for aspartate aminotransferase and sodium at follow-up visit are summarized. (NCT02634073)
Timeframe: Up to Week 5

,,,
InterventionParticipants (Number)
Aspartate AminotransferaseSodium
A: Lamivudine 300 mg11
B: Lamivudine 300 mg + Sorbitol 3.2 g11
C: Lamivudine 300 mg + Sorbitol 10.2 g11
D: Lamivudine 300 mg + Sorbitol 13.4 g11

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Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAE)

An AE is any untoward medical occurrence, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. (NCT02634073)
Timeframe: Up to 5 Weeks

,,,
InterventionParticipants (Number)
AEsSAEs
A: Lamivudine 300 mg10
B: Lamivudine 300 mg + Sorbitol 3.2 g20
C: Lamivudine 300 mg + Sorbitol 10.2 g10
D: Lamivudine 300 mg + Sorbitol 13.4 g10

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Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Change from Baseline for DBP and SBP was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. (NCT02634073)
Timeframe: Baseline and up to 5 weeks

,,,
Interventionmillimeter of mercury (mmHg) (Mean)
DBP, Day 3; n=15, 16, 16, 16DBP, Follow up; n=16, 16, 16, 16SBP, Day 3; n=15, 16, 16, 16SBP, Follow up; n=16, 16, 16, 16
A: Lamivudine 300 mg5.14.63.67.4
B: Lamivudine 300 mg + Sorbitol 3.2 g4.54.63.17.4
C: Lamivudine 300 mg + Sorbitol 10.2 g2.14.65.17.4
D: Lamivudine 300 mg + Sorbitol 13.4 g5.64.65.37.4

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Change From Baseline in Pulse Rate

Change from Baseline for pulse rate was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. (NCT02634073)
Timeframe: Baseline and up to 5 weeks

,,,
InterventionBeats/min (Mean)
Day 3; n=15, 16, 16, 16Follow up; n=16, 16, 16, 16
A: Lamivudine 300 mg6.55.8
B: Lamivudine 300 mg + Sorbitol 3.2 g3.95.8
C: Lamivudine 300 mg + Sorbitol 10.2 g6.05.8
D: Lamivudine 300 mg + Sorbitol 13.4 g7.45.8

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Change From Baseline in Platelets, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils

Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils were calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline. (NCT02634073)
Timeframe: Baseline and up to 5 weeks

,,,
Intervention10^9 cells/L (Mean)
Platelets, Day 3Platelets, Follow upNeutrophils, Day 3Neutrophils, Follow upLymphocytes, Day 3Lymphocytes, Follow upMonocytes, Day 3Monocytes, Follow upEosinophils, Day 3Eosinophils, Follow upBasophils, Day 3Basophils, Follow up
A: Lamivudine 300 mg19.22.30.35-0.120.10-0.080.01-0.08-0.03-0.01-0.01-0.01
B: Lamivudine 300 mg + Sorbitol 3.2 g13.92.30.42-0.120.17-0.080.03-0.08-0.02-0.010.00-0.01
C: Lamivudine 300 mg + Sorbitol 10.2 g13.82.30.53-0.120.00-0.08-0.02-0.08-0.04-0.01-0.01-0.01
D: Lamivudine 300 mg + Sorbitol 13.4 g6.12.30.31-0.12-0.03-0.08-0.01-0.08-0.03-0.010.00-0.01

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Change From Baseline in Mean Corpuscular Volume (MCV)

Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for MCV was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline. (NCT02634073)
Timeframe: Baseline and up to 5 weeks

,,,
InterventionFemtoliter (Mean)
Day 3Follow up
A: Lamivudine 300 mg0.71-0.77
B: Lamivudine 300 mg + Sorbitol 3.2 g0.63-0.77
C: Lamivudine 300 mg + Sorbitol 10.2 g0.35-0.77
D: Lamivudine 300 mg + Sorbitol 13.4 g0.44-0.77

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Change From Baseline in Mean Corpuscular Hemoglobin (MCH)

Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for MCH was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline. (NCT02634073)
Timeframe: Baseline and up to 5 weeks

,,,
InterventionPicogram (Mean)
Day 3Follow up
A: Lamivudine 300 mg0.02-0.14
B: Lamivudine 300 mg + Sorbitol 3.2 g-0.03-0.14
C: Lamivudine 300 mg + Sorbitol 10.2 g0.06-0.14
D: Lamivudine 300 mg + Sorbitol 13.4 g-0.24-0.14

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Change From Baseline in Hematocrit

Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for hematocrit was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline. (NCT02634073)
Timeframe: Baseline and up to 5 weeks

,,,
InterventionFraction of 1 (Mean)
Day 3Follow up
A: Lamivudine 300 mg0.03380.0091
B: Lamivudine 300 mg + Sorbitol 3.2 g0.03780.0091
C: Lamivudine 300 mg + Sorbitol 10.2 g0.03080.0091
D: Lamivudine 300 mg + Sorbitol 13.4 g0.03530.0091

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Change From Baseline in Erythrocytes

Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for erythrocytes was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/Period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline. (NCT02634073)
Timeframe: Baseline and up to 5 weeks

,,,
Intervention10^12 cells/L (Mean)
Day 3Follow up
A: Lamivudine 300 mg0.3510.142
B: Lamivudine 300 mg + Sorbitol 3.2 g0.3890.142
C: Lamivudine 300 mg + Sorbitol 10.2 g0.3390.142
D: Lamivudine 300 mg + Sorbitol 13.4 g0.3800.142

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Change From Baseline in Creatinine, Total Bilirubin and Direct Bilirubin

Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for creatinine and direct bilirubin were calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Change from Baseline in total bilirubine was not assessed. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline. (NCT02634073)
Timeframe: Baseline and up to 5 weeks

,,,
Interventionmicromole (umol)/L (Mean)
Creatinine, Day 3Creatinine, Follow upDirect bilirubin, Day 3Direct bilirubin, Follow up
A: Lamivudine 300 mg3.867590.000000.6410.107
B: Lamivudine 300 mg + Sorbitol 3.2 g2.210050.000000.1070.107
C: Lamivudine 300 mg + Sorbitol 10.2 g4.420100.000000.1070.107
D: Lamivudine 300 mg + Sorbitol 13.4 g0.552510.000000.3210.107

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Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphates

Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for AST, ALT and alkaline phosphatase were calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline. (NCT02634073)
Timeframe: Baseline and up to 5 weeks

,,,
InterventionUnit (U)/L (Mean)
AST, Day 3AST, Follow upALT, Day 3ALT, Follow upAlkaline phosphatatse, Day 3Alkaline phosphatase, Follow up
A: Lamivudine 300 mg-3.11.1-2.20.4-0.41.2
B: Lamivudine 300 mg + Sorbitol 3.2 g-3.51.1-2.70.41.11.2
C: Lamivudine 300 mg + Sorbitol 10.2 g-2.31.1-2.20.41.51.2
D: Lamivudine 300 mg + Sorbitol 13.4 g-19.11.1-2.50.4-0.21.2

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Change From Baseline in Body Temperature

Change from Baseline for body temperature was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. (NCT02634073)
Timeframe: Baseline and up to 5 weeks

,,,
InterventionDegree centigrade (Mean)
Day 3Follow up
A: Lamivudine 300 mg0.03-0.01
B: Lamivudine 300 mg + Sorbitol 3.2 g0.07-0.01
C: Lamivudine 300 mg + Sorbitol 10.2 g0.08-0.01
D: Lamivudine 300 mg + Sorbitol 13.4 g-0.03-0.01

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Change From Baseline in Albumin

Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for albumin was calculated as the post-dose Visit Value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/Period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline. (NCT02634073)
Timeframe: Baseline and up to 5 weeks

,,,
InterventionG//L (Mean)
Day 3Follow up
A: Lamivudine 300 mg1.80.6
B: Lamivudine 300 mg + Sorbitol 3.2 g2.30.6
C: Lamivudine 300 mg + Sorbitol 10.2 g2.10.6
D: Lamivudine 300 mg + Sorbitol 13.4 g2.10.6

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Plasma Lamivudine Apparent Oral Clearance (CL/F)

Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. ANOVA, considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine CL/F (NCT02634073)
Timeframe: Day 1 to Day 3 in each treatment period

InterventionLiter (L)/hr (Geometric Mean)
A: Lamivudine 300 mg22.738
B: Lamivudine 300 mg + Sorbitol 3.2 g26.621
C: Lamivudine 300 mg + Sorbitol 10.2 g33.608
D: Lamivudine 300 mg + Sorbitol 13.4 g34.875

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Lamivudine Elimination Half-life in Plasma (t1/2)

Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. ANOVA, considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine t1/2. (NCT02634073)
Timeframe: Day 1 to Day 3 in each treatment period

InterventionHour (Hr) (Geometric Mean)
A: Lamivudine 300 mg13.9
B: Lamivudine 300 mg + Sorbitol 3.2 g19.0
C: Lamivudine 300 mg + Sorbitol 10.2 g21.2
D: Lamivudine 300 mg + Sorbitol 13.4 g17.3

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Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Glucose, Calcium

Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for BUN, sodium, potassium, glucose, calcium were calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline. (NCT02634073)
Timeframe: Baseline and up to 5 weeks

,,,
Interventionmillimole (mmol)/L (Mean)
BUN, Day 3BUN, Follow upSodium, Day 3Sodium, Follow upPotassium, Day 3Potassium, Follow upGlucose, Day 3Glucose, Follow upCalcium Day 3Calcium, Follow up
A: Lamivudine 300 mg-0.0892-0.4909-2.4-0.10.060.02-0.058970.339940.09060.0328
B: Lamivudine 300 mg + Sorbitol 3.2 g-0.5578-0.4909-1.2-0.10.090.020.055500.339940.11410.0328
C: Lamivudine 300 mg + Sorbitol 10.2 g0.0223-0.4909-2.6-0.10.190.020.013880.339940.11410.0328
D: Lamivudine 300 mg + Sorbitol 13.4 g0.0446-0.4909-2.0-0.10.060.02-0.031220.339940.08750.0328

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Change From Baseline in Hemoglobin

Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for hemoglobin was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline. (NCT02634073)
Timeframe: Baseline and up to 5 weeks

,,,
InterventionG/L (Mean)
Day 3Follow up
A: Lamivudine 300 mg10.13.4
B: Lamivudine 300 mg + Sorbitol 3.2 g10.93.4
C: Lamivudine 300 mg + Sorbitol 10.2 g9.83.4
D: Lamivudine 300 mg + Sorbitol 13.4 g9.93.4

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Percentage of Participants With at Least One Central Nervous System (CNS) Toxicity of at Least Grade 2 Intensity at Week 12

A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. Percentage of participants with at least one CNS toxicity of Grade 2 or higher were recorded, based on the last observation carried forward (LOCF) approach. (NCT02652260)
Timeframe: Week 12

InterventionPercentage of participants (Number)
Immediate Switch to MK-1439A41.9
Deferred Switch to MK-1439A37.2

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Percentage of Participants With at Least One CNS Toxicity of at Least Grade 2 Intensity at Time of Switch, and at 24 Weeks Post-switch for the Combined Treatment Groups

A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. For the Immediate Switch Group (ISG) time of switch was study Day 1, and week 24 post-switch was week 24. For the Delayed Switch Group (DSG) time of switch was study week 12, and week 24 post-switch was week 36. (NCT02652260)
Timeframe: Baseline (time of switch) and 24 weeks post-switch

InterventionPercentage of participants (Number)
Combined Treatment Groups: Time of Switch68.6
Combined Treatment Groups: Week 24 Post-Switch30.2

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Percentage of Participants With at Least One CNS Toxicity of at Least Grade 2 Intensity at Week 4

A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. Percentage of participants with at least one CNS toxicity of Grade 2 or higher were recorded, based on the last observation carried forward (LOCF) approach. (NCT02652260)
Timeframe: Week 4

InterventionPercentage of participants (Number)
Immediate Switch to MK-1439A46.5
Deferred Switch to MK-1439A65.1

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Change From Baseline in Fasting Lipids at Week 12

Blood was collected under fasting conditions on Day 1 and on week 12 in order to determine the concentration of the following lipids: low-density lipoprotein (LDL) cholesterol; Non high-density lipoprotein (HDL) cholesterol; cholesterol; HDL cholesterol; and triglyceride. (NCT02652260)
Timeframe: Baseline (study Day 1) and study week 12

,
Interventionmg/dL (Mean)
LDL CholesterolNon-HDL CholesterolCholesterolHDL CholesterolTriglyceride
Deferred Switch to MK-1439A-1.88-0.370.000.377.10
Immediate Switch to MK-1439A-10.78-14.08-22.14-8.05-21.19

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Change in Fasting Lipids Between Time of Switch and Week 24 Post-switch for the Combined Treatment Groups

Blood was collected under fasting conditions at time of switch and 24 weeks post-switch in order to determine the change from baseline of the following lipids: low-density lipoprotein (LDL) cholesterol; Non high-density lipoprotein (HDL) cholesterol; cholesterol; HDL cholesterol; and triglyceride. For the ISG time of switch was study Day 1, and week 24 post-switch was week 24. For the DSG time of switch was study week 12, and week 24 post-switch was week 36. (NCT02652260)
Timeframe: Baseline (time of switch) and 24 weeks post-switch

Interventionmg/dL (Mean)
LDL CholesterolNon-HDL CholesterolCholesterolHDL CholesterolTriglyceride
Combined Treatment Groups-10.97-13.18-20.91-7.72-12.99

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Change From Baseline in CNS Toxicity Score at Week 4

A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A positive change from baseline score indicates worsening symptoms. A negative change from baseline score indicates improvement in symptoms. (NCT02652260)
Timeframe: Baseline and Week 4

InterventionPercentage of maximum score (Mean)
Immediate Switch to MK-1439A-17.6
Deferred Switch to MK-1439A-15.6

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Change From Time of Switch to Week 24 Post Switch in CD4 T-cell Count for the Combined Treatment Groups

Blood was collected at time of switch and at 24 weeks post-switch in order to determine the CD4 T-cell count. For the ISG time of switch was study Day 1, and week 24 post-switch was week 24. For the DSG time of switch was study week 12, and week 24 post-switch was week 36. (NCT02652260)
Timeframe: Baseline (time of switch) and 24 weeks post-switch

Interventioncells/mm^3 (Mean)
Combined Treatment Groups70.4

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CNS Toxicity Scores at Time of Switch, and at 24 Weeks Post-switch for the Combined Treatment Groups

A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A higher CNS score indicates worse symptoms. A positive change in CNS score indicates worsening symptoms. A negative change indicates improvement in symptoms. For the ISG time of switch was study Day 1, and week 24 post-switch was week 24. For the DSG time of switch was study week 12, and week 24 post-switch was week 36. (NCT02652260)
Timeframe: Baseline (time of switch) and 24 weeks post-switch

InterventionPercentage of maximum score (Mean)
Combined Treatment Groups: Time of Switch24.2
Combined Treatment Groups: Week 24 Post-Switch10.7

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Number of Participants Who Discontinued Treatment Due to an AE for the Combined Treatment Groups 24 Weeks After the Switch

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36. (NCT02652260)
Timeframe: 24 weeks post-switch

InterventionParticipants (Count of Participants)
Combined Treatment Groups0

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Number of Participants Who Discontinued Treatment Due to an AE Through Study Week 12

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. (NCT02652260)
Timeframe: Up to Week 12

InterventionParticipants (Count of Participants)
Immediate Switch to MK-1439A0
Deferred Switch to MK-1439A0

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Number of Participants With One or More Adverse Events (AEs) Through Study Week 12

An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. (NCT02652260)
Timeframe: Up to Week 12

InterventionParticipants (Count of Participants)
Immediate Switch to MK-1439A34
Deferred Switch to MK-1439A34

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Number of Participants With One or More AEs for the Combined Treatment Groups 24 Weeks After the Switch

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36. (NCT02652260)
Timeframe: 24 weeks post-switch

InterventionParticipants (Count of Participants)
Combined Treatment Groups71

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Percentage of Participants With HIV-1 RNA <50 and <40 Copies/ml at Week 24 Post-switch for the Combined Treatment Groups

Blood was collected under fasting conditions at 24 weeks post-switch in order to determine the HIV-1 RNA. For the ISG week 24 post-switch was week 24. For the DSG week 24 post-switch was week 36. (NCT02652260)
Timeframe: 24 weeks post-switch

InterventionPercentage of participants (Number)
< 50 copies/mL< 40 copies/mL
Combined Treatment Groups95.395.3

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Change From Baseline in CNS Toxicity Score at Week 12

A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A positive change from baseline score indicates worsening symptoms. A negative change from baseline score indicates improvement in symptoms. (NCT02652260)
Timeframe: Baseline and Week 12

InterventionPercentage of maximum score (Mean)
Immediate Switch to MK-1439A-18.1
Deferred Switch to MK-1439A-21.7

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Number of Participants With One or More SAEs for the Combined Treatment Groups 24 Weeks After the Switch

A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36. (NCT02652260)
Timeframe: 24 weeks post-switch

InterventionParticipants (Count of Participants)
Combined Treatment Groups1

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Number of Participants With One or More Serious Adverse Events (SAEs) Through Study Week 12

A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose. (NCT02652260)
Timeframe: Up to Week 12

InterventionParticipants (Count of Participants)
Immediate Switch to MK-1439A0
Deferred Switch to MK-1439A0

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Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48

Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by ([post-dose visit value minus Baseline value] divided by Baseline value). (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48

,
InterventionPercentage change (Mean)
Total/HDL Cholesterol Ratio, Week 24, n=294, 297Total/HDL Cholesterol Ratio, Week 48, n=280, 289
DTG + 3TC-Double Blind Phase-4.0-0.2
DTG + TDF/FTC-Double Blind Phase-4.6-4.4

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Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 96

Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96

InterventionRatio (Mean)
DTG + 3TC-Double Blind Phase-0.213
DTG + TDF/FTC-Double Blind Phase-0.402

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Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144

Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144

InterventionRatio (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase-0.229
DTG + TDF/FTC - Double-blind Phase + Open-label Phase-0.386

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Change From Baseline in EQ-5D-5L Utility Score at Week 96

EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Baseline was the latest pre-dose assessment (Day 1) and change from Baseline=post-dose value minus Baseline value. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 96

InterventionScores on a scale (Mean)
DTG + 3TC-Double Blind Phase0.0079
DTG + TDF/FTC-Double Blind Phase0.0091

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Change From Baseline in EQ-5D-5L Utility Score at Week 144

EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Baseline was the latest pre-dose assessment (Day 1) and change from Baseline=post-dose value minus Baseline value. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 144

InterventionScores on a scale (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase0.0143
DTG + TDF/FTC - Double-blind Phase + Open-label Phase0.0135

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Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96

EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 96

InterventionScores on a scale (Mean)
DTG + 3TC-Double Blind Phase4.1
DTG + TDF/FTC-Double Blind Phase2.4

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Change From Baseline in EQ-5D-5L Thermometer Scores at Week 144

EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 144

InterventionScores on a scale (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase5.2
DTG + TDF/FTC - Double-blind Phase + Open-label Phase3.0

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Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96

Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96

InterventionNanomoles per Liter (nmol/L) (Mean)
DTG + 3TC-Double Blind Phase-2.2
DTG + TDF/FTC-Double Blind Phase0.7

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Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144

Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144

InterventionNanomoles per Liter (nmol/L) (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase-2.0
DTG + TDF/FTC - Double-blind Phase + Open-label Phase2.9

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CD4+ Cell Counts at Week 96

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. (NCT02831673)
Timeframe: Week 96

InterventionCells per cubic millimeter (cells/mm^3) (Mean)
DTG + 3TC Double Blind Phase732.8
DTG + TDF/FTC-Double Blind Phase711.5

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CD4+ Cell Counts at Week 144

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. (NCT02831673)
Timeframe: Week 144

InterventionCells per cubic millimeter (cells/mm^3) (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase767.8
DTG + TDF/FTC - Double-blind Phase + Open-label Phase758.2

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Number of Participants Who Discontinue Treatment Due to AEs Over Week 144

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued treatment due to AEs have been reported. (NCT02831673)
Timeframe: Up to Week 144

InterventionParticipants (Count of Participants)
DTG + 3TC - Double-blind Phase + Open-label Phase18
DTG + TDF/FTC - Double-blind Phase + Open-label Phase17

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Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48

Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Urine and Serum B2M, Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Statistical analysis of changes from baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios. Estimated ratio of geometric means (each visit over Baseline) and 95% confidence interval (CI) have been presented. (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48

,
InterventionRatio (Geometric Mean)
Serum B2M, Week 24, n=338, 335Serum B2M, Week 48, n=324, 332Urine B2M, Week 24, n=121, 95Urine B2M, Week 48, n=119, 103Urine Albumin/Creatinine, Week 24, n=254, 252Urine Albumin/Creatinine , Week 48, n=237, 244Urine B2M/Urine Creatinine, Week 24, n=121, 95Urine B2M/Urine Creatinine, Week 48, n=114, 100Urine Phosphate, Week 24, n=330, 332Urine Phosphate, Week 48, n=316, 330Urine Protein/Creatinine, Week 24, n=269, 265Urine Protein/Creatinine, Week 48, n=252, 269Urine RBP 4, Week 24, n=332, 330Urine RBP 4, Week 48, n=318, 328Urine RBP 4/Urine Creatinine, Week 24, n=329, 330Urine RBP 4/Urine Creatinine, Week 48, n=304, 318
DTG + 3TC-Double Blind Phase0.7980.8060.8870.9001.0140.9340.8520.8881.1151.0610.8500.8790.9341.1150.9191.147
DTG + TDF/FTC-Double Blind Phase0.8720.8921.3511.3381.0501.0481.3311.2781.0121.0751.0161.0611.0731.4901.1101.500

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Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96

Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Statistical analysis of changes from baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios. Estimated ratio of geometric means (each visit over Baseline) and 95% confidence interval (CI) have been presented. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 96

,
InterventionRatio (Geometric Mean)
Urine Albumin/Creatinine, Week 96, n=222, 243Urine B2M/Urine Creatinine , Week 96, n=107, 104Urine Phosphate, Week 96, n=292, 316Urine Protein/Creatinine, Week 96, n=238, 258Urine RBP 4/Urine Creatinine, Week 96, n=289, 311
DTG + 3TC-Double Blind Phase0.9240.7941.1130.8681.310
DTG + TDF/FTC-Double Blind Phase1.1011.4411.0661.0531.771

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Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144

Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Urine and Serum B2M, Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Statistical analysis of changes from baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios. Estimated ratio of geometric means (each visit over Baseline) and 95% confidence interval (CI) have been presented. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 144

,
InterventionRatio (Geometric Mean)
Urine Albumin/Creatinine , Week 144, n=207, 212Urine B2M/Urine Creatinine , Week 144, n=100, 102Urine Phosphate, Week 144, n=274, 294Urine Protein/Creatinine , Week 144, n=225,232Urine RBP 4/Urine Creatinine, Week 144, n=276, 292
DTG + 3TC - Double-blind Phase + Open-label Phase1.0500.7511.0400.9881.648
DTG + TDF/FTC - Double-blind Phase + Open-label Phase1.1461.5180.9551.2102.425

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Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48

Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Weeks 24 and 48 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 48 or those who had Baseline lipids-lowering agents are not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Weeks 24 and Week 48

,
InterventionPercentage of participants (Number)
Week 24, n=309, 316Week 48, n=318, 320
DTG + 3TC-Double Blind Phase44
DTG + TDF/FTC-Double Blind Phase23

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Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24

Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200, >200), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian, Other). Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 24

,
InterventionPercentage of participants (Number)
Baseline CD4+ cell count, <=200,n=31,29Baseline CD4+ cell count, >200,n=325,329Female, n=59, 52Male, n=297, 306Age, <35,n= 211, 205Age, 35 to <50,n=116, 107Age, >=50, n=29, 46Baseline plasma HIV-1 RNA, <=100000,n=282,282Baseline plasma HIV-1 RNA, >100000,n=74, 76Race, White, n=244,247Race, African American/African H., n=39, 36Race, Asian, n=37, 42Race, Other, n=36, 33
DTG + 3TC-Double Blind Phase90939392939193939293928994
DTG + TDF/FTC-Double Blind Phase86949692959385958795819394

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Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96

Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 96

,
InterventionPercentage of participants (Number)
Baseline CD4+ cell count, <=200,n=31, 29Baseline CD4+ cell count, >200,n=325,329Female, n=59, 52Male, n=297,306,Age, <35,n= 211, 205Age, 35 to <50,n=116, 107Age, >=50, n=29,46Baseline plasma HIV-1 RNA, <=100000,n=282,282Baseline plasma HIV-1 RNA, >100000,n=74, 76Race, White, n=244,247Race, African American/African H., n=39,36Race, Asian, n=37, 42Race, Other, n=36, 33
DTG + 3TC-Double Blind Phase65868385848486858186797886
DTG + TDF/FTC-Double Blind Phase90898890908987908890819091

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Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48

Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200, >200), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian, Other). Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 48

,
InterventionPercentage of participants (Number)
Baseline CD4+ cell count, <=200,n=31,29Baseline CD4+ cell count, >200,n=325,329Female, n=59, 52Male, n=297, 306Age, <35,n= 211, 205Age, 35 to <50,n=116, 107Age, >=50, n=29, 46Baseline plasma HIV-1 RNA, <=100000,n=282,282Baseline plasma HIV-1 RNA, >100000,n=74, 76Race, White, n=244,247Race, African American/African H., n=39, 36Race, Asian, n=37, 42Race, Other, n=36, 33
DTG + 3TC-Double Blind Phase81918890928690908890879289
DTG + TDF/FTC-Double Blind Phase90939492939487939194819894

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Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144

Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 144

,
InterventionPercentage of participants (Number)
Baseline CD4+ cell count, <=200,n=31, 29Baseline CD4+ cell count, >200,n=325,329Female, n=59, 52Male, n=297,306,Age, <35,n= 211, 205Age, 35 to <50,n=116, 107Age, >=50, n=29,46Baseline plasma HIV-1 RNA, <=100000,n=282,282Baseline plasma HIV-1 RNA, >100000,n=74, 76Race, White, n=244,247Race, African American/African H., n=39,36Race, Asian, n=37, 42Race, Other, n=36, 33
DTG + 3TC - Double-blind Phase + Open-label Phase58817180778183797882697378
DTG + TDF/FTC - Double-blind Phase + Open-label Phase83838582838378828785728179

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Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48

Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value is defined as the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by ([post-dose visit value minus Baseline value] divided by Baseline value). (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48

,
InterventionPercentage change (Mean)
Serum or Plasma Cholesterol, Week 24, n=294, 297Serum or Plasma Cholesterol, Week 48, n=280, 289HDL Cholesterol, Direct, Week 24, n=294, 297HDL Cholesterol, Direct, Week 48, n=280, 289LDL Cholesterol, Week 24, n=294, 297LDL Cholesterol, Week 48, n=280, 289Triglycerides ,Week 24, n=294, 297Triglycerides , Week 48, n=280, 289
DTG + 3TC-Double Blind Phase9.410.516.415.012.414.88.512.8
DTG + TDF/FTC-Double Blind Phase-4.7-2.43.45.0-8.1-4.04.34.4

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Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144

Number of participants, who meet CVW criteria, with treatment emergent phenotypic resistance to INSTI and/or NRTI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences) and provides the overall susceptibility of the drug. Partially sensitive and resistant calls were considered resistant in this analysis. The Viral Phenotypic Population comprised of all participants in the ITT-E population who have available on-treatment phenotypic resistance data. (NCT02831673)
Timeframe: Up to Week 144

,
InterventionParticipants (Count of Participants)
INSTI, DTG, Sensitive, n=,5,4INSTI, DTG, Resistant, n=5,4INSTI, EGV, Sensitive, n=5,4INSTI, EGV, Resistant, n=5,4INSTI, RAL, Sensitive, n=5,4INSTI, RAL, Resistant, n=5,4NRTI, 3TC, Sensitive, n=5,5NRTI, 3TC, Resistant, n=5,5NRTI, ABC, Sensitive, n=5,5NRTI, ABC, Resistant, n=5,5NRTI, AZT, Sensitive, n=5,5NRTI, AZT, Resistant, n=5,5NRTI, D4T, Sensitive, n=5,5NRTI, D4T, Resistant, n=5,5NRTI, DDI, Sensitive, n=5,5NRTI, DDI, Resistant, n=5,5NRTI, FTC, Sensitive, n=5,5NRTI, FTC, Resistant, n=5,5NRTI, TDF, Sensitive, n=5,5NRTI, TDF, Resistant, n=5,5
DTG + 3TC - Double-blind Phase + Open-label Phase50505050505050505050
DTG + TDF/FTC - Double-blind Phase + Open-label Phase40404050505050505050

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Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144

Number of participants, who met confirmed virologic withdrawal (CVW) criteria, with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI) and/or Nucleoside reverse transcriptase inhibitor (NRTI) was summarized. The Viral Genotypic Population comprised of all participants in the ITT-E population who have available on-treatment genotypic resistance data. (NCT02831673)
Timeframe: Up to Week 144

,
InterventionParticipants (Count of Participants)
INSTI MutationsMajor mutations of NRTI
DTG + 3TC - Double-blind Phase + Open-label Phase00
DTG + TDF/FTC - Double-blind Phase + Open-label Phase00

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Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144

Blood samples were collected up to Week 144 for assessment of hemoglobin, leukocytes, neutrophils and platelets. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the listed hematology parameters have been presented. (NCT02831673)
Timeframe: Up to Week 144

,
InterventionParticipants (Count of Participants)
Hemoglobin, Grades 1 to 4Hemoglobin, Grades 2 to 4Hemoglobin, Grades 3 to 4Hemoglobin, Grade 1Hemoglobin, Grade 2Hemoglobin, Grade 3Hemoglobin, Grade 4Leukocytes, Grades 1 to 4Leukocytes, Grades 2 to 4Leukocytes, Grades 3 to 4Leukocytes, Grade 1Leukocytes, Grade 2Leukocytes, Grade 3Leukocytes, Grade 4Neutrophils, Grades 1 to 4Neutrophils, Grades 2 to 4Neutrophils, Grades 3 to 4Neutrophils, Grade 1Neutrophils, Grade 2Neutrophils, Grade 3Neutrophils, Grade 4Platelets, Grades 1 to 4Platelets, Grades 2 to 4Platelets, Grades 3 to 4Platelets, Grade 1Platelets, Grade 2Platelets, Grade 3Platelets, Grade 4
DTG + 3TC - Double-blind Phase + Open-label Phase9108100164012400251976125214816701
DTG + TDF/FTC - Double-blind Phase + Open-label Phase7106100320120018116755111417310

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Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144

Blood samples were collected up to Week 144 for assessment of Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate aminotransferase (AST), Bilirubin, Carbon dioxide (CO2), Cholesterol, Creatine kinase (CK), Creatinine, Direct Bilirubin, Glomerular filtration rate (GFR) from creatinine adjusted for body surface area (BSA), Hypercalcemia, Hyperglycemia, Hyperkalemia, Hypernatremia, Hypocalcemia, Hypoglycemia, Hypokalemia, Hyponatremia, Low density lipid (LDL) Cholesterol, Lactate Dehydrogenase, Lipase, Phosphate, and Triglycerides. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent chemistry toxicities in any of the chemistry parameters have been presented (NCT02831673)
Timeframe: Up to Week 144

,
InterventionParticipants (Count of Participants)
ALT, Grades 1 to 4ALT, Grades 2 to 4ALT, Grades 3 to 4ALT, Grade 1ALT, Grade 2ALT, Grade 3ALT, Grade 4Albumin, Grades 1 to 4Albumin, Grades 2 to 4Albumin, Grades 3 to 4Albumin, Grade 1Albumin, Grade 2Albumin, Grade 3Albumin, Grade 4ALP, Grades 1 to 4ALP, Grades 2 to 4ALP, Grades 3 to 4ALP, Grade 1ALP, Grade 2ALP, Grade 3ALP, Grade 4AST, Grades 1 to 4AST, Grades 2 to 4AST, Grades 3 to 4AST, Grade 1AST, Grade 2AST, Grade 3AST, Grade 4Bilirubin, Grades 1 to 4Bilirubin, Grades 2 to 4Bilirubin, Grades 3 to 4Bilirubin, Grade 1Bilirubin, Grade 2Bilirubin, Grade 3Bilirubin, Grade 4CO2, Grades 1 to 4CO2, Grades 2 to 4CO2, Grades 3 to 4CO2, Grade 1CO2, Grade 2CO2, Grade 3CO2, Grade 4Cholesterol, Grades 1 to 4Cholesterol, Grades 2 to 4Cholesterol, Grades 3 to 4Cholesterol, Grade 1Cholesterol, Grade 2Cholesterol, Grade 3Cholesterol, Grade 4CK, Grades 1 to 4CK, Grades 2 to 4CK, Grades 3 to 4CK, Grade 1CK, Grade 2CK, Grade 3CK, Grade 4Creatinine, Grades 1 to 4Creatinine, Grades 2 to 4Creatinine, Grades 3 to 4Creatinine, Grade 1Creatinine, Grade 2Creatinine, Grade 3Creatinine, Grade 4Direct Bilirubin, Grades 1 to 4Direct Bilirubin, Grades 2 to 4Direct Bilirubin, Grades 3 to 4Direct Bilirubin, Grade 1Direct Bilirubin, Grade 2Direct Bilirubin, Grade 3Direct Bilirubin, Grade 4GFR from creatinine adjusted for BSA Grades 1 to 4GFR from creatinine adjusted for BSA Grades 2 to 4GFR from creatinine adjusted for BSA Grades 3 to 4GFR from creatinine adjusted for BSA, Grade 1GFR from creatinine adjusted for BSA, Grade 2GFR from creatinine adjusted for BSA Grades 3GFR from creatinine adjusted for BSA, Grade 4Hypercalcaemia, Grades 1 to 4Hypercalcaemia, Grades 2 to 4Hypercalcaemia, Grades 3 to 4Hypercalcaemia, Grade 1Hypercalcaemia, Grade 2Hypercalcaemia, Grade 3Hypercalcaemia, Grade 4Hyperglycemia, Grades 1 to 4Hyperglycemia, Grades 2 to 4Hyperglycemia, Grades 3 to 4Hyperglycemia, Grade 1Hyperglycemia, Grade 2Hyperglycemia, Grade 3Hyperglycemia, Grade 4Hyperkalemia, Grades 1 to 4Hyperkalemia, Grades 2 to 4Hyperkalemia, Grades 3 to 4Hyperkalemia, Grade 1Hyperkalemia, Grade 2Hyperkalemia, Grade 3Hyperkalemia, Grade 4Hypernatremia, Grades 1 to 4Hypernatremia, Grades 2 to 4Hypernatremia, Grades 3 to 4Hypernatremia, Grade 1Hypernatremia, Grade 2Hypernatremia, Grade 3Hypernatremia, Grade 4Hypocalcaemia, Grades 1 to 4Hypocalcaemia, Grades 2 to 4Hypocalcaemia, Grades 3 to 4Hypocalcaemia, Grade 1Hypocalcaemia, Grade 2Hypocalcaemia, Grade 3Hypocalcaemia, Grade 4Hypoglycemia, Grades 1 to 4Hypoglycemia, Grades 2 to 4Hypoglycemia, Grades 3 to 4Hypoglycemia, Grade 1Hypoglycemia, Grade 2Hypoglycemia, Grade 3Hypoglycemia, Grade 4Hypokalemia, Grades 1 to 4Hypokalemia, Grades 2 to 4Hypokalemia, Grades 3 to 4Hypokalemia, Grade 1Hypokalemia, Grade 2Hypokalemia, Grade 3Hypokalemia, Grade 4Hyponatremia, Grades 1 to 4Hyponatremia, Grades 2 to 4Hyponatremia, Grades 3 to 4Hyponatremia, Grade 1Hyponatremia, Grade 2Hyponatremia, Grade 3Hyponatremia, Grade 4LDL Cholesterol, Grades 1 to 4LDL Cholesterol, Grades 2 to 4LDL Cholesterol, Grades 3 to 4LDL Cholesterol, Grade 1LDL Cholesterol, Grade 2LDL Cholesterol, Grade 3LDL Cholesterol, Grade 4Lactate Dehydrogenase, Grades 1 to 4Lactate Dehydrogenase, Grades 2 to 4Lactate Dehydrogenase, Grades 3 to 4Lactate Dehydrogenase, Grade 1Lactate Dehydrogenase, Grade 2Lactate Dehydrogenase, Grade 3Lactate Dehydrogenase, Grade 4Lipase, Grades 1 to 4Lipase, Grades 2 to 4Lipase, Grades 3 to 4Lipase, Grade 1Lipase, Grade 2Lipase, Grade 3Lipase, Grade 4Phosphate, Grades 1 to 4Phosphate, Grades 2 to 4Phosphate, Grades 3 to 4Phosphate, Grade 1Phosphate, Grade 2Phosphate, Grade 3Phosphate, Grade 4Triglycerides, Grades 1 to 4Triglycerides, Grades 2 to 4Triglycerides, Grades 3 to 4Triglycerides, Grade 1Triglycerides, Grade 2Triglycerides, Grade 3Triglycerides, Grade 4
DTG + 3TC - Double-blind Phase + Open-label Phase5523143297711001008305300522782519624214428102212680118800772405324007643263317151121102010014141400140185185130172130700700091383533530100100060060001440104002282146116006000252023200571754012503003000653510302582703523533208012768561
DTG + TDF/FTC - Double-blind Phase + Open-label Phase81259561645100100010109100793113481894511743413401169010790040131271210755236231621153132281201313130013022622627019925240040008125256232041130013003000133110210173114201710610028002800035144211040510410080491831311086847621416062143481121

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Number of Participants With HIV-1 Disease Progression up to Week 144

HIV-associated conditions were recorded during the study and was assessed according to the 2014 Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. Disease progressions summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrolment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrolment to Death. (NCT02831673)
Timeframe: Up to Week 144

,
InterventionParticipants (Count of Participants)
No HIV-1 disease progressionFrom CDC Stage 1 to CDC Stage 3 EventFrom CDC Stage 2 to CDC Stage 3 EventFrom CDC Stage 3 to New CDC Stage 3 EventFrom CDC Stage 1, 2 or 3 to Death
DTG + 3TC - Double-blind Phase + Open-label Phase3520211
DTG + TDF/FTC - Double-blind Phase + Open-label Phase3560200

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Number of Participants With Any AE and SAE up to Week 148

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or protocol defined event associated with liver injury and impaired liver function were categorized as SAE. Safety Population was used which comprised of all participants who received at least one dose of study treatment. (NCT02831673)
Timeframe: Up to Week 148

,
InterventionParticipants (Count of Participants)
Any AEAny SAE
DTG + 3TC - Double-blind Phase + Open-label Phase30737
DTG + TDF/FTC - Double-blind Phase + Open-label Phase31638

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Number of Participants With AEs by Maximum Severity Grades up to Week 144

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the DAIDS toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented. (NCT02831673)
Timeframe: Up to Week 144

,
InterventionParticipants (Count of Participants)
Grade 1 AEsGrade 2 AEsGrade 3 AEsGrade 4 AEsGrade 5 AEs
DTG + 3TC - Double-blind Phase + Open-label Phase332293771
DTG + TDF/FTC - Double-blind Phase + Open-label Phase352423450

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Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. . Number of participants who discontinued treatment due to AEs have been reported. (NCT02831673)
Timeframe: Up to Week 24, Week 48 and Week 96

,
InterventionParticipants (Count of Participants)
Up to Week 24Up to Week 48Up to Week 96
DTG + 3TC-Double Blind Phase6714
DTG + TDF/FTC-Double Blind Phase4811

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Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 96

,
InterventionCells per cubic millimeter (Mean)
Baseline plasma HIV-1 RNA,<=100000, n=240,253Baseline plasma HIV-1 RNA,>100000, n=61,67Baseline CD4+ cell count,<=200, n=21,26Baseline CD4+ cell count,>200, n=280,294Age group-1, <35,n= 179,185Age group-1, 35 to <50, n=97,95Age group-1, >=50, n=25, 40Female, n=49,46Male, n=252, 274Race group, White, n=210,223Race group, African Am/African H., n=31,29Race group, Asian, n=29,38Race group, Other, n=31,30
DTG + 3TC-Double Blind Phase254.8300.2240.5265.9270.2259.5237.6277.9261.4275.2228.5212.1273.4
DTG + TDF/FTC-Double Blind Phase252.9260.1244.4255.1263.0262.0195.9259.1253.5260.0230.2244.8247.3

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Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from Analysis of Covariance (ANCOVA) model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 48

,
InterventionCells per cubic millimeter (Mean)
Baseline plasma HIV-1 RNA,<=100000, n=257,264Baseline plasma HIV-1 RNA,>100000, n=67,70Baseline CD4+ cell count,<=200, n=26, 27Baseline CD4+ cell count,>200, n=298, 307Age group-1, <35,n= 194, 192Age group-1, 35 to <50, n=104, 101Age group-1, >=50, n=26, 41Female, n=54, 49Male, n=270, 285Race, White, n=224, 231Race, African Am/African H., n=33, 31Race, Asian, n=34, 41Race, Other, n=33, 31
DTG + 3TC-Double Blind Phase220.0238.5200.5225.9233.6208.7212.6237.1221.2226.0209.4246.4200.2
DTG + TDF/FTC-Double Blind Phase212.4235.5177.9220.7225.2211.2194.8226.8215.6219.7239.9197.2202.7

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Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age, Gender, and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 24

,
InterventionCells per cubic millimeter (Mean)
Baseline plasma HIV-1 RNA,<=100000, n=268,268Baseline plasma HIV-1 RNA,>100000, n=72,73Baseline CD4+ cell count,<=200, n=29,27Baseline CD4+ cell count,>200, n=311, 314Age, <35,n= 203,199Age, 35 to <50, n=109, 100Age, >=50, n=28, 42Female, n=57,50Male, n=283,291Race, White, n=236,235Race, African Am/African H., n=36,33Race, Asian, n=34, 41Race, Other, n=34,32
DTG + 3TC-Double Blind Phase187.72206.63157.01195.11202.76172.05188.79199.45190.21204.78143.84169.80174.30
DTG + TDF/FTC-Double Blind Phase167.93205.96120.17180.73177.62179.87159.34181.78175.05182.27170.51165.36149.34

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Changes From Baseline in CD4+ Cell Counts at Week 24 and 48

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is defined as the the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and Weeks 24, 48

,
InterventionCells per cubic millimeter (Mean)
Week 24, n=340,341Week 48, n=324,334
DTG + 3TC-Double Blind Phase192.2222.2
DTG + TDF/FTC-Double Blind Phase175.1217.7

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Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 144

,
InterventionCells per cubic millimeter (Mean)
Baseline plasma HIV-1 RNA,<=100000, n=214,223Baseline plasma HIV-1 RNA,>100000, n=56, 64Baseline CD4+ cell count,<=200, n=17, 24Baseline CD4+ cell count,>200, n=253, 263Age group, <35,n=155, 167Age group-1, 35 to <50, n=92, 87Age group-1, >=50, n=23,33Female, n=43, 43Male, n=227, 244Race group, White, n=190,201Race group, African Am/African H., n=26, 26Race group, Asian, n=26, 34Race group, Other, n=28,26
DTG + 3TC - Double-blind Phase + Open-label Phase295.7334.3290.2304.7298.0305.6337.4346.6295.9314.2243.8244.0346.2
DTG + TDF/FTC - Double-blind Phase + Open-label Phase296.1329.6272.9306.2316.0302.1242.2321.7300.0314.0295.1264.1279.9

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Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96

Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI and Serum or Plasma GFR from creatinine adjusted for BSA using CKD-EPI. Baseline value is the latest pre-dose Assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96

,
InterventionMilliliter/minute/1.73*meter^2 (Mean)
GFR Cystatin C adjusted, Week 96GFR creatinine adjusted, Week 96
DTG + 3TC-Double Blind Phase11.3-15.3
DTG + TDF/FTC-Double Blind Phase9.3-19.0

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Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144

Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI and Serum or Plasma GFR from creatinine adjusted for BSA using CKD-EPI. Baseline value is the latest pre-dose Assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144

,
InterventionMilliliter/minute/1.73*meter^2 (Mean)
GFR Cystatin C adjusted, Week 144, n=283,298GFR creatinine adjusted, Week 144, n=271, 289
DTG + 3TC - Double-blind Phase + Open-label Phase13.0-16.7
DTG + TDF/FTC - Double-blind Phase + Open-label Phase12.1-19.3

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Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48

Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI (GFR-cystatin C adjusted)and Serum or Plasma GFR from creatinine adjusted using CKD-EPI. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48

,
InterventionMilliliter/minute/1.73*meter^2 (Mean)
GFR-cystatin C adjusted, Week 24, n=338, 336GFR-cystatin C adjusted, Week 48, n=324, 332GFR-creatinine adjusted, Week 24, n=340, 341GFR-creatinine adjusted, Week 48, n=326,335
DTG + 3TC-Double Blind Phase4.47.0-13.5-12.1
DTG + TDF/FTC-Double Blind Phase2.24.1-16.7-15.6

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Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48

Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Serum Cystatin C and Serum Retinol Binding Protein (RBP). Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48

,
InterventionMilligrams per Liter (mg/L) (Mean)
Serum Cystatin C, Week 24, n=338, 336Serum Cystatin C, Week 48, n=324, 332Serum RBP, Week 24, n=332, 334Serum RBP, Week 48, n=322, 332
DTG + 3TC-Double Blind Phase-0.05-0.071.60.5
DTG + TDF/FTC-Double Blind Phase-0.03-0.041.90.6

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Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48

Blood and/or urine were collected to perform evaluation of renal inflammation biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48

,
InterventionMicromoles per Liter (umol/L) (Mean)
Serum or Plasma Creatinine, Week 24, n=340, 343Serum or Plasma Creatinine, Week 48, n=326, 335
DTG + 3TC-Double Blind Phase11.8810.39
DTG + TDF/FTC-Double Blind Phase15.0713.61

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Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96

Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96

,
InterventionMillimoles per liter (Mean)
Serum or Plasma Cholesterol, Week 96HDL Cholesterol, Direct, Week 96LDL Cholesterol, Week 96,Triglycerides, Week 96,
DTG + 3TC-Double Blind Phase0.3790.1990.1470.129
DTG + TDF/FTC-Double Blind Phase-0.1040.090-0.154-0.112

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Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144

Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144

,
InterventionMillimoles per liter (Mean)
Serum or Plasma Cholesterol, Week 144,HDL Cholesterol, Direct, Week 144LDL Cholesterol, Week 144,Triglycerides, Week 144
DTG + 3TC - Double-blind Phase + Open-label Phase0.3670.1810.1700.117
DTG + TDF/FTC - Double-blind Phase + Open-label Phase-0.0370.098-0.105-0.104

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Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48

EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Baseline was the latest pre-dose assessment (Day 1) and change from Baseline=post-dose value minus Baseline value. (NCT02831673)
Timeframe: Baseline (Day 1) and Weeks 4, 24, 48

,
InterventionScores on a scale (Mean)
Week 4, n=349, 348Week 24, n=352, 351Week 48, n=352, 351
DTG + 3TC-Double Blind Phase0.01300.01310.0134
DTG + TDF/FTC-Double Blind Phase0.00780.01680.0129

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Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24 48

EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value. (NCT02831673)
Timeframe: Baseline (Day 1) and Weeks 4, 24, 48

,
InterventionScores on a scale (Mean)
Week 4, n=349, 348Week 24, n=352, 350Week 48, n=352, 350
DTG + 3TC-Double Blind Phase2.33.74.3
DTG + TDF/FTC-Double Blind Phase1.23.22.8

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Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96

Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96

,
InterventionMicrograms per Liter (ug/L) (Mean)
Bone-ALP, Week 96, n=296, 317Serum Osteocalcin, Week 96, n=297, 320PINP, Week 96, n=297, 319CTX-1, Week 96, n=297, 315
DTG + 3TC-Double Blind Phase0.300.4015.00.1351
DTG + TDF/FTC-Double Blind Phase2.374.5728.30.2943

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Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144

Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144

,
InterventionMicrograms per Liter (ug/L) (Mean)
Bone-ALP, Week 144, n=281, 295Serum Osteocalcin, Week 144, n=281, 299PINP, Week 144, n=281,299CTX-1, Week 144, n=281, 296
DTG + 3TC - Double-blind Phase + Open-label Phase-0.250.294.60.0750
DTG + TDF/FTC - Double-blind Phase + Open-label Phase1.433.2113.80.2164

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Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48

Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48

,
InterventionMicrograms per Liter (ug/L) (Mean)
Bone-ALP, Week 24, n=334, 332Bone-ALP, Week 48, n=321, 331Serum Osteocalcin, Week 24, n=335, 334Serum Osteocalcin, Week 48, n=322, 330PINP, Week 24, n=337, 336PINP, Week 48, n=321, 334CTX-1, Week 24, n=337, 334CTX-1, Week 48, n=323, 331
DTG + 3TC-Double Blind Phase0.911.212.560.784.50.50.11920.1338
DTG + TDF/FTC-Double Blind Phase3.133.796.746.0118.313.10.28200.3352

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Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48

Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48

,
InterventionNanomoles per Liter (nmol/L) (Mean)
Serum Vitamin D, Week 24, n=337, 337Serum Vitamin D, Week 48, n=322, 333
DTG + 3TC-Double Blind Phase5.9-3.1
DTG + TDF/FTC-Double Blind Phase12.43.1

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CD4+ Cell Counts at Weeks 24 and 48

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. (NCT02831673)
Timeframe: Weeks 24 and 48

,
InterventionCells per cubic millimeter (cells/mm^3) (Mean)
Week 24, n=340,341Week 48, n=324,334
DTG + 3TC Double Blind Phase655.3687.7
DTG + TDF/FTC-Double Blind Phase632.8675.3

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Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144

Time of viral suppression is defined as the first viral load value <50 c/mL. Nonparametric Kaplan-Meier method was performed. Participants who withdrew for any reason without being suppressed were censored at date of withdrawal. Participants who have not been withdrawn and have not had viral suppression at time of the analysis were censored at last viral load date. Confidence Interval (CI) was estimated using the Brookmeyer-Crowley method. (NCT02831673)
Timeframe: Up to Week 144

InterventionDays (Median)
DTG + 3TC - Double-blind Phase + Open-label Phase29.0
DTG + TDF/FTC - Double-blind Phase + Open-label Phase29.0

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Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48

Percentage of participants with HIV-1 RNA<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights. Intent-To-Treat Exposed (ITT-E) Population was used which comprised of all randomized participants who received at least one dose of study treatment. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 48

InterventionPercentage of participants (Number)
DTG + 3TC-Double Blind Phase90
DTG + TDF/FTC-Double Blind Phase93

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Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96

Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel weights. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 96

InterventionPercentage of participants (Number)
DTG + 3TC-Double Blind Phase84
DTG + TDF/FTC-Double Blind Phase89

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Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24

Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel weights. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 24

InterventionPercentage of participants (Number)
DTG + 3TC-Double Blind Phase92
DTG + TDF/FTC-Double Blind Phase93

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Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144

Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 144

InterventionPercentage of participants (Number)
DTG + 3TC - Double-blind Phase + Open-label Phase79
DTG + TDF/FTC - Double-blind Phase + Open-label Phase83

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Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 96

Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Week 96 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 96 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 96

InterventionPercentage of participants (Number)
DTG + 3TC-Double Blind Phase5
DTG + TDF/FTC-Double Blind Phase4

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Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 144

Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Week 144 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 144 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 144

InterventionPercentage of participants (Number)
DTG + 3TC - Double-blind Phase + Open-label Phase5
DTG + TDF/FTC - Double-blind Phase + Open-label Phase4

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Changes From Baseline in CD4+ Cell Counts at Week 96

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 96

InterventionCells per cubic millimeter (Mean)
DTG + 3TC - Double-blind Phase264.7
DTG + TDF/FTC-Double Blind Phase253.8

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Changes From Baseline in CD4+ Cell Counts at Week 144

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 144

InterventionCells per cubic millimeter (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase301.8
DTG + TDF/FTC - Double-blind Phase + Open-label Phase303.2

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Change From Baseline in Renal Biomarker-Serum RBP at Week 96

Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum RBP. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96

InterventionMicrogram per millimoles (ug/mmol) (Mean)
DTG + 3TC-Double Blind Phase1.535
DTG + TDF/FTC-Double Blind Phase7.704

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Change From Baseline in Renal Biomarker-Serum RBP at Week 144

Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum RBP. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144

InterventionMicrogram per millimoles (ug/mmol) (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase1.760
DTG + TDF/FTC - Double-blind Phase + Open-label Phase8.855

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Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96

Blood and/or urine were collected to perform evaluation of renal inflammation biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96

InterventionMicromoles per Liter (umol/L) (Mean)
DTG + 3TC-Double Blind Phase12.75
DTG + TDF/FTC-Double Blind Phase16.10

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Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144

Blood and/or urine were collected to perform evaluation of renal inflammation biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144

InterventionMicromoles per Liter (umol/L) (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase12.89
DTG + TDF/FTC - Double-blind Phase + Open-label Phase15.87

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Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96

Blood samples were collected to perform evaluation of renal inflammation biomarkers which included Serum Cystatin C . Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96

InterventionMilligrams per Liter (mg/L) (Mean)
DTG + 3TC-Double Blind Phase-0.11
DTG + TDF/FTC-Double Blind Phase-0.09

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Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144

Blood samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Adjusted mean and standard error is presented. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144

InterventionMilligrams per Liter (mg/L) (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase-0.12
DTG + TDF/FTC - Double-blind Phase + Open-label Phase-0.11

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Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144

Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers: Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine. Baseline value was the latest pre-dose assessment. Change from Baseline was performed on log-transformed data. Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Biomarkers were Adjusted for treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, loge transformed Baseline biomarker value, treatment and visit interaction, and loge transformed Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Week 144

,
InterventionRatio (Geometric Mean)
Urine Albumin/Creatinine, Week 144, n=230, 221Urine B2M/Urine Creatinine, Week 144, n=108, 93Urine Phosphate, Week 144, n=301, 301Urine Protein/Creatinine, Week 144, n=236, 246Urine RBP 4/Urine Creatinine, Week 144, n=294, 289
DTG + 3TC - Double-blind Phase + Open-label Phase1.0360.8721.0830.9991.159
DTG + TDF/FTC - Double-blind Phase + Open-label Phase1.0671.4941.0841.1801.567

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Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96

Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers: Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine. Baseline value was the latest pre-dose assessment. Change from Baseline was performed on log-transformed data. Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Biomarkers were Adjusted for treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, loge transformed Baseline biomarker value, treatment and visit interaction, and loge transformed Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and Week 96

,
InterventionRatio (Geometric Mean)
Urine Albumin/Creatinine, Week 96, n=239, 243Urine B2M/Urine Creatinine, Week 96, n=101, 96Urine Phosphate, Week 96, n=316, 322Urine Protein/Creatinine, Week 96, n=251, 261Urine RBP 4/Urine Creatinine, Week 96, n=314, 318
DTG + 3TC - Double-blind Phase0.9390.8441.1560.8871.030
DTG + TDF/FTC - Double-blind Phase0.9971.2591.0691.0161.287

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Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48

Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers: Urine and Serum B2M, Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value was the latest pre-dose assessment. Change from Baseline was performed on log-transformed data. Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Geometric mean ratio and 95% CI of geometric mean ratio have been presented. Biomarkers were Adjusted for treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, loge transformed Baseline biomarker value, treatment and visit interaction, and loge transformed Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and Weeks 24, 48

,
InterventionRatio (Geometric Mean)
Serum B2M, Week 24, n=344,346Serum B2M, Week 48, n=335,336Urine B2M, Week 24, n=124,106Urine B2M, Week 48, n=109, 103Urine Albumin/Creatinine, Week 24, n=259, 251Urine Albumin/Creatinine , Week 48, n=249, 240Urine B2M/Urine Creatinine , Week 24, n=122, 104Urine B2M/Urine Creatinine , Week 48, n=108, 103Urine Phosphate, Week 24, n=343, 340Urine Phosphate, Week 48, n=335, 332Urine Protein/Creatinine, Week 24, n=263,279Urine Protein/Creatinine , Week 48, n=259, 261Urine RBP 4, Week 24, n=340, 338Urine RBP 4, Week 48, n=333, 331Urine RBP 4/Urine Creatinine, Week 24, n=338, 335Urine RBP 4/Urine Creatinine, Week 48, n=331, 328
DTG + 3TC - Double-blind Phase0.8090.8110.8440.9170.9070.9110.8800.9691.0411.1210.8180.8660.6560.7400.6700.749
DTG + TDF/FTC - Double-blind Phase0.8820.8871.1291.3231.0210.9711.1261.3071.0631.0560.9911.0070.8240.8190.8110.844

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Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96

EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 96

InterventionScores on a scale (Mean)
DTG + 3TC - Double-blind Phase4.4
DTG + TDF/FTC - Double-blind Phase5.1

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CD4+ Cell Counts at Week 144

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. (NCT02831764)
Timeframe: Week 144

InterventionCells/mm^3 (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase763.8
DTG + TDF/FTC - Double-blind Phase + Open-label Phase770.4

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CD4+ Cell Counts at Week 96

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. (NCT02831764)
Timeframe: Week 96

InterventionCells/mm^3 (Mean)
DTG + 3TC - Double-blind Phase734.9
DTG + TDF/FTC - Double-blind Phase739.9

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Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144

Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. (NCT02831764)
Timeframe: Baseline and at Week 144

InterventionNanomoles per Liter (nmol/L) (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase1.1
DTG + TDF/FTC - Double-blind Phase + Open-label Phase1.4

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Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96

Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. (NCT02831764)
Timeframe: Baseline and at Week 96

InterventionNanomoles per Liter (nmol/L) (Mean)
DTG + 3TC - Double-blind Phase-1.7
DTG + TDF/FTC - Double-blind Phase1.3

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Change From Baseline in EQ-5D-5L Thermometer Scores at Week 144

EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 144

InterventionScores on a scale (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase4.8
DTG + TDF/FTC - Double-blind Phase + Open-label Phase4.5

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Change From Baseline in EQ-5D-5L Utility Score at Week 144

EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. MMRM was run on LOCF dataset. Baseline was the latest pre-dose assessment and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 144

InterventionScores on a scale (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase0.0210
DTG + TDF/FTC - Double-blind Phase + Open-label Phase0.0131

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Change From Baseline in EQ-5D-5L Utility Score at Week 96

EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. MMRM was run on LOCF dataset. Baseline was the latest pre-dose assessment and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 96

InterventionScores on a scale (Mean)
DTG + 3TC - Double-blind Phase0.0168
DTG + TDF/FTC - Double-blind Phase0.0171

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Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144

Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the latest pre-dose assessment (Day 1). Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and at Week 144

InterventionRatio (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase-0.245
DTG + TDF/FTC - Double-blind Phase + Open-label Phase-0.359

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Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 96

Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the latest pre-dose assessment (Day 1). Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and at Week 96

InterventionRatio (Mean)
DTG + 3TC - Double-blind Phase-0.113
DTG + TDF/FTC - Double-blind Phase-0.395

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Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144

Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline and at Week 144

Interventionmg/L (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase-0.11
DTG + TDF/FTC - Double-blind Phase + Open-label Phase-0.08

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Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96

Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline and at Week 96

Interventionmg/L (Mean)
DTG + 3TC - Double-blind Phase-0.09
DTG + TDF/FTC - Double-blind Phase-0.08

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Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144

Blood and samples were collected to perform evaluation of renal biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was calculated as value at the inidcated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Adjusted mean and standard error has been presented. (NCT02831764)
Timeframe: Baseline and at Week 144

InterventionMicromoles per Liter (umol/L) (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase12.28
DTG + TDF/FTC - Double-blind Phase + Open-label Phase15.14

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Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96

Blood and samples were collected to perform evaluation of renal biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was calculated as value at the inidcated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Adjusted mean and standard error has been presented. (NCT02831764)
Timeframe: Baseline and at Week 96

InterventionMicromoles per Liter (umol/L) (Mean)
DTG + 3TC - Double-blind Phase11.71
DTG + TDF/FTC - Double-blind Phase14.75

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Change From Baseline in Renal Biomarker-Serum RBP at Week 144

Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum RBP. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Week 144

InterventionMicrogram per millimoles (ug/mmol) (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase0.560
DTG + TDF/FTC - Double-blind Phase + Open-label Phase3.813

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Change From Baseline in Renal Biomarker-Serum RBP at Week 96

Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum RBP. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Week 96

InterventionMicrogram per millimoles (ug/mmol) (Mean)
DTG + 3TC - Double-blind Phase0.557
DTG + TDF/FTC - Double-blind Phase2.483

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Changes From Baseline in CD4+ Cell Counts at Week 144

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and Week 144

InterventionCells/mm^3 (Mean)
DTG + 3TC - Double-blind Phase + Open-label Phase301.7
DTG + TDF/FTC - Double-blind Phase + Open-label Phase296.6

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Changes From Baseline in CD4+ Cell Counts at Week 96

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and Week 96

InterventionCells/mm^3 (Mean)
DTG + 3TC - Double-blind Phase272.0
DTG + TDF/FTC - Double-blind Phase264.6

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Number of Participants Who Discontinue Treatment Due to AEs Over Week 144

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued treatment due to AEs have been reported. (NCT02831764)
Timeframe: Up to Week 144

InterventionParticipants (Count of Participants)
DTG + 3TC - Double-blind Phase + Open-label Phase13
DTG + TDF/FTC - Double-blind Phase + Open-label Phase16

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Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 144

Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Week 144 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 144 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded-off. (NCT02831764)
Timeframe: Week 144

InterventionPercentage of participants (Number)
DTG + 3TC - Double-blind Phase + Open-label Phase6
DTG + TDF/FTC - Double-blind Phase + Open-label Phase4

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Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 96

Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Week 96 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 96 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded-off. (NCT02831764)
Timeframe: Week 96

InterventionPercentage of participants (Number)
DTG + 3TC - Double-blind Phase6
DTG + TDF/FTC - Double-blind Phase2

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Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24

Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights. Percentage values are rounded off. (NCT02831764)
Timeframe: Week 24

InterventionPercentage of participants (Number)
DTG + 3TC - Double-blind Phase94
DTG + TDF/FTC - Double-blind Phase94

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Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96

Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights. Percentage values are rounded off. (NCT02831764)
Timeframe: Week 96

InterventionPercentage of participants (Number)
DTG + 3TC - Double-blind Phase88
DTG + TDF/FTC - Double-blind Phase90

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Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48

Percentage of participants with HIV-1 RNA<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights. Intent-To-Treat Exposed (ITT-E) Population was used which comprised of all randomized participants who received at least one dose of study treatment. Percentage values are rounded off. (NCT02831764)
Timeframe: Week 48

InterventionPercentage of participants (Number)
DTG + 3TC - Double-blind Phase93
DTG + TDF/FTC - Double-blind Phase94

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Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144

Time of viral suppression is defined as the first viral load value <50 c/mL. Nonparametric Kaplan-Meier method was performed. Participants who withdrew for any reason without being suppressed were censored at date of withdrawal. Participants who have not been withdrawn and have not had viral suppression at time of the analysis were censored at last viral load date. Confidence Interval (CI) was estimated using the Brookmeyer-Crowley method. (NCT02831764)
Timeframe: Up to Week 144

InterventionDays (Median)
DTG + 3TC - Double-blind Phase + Open-label Phase29.0
DTG + TDF/FTC - Double-blind Phase + Open-label Phase29.0

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CD4+ Cell Counts at Weeks 24 and 48

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. (NCT02831764)
Timeframe: Weeks 24 and 48

,
InterventionCells/mm^3 (Mean)
Week 24, n=349,345Week 48, n=337,340
DTG + 3TC - Double-blind Phase650.4688.1
DTG + TDF/FTC - Double-blind Phase633.0689.8

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Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48

Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. (NCT02831764)
Timeframe: Baseline and at Weeks 24, 48

,
InterventionNanomoles per Liter (nmol/L) (Least Squares Mean)
Serum Vitamin D, Week 24, n=346, 344Serum Vitamin D, Week 48, n=336, 335
DTG + 3TC - Double-blind Phase11.20.3
DTG + TDF/FTC - Double-blind Phase15.40.4

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Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48

Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. (NCT02831764)
Timeframe: Baseline (Day 1) and at Weeks 24, 48

,
InterventionMicrograms per Liter (ug/L) (Mean)
Bone-ALP, Week 24, n=345, 346Bone-ALP, Week 48, n=334, 337Serum Osteocalcin, Week 24, n=345, 346Serum Osteocalcin, Week 48, n=335, 336PINP, Week 24, n=344, 346PINP, Week 48, n=335, 337CTX-1, Week 24, n=342, 342CTX-1, Week 48, n=332, 333
DTG + 3TC - Double-blind Phase0.721.242.130.401.70.40.15410.1345
DTG + TDF/FTC - Double-blind Phase3.384.336.806.3015.213.30.28120.3388

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Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144

Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type CTX-1. Adjusted mean is the estimated mean change from Baseline in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and at Week 144

,
InterventionMicrograms per Liter (ug/L) (Mean)
Bone-ALP, Week 144, n=302, 305Serum Osteocalcin, Week 144, n=300, 304PINP, Week 144, n=299, 300CTX-1, Week 144, n=291, 298
DTG + 3TC - Double-blind Phase + Open-label Phase-0.25-1.02-0.10.0505
DTG + TDF/FTC - Double-blind Phase + Open-label Phase1.882.879.40.1868

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Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96

Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type CTX-1. Adjusted mean is the estimated mean change from Baseline in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and at Week 96

,
InterventionMicrograms per Liter (ug/L) (Mean)
Bone-ALP, Week 96, n=315, 326Serum Osteocalcin, Week 96, n=315, 326PINP, Week 96, n=315, 325CTX-1, Week 96, n=311, 318
DTG + 3TC - Double-blind Phase0.260.137.00.0604
DTG + TDF/FTC - Double-blind Phase2.393.9019.50.1787

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Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144

Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and at Week 144

,
InterventionMillimoles per liter (Mean)
Serum or Plasma Cholesterol, Week 144, n=263, 278HDL Cholesterol, Direct, Week 144, n=264, 278LDL Cholesterol, Week 144, n=263, 278Triglycerides, Week 144, n=264, 278
DTG + 3TC - Double-blind Phase + Open-label Phase0.3600.1800.1430.078
DTG + TDF/FTC - Double-blind Phase + Open-label Phase-0.0150.093-0.085-0.057

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Change From Baseline in European Quality of Life [EuroQoL] - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48

EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. MMRM was run on LOCF dataset. Baseline was the latest pre-dose assessment and change from Baseline=post-dose value minus Baseline value. (NCT02831764)
Timeframe: Baseline (Day 1) and Weeks 4, 24, 48

,
InterventionScores on a scale (Least Squares Mean)
Week 4, n=359, 355Week 24, n=360, 358Week 48, n=360, 358
DTG + 3TC - Double-blind Phase0.01110.02070.0189
DTG + TDF/FTC - Double-blind Phase0.01300.02030.0208

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Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24, 48

EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value and change from Baseline=post-dose value minus Baseline value. (NCT02831764)
Timeframe: Baseline (Day 1) and Weeks 4, 24, 48

,
InterventionScores on a scale (Least Squares Mean)
Week 4, n=358, 355Week 24, n=359, 358Week 48, n=359, 358
DTG + 3TC - Double-blind Phase1.83.94.0
DTG + TDF/FTC - Double-blind Phase3.14.54.6

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Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96

Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and at Week 96

,
InterventionMillimoles per liter (Mean)
Serum or Plasma Cholesterol, Week 96, n=270, 289HDL Cholesterol, Direct, Week 96, n=271, 289LDL Cholesterol, Week 96, n=270, 289Triglycerides, Week 96, n=271, 289
DTG + 3TC - Double-blind Phase0.3450.1850.1390.105
DTG + TDF/FTC - Double-blind Phase-0.1320.071-0.160-0.102

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Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48

Blood and samples were collected to perform evaluation of renal biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was calculated as value at the inidcated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Weeks 24, 48

,
InterventionMicromoles per Liter (umol/L) (Mean)
Serum or Plasma Creatinine, Week 24, n=346, 344Serum or Plasma Creatinine, Week 48, n=335, 337
DTG + 3TC - Double-blind Phase10.5110.32
DTG + TDF/FTC - Double-blind Phase13.5313.44

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Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48

Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C and Serum RBP. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Weeks 24, 48

,
InterventionMilligrams per Liter (mg/L) (Least Squares Mean)
Serum Cystatin C, Week 24, n=345,345Serum Cystatin C, Week 48, n=335,336Serum RBP, Week 24, n=345,343Serum RBP, Week 48, n=334, 334
DTG + 3TC - Double-blind Phase-0.04-0.051.20.6
DTG + TDF/FTC - Double-blind Phase0.00-0.041.4-0.1

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Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48

Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI (GFR-cystatin C adjusted) and Serum or Plasma GFR from creatinine adjusted using CKD-EPI. Baseline value is the latest pre-dose Assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Weeks 24, 48

,
InterventionMilliliter/minute/1.73 meter^2 (Mean)
GFR Cystatin C adjusted, Week 24, n=345,345GFR Cystatin C adjusted, Week 48, n=335,336GFR creatinine adjusted, Week 24, n=346,344GFR creatinine adjusted, Week 48, n=335, 337
DTG + 3TC - Double-blind Phase3.85.4-12.0-12.1
DTG + TDF/FTC - Double-blind Phase0.23.6-15.4-15.4

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Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144

Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI and Serum or Plasma GFR from creatinine adjusted for BSA using CKD-EPI. Baseline value is the latest pre-dose Assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Week 144

,
InterventionMilliliter/minute/1.73 meter^2 (Mean)
GFR Cystatin C adjusted, Week 144, n=301,304GFR creatinine adjusted, Week 144, n=292,292
DTG + 3TC - Double-blind Phase + Open-label Phase10.3-15.5
DTG + TDF/FTC - Double-blind Phase + Open-label Phase10.1-18.2

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Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96

Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI and Serum or Plasma GFR from creatinine adjusted for BSA using CKD-EPI. Baseline value is the latest pre-dose Assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Week 96

,
InterventionMilliliter/minute/1.73 meter^2 (Mean)
GFR Cystatin C adjusted, Week 96, n=316,326GFR creatinine adjusted, Week 96, n=315,325
DTG + 3TC - Double-blind Phase9.1-14.2
DTG + TDF/FTC - Double-blind Phase9.5-17.5

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Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 144

,
InterventionCells/mm^3 (Mean)
Baseline plasma HIV-1 RNA,<=100000, n=241,234Baseline plasma HIV-1 RNA,>100000, n=55,58Baseline CD4+ cell count,<=200, n=25, 19Baseline CD4+ cell count,>200, n=271, 273Age group, <35,n=171, 159Age group-1, 35 to <50, n=95, 103Age group-1, >=50, n=30, 30Female, n=40, 37Male, n=256, 255Race group, White, n=202, 211Race group, African Am/African H., n=34, 24Race group, Asian, n=29, 25Race group, Other, n=31, 32
DTG + 3TC - Double-blind Phase + Open-label Phase286.8338.2264.8300.3302.9292.8274.1355.0287.7300.0256.4258.5355.0
DTG + TDF/FTC - Double-blind Phase + Open-label Phase277.8354.7208.9297.9277.1329.2250.0381.8279.6296.5377.6245.4240.7

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Changes From Baseline in CD4+ Cell Counts at Week 24 and 48

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted least mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and Weeks 24, 48

,
InterventionCells/mm^3 (Least Squares Mean)
Week 24, n=349, 345Week 48, n=337, 340
DTG + 3TC - Double-blind Phase188.8225.7
DTG + TDF/FTC - Double-blind Phase163.2217.2

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Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 24

,
InterventionCells/mm^3 (Mean)
Baseline plasma HIV-1 RNA,<=100000, n=283,273Baseline plasma HIV-1 RNA,>100000, n=66,72Baseline CD4+ cell count,<=200, n=29, 26Baseline CD4+ cell count,>200, n=320, 319Age group, <35,n= 201, 193Age group-1, 35 to <50, n=113, 119Age group-1, >=50, n=35, 33Female, n=52, 42Male, n=297, 303Race group, White, n=236, 243Race group, African Am/African H., n=48, 34Race group, Asian, n=33, 28Race group, Other, n=32, 40
DTG + 3TC - Double-blind Phase186.01193.90167.95189.91190.12180.50198.74213.58183.41186.48195.18154.03222.21
DTG + TDF/FTC - Double-blind Phase148.21220.71106.23167.35151.13190.40133.21153.92164.18167.44151.93141.24160.20

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Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from Analysis of Covariance (ANCOVA) model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 48

,
InterventionCells/mm^3 (Least Squares Mean)
Baseline plasma HIV-1 RNA,<=100000, n=273,271Baseline plasma HIV-1 RNA,>100000, n=64,69Baseline CD4+ cell count,<=200, n=28, 25Baseline CD4+ cell count,>200, n=309, 315Age group-1, <35,n= 193, 191Age group-1, 35 to <50, n=112, 117Age group-1, >=50, n=32, 32Age group-2, <50,n= 305, 308Age group-2, >=50, n= 32, 32Female, n=48, 41Male, n=289, 299Race group, White, n=230, 244Race group, African Am/African H., n=42, 31Race group, Asian, n=33, 27Race group, Other, n=32, 38
DTG + 3TC - Double-blind Phase215.6261.8210.9225.8234.2212.7209.1226.4208.5236.2222.8225.5201.2204.9270.2
DTG + TDF/FTC - Double-blind Phase208.7248.7153.2221.7201.7244.2203.9217.8204.1263.6210.0214.2239.0189.3232.6

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Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 96

,
InterventionCells/mm^3 (Mean)
Baseline plasma HIV-1 RNA,<=100000, n=259,260Baseline plasma HIV-1 RNA,>100000, n=59,67Baseline CD4+ cell count,<=200, n=25, 23Baseline CD4+ cell count,>200, n=293, 304Age group-1, <35,n= 186, 187Age group-1, 35 to <50, n=101, 110Age group-1, >=50, n=31, 30Female, n=44, 40Male, n=274, 287Race group, White, n=221, 234Race group, African Am/African H., n=35, 30Race group, Asian, n=31, 27Race group, Other, n=31, 36
DTG + 3TC - Double-blind Phase257.9312.1229.4272.3266.0273.6265.8312.7261.4272.1246.3224.0312.0
DTG + TDF/FTC - Double-blind Phase257.5297.4202.9269.4257.7286.8233.1307.6259.3258.3303.7264.0278.9

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Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued treatment due to AEs have been reported. (NCT02831764)
Timeframe: Up to Weeks 24, 48 and 96

,
InterventionParticipants (Count of Participants)
Week 24Week 48Week 96
DTG + 3TC - Double-blind Phase6810
DTG + TDF/FTC - Double-blind Phase4812

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Number of Participants With AEs by Maximum Severity Grades up to Week 148

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented. (NCT02831764)
Timeframe: Up to Week 148

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InterventionParticipants (Count of Participants)
Grade 1 AEsGrade 2 AEsGrade 3 AEsGrade 4 AEsGrade 5 AEs
DTG + 3TC - Double-blind Phase + Open-label Phase542113272
DTG + TDF/FTC - Double-blind Phase + Open-label Phase542054361

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Number of Participants With Any Adverse Event (AE) and Serious AE (SAE) up to Week 148

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or protocol-defined event associated with liver injury and impaired liver function were categorized as SAE. Safety Population was used which comprised of all participants who received at least one dose of study treatment. (NCT02831764)
Timeframe: Up to Week 148

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InterventionParticipants (Count of Participants)
Any AEAny SAE
DTG + 3TC - Double-blind Phase + Open-label Phase30639
DTG + TDF/FTC - Double-blind Phase + Open-label Phase30947

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Number of Participants With HIV-1 Disease Progression up to Week 144

HIV-associated conditions were recorded during the study and was assessed according to the 2014 Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. Disease progressions summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrolment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrolment to Death. Participants may have more than one indicators of clinical disease progression including death, hence they may contribute to data in more than one categories. (NCT02831764)
Timeframe: Up to Week 144

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InterventionParticipants (Count of Participants)
No disease progressionFrom CDC Stage 1 to CDC Stage 3 EventFrom CDC Stage 2 to CDC Stage 3 EventFrom CDC Stage 3 to New CDC Stage 3 EventFrom CDC Stage 1, 2 or 3 to Death
DTG + 3TC - Double-blind Phase + Open-label Phase3560212
DTG + TDF/FTC - Double-blind Phase + Open-label Phase3570101

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Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144

Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights. Percentage values are rounded off. (NCT02831764)
Timeframe: Week 144

InterventionPercentage of participants (Number)
DTG + 3TC - Double-blind Phase + Open-label Phase84
DTG + TDF/FTC - Double-blind Phase + Open-label Phase84

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Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144

Blood samples were collected up to Week 144 for assessment of Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate aminotransferase (AST), Bilirubin, Carbon dioxide (CO2), Cholesterol, Creatine kinase (CK), Creatinine, Direct Bilirubin, Glomerular filtration rate (GFR), Hypercalcemia, Hyperglycemia, Hyperkalemia, Hypernatremia, Hypocalcemia, Hypoglycemia, Hypokalemia, Hyponatremia, Low density lipid (LDL) Cholesterol, Lactate Dehydrogenase, Lipase, Phosphate, and Triglycerides. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent chemistry toxicities in any of the chemistry parameters have been presented. (NCT02831764)
Timeframe: Up to Week 144

,
InterventionParticipants (Count of Participants)
ALT, Grades 1 to 4ALT, Grades 2 to 4ALT, Grades 3 to 4ALT, Grade 1ALT, Grade 2ALT, Grade 3ALT, Grade 4Albumin, Grades 1 to 4Albumin, Grades 2 to 4Albumin, Grades 3 to 4Albumin, Grade 1Albumin, Grade 2Albumin, Grade 3Albumin, Grade 4ALP, Grades 1 to 4ALP, Grades 2 to 4ALP, Grades 3 to 4ALP, Grade 1ALP, Grade 2ALP, Grade 3ALP, Grade 4AST, Grades 1 to 4AST, Grades 2 to 4AST, Grades 3 to 4AST, Grade 1AST, Grade 2AST, Grade 3AST, Grade 4Bilirubin, Grades 1 to 4Bilirubin, Grades 2 to 4Bilirubin, Grades 3 to 4Bilirubin, Grade 1Bilirubin, Grade 2Bilirubin, Grade 3Bilirubin, Grade 4CO2, Grades 1 to 4CO2, Grades 2 to 4CO2, Grades 3 to 4CO2, Grade 1CO2, Grade 2CO2, Grade 3CO2, Grade 4Cholesterol, Grades 1 to 4Cholesterol, Grades 2 to 4Cholesterol, Grades 3 to 4Cholesterol, Grade 1Cholesterol, Grade 2Cholesterol, Grade 3Cholesterol, Grade 4CK, Grades 1 to 4CK, Grades 2 to 4CK, Grades 3 to 4CK, Grade 1CK, Grade 2CK, Grade 3CK, Grade 4Creatinine, Grades 1 to 4Creatinine, Grades 2 to 4Creatinine, Grades 3 to 4Creatinine, Grade 1Creatinine, Grade 2Creatinine, Grade 3Creatinine, Grade 4Direct Bilirubin, Grades 1 to 4Direct Bilirubin, Grades 2 to 4Direct Bilirubin, Grades 3 to 4Direct Bilirubin, Grade 1Direct Bilirubin, Grade 2Direct Bilirubin, Grade 3Direct Bilirubin, Grade 4GFR, Grades 1 to 4GFR, Grades 2 to 4GFR, Grades 3 to 4GFR, Grade 1GFR, Grade 2GFR, Grade 3GFR, Grade 4Hypercalcaemia, Grades 1 to 4Hypercalcaemia, Grades 2 to 4Hypercalcaemia, Grades 3 to 4Hypercalcemia, Grade 1Hypercalcaemia, Grade 2Hypercalcaemia, Grade 3Hypercalcaemia, Grade 4Hyperglycaemia, Grades 1 to 4Hyperglycaemia, Grades 2 to 4Hyperglycaemia, Grades 3 to 4Hyperglycaemia, Grade 1Hyperglycaemia, Grade 2Hyperglycaemia, Grade 3Hyperglycaemia, Grade 4Hyperkalemia, Grades 1 to 4Hyperkalemia, Grades 2 to 4Hyperkalemia, Grades 3 to 4Hyperkalemia, Grade 1Hyperkalemia, Grade 2Hyperkalemia, Grade 3Hyperkalemia, Grade 4Hypernatremia, Grades 1 to 4Hypernatremia, Grades 2 to 4Hypernatremia, Grades 3 to 4Hypernatremia, Grade 1Hypernatremia, Grade 2Hypernatremia, Grade 3Hypernatremia, Grade 4Hypocalcaemia, Grades 1 to 4Hypocalcaemia, Grades 2 to 4Hypocalcaemia, Grades 3 to 4Hypocalcaemia, Grade 1Hypocalcaemia, Grade 2Hypocalcaemia, Grade 3Hypocalcaemia, Grade 4Hypoglycaemia, Grades 1 to 4Hypoglycaemia, Grades 2 to 4Hypoglycaemia, Grades 3 to 4Hypoglycaemia, Grade 1Hypoglycaemia, Grade 2Hypoglycaemia, Grade 3Hypoglycaemia, Grade 4Hypokalemia, Grades 1 to 4Hypokalemia, Grades 2 to 4Hypokalemia, Grades 3 to 4Hypokalemia, Grade 1Hypokalemia, Grade 2Hypokalemia, Grade 3Hypokalemia, Grade 4Hyponatremia, Grades 1 to 4Hyponatremia, Grades 2 to 4Hyponatremia, Grades 3 to 4Hyponatremia, Grade 1Hyponatremia, Grade 2Hyponatremia, Grade 3Hyponatremia, Grade 4LDL Cholesterol, Grades 1 to 4LDL Cholesterol, Grades 2 to 4LDL Cholesterol, Grades 3 to 4LDL Cholesterol, Grade 1LDL Cholesterol, Grade 2LDL Cholesterol, Grade 3LDL Cholesterol, Grade 4Lactate Dehydrogenase, Grades 1 to 4Lactate Dehydrogenase, Grades 2 to 4Lactate Dehydrogenase, Grades 3 to 4Lactate Dehydrogenase, Grade 1Lactate Dehydrogenase, Grade 2Lactate Dehydrogenase, Grade 3Lactate Dehydrogenase, Grade 4Lipase, Grades 1 to 4Lipase, Grades 2 to 4Lipase, Grades 3 to 4Lipase, Grade 1Lipase, Grade 2Lipase, Grade 3Lipase, Grade 4Phosphate, Grades 1 to 4Phosphate, Grades 2 to 4Phosphate, Grades 3 to 4Phosphate, Grade 1Phosphate, Grade 2Phosphate, Grade 3Phosphate, Grade 4Triglycerides, Grades 1 to 4Triglycerides, Grades 2 to 4Triglycerides, Grades 3 to 4Triglycerides, Grade 1Triglycerides, Grade 2Triglycerides, Grade 3Triglycerides, Grade 4
DTG + 3TC - Double-blind Phase + Open-label Phase773013471767220020010208200713015411587461343390411110010110009823175221091492942201118185013500111111001101981982001782004004000106493574621721510141031001761115102264162319009000230023000662164515604301300723793528637550725437089224671840
DTG + TDF/FTC - Double-blind Phase + Open-label Phase712915421487111001017311421083321451181135616340132111140107400501203812008347283619111728212611010101000100219219290190281511400186383483521711601070070002111310821215116401510410022311920140132271120200200081431738261347851727447075151601410

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Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144

Blood samples were collected up to Week 144 for assessment of hemoglobin, leukocytes, neutrophils and platelet count. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the listed hematology parameters have been presented. (NCT02831764)
Timeframe: Up to Week 144

,
InterventionParticipants (Count of Participants)
Hemoglobin, Grades 1 to 4Hemoglobin, Grades 2 to 4Hemoglobin, Grades 3 to 4Hemoglobin, Grade 1Hemoglobin, Grade 2Hemoglobin, Grade 3Hemoglobin, Grade 4Leukocytes, Grades 1 to 4Leukocytes, Grades 2 to 4Leukocytes, Grades 3 to 4Leukocytes, Grade 1Leukocytes, Grade 2Leukocytes, Grade 3Leukocytes, Grade 4Neutrophils, Grades 1 to 4Neutrophils, Grades 2 to 4Neutrophils, Grades 3 to 4Neutrophils, Grade 1Neutrophils, Grade 2Neutrophils, Grade 3Neutrophils, Grade 4Platelets, Grades 1 to 4Platelets, Grades 2 to 4Platelets, Grades 3 to 4Platelets, Grade 1Platelets, Grade 2Platelets, Grade 3Platelets, Grade 4
DTG + 3TC - Double-blind Phase + Open-label Phase8622411510410023841542213508500
DTG + TDF/FTC - Double-blind Phase + Open-label Phase10614510500500073142109504500

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Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144

Number of participants, who met confirmed virologic withdrawal (CVW) criteria, with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI) and/or Nucleoside reverse transcriptase inhibitor (NRTI) was summarized. The Viral Genotypic Population comprised of all participants in the ITT-E population who have available on-treatment genotypic resistance data. (NCT02831764)
Timeframe: Up to Week 144

,
InterventionParticipants (Count of Participants)
INSTI MutationsMajor mutations of the NRTI
DTG + 3TC - Double-blind Phase + Open-label Phase00
DTG + TDF/FTC - Double-blind Phase + Open-label Phase00

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Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144

Number of participants, who met CVW criteria, with treatment emergent phenotypic resistance to INSTI and/or NRTI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results were interpreted through a proprietary algorithm (from Monogram Biosciences) and provides the overall susceptibility of the drugs (DTG, 3TC, Abacavir [ABC], elvitegravir [EGV], raltegravir [RAL], zidovudine [AZT], stavudine [D4T], didanosine [DDI]), emtricitabine [FTC], tenofovir disiproxil fumarate [TDF]). Partially sensitive and resistant cells were considered resistant in this analysis. The Viral Phenotypic Population comprised of all participants in the ITT-E population who have available on-treatment phenotypic resistance data. (NCT02831764)
Timeframe: Up to Week 144

,
InterventionParticipants (Count of Participants)
INSTI, DTG, Sensitive, n=7,2INSTI, DTG, Resistant, n=7,2INSTI, EGV, Sensitive, n=7,2INSTI, EGV, Resistant, n=7,2INSTI, RAL, Sensitive, n=7,2INSTI, RAL, Resistant, n=7,2NRTI, 3TC, Sensitive, n=7,3NRTI, 3TC, Resistant, n=7,3NRTI, ABC, Sensitive, n=7,3NRTI, ABC, Resistant, n=7,3NRTI, AZT, Sensitive, n=7,3NRTI, AZT, Resistant, n=7,3NRTI, D4T, Sensitive, n=7,3NRTI, D4T, Resistant, n=7,3NRTI, DDI, Sensitive, n=7,3NRTI, DDI, Resistant, n=7,3NRTI, FTC, Sensitive, n=7,3NRTI, FTC, Resistant, n=7,3NRTI, TDF, Sensitive, n=7,3NRTI, TDF, Resistant, n=7,3
DTG + 3TC - Double-blind Phase + Open-label Phase70707070707070707070
DTG + TDF/FTC - Double-blind Phase + Open-label Phase20202030303030303030

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Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48

Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by ([post-dose visit value minus Baseline value] divided by Baseline value). Lipid last observation carried forwarded (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Participants on lipid-lowering agents at Baseline were excluded. (NCT02831764)
Timeframe: Baseline (Day 1) and at Weeks 24, 48

,
InterventionPercentage change (Mean)
Total/HDL Cholesterol Ratio, Week 24, n=298, 310Total/HDL Cholesterol Ratio, Week 48, n=298, 307
DTG + 3TC - Double-blind Phase-4.4-2.8
DTG + TDF/FTC - Double-blind Phase-7.5-4.5

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Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48

Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value is defined as the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by ([post-dose visit value minus Baseline value] divided by Baseline value). (NCT02831764)
Timeframe: Baseline and at Weeks 24, 48

,
InterventionPercentage change (Mean)
Serum or Plasma Cholesterol, Week 24, n=298, 310Serum or Plasma Cholesterol, Week 48, n=298, 307HDL Cholesterol, Direct, Week 24, n=299, 310HDL Cholesterol, Direct, Week 48, n=299, 307LDL Cholesterol, Week 24, n=298, 309LDL Cholesterol, Week 48, n=297, 307Triglycerides,Week 24, n=299, 310Triglycerides, Week 48, n=299, 307
DTG + 3TC - Double-blind Phase5.09.313.915.33.810.77.07.3
DTG + TDF/FTC - Double-blind Phase-4.5-3.37.24.0-7.8-4.10.5-0.3

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Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144

Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded-off. (NCT02831764)
Timeframe: Week 144

,
InterventionPercentage of participants (Number)
Baseline CD4+ cell count, <=200,n=32, 26Baseline CD4+ cell count, >200,n=328,333Female, n=54, 46Male, n=306, 313Age, <35,n= 209, 203Age, 35 to <50,n=115, 122Age, >=50, n=36, 34Baseline plasma HIV-1 RNA, <=100000,n=294, 282Baseline plasma HIV-1 RNA, >100000,n=66, 77Race, White, n=240,252Race, African American/African H., n=51, 35Race, Asian, n=34, 30Race, Other, n=35, 42
DTG + 3TC - Double-blind Phase + Open-label Phase75857885838683848688658589
DTG + TDF/FTC - Double-blind Phase + Open-label Phase69868385838588858187748379

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Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48

Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3 for group-1), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded-off. (NCT02831764)
Timeframe: Week 48

,
InterventionPercentage of participants (Number)
Baseline CD4+ cell count Group-1, <=200,n=32, 26Baseline CD4+ cell count Group-1, >200,n=328,333Female, n=54, 46Male, n=306, 313Age, <35,n= 209,203Age, 35 to <50,n=115, 122Age, >=50, n=36, 34Baseline plasma HIV-1 RNA, <=100000,n=294,282Baseline plasma HIV-1 RNA, >100000,n=66, 77Race, White, n=240, 252Race, African American/African H., n=51, 35Race, Asian, n=34, 30Race, Other, n=35, 42
DTG + 3TC - Double-blind Phase78958994929789929796809786
DTG + TDF/FTC - Double-blind Phase96948795949494959096869090

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Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96

Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded-off. (NCT02831764)
Timeframe: Week 96

,
InterventionPercentage of participants (Number)
Baseline CD4+ cell count, <=200,n=32, 26Baseline CD4+ cell count, >200,n=328,333Female, n=54, 46Male, n=306, 313Age, <35,n= 209, 203Age, 35 to <50,n=115, 122Age, >=50, n=36, 34Baseline plasma HIV-1 RNA, <=100000,n=294, 282Baseline plasma HIV-1 RNA, >100000,n=66, 77Race, White, n=240,252Race, African American/African H., n=51, 35Race, Asian, n=34, 30Race, Other, n=35, 42
DTG + 3TC - Double-blind Phase72898189889083888692698889
DTG + TDF/FTC - Double-blind Phase85908590918988918491869083

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Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24

Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3 for group-1), Baseline HIV-1 RNA (<=100000, >100000 c/mL) and Race (White, African American/African heritage (H.), Asian other). Percentage values are rounded-off. (NCT02831764)
Timeframe: Week 24

,
InterventionPercentage of participants (Number)
Baseline CD4+ cell count Group-1, <=200,n=32,26Baseline CD4+ cell count Group-1, >200,n=328,333Female, n=54, 46Male, n=306, 313Age, <35,n= 209, 203Age, 35 to <50,n=115, 122Age, >=50, n=36, 34Baseline plasma HIV-1 RNA, <=100000,n=294,282Baseline plasma HIV-1 RNA, >100000,n=66, 77Race, White, n=240, 252Race, African American/African H., n=51, 35Race, Asian, n=34, 30Race, Other, n=35, 42
DTG + 3TC - Double-blind Phase78959394939694949295909789
DTG + TDF/FTC - Double-blind Phase92948995949491959095899093

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Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48

Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Weeks 24 and 48 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 48 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded-off. (NCT02831764)
Timeframe: Weeks 24 and 48

,
InterventionPercentage of participants (Number)
Week 24, n=313, 320Week 48, n=324, 332
DTG + 3TC - Double-blind Phase44
DTG + TDF/FTC - Double-blind Phase02

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Apparent Elimination Rate Constant (Lambda z) of DTG and 3TC in the Fasted State: Part 1

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionPer hour (Median)
DTG3TC
A: DTG 50 mg + EPIVIR 300 mg0.04720.0407
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC0.04700.0400

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Apparent Oral Clearance (CL/F) of DTG and 3TC in the Fasted State: Part 1

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionLiters per hour (Geometric Mean)
DTG3TC
A: DTG 50 mg + EPIVIR 300 mg1.158924.3236
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC0.911123.5104

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Apparent Oral Volume of Distribution (Vz/F) of DTG and 3TC in the Fasted State: Part 1

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionLiters (Geometric Mean)
DTG3TC
A: DTG 50 mg + EPIVIR 300 mg24.6254616.7365
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC19.3399598.8651

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Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity [AUC (0-Inf)] of Plasma DTG and 3TC in the Fasted State: Part 1

Blood samples were collected at indicated time points to study the pharmacokinetic (PK) profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHour*micrograms per milliliter (Geometric Mean)
DTG3TC
A: DTG 50 mg + EPIVIR 300 mg43.145612.3337
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC54.879312.7603

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Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Time Point (AUC[0-t]) of Plasma DTG and 3TC in the Fasted State: Part 1

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHours*micrograms per milliliter (Geometric Mean)
DTG3TC
A: DTG 50 mg + EPIVIR 300 mg41.420712.1571
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC52.875412.6147

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AUC (0-Inf) of Plasma DTG and 3TC in the Fasted State: Part 2

Blood samples were collected at given time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted conditions in Periods 1 and 2 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHours*micrograms per milliliter (Geometric Mean)
DTG, n= 74,743TC, n= 73,74
A: DTG 50 mg + EPIVIR 300 mg47.239112.7713
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC54.559413.5624

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AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 1

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHours*microgram per milliliter (Geometric Mean)
DTG3TC
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC62.343513.4357
Bfed: DTG 50 mg/3TC 300 mg Monolayer FDC Fed71.977712.8668

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AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 2

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHours*microgram per milliliter (Geometric Mean)
DTG3TC
C: DTG 50 mg and 3TC 300 mg Bilayer FDC57.656114.6420
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed76.428313.3443

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AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 1

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHour*microgram per milliliter (Geometric Mean)
DTG3TC
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC60.321213.2818
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed69.256012.6491

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AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 2

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHour*microgram per milliliter (Geometric Mean)
DTG3TC
C: DTG 50 mg and 3TC 300 mg Bilayer FDC55.217614.4706
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed72.754513.0923

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AUC of 0 to 24 Hours (AUC[0-24]) of DTG and 3TC in the Fasted State: Part 1

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHours*microgram per milliliter (Geometric Mean)
DTG3TC
A: DTG 50 mg + EPIVIR 300 mg29.425711.3960
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC37.611211.9418

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AUC(0-24) of DTG and 3TC in the Fasted State: Part 2

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHours*microgram per milliliter (Geometric Mean)
DTG3TC
A: DTG 50 mg + EPIVIR 300 mg31.566411.6419
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC36.612612.5810

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AUC(0-24) of DTG and 3TC in the Fed State: Part 1

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHour*microgram per milliliter (Geometric Mean)
DTG3TC
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC43.187912.6113
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed46.855511.8076

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AUC(0-24) of DTG and 3TC in the Fed State: Part 2

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHour*microgram per milliliter (Geometric Mean)
DTG3TC
C: DTG 50 mg and 3TC 300 mg Bilayer FDC38.632513.7012
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed48.201212.1065

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AUC(0-t) of Plasma DTG and 3TC in the Fasted State: Part 2

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHour*microgram/milliliter (Geometric Mean)
DTG3TC
A: DTG 50 mg + EPIVIR 300 mg45.204312.4790
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC52.337213.3552

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C24 of DTG and 3TC in the Fasted State: Part 2

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionMicrograms per milliliter (Geometric Mean)
DTG3TC
A: DTG 50 mg + EPIVIR 300 mg0.70650.0366
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC0.80710.0350

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C24 of DTG and 3TC in the Fed State: Part 1

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionMicrograms per milliliter (Geometric Mean)
DTG3TC
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC0.92160.0304
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed1.19160.0366

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C24 of DTG and 3TC in the Fed State: Part 2

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionMicrograms per milliliter (Geometric Mean)
DTG3TC
C: DTG 50 mg and 3TC 300 mg Bilayer FDC0.83550.0350
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed1.22730.0417

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Change From Baseline in Heart Rate (HR): Part 1 and 2

HR was measured in the supine or semi-supine position after 5 minutes rest. The Baseline value was considered to be the participant's last available assessment prior to time of the first dose. Change from Baseline was defined as post dose visit value minus Baseline value. Data for HR for Part 1 and 2 is presented. (NCT03078556)
Timeframe: Up to Day 31 in Part 1 and Part 2

,,,,,
InterventionBeats per minute (Mean)
4 hour,n=75,76,16,75,75,16Day 2,n=74,75,16,75,75,16Day 3,n=74,75,16,75,75,16Day 4,n=73,75,16,75,75,16
Part 1- A: DTG 50 mg + EPIVIR 300 mg0.62.25.17.5
Part 1- B: DTG 50 mg/ 3TC 300 mg Monolayer FDC0.41.96.08.9
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed4.92.95.89.6
Part 2- A: DTG 50 mg + EPIVIR 300 mg0.11.65.38.9
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC-0.30.63.86.1
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed3.01.67.79.5

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Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2

SBP and DBP were measured in the supine or semi-supine position after 5 minutes rest. The Baseline value was considered to be the participant's last available assessment prior to time of the first dose. Change from Baseline was defined as post dose visit value minus Baseline value. Data for SBP and DBP for Part 1 and 2 is presented. (NCT03078556)
Timeframe: Up to Day 31 in Part 1 and Part 2

,,,,,
InterventionMillimeters of mercury (Mean)
DBP,4 hour,n=75,76,16,75,75,16DBP,Day 2,n=74,75,16,75,75,16DBP,Day 3,n=74,75,16,75,75,16DBP,Day 4,n=73,75,16,75,75,16SBP,4 hour,n=75,76,16,75,75,16SBP,Day 2,n=74,75,16,75,75,16SBP,Day 3,n=74,75,16,75,75,16SBP,Day 4,n=73,75,16,75,75,16
Part 1- A: DTG 50 mg + EPIVIR 300 mg0.1-0.33.27.41.5-0.54.08.2
Part 1- B: DTG 50 mg/ 3TC 300 mg Monolayer FDC0.2-0.92.75.40.6-1.42.77.5
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed-2.10.41.36.1-0.80.42.97.0
Part 2- A: DTG 50 mg + EPIVIR 300 mg-0.5-1.71.74.90.0-1.51.97.0
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC-0.3-1.11.25.30.5-1.71.67.2
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed0.03.13.48.31.01.92.37.6

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CL/F of DTG and 3TC in the Fasted State: Part 2

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionLiters per hour (Geometric Mean)
DTG, n= 74, 743TC, n= 73, 74
A: DTG 50 mg + EPIVIR 300 mg1.058423.4901
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC0.916422.1200

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CL/F of DTG and 3TC in the Fed State: Part 1

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionLiters per hour (Geometric Mean)
DTG3TC
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC0.802022.3285
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed0.694723.3159

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CL/F of DTG and 3TC in the Fed State: Part 2

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionLiters per hour (Geometric Mean)
DTG3TC
C: DTG 50 mg and 3TC 300 mg Bilayer FDC0.867220.4890
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed0.654222.4815

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Clast of DTG and 3TC in in the Fed State: Part 1

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionMicrograms per milliliter (Median)
DTG3TC
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC0.10600.0048
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed0.11900.0066

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Clast of DTG and 3TC in in the Fed State: Part 2

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionMicrograms per milliliter (Median)
DTG3TC
C: DTG 50 mg and 3TC 300 mg Bilayer FDC0.09750.0059
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed0.13100.0091

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Clast of DTG and 3TC in the Fasted State: Part 2

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionMicrograms per milliliter (Geometric Mean)
DTG3TC
A: DTG 50 mg + EPIVIR 300 mg0.08000.0069
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC0.08620.0062

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Cmax of Plasma DTG and 3TC in the Fasted State: Part 2

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionMicrograms per milliliter (Geometric Mean)
DTG3TC
A: DTG 50 mg + EPIVIR 300 mg2.55312.4428
B: DTG 50 mg/ 3TC 300 mg Bilayer FDC2.91323.2185

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Cmax of Plasma DTG and 3TC in the Fed State: Part 1

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionMicrograms per milliliter (Geometric Mean)
DTG3TC
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC3.50683.5413
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed3.79002.5132

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Cmax of Plasma DTG and 3TC in the Fed State: Part 2

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionMicrograms per milliliter (Geometric Mean)
DTG3TC
C: DTG 50 mg and 3TC 300 mg Bilayer FDC3.10153.5824
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed3.75162.4453

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Concentration at 24 Hours Post-dose (C24) of DTG and 3TC in the Fasted State: Part 1

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionMicrograms per milliliter (Geometric Mean)
DTG3TC
A: DTG 50 mg + EPIVIR 300 mg0.63730.0331
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC0.80590.0318

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Lambda z of DTG and 3TC in in the Fasted State: Part 2

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionPer hour (Median)
DTG, n=74,743TC, n= 73,74
A: DTG 50 mg + EPIVIR 300 mg0.04570.0388
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC0.04690.0383

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Lambda z of DTG and 3TC in in the Fed State: Part 1

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionPer hour (Median)
DTG3TC
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC0.04750.0378
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed0.04750.0349

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Lambda z of DTG and 3TC in in the Fed State: Part 2

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionPer hour (Median)
DTG3TC
C: DTG 50 mg and 3TC 300 mg Bilayer FDC0.04630.0403
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed0.04570.0351

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Maximum Observed Concentration (Cmax) of Plasma DTG and 3TC in the Fasted State: Part 1

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionMicrograms per milliliter (Geometric Mean)
DTG3TC
A: DTG 50 mg + EPIVIR 300 mg2.40652.6650
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC3.08173.1885

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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Participants having any AE or SAE are presented. (NCT03078556)
Timeframe: Up to Week 11

,,,,,
InterventionParticipants (Count of Participants)
AEsSAEs
Part 1- A: DTG 50 mg + EPIVIR 300 mg140
Part 1- B: DTG 50 mg/ 3TC 300 mg Monolayer FDC180
Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed10
Part 2- A: DTG 50 mg + EPIVIR 300 mg150
Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC120
Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed10

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Percentage of Extrapolated AUC (0 to Inf) of DTG and 3TC in the Fasted State: Part 1

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionPercentage of AUC (Median)
DTG3TC
A: DTG 50 mg + EPIVIR 300 mg3.49671.0287
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC3.25820.9052

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Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 1

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionPercentage of AUC (Median)
DTG3TC
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC3.33050.8856
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed3.88701.4830

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Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 2

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionPercentage of AUC (Median)
DTG3TC
C: DTG 50 mg and 3TC 300 mg Bilayer FDC3.68351.0443
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed3.87901.7467

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Percentage of Extrapolated AUC(0 to Inf) of DTG and 3TC in the Fasted State: Part 2

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionPercentage of AUC (Median)
DTG, n= 74,743TC, n= 73,74
A: DTG 50 mg + EPIVIR 300 mg3.89231.2518
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC3.57731.1432

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t1/2 of DTG and 3TC in the Fasted State: Part 2

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2 (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHour (Median)
DTG, n= 74,743TC, n= 73,74
A: DTG 50 mg + EPIVIR 300 mg15.153817.8421
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC14.789318.1071

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T1/2 of DTG and 3TC in the Fed State: Part 1

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHour (Median)
DTG3TC
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC14.584318.3614
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed14.581619.8579

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T1/2 of DTG and 3TC in the Fed State: Part 2

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHour (Median)
DTG3TC
C: DTG 50 mg and 3TC 300 mg Bilayer FDC14.982817.2250
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed15.171819.7311

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Time of the Last Quantifiable Concentration (Tlast) of DTG and 3TC in the Fasted State: Part 1

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHour (Median)
DTG3TC
A: DTG 50 mg + EPIVIR 300 mg72.003171.9289
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC71.930371.9303

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Time to Reach Half the Maximum Plasma Concentration (t1/2) of DTG and 3TC in the Fasted State: Part 1

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHour (Median)
DTG3TC
A: DTG 50 mg + EPIVIR 300 mg14.691717.0395
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC14.755717.3436

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Time to Reach Maximum Plasma Concentration (Tmax) of DTG and 3TC in the Fasted State: Part 1

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHour (Median)
DTG3TC
A: DTG 50 mg + EPIVIR 300 mg2.00721.0047
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC2.00171.0008

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Tlag of DTG and 3TC in Fasted State: Part 2

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHour (Median)
DTG3TC
A: DTG 50 mg + EPIVIR 300 mg0.00000.0000
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC0.00000.0000

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Tlag of DTG and 3TC in Fed State: Part 1

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHour (Median)
DTG3TC
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC0.00000.0000
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed0.25220.0000

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Tlag of DTG and 3TC in Fed State: Part 2

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHour (Median)
DTG3TC
C: DTG 50 mg and 3TC 300 mg Bilayer FDC0.00000.0000
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed0.12530.0000

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Tlast of DTG and 3TC in the Fasted State: Part 2

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2 (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHour (Median)
DTG3TC
A: DTG 50 mg + EPIVIR 300 mg71.681371.7138
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC71.824371.8153

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Tlast of DTG and 3TC in the Fed State: Part 1

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHours (Median)
DTG3TC
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC71.826571.8265
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed71.975871.9758

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Tlast of DTG and 3TC in the Fed State: Part 2

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHours (Median)
DTG3TC
C: DTG 50 mg and 3TC 300 mg Bilayer FDC72.029272.0292
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed71.871171.8711

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Tmax of DTG and 3TC in the Fasted State: Part 2

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2 (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHour (Median)
DTG3TC
A: DTG 50 mg + EPIVIR 300 mg2.50081.0063
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC2.50041.0011

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Tmax of DTG and 3TC in the Fed State: Part 1

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHour (Median)
DTG3TC
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC1.50131.0001
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed5.00063.5003

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Tmax of DTG and 3TC in the Fed State: Part 2

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHour (Median)
DTG3TC
C: DTG 50 mg and 3TC 300 mg Bilayer FDC1.50071.0003
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed5.00192.7508

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Vz/F of DTG and 3TC in the Fasted State: Part 2

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionLiters (Geometric Mean)
DTG, n= 74, 743TC, n= 73, 74
A: DTG 50 mg + EPIVIR 300 mg23.1159650.7952
C: DTG 50 mg/ 3TC 300 mg Bilayer FDC19.8124599.5525

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Vz/F of DTG and 3TC in the Fed State: Part 1

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionLiters (Geometric Mean)
DTG3TC
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC16.7520593.2054
Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed14.4964643.0977

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Vz/F of DTG and 3TC in the Fed State: Part 2

Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionLiters (Geometric Mean)
DTG3TC
C: DTG 50 mg and 3TC 300 mg Bilayer FDC19.0954535.8125
Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed14.6215641.3744

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Last Quantifiable Concentration (Clast) of DTG and 3TC in the Fasted State: Part 1

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionMicrograms per milliliter (Geometric Mean)
DTG3TC
A: DTG 50 mg + EPIVIR 300 mg0.07020.0056
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC0.08320.0050

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Absorption Lag Time (Tlag) of DTG and 3TC in Fasted State: Part 1

Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. (NCT03078556)
Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose

,
InterventionHour (Median)
DTG3TC
A: DTG 50 mg + EPIVIR 300 mg0.00000.0000
B: DTG 50 mg/ 3TC 300 mg Monolayer FDC0.00000.0000

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Overall Response Rate

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan or MRI, complete response (CR) is the disappearance of all target lesions and partial response (PR) is a >/=30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. (NCT03144804)
Timeframe: 2 years

Interventionparticipants (Number)
Lamivudine0

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Progression Free Survival

Progression-Free Survival (PFS) is defined as the time from registration to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. (NCT03144804)
Timeframe: 2 years

Interventiondays (Median)
Lamivudine56

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The Time to Cessation of Mucosal ex Vivo Protection From HIV After Stopping ART at Steady State.

Time in days from stopping antiretroviral (Raltegravir 400mg +/-lamivudine) until ex vivo protection (against high or low viral titre of HIV-1BaL) was no longer observed. (NCT03205566)
Timeframe: 5 days post last dose

,
InterventionDays (Mean)
Time to cessation of rectal ex vivo protection from high HIV dose challenge post ART at steady stateTime to cessation of rectal ex vivo protection from low HIV dose challenge post ART at steady stateTime to cessation of vaginal ex vivo protection from high HIVdose challenge post ART at steady stateTime to cessation of vaginal ex vivo protection from low HIV dose challenge post ART at steady state
Raltegravir3.33NA45
Raltegravir LamivudineNANANANA

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The Time From First Dose of Drug to Maximum Mucosal ex Vivo Protection From HIV.

Time in days from first receipt of antiretroviral (Raltegravir 400mg +/-lamivudine) until maximal ex vivo protection (against high or low titre of HIV-1BaL) was observed. (NCT03205566)
Timeframe: Up to 7 days from first dose

InterventionDays (Mean)
Time from first dose of drug to maximum rectal ex vivo protection from low titer HIV infectionTime from first dose of drug to maximum rectal ex vivo protection from High titer HIV infectionTime from first dose of drug to maximum vaginal ex vivo protection from low titer HIV infection
Raltegravir Lamivudine2233.67

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The Time From First Dose of Drug to Maximum Mucosal ex Vivo Protection From HIV.

Time in days from first receipt of antiretroviral (Raltegravir 400mg +/-lamivudine) until maximal ex vivo protection (against high or low titre of HIV-1BaL) was observed. (NCT03205566)
Timeframe: Up to 7 days from first dose

InterventionDays (Mean)
Time from first dose of drug to maximum rectal ex vivo protection from high titer HIV infectionTime from first dose of drug to maximum rectal ex vivo protection from low titer HIV infectionTime from first dose of drug to maximum vaginal ex vivo protection from low titer HIV infection
Raltegravir322.673

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The Level of Raltegravir Alone or Raltegravir /Lamivudine Required in the Plasma, Vagina and Rectum for 100% ex Vivo Protection From HIV

"The level of Raltegravir alone or Raltegravir /lamivudine required in the plasma, vagina and rectum for 100% ex vivo protection from HIV .~High viral dose challenge: ex vivo challenge of tissue with 104 TCID50/mL HIV-1BaL Low viral dose challenge: ex vivo challenge of tissue with 102 TCID50/mL HIV-1BaL" (NCT03205566)
Timeframe: Through Study completion, an average of 55 days

,,
Interventionng/mL (Mean)
Plasma: High Dose Challenge in rectal tissuePlasma: Low viral dose challenge in rectal tissueRectal: high viral dose challenge in rectal tissueRectal: Low viral dose challenge in rectal tissuePlasma: high viral dose challenge in vaginal tissuPlasma: low viral dose challenge in vaginal tissuePlasma: high dose in vaginal tissuePlasma: low dose in vaginal tissue
Lamivudine During Combination Treatment265.10265.101722.021722.02266.40169.101557.801437.80
RaltegravirNA979.8NA729.36NA979.8NA607.60
Raltegravir During Combination Treatment669.90669.90862.35862.35828.60281.60648.24273.02

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Number of Adverse Events Based on PE, Blood Test and Event Reporting on Raltegravir Based PrEP, in HIV Negative Individuals

Subject safety and tolerability will be determined by physical examination, blood tests and adverse event reporting. FBC, U&E and LFTs will be carried out at baseline and thereafter as symptom directed. Adverse event review. If significant adverse events have been reported, these will be clinically followed in accordance to the instruction of the study physician. (NCT03205566)
Timeframe: Through Study completion, an average of 55 days

InterventionAdverse event (Number)
Arm A Raltegravir12
Arm B Raltegravir Lamivudine15

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Number of Participants Experiencing Adverse Events (AEs) up to Week 144

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. (NCT03272347)
Timeframe: Up to 144 weeks

InterventionParticipants (Count of Participants)
Islatravir 0.25 mg26
Islatravir 0.75 mg27
Islatravir 2.25 mg24
DOR/3TC/TDF27

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Number of Participants Discontinuing Study Drug Due to AEs up to Week 144

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. (NCT03272347)
Timeframe: Up to 144 weeks

InterventionParticipants (Count of Participants)
Islatravir 0.25 mg1
Islatravir 0.75 mg0
Islatravir 2.25 mg2
DOR/3TC/TDF1

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Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 48 Weeks After Starting Open-label Doravirine/Islatravir Regimen (Part 4)

Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure. The percentage of participants with HIV-1 RNA <50 copies in Part 4 are reported. (NCT03272347)
Timeframe: Up to Week 192

InterventionPercentage of participants (Number)
DOR/ISL Continued (Part 4)85.1
DOR/ISL Switch (Part 4)95.5

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Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 48 Weeks After 3TC and Placebo Are Discontinued From the Regimen

Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL, and missing values were counted as failure. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52. (NCT03272347)
Timeframe: Up to 48 weeks

InterventionPercentage of participants (Number)
Islatravir 0.25 mg62.1
Islatravir 0.75 mg56.7
Islatravir 2.25 mg59.3
DOR/3TC/TDF60.7

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Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen

Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL, and missing values were counted as failure. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52. (NCT03272347)
Timeframe: Up to 24 weeks after 3TC and Placebo are discontinued from the regimen (up to approximately 60 weeks after initiating treatment)

InterventionPercentage of participants (Number)
Islatravir 0.25 mg86.2
Islatravir 0.75 mg90.0
Islatravir 2.25 mg88.9
DOR/3TC/TDF96.4

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Change From Baseline in CD4+ T-cell Count at Week 192 (Part 4)

Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Week 144 value. The change from baseline in CD4+ T-cell count at Week 192 (Part 4) are reported. (NCT03272347)
Timeframe: Baseline and Week 192

Interventioncells/mm^3 (Mean)
DOR/ISL Continued (Part 4)3.8
DOR/ISL Switch (Part 4)-3.4

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Change From Baseline in CD4+ T-cell Count at Week 48

Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication. (NCT03272347)
Timeframe: Baseline and Week 48

Interventioncells/mm^3 (Mean)
Islatravir 0.25 mg182.0
Islatravir 0.75 mg183.0
Islatravir 2.25 mg100.7
DOR/3TC/TDF181.4

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Number of Participants Discontinuing Study Drug Due to AEs From Week 96 Through Study Duration

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. (NCT03272347)
Timeframe: Week 96 up to Week 192

InterventionParticipants (Count of Participants)
Islatravir 0.25 mg1
Islatravir 0.75 mg0
Islatravir 2.25 mg0
DOR/3TC/TDF0
DOR/ISL Continued0
DOR/ISL Switch0

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Change From Baseline in CD4+ T-cell Count at Week 96

Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication. (NCT03272347)
Timeframe: Baseline and Week 96

Interventioncells/mm^3 (Mean)
Islatravir 0.25 mg243.4
Islatravir 0.75 mg161.3
Islatravir 2.25 mg136.5
DOR/3TC/TDF268.9

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Change From Baseline in CD4+ T-cell Count at Week 144

Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication. (NCT03272347)
Timeframe: Baseline and Week 144

Interventioncells/mm^3 (Mean)
Islatravir 0.25 mg204.4
Islatravir 0.75 mg209.0
Islatravir 2.25 mg162.9
DOR/3TC/TDF270.0

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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 24

Blood samples were collected and plasma human immunodeficiency virus 1 (HIV-1) ribonucleic acid (RNA) were quantified using a real time polymerase chain reaction (PCR) assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure. (NCT03272347)
Timeframe: Week 24

InterventionPercentage of participants (Number)
Islatravir 0.25 mg93.1
Islatravir 0.75 mg100.0
Islatravir 2.25 mg90.3
DOR/3TC/TDF90.3

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Change From Baseline in Mature T-helper (CD4+ T)-Cell Count at Week 24

Blood samples were collected and cluster of differentiation (CD4)+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication. (NCT03272347)
Timeframe: Baseline and Week 24

Interventioncells/mm^3 (Mean)
Islatravir 0.25 mg220.5
Islatravir 0.75 mg192.8
Islatravir 2.25 mg142.9
DOR/3TC/TDF142.1

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Number of Participants Discontinuing Study Drug Due to AEs Through 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52. (NCT03272347)
Timeframe: Up to 24 weeks

InterventionParticipants (Count of Participants)
Islatravir 0.25 mg0
Islatravir 0.75 mg0
Islatravir 2.25 mg2
DOR/3TC/TDF1

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Number of Participants Discontinuing Study Drug Due to AEs During Open Label Doravirine/Islatravir Treatment After Week 144 up to Week 192 (Part 4)

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinued the study drug due to AEs in Part 4 are reported. (NCT03272347)
Timeframe: Week 144 up to Week 192

InterventionParticipants (Count of Participants)
DOR/ISL Continued (Part 4)0
DOR/ISL Switch (Part 4)0

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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48

Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure. (NCT03272347)
Timeframe: Week 48

InterventionPercentage of participants (Number)
Islatravir 0.25 mg89.7
Islatravir 0.75 mg90.0
Islatravir 2.25 mg77.4
DOR/3TC/TDF83.9

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Number of Participants Experiencing AEs Through 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52. (NCT03272347)
Timeframe: Up to 24 weeks

InterventionParticipants (Count of Participants)
Islatravir 0.25 mg18
Islatravir 0.75 mg20
Islatravir 2.25 mg14
DOR/3TC/TDF16

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Number of Participants Experiencing AEs From Week 96 Through Study Duration

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. (NCT03272347)
Timeframe: Week 96 up to Week 192

InterventionParticipants (Count of Participants)
Islatravir 0.25 mg12
Islatravir 0.75 mg19
Islatravir 2.25 mg11
DOR/3TC/TDF12
DOR/ISL Continued36
DOR/ISL Switch14

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Number of Participants Experiencing AEs During Open Label Doravirine/Islatravir Treatment After Week 144 up to Week 192 (Part 4)

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experienced AEs during Part 4 are reported. (NCT03272347)
Timeframe: Week 144 up to Week 192

InterventionParticipants (Count of Participants)
DOR/ISL Continued (Part 4)36
DOR/ISL Switch (Part 4)14

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Summary of Changes in CD4 Count From Baseline to Week 24 (Cohort 2)

The mean difference is calculated as CD4 count at Week 24 minus CD4 count at Day 0 with associated 95% Clopper-Pearson CI. (NCT03332095)
Timeframe: Measured at Day 0 and week 24.

Interventioncells/mm^3 (Mean)
Cohort 2: DOR/3TC/TDF84.8

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Summary of Changes in CD4 Count From Baseline to Week 48 (Cohort 2)

The mean differences is calculated as CD4 count at Week 48 minus CD4 count at Day 0 with associated 95% Clopper-Pearson CI. (NCT03332095)
Timeframe: Measured at Day 0 and week 48.

Interventioncells/mm^3 (Mean)
Cohort 2: DOR/3TC/TDF80.1

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Summary of Changes in CD4 Count From Baseline to Week 96 (Cohort 2)

The mean difference is calculated as CD4 count at Week 96 minus CD4 count at Day 0 with associated 95% Clopper-Pearson CI. (NCT03332095)
Timeframe: Measured at Day 0 and week 96.

Interventioncells/mm^3 (Mean)
Cohort 2: DOR/3TC/TDF42.5

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Summary of Changes in CD4% From Baseline to Week 24 (Cohort 2)

The mean difference is calculated as CD4% at Week 24 minus CD4% at Day 0 with associated 95% Clopper-Pearson CI. (NCT03332095)
Timeframe: Measured at Day 0 and week 24.

InterventionPercent of total lymphocytes (Mean)
Cohort 2: DOR/3TC/TDF-1.5

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Summary of Changes in CD4% From Baseline to Week 48 (Cohort 2)

The mean difference is calculated as CD4% at Week 48 minus CD4% at Day 0 with associated 95% Clopper-Pearson CI. (NCT03332095)
Timeframe: Measured at Day 0 and week 48.

InterventionPercent of total lymphocytes (Mean)
Cohort 2: DOR/3TC/TDF-0.4

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Summary of Changes in CD4% From Baseline to Week 96 (Cohort 2)

The mean difference is calculated as CD4% at Week 96 minus CD4% at the Day 0 with associated 95% Clopper-Pearson CI. (NCT03332095)
Timeframe: Measured at Day 0 and week 96.

InterventionPercent of total lymphocytes (Mean)
Cohort 2: DOR/3TC/TDF-0.5

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Summary of log10 Drop From Baseline to Week 24 in Plasma HIV-1 RNA (ART-naive Participants) (Cohort 2)

The differences between log10 HIV RNA at Week 24 minus at Day 0 are summarized. (NCT03332095)
Timeframe: Measured at Day 0 and week 24.

InterventionLog10 plasma HIV-1 RNA (Mean)
Cohort 2: DOR/3TC/TDF-2.6

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Summary of log10 Drop From Baseline to Week 48 in Plasma HIV-1 RNA (ART-naive Participants) (Cohort 2)

The differences between log10 HIV RNA at Week 48 minus at Day 0 are summarized. (NCT03332095)
Timeframe: Measured at Day 0 and week 48.

InterventionLog10 plasma HIV-1 RNA (Mean)
Cohort 2: DOR/3TC/TDF-2.1

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Summary of log10 Drop From Baseline to Week 96 in Plasma HIV-1 RNA (ART-naive Participants) (Cohort 2)

The differences between log10 HIV RNA at Week 96 minus at Day 0 are summarized. (NCT03332095)
Timeframe: Measured at Day 0 and week 96.

InterventionLog10 plasma HIV-1 RNA (Mean)
Cohort 2: DOR/3TC/TDF-4.3

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PK Parameter: C24hr of Tenofovir (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). C24hr was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.

Interventionng/mL (Geometric Mean)
Cohort 2: DOR/3TC/TDF50.2

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Percentage of Participants With Grade 5 Adverse Events (Death) Regardless of Relationship to Study Drug

Percentage and Clopper-Pearson 95% CI of participants with Grade 5 AEs (death) regardless of relationship to study drug. (NCT03332095)
Timeframe: Cohort 1: Measured from Day 0 through Week 2; Cohort 2: Measured from Day 0 through Week 24.

Interventionpercentage of participants (Number)
Cohort 1: DOR0
Cohort 2: DOR/3TC/TDF0

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Percentage of Participants With Plasma HIV-1 RNA Less Than 200 Copies/mL at Week 24 (Cohort 2)

Virologic responses were assessed at week 24 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >200 copies/mL; otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 24.

InterventionPercentage of participants (Number)
Cohort 2: DOR/3TC/TDF97.7

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Percentage of Participants With Grade 5 Adverse Events (Death) Regardless of Relationship to Study Drug (Cohort 2) Through End of Study

Percentage and Clopper-Pearson 95% CI of participants with Grade 5 adverse events (death). (NCT03332095)
Timeframe: Measured from Day 0 through Week 96.

Interventionpercentage of participants (Number)
Cohort 2: DOR/3TC/TDF0

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Percentage of Participants With Plasma HIV-1 RNA Less Than 200 Copies/mL at Week 48 (Cohort 2)

Virologic responses were assessed at week 48 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >200 copies/mL; otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 48.

InterventionPercentage of participants (Number)
Cohort 2: DOR/3TC/TDF97.7

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Percentage of Participants With Plasma HIV-1 RNA Less Than 200 Copies/mL at Week 96 (Cohort 2)

Virologic responses were assessed at week 96 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >200 copies/mL; otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 96.

InterventionPercentage of participants (Number)
Cohort 2: DOR/3TC/TDF92.9

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Percentage of Participants With Plasma HIV-1 RNA Less Than 40 Copies/mL at Week 24 (Cohort 2)

Virologic responses were assessed at week 24 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >40 copies/mL; Otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 24.

InterventionPercentage of participants (Number)
Cohort 2: DOR/3TC/TDF97.7

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Percentage of Participants With Plasma HIV-1 RNA Less Than 40 Copies/mL at Week 48 (Cohort 2)

Virologic responses were assessed at week 48 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >40 copies/mL; Otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 48.

InterventionPercentage of participants (Number)
Cohort 2: DOR/3TC/TDF97.6

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Percentage of Participants With Plasma HIV-1 RNA Less Than 40 Copies/mL at Week 96 (Cohort 2)

Virologic responses were assessed at week 96 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >40 copies/mL; Otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 96.

InterventionPercentage of participants (Number)
Cohort 2: DOR/3TC/TDF92.5

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Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/mL at Week 24 (Cohort 2)

Virologic responses were assessed at week 24 as percentage of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >50 copies/mL. Otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 24.

InterventionPercentage of participants (Number)
Cohort 2: DOR/3TC/TDF97.7

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Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/mL at Week 48 (Cohort 2)

Virologic responses were assessed at week 48 as percentage of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >50 copies/mL. Otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 48.

InterventionPercentage of participants (Number)
Cohort 2: DOR/3TC/TDF97.6

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Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/mL at Week 96 (Cohort 2)

Virologic responses were assessed at week 96 as percentage of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >50 copies/mL. Otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 96.

InterventionPercentage of participants (Number)
Cohort 2: DOR/3TC/TDF92.5

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Pharmacokinetic (PK) Parameter: Single-dose Area-under-the-curve (AUC0-∞) of Doravirine (DOR) (Cohort 1)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin version 6.3, Pharsight Corp., Mountain View, CA). Area under the curve (AUC) was determined using non-compartmental analyses and estimated by the linear up/log down trapezoidal rule, from time zero to infinity. Steady state AUC0-24 is equivalent to single dose AUC0-∞. (NCT03332095)
Timeframe: Measured during the entry (day 0) visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12, 24, 48 and 72 hours post-dose.

InterventionµM*hr (Geometric Mean)
Cohort 1: DOR34.8

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PK Parameter: AUC0-24hr of 3TC (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Area under the curve (AUC) was determined using non-compartmental analyses and estimated by the linear up/log down trapezoidal rule, from time zero to 24 hours. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.

Interventionh.ng/mL (Geometric Mean)
Cohort 2: DOR/3TC/TDF11300

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PK Parameter: AUC0-24hr of DOR (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Area under the curve (AUC) was determined using non-compartmental analyses and estimated by the linear up/log down trapezoidal rule, from time zero to 24 hours. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 2, 4, 12 and 24 hours post-dose.

InterventionµM*hr (Geometric Mean)
Cohort 2: DOR/3TC/TDF22.9

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PK Parameter: AUC0-24hr of Tenofovir (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Area under the curve (AUC) was determined using non-compartmental analyses and estimated by the linear up/log down trapezoidal rule, from time zero to 24 hours. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.

Interventionh.ng/mL (Geometric Mean)
Cohort 2: DOR/3TC/TDF2550

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PK Parameter: C24hr of 3TC (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). C24hr was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.

Interventionng/mL (Geometric Mean)
Cohort 2: DOR/3TC/TDF66.3

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PK Parameter: C24hr of DOR (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). C24hr was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 2, 4, 12 and 24 hours post-dose.

InterventionnM (Geometric Mean)
Cohort 2: DOR/3TC/TDF282

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PK Parameter: Cmax of 3TC (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Cmax was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.

Interventionng/mL (Geometric Mean)
Cohort 2: DOR/3TC/TDF2100

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PK Parameter: Cmax of DOR (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Cmax was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 2, 4, 12 and 24 hours post-dose.

InterventionµM (Geometric Mean)
Cohort 2: DOR/3TC/TDF2.13

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PK Parameter: Cmax of Tenofovir (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Cmax was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.

Interventionng/mL (Geometric Mean)
Cohort 2: DOR/3TC/TDF293

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PK Parameter: Single-dose 24 Hour-concentration (C24hr) of DOR (Cohort 1)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). (NCT03332095)
Timeframe: Measured during the entry (day 0) visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12, 24, 48 and 72 hours post-dose.

InterventionnM (Geometric Mean)
Cohort 1: DOR514

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PK Parameter: Single-dose Maximum Concentration (Cmax) of DOR (Cohort 1)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). (NCT03332095)
Timeframe: Measured during the entry (day 0) visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12, 24, 48 and 72 hours post-dose.

InterventionµM (Geometric Mean)
Cohort 1: DOR2.14

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Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve

Parent/guardian-reported satisfaction with the number of study drug tablets to dissolve according to acceptability questionnaire responses (NCT03760458)
Timeframe: Weeks 4, 12, 24, and 48

InterventionParticipants (Count of Participants)
Week 472570429Week 472570427Week 472570428Week 472570430Week 1272570427Week 1272570428Week 1272570429Week 1272570430Week 2472570429Week 2472570430Week 2472570427Week 2472570428Week 4872570429Week 4872570427Week 4872570430Week 4872570428
It is too fewIt is acceptableIt is too many
Weight Band #2 (10 to Less Than 14 kg at Study Entry)10
Weight Band #4 (20 to Less Than 25 kg at Study Entry)8
Weight Band #1 (6 to Less Than 10 kg at Study Entry)1
Weight Band #2 (10 to Less Than 14 kg at Study Entry)1
Weight Band #4 (20 to Less Than 25 kg at Study Entry)2
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0
Weight Band #1 (6 to Less Than 10 kg at Study Entry)8
Weight Band #4 (20 to Less Than 25 kg at Study Entry)9
Weight Band #1 (6 to Less Than 10 kg at Study Entry)0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)1
Weight Band #3 (14 to Less Than 20 kg at Study Entry)14
Weight Band #4 (20 to Less Than 25 kg at Study Entry)10
Weight Band #3 (14 to Less Than 20 kg at Study Entry)1
Weight Band #1 (6 to Less Than 10 kg at Study Entry)7
Weight Band #2 (10 to Less Than 14 kg at Study Entry)11
Weight Band #3 (14 to Less Than 20 kg at Study Entry)15
Weight Band #4 (20 to Less Than 25 kg at Study Entry)4
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0

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Median (Q1,Q3) Change From Baseline in Triglycerides

Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation. (NCT03760458)
Timeframe: Baseline, Weeks 24 and 48

,,,,
Interventionmmol/L (Median)
Baseline to Week 24Baseline to Week 48
Weight Band #1 (6 to Less Than 10 kg at Study Entry)-0.51-0.43
Weight Band #2 (10 to Less Than 14 kg at Study Entry)-0.51-0.32
Weight Band #3 (14 to Less Than 20 kg at Study Entry)-0.17-0.21
Weight Band #4 (20 to Less Than 25 kg at Study Entry)-0.200.00
Weight Band #5 (25 kg or Greater at Study Entry)-0.24-0.27

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Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC

Based on analysis of intensive PK samples. Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens. (NCT03760458)
Timeframe: Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.

,,,,
Interventionug/mL (Geometric Mean)
ABCDTG3TC
Weight Band #1 (6 to Less Than 10 kg at Study Entry)7.307.402.29
Weight Band #2 (10 to Less Than 14 kg at Study Entry)8.368.853.55
Weight Band #3 (14 to Less Than 20 kg at Study Entry)6.267.042.92
Weight Band #4 (20 to Less Than 25 kg at Study Entry)6.657.292.99
Weight Band #5 (25 kg or Greater at Study Entry)9.046.254.15

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Median (Q1, Q3) CD4+ Cell Count

Per protocol, CD4 + cell counts were not required at Week 60. CD4 results were therefore analyzed through Week 48. For participants who discontinued study drug prior to the other timepoints due to safety or virologic failure, results imputed using the baseline value. (NCT03760458)
Timeframe: Weeks 4, 24, and 48

,,,,
Interventioncells/mm^3 (Median)
Week 4Week 24Week 48
Weight Band #1 (6 to Less Than 10 kg at Study Entry)352822081853
Weight Band #2 (10 to Less Than 14 kg at Study Entry)138511841235
Weight Band #3 (14 to Less Than 20 kg at Study Entry)812894930
Weight Band #4 (20 to Less Than 25 kg at Study Entry)992944942
Weight Band #5 (25 kg or Greater at Study Entry)841920777

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Percentage of Participants Who Experienced Virologic Failure Through Week 60

Percentage of participants who experienced virologic failure based on the following definition: ART-experienced participants who had two subsequent viral loads greater or equal to 200 copies/mL at any time, or for ART-naive participants, two subsequent viral loads greater to or equal to 200 copies/mL at 24 weeks or after. The results are presented by ART experienced, ART naïve, and overall. (NCT03760458)
Timeframe: Measured from treatment initiation through Week 60

Interventionpercentage of participants (Number)
OverallART-experiencedART-naive
Weight Band #1 (6 to Less Than 10 kg at Study Entry)12.50.033.3

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Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm

Percentage of participants with virologic success of HIV-1 RNA less than 50 copies/mL using FDA snapshot algorithm at Weeks 4, 24, and 48. Viral loads less than the lower limit of quantification were imputed as one less than the lower limit. (NCT03760458)
Timeframe: Weeks 4, 24, and 48

,,,,
Interventionpercentage of participants (Number)
Week 4Week 24Week 48
Weight Band #1 (6 to Less Than 10 kg at Study Entry)44.477.877.8
Weight Band #2 (10 to Less Than 14 kg at Study Entry)91.783.366.7
Weight Band #3 (14 to Less Than 20 kg at Study Entry)86.793.386.7
Weight Band #4 (20 to Less Than 25 kg at Study Entry)80.0100.070.0
Weight Band #5 (25 kg or Greater at Study Entry)100.0100.090.9

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Percentage of Participants Who Experienced Virologic Failure Through Week 60

Percentage of participants who experienced virologic failure based on the following definition: ART-experienced participants who had two subsequent viral loads greater or equal to 200 copies/mL at any time, or for ART-naive participants, two subsequent viral loads greater to or equal to 200 copies/mL at 24 weeks or after. The results are presented by ART experienced, ART naïve, and overall. (NCT03760458)
Timeframe: Measured from treatment initiation through Week 60

,,,
Interventionpercentage of participants (Number)
OverallART-experienced
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0.00.0
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0.00.0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0.00.0
Weight Band #5 (25 kg or Greater at Study Entry)0.00.0

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Percentage of Participants Who Experienced Virologic Failure Through Week 48

Percentage of participants who experienced virologic failure based on the following definition: ART-experienced participants who had two subsequent viral loads greater or equal to 200 copies/mL at any time, or for ART-naive participants, two subsequent viral loads greater to or equal to 200 copies/mL at 24 weeks or after. The results are presented by ART experienced, ART naïve, and overall. (NCT03760458)
Timeframe: Measured from treatment initiation through Week 48

Interventionpercentage of participants (Number)
OverallART-experiencedART-naive
Weight Band #1 (6 to Less Than 10 kg at Study Entry)12.50.033.3

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Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC

Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band. (NCT03760458)
Timeframe: Measured from Week 1 through Week 48 over 24 hours post-dose

,,,,
Interventionug*h/mL (Geometric Mean)
ABCDTG3TC
Weight Band #1 (6 to Less Than 10 kg at Study Entry)17.3082.209.97
Weight Band #2 (10 to Less Than 14 kg at Study Entry)18.9086.9014.90
Weight Band #3 (14 to Less Than 20 kg at Study Entry)17.2071.5013.60
Weight Band #4 (20 to Less Than 25 kg at Study Entry)19.5081.6013.10
Weight Band #5 (25 kg or Greater at Study Entry)26.1072.6020.30

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Percentage of Participants Who Experienced Virologic Failure Through Week 48

Percentage of participants who experienced virologic failure based on the following definition: ART-experienced participants who had two subsequent viral loads greater or equal to 200 copies/mL at any time, or for ART-naive participants, two subsequent viral loads greater to or equal to 200 copies/mL at 24 weeks or after. The results are presented by ART experienced, ART naïve, and overall. (NCT03760458)
Timeframe: Measured from treatment initiation through Week 48

,,,
Interventionpercentage of participants (Number)
OverallART-experienced
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0.00.0
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0.00.0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0.00.0
Weight Band #5 (25 kg or Greater at Study Entry)0.00.0

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Percentage of Participants Who Had at Least One Adverse Event Through Week 24

Adverse event (AE) grading was based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. AEs of any grade were reported. (NCT03760458)
Timeframe: Measured from treatment initiation through Week 24

Interventionpercentage of participants (Number)
Weight Band #1 (6 to Less Than 10 kg at Study Entry)100.0
Weight Band #2 (10 to Less Than 14 kg at Study Entry)90.9
Weight Band #3 (14 to Less Than 20 kg at Study Entry)100.0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)80.0
Weight Band #5 (25 kg or Greater at Study Entry)80.0

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Percentage of Participants Who Had at Least One Adverse Event Through Week 60

AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. (NCT03760458)
Timeframe: Measured from treatment initiation through Week 60

Interventionpercentage of participants (Number)
Weight Band #1 (6 to Less Than 10 kg at Study Entry)100.0
Weight Band #2 (10 to Less Than 14 kg at Study Entry)90.9
Weight Band #3 (14 to Less Than 20 kg at Study Entry)100.0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)100.0
Weight Band #5 (25 kg or Greater at Study Entry)90.0

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Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC

Based on analysis of intensive PK samples. The geometric mean C24h for each Weight Band was compared to the lower and upper reference values (in ug/mL) for DTG (0.67, 2.97). Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens. (NCT03760458)
Timeframe: Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.

,,,,
Interventionug/mL (Geometric Mean)
ABCDTG3TC
Weight Band #1 (6 to Less Than 10 kg at Study Entry)0.0030.910.055
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0.0051.220.046
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0.0030.790.058
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0.0041.350.060
Weight Band #5 (25 kg or Greater at Study Entry)0.0110.980.084

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Parent/Guardian-reported Time for Study Drug Tablets to Dissolve

Parent/guardian-reported time for study drug tablets to dissolve according to acceptability questionnaire responses (NCT03760458)
Timeframe: Weeks 4, 12, 24, and 48

InterventionParticipants (Count of Participants)
Week 472570429Week 472570428Week 472570427Week 472570430Week 1272570429Week 1272570427Week 1272570428Week 1272570430Week 2472570427Week 2472570428Week 2472570429Week 2472570430Week 4872570427Week 4872570428Week 4872570429Week 4872570430
Less than 1 minute1 to less than 3 minutes3 to 5 minutes
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0
Weight Band #2 (10 to Less Than 14 kg at Study Entry)5
Weight Band #4 (20 to Less Than 25 kg at Study Entry)7
Weight Band #3 (14 to Less Than 20 kg at Study Entry)4
Weight Band #4 (20 to Less Than 25 kg at Study Entry)1
Weight Band #1 (6 to Less Than 10 kg at Study Entry)5
Weight Band #2 (10 to Less Than 14 kg at Study Entry)7
Weight Band #3 (14 to Less Than 20 kg at Study Entry)8
Weight Band #4 (20 to Less Than 25 kg at Study Entry)6
Weight Band #2 (10 to Less Than 14 kg at Study Entry)2
Weight Band #3 (14 to Less Than 20 kg at Study Entry)3
Weight Band #4 (20 to Less Than 25 kg at Study Entry)3
Weight Band #3 (14 to Less Than 20 kg at Study Entry)10
Weight Band #4 (20 to Less Than 25 kg at Study Entry)5
Weight Band #1 (6 to Less Than 10 kg at Study Entry)1
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0
Weight Band #3 (14 to Less Than 20 kg at Study Entry)1
Weight Band #1 (6 to Less Than 10 kg at Study Entry)3
Weight Band #2 (10 to Less Than 14 kg at Study Entry)4
Weight Band #2 (10 to Less Than 14 kg at Study Entry)6
Weight Band #3 (14 to Less Than 20 kg at Study Entry)11
Weight Band #4 (20 to Less Than 25 kg at Study Entry)2
Weight Band #1 (6 to Less Than 10 kg at Study Entry)2
Weight Band #2 (10 to Less Than 14 kg at Study Entry)1
Weight Band #3 (14 to Less Than 20 kg at Study Entry)2
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0

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Median (Q1,Q3) Change From Baseline in LDL

Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation. (NCT03760458)
Timeframe: Baseline, Weeks 24 and 48

,,,,
Interventionmmol/L (Median)
Baseline to Week 24Baseline to Week 48
Weight Band #1 (6 to Less Than 10 kg at Study Entry)0.180.05
Weight Band #2 (10 to Less Than 14 kg at Study Entry)-0.20-0.13
Weight Band #3 (14 to Less Than 20 kg at Study Entry)-0.26-0.30
Weight Band #4 (20 to Less Than 25 kg at Study Entry)-0.220.00
Weight Band #5 (25 kg or Greater at Study Entry)-0.210.03

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Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to

Parent/guardian-reported response of how well the person usually responsible administered the study drug in the way they were supposed to in the 30 days prior to the study visit according to adherence questionnaire responses. (NCT03760458)
Timeframe: Weeks 4, 24, and 48

InterventionParticipants (Count of Participants)
Week 472570427Week 472570428Week 472570429Week 472570430Week 472570431Week 2472570427Week 2472570428Week 2472570429Week 2472570430Week 2472570431Week 4872570427Week 4872570428Week 4872570430Week 4872570431Week 4872570429
ExcellentVery goodGoodFairPoor
Weight Band #1 (6 to Less Than 10 kg at Study Entry)4
Weight Band #3 (14 to Less Than 20 kg at Study Entry)12
Weight Band #4 (20 to Less Than 25 kg at Study Entry)7
Weight Band #5 (25 kg or Greater at Study Entry)9
Weight Band #1 (6 to Less Than 10 kg at Study Entry)3
Weight Band #2 (10 to Less Than 14 kg at Study Entry)4
Weight Band #3 (14 to Less Than 20 kg at Study Entry)2
Weight Band #4 (20 to Less Than 25 kg at Study Entry)2
Weight Band #1 (6 to Less Than 10 kg at Study Entry)2
Weight Band #2 (10 to Less Than 14 kg at Study Entry)7
Weight Band #3 (14 to Less Than 20 kg at Study Entry)10
Weight Band #4 (20 to Less Than 25 kg at Study Entry)5
Weight Band #1 (6 to Less Than 10 kg at Study Entry)5
Weight Band #2 (10 to Less Than 14 kg at Study Entry)3
Weight Band #3 (14 to Less Than 20 kg at Study Entry)4
Weight Band #4 (20 to Less Than 25 kg at Study Entry)1
Weight Band #5 (25 kg or Greater at Study Entry)2
Weight Band #1 (6 to Less Than 10 kg at Study Entry)1
Weight Band #2 (10 to Less Than 14 kg at Study Entry)1
Weight Band #3 (14 to Less Than 20 kg at Study Entry)1
Weight Band #4 (20 to Less Than 25 kg at Study Entry)3
Weight Band #5 (25 kg or Greater at Study Entry)0
Weight Band #1 (6 to Less Than 10 kg at Study Entry)0
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0
Weight Band #5 (25 kg or Greater at Study Entry)11
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0

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Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to

Parent/guardian-reported response of how often the child received the study drug in the way they were supposed to in the 30 days prior to the study visit according to adherence questionnaire responses. (NCT03760458)
Timeframe: Weeks 4, 24, and 48

InterventionParticipants (Count of Participants)
Week 472570431Week 472570428Week 472570430Week 472570427Week 472570429Week 2472570431Week 2472570427Week 2472570428Week 2472570429Week 2472570430Week 4872570430Week 4872570431Week 4872570427Week 4872570428Week 4872570429
AlwaysAlmost alwaysUsuallySometimesNever
Weight Band #1 (6 to Less Than 10 kg at Study Entry)8
Weight Band #2 (10 to Less Than 14 kg at Study Entry)9
Weight Band #3 (14 to Less Than 20 kg at Study Entry)14
Weight Band #4 (20 to Less Than 25 kg at Study Entry)10
Weight Band #5 (25 kg or Greater at Study Entry)10
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0
Weight Band #5 (25 kg or Greater at Study Entry)1
Weight Band #5 (25 kg or Greater at Study Entry)0
Weight Band #1 (6 to Less Than 10 kg at Study Entry)0
Weight Band #1 (6 to Less Than 10 kg at Study Entry)7
Weight Band #3 (14 to Less Than 20 kg at Study Entry)12
Weight Band #4 (20 to Less Than 25 kg at Study Entry)6
Weight Band #5 (25 kg or Greater at Study Entry)9
Weight Band #1 (6 to Less Than 10 kg at Study Entry)1
Weight Band #2 (10 to Less Than 14 kg at Study Entry)2
Weight Band #3 (14 to Less Than 20 kg at Study Entry)3
Weight Band #4 (20 to Less Than 25 kg at Study Entry)2
Weight Band #5 (25 kg or Greater at Study Entry)2
Weight Band #4 (20 to Less Than 25 kg at Study Entry)1
Weight Band #1 (6 to Less Than 10 kg at Study Entry)6
Weight Band #2 (10 to Less Than 14 kg at Study Entry)7
Weight Band #3 (14 to Less Than 20 kg at Study Entry)13
Weight Band #4 (20 to Less Than 25 kg at Study Entry)9
Weight Band #5 (25 kg or Greater at Study Entry)11
Weight Band #2 (10 to Less Than 14 kg at Study Entry)3
Weight Band #3 (14 to Less Than 20 kg at Study Entry)1
Weight Band #2 (10 to Less Than 14 kg at Study Entry)1
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0

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Parent/Guardian-reported Response of Child's Face When Taking Study Drug

Parent/guardian-reported response of child's face when taking study drug according to palatability questionnaire responses. (NCT03760458)
Timeframe: Weeks 4, 12, 24, and 48

InterventionParticipants (Count of Participants)
Week 472570427Week 472570428Week 472570429Week 472570430Week 472570431Week 1272570427Week 1272570428Week 1272570429Week 1272570431Week 1272570430Week 2472570427Week 2472570428Week 2472570429Week 2472570430Week 2472570431Week 4872570428Week 4872570429Week 4872570430Week 4872570431Week 4872570427
Very badVery goodGoodAverageBad
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0
Weight Band #5 (25 kg or Greater at Study Entry)5
Weight Band #3 (14 to Less Than 20 kg at Study Entry)10
Weight Band #2 (10 to Less Than 14 kg at Study Entry)2
Weight Band #1 (6 to Less Than 10 kg at Study Entry)2
Weight Band #2 (10 to Less Than 14 kg at Study Entry)3
Weight Band #3 (14 to Less Than 20 kg at Study Entry)4
Weight Band #5 (25 kg or Greater at Study Entry)6
Weight Band #3 (14 to Less Than 20 kg at Study Entry)5
Weight Band #5 (25 kg or Greater at Study Entry)2
Weight Band #1 (6 to Less Than 10 kg at Study Entry)4
Weight Band #2 (10 to Less Than 14 kg at Study Entry)4
Weight Band #3 (14 to Less Than 20 kg at Study Entry)3
Weight Band #5 (25 kg or Greater at Study Entry)3
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0
Weight Band #3 (14 to Less Than 20 kg at Study Entry)2
Weight Band #5 (25 kg or Greater at Study Entry)0
Weight Band #2 (10 to Less Than 14 kg at Study Entry)1
Weight Band #3 (14 to Less Than 20 kg at Study Entry)1
Weight Band #4 (20 to Less Than 25 kg at Study Entry)1
Weight Band #2 (10 to Less Than 14 kg at Study Entry)5
Weight Band #4 (20 to Less Than 25 kg at Study Entry)3
Weight Band #1 (6 to Less Than 10 kg at Study Entry)3
Weight Band #4 (20 to Less Than 25 kg at Study Entry)2
Weight Band #5 (25 kg or Greater at Study Entry)4
Weight Band #5 (25 kg or Greater at Study Entry)1
Weight Band #1 (6 to Less Than 10 kg at Study Entry)1
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0
Weight Band #3 (14 to Less Than 20 kg at Study Entry)6
Weight Band #1 (6 to Less Than 10 kg at Study Entry)0

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Parent/Guardian-reported Response of Child's Face When Taking Favorite Food

Parent/guardian-reported response of child's face when taking favorite food according to palatability questionnaire responses. (NCT03760458)
Timeframe: Weeks 4, 12, 24, and 48

InterventionParticipants (Count of Participants)
Week 472570427Week 472570431Week 472570430Week 472570428Week 472570429Week 1272570427Week 1272570428Week 1272570430Week 1272570431Week 1272570429Week 2472570427Week 2472570428Week 2472570430Week 2472570431Week 2472570429Week 4872570427Week 4872570428Week 4872570429Week 4872570430Week 4872570431
AverageVery goodGoodBadVery bad
Weight Band #1 (6 to Less Than 10 kg at Study Entry)3
Weight Band #2 (10 to Less Than 14 kg at Study Entry)7
Weight Band #4 (20 to Less Than 25 kg at Study Entry)4
Weight Band #5 (25 kg or Greater at Study Entry)8
Weight Band #3 (14 to Less Than 20 kg at Study Entry)9
Weight Band #5 (25 kg or Greater at Study Entry)2
Weight Band #2 (10 to Less Than 14 kg at Study Entry)1
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0
Weight Band #1 (6 to Less Than 10 kg at Study Entry)4
Weight Band #2 (10 to Less Than 14 kg at Study Entry)6
Weight Band #3 (14 to Less Than 20 kg at Study Entry)7
Weight Band #4 (20 to Less Than 25 kg at Study Entry)6
Weight Band #5 (25 kg or Greater at Study Entry)10
Weight Band #1 (6 to Less Than 10 kg at Study Entry)1
Weight Band #2 (10 to Less Than 14 kg at Study Entry)2
Weight Band #3 (14 to Less Than 20 kg at Study Entry)4
Weight Band #4 (20 to Less Than 25 kg at Study Entry)3
Weight Band #5 (25 kg or Greater at Study Entry)1
Weight Band #2 (10 to Less Than 14 kg at Study Entry)3
Weight Band #3 (14 to Less Than 20 kg at Study Entry)3
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0
Weight Band #5 (25 kg or Greater at Study Entry)0
Weight Band #1 (6 to Less Than 10 kg at Study Entry)0
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)1
Weight Band #3 (14 to Less Than 20 kg at Study Entry)1
Weight Band #1 (6 to Less Than 10 kg at Study Entry)6
Weight Band #3 (14 to Less Than 20 kg at Study Entry)8
Weight Band #2 (10 to Less Than 14 kg at Study Entry)4
Weight Band #3 (14 to Less Than 20 kg at Study Entry)5
Weight Band #4 (20 to Less Than 25 kg at Study Entry)2
Weight Band #3 (14 to Less Than 20 kg at Study Entry)2
Weight Band #1 (6 to Less Than 10 kg at Study Entry)8
Weight Band #4 (20 to Less Than 25 kg at Study Entry)7
Weight Band #5 (25 kg or Greater at Study Entry)11
Weight Band #3 (14 to Less Than 20 kg at Study Entry)6

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Parent/Guardian-reported Reason for Missed Doses of Study Drug

Parent/guardian-reported reason for missed doses of study drug in the 30 days prior to the study visit according to adherence questionnaire responses. (NCT03760458)
Timeframe: Weeks 4, 24, and 48

InterventionParticipants (Count of Participants)
Week 472570429Week 472570430Week 472570431Week 472570427Week 472570428Week 2472570428Week 2472570430Week 2472570427Week 2472570429Week 2472570431Week 4872570429Week 4872570431Week 4872570428Week 4872570430Week 4872570427
Tried to spit it out because of taste (away from cNo missed dosesBoth parents were admitted in the hospitalCaregiver too sickCaregiver was too busy to give the medicationChange in daily routineForgot to administer medicationMom was in a hurry and forgot to give child medica
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0
Weight Band #5 (25 kg or Greater at Study Entry)1
Weight Band #1 (6 to Less Than 10 kg at Study Entry)8
Weight Band #2 (10 to Less Than 14 kg at Study Entry)10
Weight Band #3 (14 to Less Than 20 kg at Study Entry)14
Weight Band #4 (20 to Less Than 25 kg at Study Entry)10
Weight Band #5 (25 kg or Greater at Study Entry)0
Weight Band #3 (14 to Less Than 20 kg at Study Entry)1
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)1
Weight Band #1 (6 to Less Than 10 kg at Study Entry)7
Weight Band #2 (10 to Less Than 14 kg at Study Entry)8
Weight Band #3 (14 to Less Than 20 kg at Study Entry)13
Weight Band #5 (25 kg or Greater at Study Entry)10
Weight Band #1 (6 to Less Than 10 kg at Study Entry)1
Weight Band #2 (10 to Less Than 14 kg at Study Entry)1
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0
Weight Band #1 (6 to Less Than 10 kg at Study Entry)0
Weight Band #1 (6 to Less Than 10 kg at Study Entry)5
Weight Band #2 (10 to Less Than 14 kg at Study Entry)9
Weight Band #4 (20 to Less Than 25 kg at Study Entry)9

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Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC

Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band. (NCT03760458)
Timeframe: Measured from Week 1 through Week 48 over 24 hours post-dose

,,,,
Interventionhours (Median)
ABCDTG3TC
Weight Band #1 (6 to Less Than 10 kg at Study Entry)1.002.002.00
Weight Band #2 (10 to Less Than 14 kg at Study Entry)1.002.002.00
Weight Band #3 (14 to Less Than 20 kg at Study Entry)1.002.002.00
Weight Band #4 (20 to Less Than 25 kg at Study Entry)1.002.502.00
Weight Band #5 (25 kg or Greater at Study Entry)1.003.002.00

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Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC

Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band. (NCT03760458)
Timeframe: Measured from Week 1 through Week 48 over 24 hours post-dose

,,,,
Interventionug/mL (Geometric Mean)
ABCDTG3TC
Weight Band #1 (6 to Less Than 10 kg at Study Entry)6.046.792.29
Weight Band #2 (10 to Less Than 14 kg at Study Entry)7.426.632.64
Weight Band #3 (14 to Less Than 20 kg at Study Entry)7.076.362.98
Weight Band #4 (20 to Less Than 25 kg at Study Entry)8.046.592.65
Weight Band #5 (25 kg or Greater at Study Entry)9.605.433.59

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Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC

Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band. (NCT03760458)
Timeframe: Measured from Week 1 through Week 48 over 24 hours post-dose

,,,,
Interventionhours (Geometric Mean)
ABCDTG3TC
Weight Band #1 (6 to Less Than 10 kg at Study Entry)3.218.343.38
Weight Band #2 (10 to Less Than 14 kg at Study Entry)3.439.423.23
Weight Band #3 (14 to Less Than 20 kg at Study Entry)3.726.752.97
Weight Band #4 (20 to Less Than 25 kg at Study Entry)3.328.343.46
Weight Band #5 (25 kg or Greater at Study Entry)3.308.143.51

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Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC

Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band. (NCT03760458)
Timeframe: Measured from Week 1 through Week 48 over 24 hours post-dose

,,,,
Interventionug/mL (Geometric Mean)
ABCDTG3TC
Weight Band #1 (6 to Less Than 10 kg at Study Entry)0.011.080.01
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0.021.350.03
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0.010.710.02
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0.011.090.01
Weight Band #5 (25 kg or Greater at Study Entry)0.021.010.02

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Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC

Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band. (NCT03760458)
Timeframe: Measured from Week 1 through Week 48 over 24 hours post-dose

,,,,
Interventionug/mL (Geometric Mean)
ABCDTG3TC
Weight Band #1 (6 to Less Than 10 kg at Study Entry)0.011.080.01
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0.021.350.02
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0.010.710.01
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0.011.090.02
Weight Band #5 (25 kg or Greater at Study Entry)0.021.010.03

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Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC

Based on analysis of intensive pharmacokinetic (PK) samples. The geometric mean AUC0-24h for each Weight Band was compared to the lower and upper reference values (in ug*h/mL) for DTG (35.1, 134), ABC (6.3, 50.4), and 3TC (6.3, 26.5). Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens. (NCT03760458)
Timeframe: Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.

,,,,
Interventionh*ug/mL (Geometric Mean)
Abacavir (ABC)Dolutegravir (DTG)Lamivudine (3TC)
Weight Band #1 (6 to Less Than 10 kg at Study Entry)17.775.910.7
Weight Band #2 (10 to Less Than 14 kg at Study Entry)19.891.014.2
Weight Band #3 (14 to Less Than 20 kg at Study Entry)15.171.413.0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)17.484.414.5
Weight Band #5 (25 kg or Greater at Study Entry)25.771.821.7

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Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC

Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band. (NCT03760458)
Timeframe: Measured from Week 1 through Week 48 over 24 hours post-dose

,,,,
InterventionL/hour (Geometric Mean)
ABCDTG3TC
Weight Band #1 (6 to Less Than 10 kg at Study Entry)10.400.189.03
Weight Band #2 (10 to Less Than 14 kg at Study Entry)12.700.238.04
Weight Band #3 (14 to Less Than 20 kg at Study Entry)17.400.3511.00
Weight Band #4 (20 to Less Than 25 kg at Study Entry)18.400.3713.80
Weight Band #5 (25 kg or Greater at Study Entry)23.000.6914.80

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Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm

Percentage of participants with virologic success of HIV-1 RNA less than 200 copies/mL using FDA snapshot algorithm at Weeks 4, 24, and 48. Viral loads less than the lower limit of quantification were imputed as one less than the lower limit. (NCT03760458)
Timeframe: Weeks 4, 24, and 48

,,,,
Interventionpercentage of participants (Number)
Week 4Week 24Week 48
Weight Band #1 (6 to Less Than 10 kg at Study Entry)66.777.888.9
Weight Band #2 (10 to Less Than 14 kg at Study Entry)100.091.791.7
Weight Band #3 (14 to Less Than 20 kg at Study Entry)100.0100.0100.0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)100.0100.090.0
Weight Band #5 (25 kg or Greater at Study Entry)100.0100.0100.0

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Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL

Viral loads less than the lower limit of quantification were imputed as one less than the lower limit. (NCT03760458)
Timeframe: Weeks 4, 24, and 48

,,,,
Interventionpercentage of participants (Number)
Week 4Week 24Week 48
Weight Band #1 (6 to Less Than 10 kg at Study Entry)75.087.5100.0
Weight Band #2 (10 to Less Than 14 kg at Study Entry)100.0100.0100.0
Weight Band #3 (14 to Less Than 20 kg at Study Entry)100.0100.0100.0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)100.0100.0100.0
Weight Band #5 (25 kg or Greater at Study Entry)100.0100.0100.0

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Antiretroviral (ARV) Resistance Mutations

ARV resistance mutations at time of virologic failure and at entry for children with virologic failure. (NCT03760458)
Timeframe: Entry and confirmation of virologic failure

InterventionParticipants (Count of Participants)
Entry Visit: Integrase K14REntry Visit: Integrase A21TEntry Visit: Integrase V31IEntry Visit: Integrase V72IEntry Visit: Integrase L74IEntry Visit: Integrase T112VEntry Visit: Integrase V113IEntry Visit: Integrase T125AEntry Visit: Integrase V126LEntry Visit: Integrase G134NEntry Visit: Integrase I135VEntry Visit: Integrase K136REntry Visit: Integrase V165IEntry Visit: Integrase A196PEntry Visit: Integrase V236IEntry Visit: Integrase V281MEntry Visit: Integrase S283GEntry Visit: Protease L10VEntry Visit: Protease I13VEntry Visit: Protease G16EEntry Visit: Protease E35DEntry Visit: Protease M36IEntry Visit: Protease R41KEntry Visit: Protease K43REntry Visit: Protease H69KEntry Visit: Protease I72VEntry Visit: Protease L89MEntry Visit: Reverse Transcriptase E6DEntry Visit: Reverse Transcriptase K11TEntry Visit: Reverse Transcriptase K20REntry Visit: Reverse Transcriptase V35TEntry Visit: Reverse Transcriptase T39KEntry Visit: Reverse Transcriptase K43EEntry Visit: Reverse Transcriptase Q102KEntry Visit: Reverse Transcriptase K122EEntry Visit: Reverse Transcriptase D123SEntry Visit: Reverse Transcriptase C162SEntry Visit: Reverse Transcriptase T165IEntry Visit: Reverse Transcriptase K173AEntry Visit: Reverse Transcriptase Q174KEntry Visit: Reverse Transcriptase D177EEntry Visit: Reverse Transcriptase T200AEntry Visit: Reverse Transcriptase I202VEntry Visit: Reverse Transcriptase Q207AEntry Visit: Reverse Transcriptase L210MEntry Visit: Reverse Transcriptase R211SEntry Visit: Reverse Transcriptase V245EEntry Visit: Reverse Transcriptase A272PEntry Visit: Reverse Transcriptase R277KEntry Visit: Reverse Transcriptase T286AEntry Visit: Reverse Transcriptase L295L/IEntry Visit: Reverse Transcriptase E312NEntry Visit: Reverse Transcriptase I326VEntry Visit: Reverse Transcriptase I329VEntry Visit: Reverse Transcriptase G335DEntry Visit: Reverse Transcriptase M357KEntry Visit: Reverse Transcriptase K358REntry Visit: Reverse Transcriptase G359SEntry Visit: Reverse Transcriptase K366REntry Visit: Reverse Transcriptase A371VEntry Visit: Reverse Transcriptase T377SEntry Visit: Reverse Transcriptase K390REntry Visit: Reverse Transcriptase K395REntry Visit: Reverse Transcriptase A400T
Weight Band #1 (6 to Less Than 10 kg at Study Entry)1111111111111111111111111111111111111111111111111111111111111111

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Percentage of Participants With at Least One Adverse Event Through Week 48

AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. (NCT03760458)
Timeframe: Measured from treatment initiation through Week 48

Interventionpercentage of participants (Number)
Weight Band #1 (6 to Less Than 10 kg at Study Entry)100.0
Weight Band #2 (10 to Less Than 14 kg at Study Entry)90.9
Weight Band #3 (14 to Less Than 20 kg at Study Entry)100.0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)100.0
Weight Band #5 (25 kg or Greater at Study Entry)90.0

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Median (Q1, Q3) CD4+ Percentage

Per protocol, CD4+ cell count percentages were not required at Week 60. CD4 results were therefore analyzed through Week 48. For participants who discontinued study drug prior to the other timepoints due to safety or virologic failure, results imputed using the baseline value. (NCT03760458)
Timeframe: Weeks 4, 24, and 48

,,,,
Interventionpercentage of CD4+ in total lymphocytes (Median)
Week 4Week 24Week 48
Weight Band #1 (6 to Less Than 10 kg at Study Entry)41.636.634.8
Weight Band #2 (10 to Less Than 14 kg at Study Entry)33.935.234.1
Weight Band #3 (14 to Less Than 20 kg at Study Entry)32.433.530.5
Weight Band #4 (20 to Less Than 25 kg at Study Entry)34.437.733.5
Weight Band #5 (25 kg or Greater at Study Entry)39.538.637.6

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Parent/Guardian-reported Ease of Giving Study Drug

Parent/guardian-reported ease of giving study drug according to palatability questionnaire responses. (NCT03760458)
Timeframe: Weeks 4, 12, 24, and 48

InterventionParticipants (Count of Participants)
Week 472570431Week 472570427Week 472570428Week 472570429Week 472570430Week 1272570427Week 1272570428Week 1272570429Week 1272570430Week 1272570431Week 2472570427Week 2472570428Week 2472570429Week 2472570430Week 2472570431Week 4872570429Week 4872570427Week 4872570428Week 4872570430Week 4872570431
The child takes by themselves easilyThe child takes easily with helpThe child takes with help but you need to threatenYou need to hold and force the child
Weight Band #2 (10 to Less Than 14 kg at Study Entry)2
Weight Band #3 (14 to Less Than 20 kg at Study Entry)11
Weight Band #4 (20 to Less Than 25 kg at Study Entry)9
Weight Band #5 (25 kg or Greater at Study Entry)9
Weight Band #1 (6 to Less Than 10 kg at Study Entry)6
Weight Band #2 (10 to Less Than 14 kg at Study Entry)8
Weight Band #5 (25 kg or Greater at Study Entry)2
Weight Band #1 (6 to Less Than 10 kg at Study Entry)2
Weight Band #2 (10 to Less Than 14 kg at Study Entry)0
Weight Band #3 (14 to Less Than 20 kg at Study Entry)10
Weight Band #4 (20 to Less Than 25 kg at Study Entry)7
Weight Band #3 (14 to Less Than 20 kg at Study Entry)5
Weight Band #3 (14 to Less Than 20 kg at Study Entry)0
Weight Band #2 (10 to Less Than 14 kg at Study Entry)3
Weight Band #3 (14 to Less Than 20 kg at Study Entry)12
Weight Band #4 (20 to Less Than 25 kg at Study Entry)8
Weight Band #5 (25 kg or Greater at Study Entry)8
Weight Band #2 (10 to Less Than 14 kg at Study Entry)6
Weight Band #3 (14 to Less Than 20 kg at Study Entry)3
Weight Band #5 (25 kg or Greater at Study Entry)3
Weight Band #2 (10 to Less Than 14 kg at Study Entry)4
Weight Band #4 (20 to Less Than 25 kg at Study Entry)6
Weight Band #5 (25 kg or Greater at Study Entry)10
Weight Band #1 (6 to Less Than 10 kg at Study Entry)8
Weight Band #2 (10 to Less Than 14 kg at Study Entry)5
Weight Band #3 (14 to Less Than 20 kg at Study Entry)4
Weight Band #4 (20 to Less Than 25 kg at Study Entry)2
Weight Band #5 (25 kg or Greater at Study Entry)1
Weight Band #3 (14 to Less Than 20 kg at Study Entry)1
Weight Band #4 (20 to Less Than 25 kg at Study Entry)1
Weight Band #1 (6 to Less Than 10 kg at Study Entry)0
Weight Band #2 (10 to Less Than 14 kg at Study Entry)1
Weight Band #4 (20 to Less Than 25 kg at Study Entry)0
Weight Band #5 (25 kg or Greater at Study Entry)0

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Parent/Guardian-reported Percent Adherence to Study Drug

Parent/guardian-reported percent adherence to study drug in the 30 days prior to the study visit according to adherence questionnaire responses. (NCT03760458)
Timeframe: Weeks 4, 24, and 48

,,,,
Interventionpercentage of study drug taken (Median)
Week 4Week 24Week 48
Weight Band #1 (6 to Less Than 10 kg at Study Entry)100.0100.0100.0
Weight Band #2 (10 to Less Than 14 kg at Study Entry)100.0100.0100.0
Weight Band #3 (14 to Less Than 20 kg at Study Entry)100.0100.0100.0
Weight Band #4 (20 to Less Than 25 kg at Study Entry)100.0100.0100.0
Weight Band #5 (25 kg or Greater at Study Entry)100.0100.0100.0

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Parent/Guardian-reported Number of Missed Doses of Study Drug

Parent/guardian-reported number of missed doses of study drug in the 30 days prior to the study visit according to adherence questionnaire responses. (NCT03760458)
Timeframe: Weeks 4, 24, and 48

,,,,
Interventionmissed doses (Median)
Week 4Week 24Week 48
Weight Band #1 (6 to Less Than 10 kg at Study Entry)000
Weight Band #2 (10 to Less Than 14 kg at Study Entry)000
Weight Band #3 (14 to Less Than 20 kg at Study Entry)000
Weight Band #4 (20 to Less Than 25 kg at Study Entry)000
Weight Band #5 (25 kg or Greater at Study Entry)000

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Median (Q1,Q3) Change From Baseline in HDL

Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation. (NCT03760458)
Timeframe: Baseline, Weeks 24 and 48

,,,,
Interventionmmol/L (Median)
Baseline to Week 24Baseline to Week 48
Weight Band #1 (6 to Less Than 10 kg at Study Entry)-0.01-0.10
Weight Band #2 (10 to Less Than 14 kg at Study Entry)-0.06-0.20
Weight Band #3 (14 to Less Than 20 kg at Study Entry)-0.19-0.24
Weight Band #4 (20 to Less Than 25 kg at Study Entry)-0.15-0.19
Weight Band #5 (25 kg or Greater at Study Entry)-0.060.05

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Median (Q1,Q3) Change From Baseline in Total Cholesterol

Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation. (NCT03760458)
Timeframe: Baseline, Weeks 24 and 48

,,,,
Interventionmmol/L (Median)
Baseline to Week 24Baseline to Week 48
Weight Band #1 (6 to Less Than 10 kg at Study Entry)-0.310.00
Weight Band #2 (10 to Less Than 14 kg at Study Entry)-0.70-0.50
Weight Band #3 (14 to Less Than 20 kg at Study Entry)-0.67-0.68
Weight Band #4 (20 to Less Than 25 kg at Study Entry)-0.32-0.25
Weight Band #5 (25 kg or Greater at Study Entry)-0.18-0.09

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Percentage of Participants With Plasma HIV-1 RNA <50 c/mL Regardless of ART Regimen at Week 48 by ITT-E Missing = Failure Analysis

"Participants were classified as HIV-1 RNA <50 c/mL using an ITT-E Missing = Failure analysis. Participants were classified as 'HIV-1 RNA < 50 c/mL' if the last viral load within the Week 48 visit window was <50/c/mL, regardless of the ART regimen they were on at the time of viral load assessment (in other words switch from DTG plus 3TC FDC to another ART was not penalized) and as HIV-1 RNA >= 50 c/mL in all other cases (i.e. last viral load within Week 48 visit window >= 50 c/mL, on study but having missing viral load data at Week 48, discontinued early from study due to LFU, withdrew consent or any other reason). CI were calculated based on the Exact Clopper-Pearson method. Percentage of participants with plasma HIV-1 RNA < 50 c/mL based on ITT-E missing = Failure analysis at Week 48 are presented." (NCT03945981)
Timeframe: At Week 48

InterventionPercentage of Participants (Number)
DTG Plus 3TC82

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Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) Regardless of Antiretroviral Therapy (ART) Regimen at Week 24 by ITT-E Missing = Failure Analysis

"Participants were classified as HIV-1 RNA <50 c/mL using an ITT-E missing = Failure analysis. Participants were classified as 'HIV-1 RNA < 50 c/mL' if the last viral load within the Week 24 visit window was <50/c/mL, regardless of the ART regimen they were on at the time of viral load assessment (in other words switch from DTG plus 3TC fixed-dose combination [FDC] to another ART was not penalized) and as HIV-1 RNA >= 50 c/mL in all other cases (i.e. last viral load within Week 24 visit window >= 50 c/mL, on study but having missing viral load data at Week 24, discontinued early from study due to lost to follow-up (LFU), withdrew consent or any other reason). Confidence intervals (CI) were calculated based on the Exact Clopper-Pearson method. Percentage of participants with plasma HIV-1 RNA < 50 c/mL based on ITT-E missing = Failure analysis at Week 24 are presented." (NCT03945981)
Timeframe: At Week 24

InterventionPercentage of Participants (Number)
DTG Plus 3TC78

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Time to Viral Suppression (HIV-1 RNA<50 c/mL) for Participants Who Had HIV-1 RNA >= 50 c/mL at Baseline

Time of viral suppression for participants who had HIV-1 RNA >= 50 c/mL at Baseline is defined as the time to first viral load value < 50 c/mL, irrespective of the ART regimen a participant was on when that occurred. Non parametric Kaplan-Meier method was used. Participants who withdrew for any reason without being suppressed were censored at date of withdrawal. Participants who have not been withdrawn and have not had viral suppression at time of the analysis were censored at last viral load date. Median time (i.e. time when 50% of participants have reached HIV-1 RNA < 50 c/mL) along with 95% CI is presented. (NCT03945981)
Timeframe: Up to Week 48

InterventionDays (Median)
DTG Plus 3TC35

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Change From Baseline in CD4+/CD8+ Cell Count Ratio for Participants Under Treatment With DTG + 3TC FDC

Blood samples were collected at specified time points to assess CD4+/CD8+ cell count ratio. It was assessed by flow cyclometry to evaluate the immunologic activity of DTG plus 3TC. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03945981)
Timeframe: Baseline (Day 1) and Week 24 and Week 48

InterventionRatio (Mean)
Week 24, n= 106Week 48, n=102
DTG Plus 3TC0.300.39

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Change From Baseline in Cluster of Differentiation (CD4+) Cell Counts for Participants Under Treatment With DTG + 3TC FDC

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells decline. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03945981)
Timeframe: Baseline (Day 1) and Week 24 and Week 48

InterventionCells per cubic millimeter (Mean)
Week 24, n=106Week 48, n=103
DTG Plus 3TC185.9273.4

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Number of Participants Who Changed First Line Regimen of DTG + 3TC FDC Due to Baseline Laboratory Results or HIV-1 Resistance Mutation Results

Number of participants who switched from first line regimen of DTG + 3TC FDC due to abnormal Baseline laboratory values or Baseline HIV-1 resistance mutation results are presented. (NCT03945981)
Timeframe: Up to Week 48

InterventionParticipants (Count of Participants)
Switched due to abnormal Baseline laboratory results (HBV Infection)Switched due to HIV-1 resistance mutation results
DTG Plus 3TC51

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Number of Participants Who Completed 24 and 48 Weeks on Study

Number of participants who completed 24 and 48 weeks on study are presented. (NCT03945981)
Timeframe: Week 24 and Week 48

InterventionParticipants (Count of Participants)
Week 24Week 48
DTG Plus 3TC115112

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Number of Participants With Any Serious Adverse Events (SAEs) and Any Common (>=2%) Non-serious Adverse Events (Non-SAEs) Under Treatment With DTG + 3TC FDC

An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations as judged by physician. Number of participants with any SAE and common (>=2%) non-SAEs are presented. (NCT03945981)
Timeframe: Up to Week 48

InterventionParticipants (Count of Participants)
Any non-SAEAny SAE
DTG Plus 3TC852

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Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC

Blood samples were collected up to Week 48 for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), albumin, aspartate aminotransferase (AST), Alkaline Phosphatase (ALP), bilirubin, carbon dioxide (CO2), creatinine kinase (CK), creatinine, glomerular filtration rate (GFR) from creatinine adjusted for body surface area (BSA), glucose, hypercalcemia, hyperkalemia, hypernatremia, hypocalcemia, hypokalemia, hyponatremia and phosphate. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Higher grade indicates more severity. Only those participants with maximum post-Baseline emergent chemistry toxicities in any of the chemistry parameters have been presented. (NCT03945981)
Timeframe: Up to Week 48

InterventionParticipants (Count of Participants)
ALT, Grade 1ALT, Grade 2ALT, Grade 3ALT, Grade 4Albumin, Grade 1Albumin, Grade 2Albumin, Grade 3Albumin, Grade 4AST, Grade 1AST, Grade 2AST, Grade 3AST, Grade 4Bilirubin, Grade 1Bilirubin, Grade 2Bilirubin, Grade 3Bilirubin, Grade 4CO2, Grade 1CO2, Grade 2CO2, Grade 3CO2, Grade 4CK, Grade 1CK, Grade 2CK, Grade 3CK, Grade 4Creatinine, Grade 1Creatinine, Grade 2Creatinine, Grade 3Creatinine, Grade 4GFR from creatinine adjusted for BSA,Grade 1GFR from creatinine adjusted for BSA,Grade 2GFR from creatinine adjusted for BSA,Grade 3GFR from creatinine adjusted for BSA,Grade 4Glucose, Grade 1Glucose, Grade 2Glucose, Grade 3Glucose, Grade 4Hypercalcaemia, Grade 1Hypercalcaemia, Grade 2Hypercalcaemia, Grade 3Hypercalcaemia, Grade 4Hyperkalemia, Grade 1Hyperkalemia, Grade 2Hyperkalemia, Grade 3Hyperkalemia, Grade 4Hypernatremia, Grade 1Hypernatremia, Grade 2Hypernatremia, Grade 3Hypernatremia, Grade 4Hypokalemia, Grade 1Hypokalemia, Grade 2Hypokalemia, Grade 3Hypokalemia, Grade 4Hyponatremia, Grade 1Hyponatremia, Grade 2Hyponatremia, Grade 3Hyponatremia, Grade 4Phosphate, Grade 1Phosphate, Grade 2Phosphate, Grade 3Phosphate, Grade 4Hypocalcaemia, Grade 1Hypocalcaemia, Grade 2Hypocalcaemia, Grade 3Hypocalcaemia, Grade 4ALP, Grade 1ALP, Grade 2ALP, Grade 3ALP, Grade 4
DTG Plus 3TC720101006111501020000010091200388127142050000100200010009000800051001000

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Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Under Treatment With DTG + 3TC FDC

Blood samples were collected up to Week 48 visit for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes Any abnormality was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Higher grade indicates more severity. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented. (NCT03945981)
Timeframe: Up to Week 48

InterventionParticipants (Count of Participants)
Hemoglobin, Grade 1Hemoglobin, Grade 2Hemoglobin, Grade 3Hemoglobin, Grade 4Leukocytes, Grade 1Leukocytes, Grade 2Leukocytes, Grade 3Leukocytes, Grade 4Neutrophils, Grade 1Neutrophils, Grade 2Neutrophils, Grade 3Neutrophils, Grade 4Platelets, Grade 1Platelets, Grade 2Platelets, Grade 3Platelets, Grade 4
DTG Plus 3TC5100521044211100

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Number of Participants With Treatment-emergent Genotypic Resistance

Blood samples were collected for genotypic resistance testing post-Baseline when Confirmed Virologic Failure criteria were met or in other occasion as needed (e.g. at time of study withdrawal when HIV-1 RNA >= 400 c/mL). New mutations were tabulated by drug class: integrase strand transfer inhibitor (INSTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI) and protease inhibitor (PI). Number of participants with treatment-emergent resistance associated mutations to any class (INSTI, NNRTI, NRTI, PI) from post-Baseline genotypic resistance data up to Week 48 have been presented. (NCT03945981)
Timeframe: Up to Week 48

InterventionParticipants (Count of Participants)
NNRTIINSTINRTIPI
DTG Plus 3TC0000

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Percentage of Participants With HIV-1 RNA < 50 c/mL at Weeks 24 and 48 Among Participants With Available HIV-1 RNA Assessment Regardless of ART

Participants with at least one viral load assessment within Week 24 and 48 visit window have been considered. Participants who discontinued from study prior to Week 24 and Week 48 or who were still on study at Week 24 and Week 48 but with missing viral load assessment have been excluded. Viral load assessments performed under DTG + 3TC FDC treatment or under any Modified ART treatment at Week 24 and Week 48 have been considered. Percentage of participants with HIV-1 RNA < 50 c/mL at Weeks 24 and 48 among participants with available HIV-1 RNA assessment regardless of ART have been presented. (NCT03945981)
Timeframe: At Week 24 and Week 48

InterventionPercentage of Participants (Number)
Week 24, n=111Week 48, n=110
DTG Plus 3TC9297

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Percentage of Participants With Plasma HIV-1 RNA <50 c/mL Using Food and Drug Administration (FDA) Snapshot Algorithm

Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (either due to missing plasma HIV-1 RNA assessment but on study, or due to permanent discontinuation of study treatment prior to visit window) as virologic non-success, as well as participants who switched from first line regimen of DTG + 3TC FDC for any reason prior to the visit of interest. Confidence intervals were calculated based on the Exact Clopper-Pearson method. Percentage of participants with plasma HIV-1 RNA <50 c/mL obtained using FDA Snapshot algorithm are presented. (NCT03945981)
Timeframe: At Week 24 and Week 48

InterventionPercentage of Participants (Number)
Week 24Week 48
DTG Plus 3TC7476

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Number of Participants With HIV-1 Disease Progression to Stage 3 HIV-associated Conditions, Acquired Immunodeficiency Syndrome (AIDS) or Death (for Participants Under Treatment With DTG + 3TC FDC)

HIV-associated conditions were recorded during the study and was assessed according to the 2014 Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. CDC classification for HIV were stage 1, 2 and 3. Higher stage indicates more severity. Disease progression summarize participants who had HIV infection stage 3 associated conditions, AIDS and/or death. Number of participants with HIV-1 disease progression to stage 3 HIV-associated conditions, AIDS or death are presented. (NCT03945981)
Timeframe: Up to Week 48

InterventionParticipants (Count of Participants)
DTG Plus 3TC1

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Number of Participants Retained in Care for 24 and 48 Weeks on Study and Have HIV-1 RNA <200 c/mL

Number of participants retained in care for 24 and 48 weeks on study and have HIV-1 RNA <200 c/mL have been presented. (NCT03945981)
Timeframe: Week 24 and Week 48

InterventionParticipants (Count of Participants)
Week 24Week 48
DTG Plus 3TC110109

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Number of Participants With Treatment-emergent Phenotypic Resistance

Blood samples were collected for drug resistance testing post-Baseline when Confirmed Virologic Failure criteria were met or in other occasion as needed (e.g. at time of study withdrawal when HIV-1 RNA >= 400 c/mL). Assessment of antiviral activity of ART using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences) and provides the overall susceptibility of the drug. Number of participants with phenotypic resistance to DTG and/or 3TC or any other ART (if treatment is modified) taken during the study in participants with post-Baseline phenotypic resistance data up to Week 48 have been presented. (NCT03945981)
Timeframe: Up to Week 48

InterventionParticipants (Count of Participants)
DTG Plus 3TC0

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Number of Participants Who Discontinued the Study Treatment (DTG+3TC FDC) Due to AEs

An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued the study treatment (DTG plus 3TC) due to AEs are presented. (NCT03945981)
Timeframe: Up to Week 48

InterventionParticipants (Count of Participants)
DTG Plus 3TC1

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Change From Baseline in HIV-1 RNA Through Week 24

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log 10) values for plasma HIV-1 RNA has been presented. Change from Baseline is defined as post-dose visit value minus Baseline value. (NCT04900038)
Timeframe: At Week 24 compared to baseline (Day 1)

Interventionlog10 c/mL (Mean)
GSK3640254 100 mg + Dolutegravir (DTG) 50 mg-3.306
GSK3640254 150 mg + DTG 50 mg-2.874
GSK3640254 200 mg + DTG 50 mg-3.186
DTG 50 mg + Lamivudine (3TC) 300 mg-2.767

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Number of Participants Who Develop Genotypic Resistance up to Week 24

"Blood samples were collected for drug resistance testing to assess the development of viral resistance to GSK3640254 through Week 24. New mutations were tabulated by drug class: integrase strand transfer inhibitor (INSTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI) and protease inhibitor (PI).~Protocol-Defined Virologic Failure (PDVF) was defined as having virologic non-response (HIV-1 RNA <1.0 log10 c/mL reduction from baseline and <200 copies/mL by Week 12, confirmed levels >=200 c/mL at or after Week 24 and plasma HIV-1 RNA <= 50 c/mL from testing on Week 24, virologic rebound (confirmed HIV-1 RNA >=200 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL)." (NCT04900038)
Timeframe: From Day 1 up to Week 24

InterventionParticipants (Count of Participants)
GSK3640254 100 mg + Dolutegravir (DTG) 50 mg0
GSK3640254 150 mg + DTG 50 mg0
GSK3640254 200 mg + DTG 50 mg0
DTG 50 mg + Lamivudine (3TC) 300 mg0

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Number of Participants Who Develop Phenotypic Resistance up to Week 24

Blood samples were collected for drug resistance testing to assess the development of viral resistance to GSK3640254 and other on-study Anti-Retroviral Therapy (ART) in participants experiencing virologic failure through Week 24. Only plasma HIV-1 RNA values determined by the central laboratory were used to assess virologic failure. PDVF was defined as having virologic non-response (HIV-1 RNA <1.0 log10 c/mL reduction from baseline and <200 copies/mL by Week 12, confirmed levels >=200 c/mL at or after Week 24 and plasma HIV-1 RNA <= 50 c/mL from testing on Week 24, virologic rebound (confirmed HIV-1 RNA >=200 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL). (NCT04900038)
Timeframe: From Day 1 up to Week 24

InterventionParticipants (Count of Participants)
GSK3640254 100 mg + Dolutegravir (DTG) 50 mg0
GSK3640254 150 mg + DTG 50 mg0
GSK3640254 200 mg + DTG 50 mg0
DTG 50 mg + Lamivudine (3TC) 300 mg0

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Number of Participants With Adverse Events (AEs) Leading to Discontinuation, up to End of Continued Access to Treatment Post-study Termination (Day 478)

Number of participants who discontinued treatment due to AEs are presented. The study was terminated by the sponsor after primary analysis (at week 24). Adverse event data were collected up to end of continued access to treatment post-study termination (Day 478). (NCT04900038)
Timeframe: From Day 1 up to end of continued access to treatment post-study termination (Day 478)

InterventionParticipants (Count of Participants)
GSK3640254 100 mg + Dolutegravir (DTG) 50 mg1
GSK3640254 150 mg + DTG 50 mg0
GSK3640254 200 mg + DTG 50 mg1
DTG 50 mg + Lamivudine (3TC) 300 mg0

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Absolute Values of Cluster of Differentiation 4+ (CD4+) T-cell Counts Through Week 24

Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity. Baseline is defined as the latest non-missing value prior to first dose of treatment according to date and time including unscheduled visits. (NCT04900038)
Timeframe: At Baseline (Day 1) and Week 24

,,,
Interventioncells per cubic millimeter (cells/mm^3) (Mean)
Baseline (Day 1)Week 24
DTG 50 mg + Lamivudine (3TC) 300 mg506.9627.5
GSK3640254 100 mg + Dolutegravir (DTG) 50 mg436.7753.4
GSK3640254 150 mg + DTG 50 mg451.4661.0
GSK3640254 200 mg + DTG 50 mg534.8756.1

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Absolute Values of HIV-1 RNA Through Week 24

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log 10) values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest non-missing value prior to first dose of treatment according to date and time including unscheduled visits. (NCT04900038)
Timeframe: At Baseline (Day 1) and Week 24

,,,
Interventionlog10 copies per milliliter(log10 c/mL) (Mean)
Baseline (Day 1)Week 24
DTG 50 mg + Lamivudine (3TC) 300 mg4.1791.379
GSK3640254 100 mg + Dolutegravir (DTG) 50 mg4.6141.315
GSK3640254 150 mg + DTG 50 mg4.4461.532
GSK3640254 200 mg + DTG 50 mg4.5351.349

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Number of Participants With Adverse Events of Special Interest (AESIs), up to End of Continued Access to Treatment Post-study Termination (Day 478)

"AEs of special interest (AESIs) included AEs related to QT prolongation, gastrointestinal (GI) intolerability/toxicity, psychiatric events, nervous system disorders, skin and subcutaneous tissue disorders and cardiac disorders.~The study was terminated by the sponsor after primary analysis (at week 24). Adverse event data were collected up to end of continued access to treatment post-study termination (Day 478)." (NCT04900038)
Timeframe: From Day 1 up to end of continued access to treatment post-study termination (Day 478)

,,,
InterventionParticipants (Count of Participants)
AEs related to QT prolongationAEs related to GI intolerability/toxicityAEs related to psychiatric eventsAEs related to nervous system disordersAEs related to skin and subcutaneous tissue disorderAEs related to cardiac disorders
DTG 50 mg + Lamivudine (3TC) 300 mg054200
GSK3640254 100 mg + Dolutegravir (DTG) 50 mg050241
GSK3640254 150 mg + DTG 50 mg073400
GSK3640254 200 mg + DTG 50 mg080540

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Number of Participants With Serious Adverse Events (SAEs) and Deaths, up to End of Continued Access to Treatment Post-study Termination (Day 478)

"An SAE is defined as any serious adverse event that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity and is a congenital anomaly/birth defect.~The study was terminated by the sponsor after primary analysis (at week 24). Adverse event data were collected up to end of continued access to treatment post-study termination (Day 478)." (NCT04900038)
Timeframe: From Day 1 up to end of continued access to treatment post-study termination (Day 478)

,,,
InterventionParticipants (Count of Participants)
SAEsDeath
DTG 50 mg + Lamivudine (3TC) 300 mg10
GSK3640254 100 mg + Dolutegravir (DTG) 50 mg20
GSK3640254 150 mg + DTG 50 mg00
GSK3640254 200 mg + DTG 50 mg00

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Trough Concentration (Ctrough) of GSK3640254 at Weeks 2, 4, 8, 12 and 24

Trough concentration (Ctrough) is the concentration reached by a drug immediately before the next dose is administered. This was determined to assess the steady-state exposure of GSK3640254 when given in combination with DTG. (NCT04900038)
Timeframe: At Weeks 2, 4, 8, 12 (PRE DOSE), 12 (2-6HR POST DOSE), 24 (PRE DOSE), 24 (2-6HR POST DOSE)

,,
Interventionnanogram per milliliter (ng/mL) (Geometric Mean)
Week 2Week 4Week 8Week 12 ( PRE DOSE)Week 12 (2-6HR POST DOSE)Week 24 ( PRE DOSE)Week 24 (2-6HR POST DOSE)
GSK3640254 100 mg + Dolutegravir (DTG) 50 mg340.2417.8386.2481.3767.8396.0759.0
GSK3640254 150 mg + DTG 50 mg549.9632.7646.6611.41081.2570.11107.0
GSK3640254 200 mg + DTG 50 mg724.2799.6821.1877.21658.1848.81584.1

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Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (c/mL) at Week 24

Percentage of participants with plasma HIV-1 RNA <50 c/mL at Week 24 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to evaluate the antiviral activity in HIV-1 infected ART (anti-retroviral therapy)-naïve participants. (NCT04900038)
Timeframe: At Week 24

InterventionPercentage of participants (Number)
GSK3640254 100 mg + Dolutegravir (DTG) 50 mg95
GSK3640254 150 mg + DTG 50 mg85
GSK3640254 200 mg + DTG 50 mg77
DTG 50 mg + Lamivudine (3TC) 300 mg86

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Change From Baseline in CD4+ T-cell Counts Through Week 24

Blood samples were collected and CD4+ cell count assessment was carried out to evaluate the immunologic activity. Change from Baseline is defined as post-dose visit value minus Baseline value. (NCT04900038)
Timeframe: At Week 24 compared to baseline (Day 1)

Interventioncells/mm^3 (Mean)
GSK3640254 100 mg + Dolutegravir (DTG) 50 mg317.7
GSK3640254 150 mg + DTG 50 mg200.6
GSK3640254 200 mg + DTG 50 mg241.2
DTG 50 mg + Lamivudine (3TC) 300 mg139.5

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