Page last updated: 2024-10-16

adenine and Complications, Infectious Pregnancy

adenine has been researched along with Complications, Infectious Pregnancy in 62 studies

Research Excerpts

ExcerptRelevanceReference
"When started in pregnancy, dolutegravir-containing regimens had superior virological efficacy at delivery compared with the efavirenz, emtricitabine, and tenofovir disoproxil fumarate regimen."9.41Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2 ( Amico, KR; Brummel, SS; Cassim, H; Chakhtoura, N; Chinula, L; Coletti, A; Currier, J; Fairlie, L; Frenkel, LM; Hanley, S; Hoffman, RM; Holmes, LB; Jean-Philippe, P; João, E; Johnston, B; Korutaro, V; Krotje, C; Lockman, S; Masheto, G; McCarthy, K; Mmbaga, BT; Momper, JD; Moyo, S; Purdue, L; Rooney, JF; Sax, PE; Shapiro, RL; Stranix-Chibanda, L; Stringer, JS; Thoofer, NK; Ziemba, L, 2021)
"Atazanavir exposure is reduced by pregnancy and by concomitant tenofovir use."9.15Atazanavir pharmacokinetics with and without tenofovir during pregnancy. ( Basar, M; Best, BM; Burchett, SK; Capparelli, EV; Hawkins, E; Hu, C; Mirochnick, M; Read, JS; Rossi, SS; Smith, E; Stek, AM, 2011)
"Tenofovir disoproxil fumarate (TDF) safety during pregnancy has important public health implications."8.89Safety of tenofovir during pregnancy for the mother and fetus: a systematic review. ( Bulterys, M; Ellington, S; Kourtis, AP; Legardy-Williams, J; Wang, L, 2013)
"We reviewed the published literature by conducting database searches of in vitro, animal and clinical studies, reported in journals and at conferences, using the search terms Tenofovir/gs4331/viread, pregnant/pregnancy, lactate, lactation, natal, reproduce/reproduction, placenta/placental, malformation, and teratogenicity/teratogenic."8.85Tenofovir disoproxil fumarate in pregnancy and prevention of mother-to-child transmission of HIV-1: is it time to move on from zidovudine? ( Foster, C; Gibb, DM; Lyall, H; Olmscheid, B; Pearce, G; Zhang, S, 2009)
" These pregnant females developed lamivudine (LAM)- or telbivudine (LdT)-resistant chronic hepatitis B and received tenofovir (TDF) therapy (300 mg/d), and its curative effect, maternal and perinatal adverse events, fetal growth and development, and neonatal prognosis were evaluated."7.81Tenofovir rescue therapy in pregnant females with chronic hepatitis B. ( Cai, HD; Cao, YJ; Hu, YH; Liu, M; Yi, W, 2015)
"To determine whether maternal use of tenofovir disoproxil fumarate for treatment of HIV in pregnancy predicts fetal and infant growth."7.79Infant growth outcomes after maternal tenofovir disoproxil fumarate use during pregnancy. ( Huo, Y; Livingston, EG; Patel, K; Ransom, CE; Scott, GB; Siberry, GK; Watts, HD; Williams, P, 2013)
"To evaluate the effects of tenofovir disoproxil fumarate (TDF) use during late pregnancy to reduce hepatitis B virus (HBV) transmission in highly viremic mothers."7.79Efficacy and safety of tenofovir disoproxil fumarate in pregnancy for the prevention of vertical transmission of HBV infection. ( Ay, M; Ayaz, C; Barcin, T; Celen, MK; Dal, MS; Dal, T; Gulsun, S; Kalkanli, S; Kaya, S; Mert, D; Yildirim, N, 2013)
"Tenofovir may be associated with a lower hazard or rate of pregnancy in women receiving HAART."7.78Tenofovir use and pregnancy among women initiating HAART. ( Firnhaber, C; Maskew, M; Sanne, I; Westreich, D, 2012)
"To evaluate the association of tenofovir disoproxil fumarate (TDF) use during pregnancy with early growth parameters in HIV-exposed, uninfected (HEU) infants."7.78Safety of tenofovir use during pregnancy: early growth outcomes in HIV-exposed uninfected infants. ( DiMeglio, LA; Griner, R; Hazra, R; Jacobson, DL; Kacanek, D; Mendez, H; Miller, T; Mofenson, LM; Rich, KC; Seage, GR; Siberry, GK; Tassiopoulos, K; Watts, DH; Williams, PL, 2012)
"According to the European AIDS Clinical Society, tenofovir disoproxil fumarate can be used in HIV-infected pregnant women if started prior to pregnancy, although no data are available on the pharmacokinetics of tenofovir (TFV) during pregnancy."7.78Pregnancy-related effects on tenofovir pharmacokinetics: a population study with 186 women. ( Benaboud, S; Bouazza, N; Chappuy, H; Firtion, G; Foissac, F; Hirt, D; Launay, O; Pannier, E; Rey, E; Tréluyer, JM; Urien, S, 2012)
"International Maternal Pediatric Adolescent AIDS Clinical Trials Group 1026s is a prospective, nonblinded, pharmacokinetic study of HIV-infected pregnant women taking antiretrovirals for clinical indications, including 2 cohorts (with or without tenofovir) receiving atazanavir/ritonavir 300/100 mg once daily during the second trimester, 400/100 mg during the third trimester, and 300/100 mg postpartum (PP)."6.78Pharmacokinetics of an increased atazanavir dose with and without tenofovir during the third trimester of pregnancy. ( Best, BM; Burchett, SK; Byroads, M; Caparelli, E; Cressey, TR; Hawkins, E; Kreitchmann, R; Mirochnick, M; Rossi, S; Shapiro, DE; Smith, E; Stek, A; Wang, J; Watts, DH, 2013)
"During follow-up, no bone fractures were reported to have occurred; 12/368 creatinines and seven out of 305 phosphates were grade one (16) or two (three) in 14 children with no effect of in utero tenofovir (p>0."6.77Pregnancy and infant outcomes among HIV-infected women taking long-term ART with and without tenofovir in the DART trial. ( Chidziva, E; Gibb, DM; Gilks, CF; Grosskurth, H; Hakim, J; Kizito, H; Kyomugisha, H; Munderi, P; Musoke, P; Nalumenya, R; Nathoo, K; Russell, EC; Spyer, M; Tumukunde, D; Walker, AS; Zalwango, E, 2012)
"When started in pregnancy, dolutegravir-containing regimens had superior virological efficacy at delivery compared with the efavirenz, emtricitabine, and tenofovir disoproxil fumarate regimen."5.41Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2 ( Amico, KR; Brummel, SS; Cassim, H; Chakhtoura, N; Chinula, L; Coletti, A; Currier, J; Fairlie, L; Frenkel, LM; Hanley, S; Hoffman, RM; Holmes, LB; Jean-Philippe, P; João, E; Johnston, B; Korutaro, V; Krotje, C; Lockman, S; Masheto, G; McCarthy, K; Mmbaga, BT; Momper, JD; Moyo, S; Purdue, L; Rooney, JF; Sax, PE; Shapiro, RL; Stranix-Chibanda, L; Stringer, JS; Thoofer, NK; Ziemba, L, 2021)
" The likelihood of renal toxicity (proximal renal tubular dysfunction [PRTD]) correlated with plasma drug concentrations, which depended on the dosage regimen and age-related changes in drug clearance."5.35Chronic administration of tenofovir to rhesus macaques from infancy through adulthood and pregnancy: summary of pharmacokinetics and biological and virological effects. ( Abel, K; Bischofberger, N; Brignolo, LL; Cihlar, T; Durand-Gasselin, L; Jerome, C; Kearney, BP; Marthas, ML; Moore, J; Ray, AS; Reiser, H; Spinner, A; Van Rompay, KK, 2008)
"Atazanavir exposure is reduced by pregnancy and by concomitant tenofovir use."5.15Atazanavir pharmacokinetics with and without tenofovir during pregnancy. ( Basar, M; Best, BM; Burchett, SK; Capparelli, EV; Hawkins, E; Hu, C; Mirochnick, M; Read, JS; Rossi, SS; Smith, E; Stek, AM, 2011)
"Tenofovir disoproxil fumarate (TDF) safety during pregnancy has important public health implications."4.89Safety of tenofovir during pregnancy for the mother and fetus: a systematic review. ( Bulterys, M; Ellington, S; Kourtis, AP; Legardy-Williams, J; Wang, L, 2013)
"We reviewed the published literature by conducting database searches of in vitro, animal and clinical studies, reported in journals and at conferences, using the search terms Tenofovir/gs4331/viread, pregnant/pregnancy, lactate, lactation, natal, reproduce/reproduction, placenta/placental, malformation, and teratogenicity/teratogenic."4.85Tenofovir disoproxil fumarate in pregnancy and prevention of mother-to-child transmission of HIV-1: is it time to move on from zidovudine? ( Foster, C; Gibb, DM; Lyall, H; Olmscheid, B; Pearce, G; Zhang, S, 2009)
"Tenofovir alafenamide (TAF) is a key component of HIV treatment, but pharmacokinetic data supporting the use of TAF during pregnancy are limited."4.12Pharmacokinetics of Tenofovir Alafenamide With Boosted Protease Inhibitors in Pregnant and Postpartum Women Living With HIV: Results From IMPAACT P1026s. ( Barr, E; Best, BM; Brooks, KM; Browning, R; Capparelli, EV; Chakhtoura, N; Deville, JG; Febo, IL; George, K; Knowles, K; Mirochnick, M; Paul, ME; Pinilla, M; Rungruengthanakit, K; Shapiro, DE; Stek, AM, 2022)
"To observe the clinical efficacy of combination therapy with peg-IFNalpha and adefovir (CPIA) in women who were hepatfis B virus (HBV) carriers and had just given birth and received telbivudine (LdT) during pregnancy for prevention of mother-to-child transmission."3.81[Efficacy of combination antiviral therapy following childbirth in pregnant HBV carriers receiving telbivudine for prevention of mother-to-child transmission]. ( Cao, ZH; Chen, XY; He, ZM; Jin, Y; Liu, YL; Lu, JF; Ma, LN; Zhang, SB, 2015)
" These pregnant females developed lamivudine (LAM)- or telbivudine (LdT)-resistant chronic hepatitis B and received tenofovir (TDF) therapy (300 mg/d), and its curative effect, maternal and perinatal adverse events, fetal growth and development, and neonatal prognosis were evaluated."3.81Tenofovir rescue therapy in pregnant females with chronic hepatitis B. ( Cai, HD; Cao, YJ; Hu, YH; Liu, M; Yi, W, 2015)
"To evaluate the effects of tenofovir disoproxil fumarate (TDF) use during late pregnancy to reduce hepatitis B virus (HBV) transmission in highly viremic mothers."3.79Efficacy and safety of tenofovir disoproxil fumarate in pregnancy for the prevention of vertical transmission of HBV infection. ( Ay, M; Ayaz, C; Barcin, T; Celen, MK; Dal, MS; Dal, T; Gulsun, S; Kalkanli, S; Kaya, S; Mert, D; Yildirim, N, 2013)
"To determine whether maternal use of tenofovir disoproxil fumarate for treatment of HIV in pregnancy predicts fetal and infant growth."3.79Infant growth outcomes after maternal tenofovir disoproxil fumarate use during pregnancy. ( Huo, Y; Livingston, EG; Patel, K; Ransom, CE; Scott, GB; Siberry, GK; Watts, HD; Williams, P, 2013)
"Emerging international guidelines for the prevention of mother-to-child transmission of HIV infection across sub-Saharan Africa call for the initiation of a triple-drug antiretroviral regimen containing tenofovir, a potentially nephrotoxic agent, in all HIV-infected pregnant women at the first antenatal clinic visit."3.79Low prevalence of renal dysfunction in HIV-infected pregnant women: implications for guidelines for the prevention of mother-to-child transmission of HIV. ( Bekker, LG; Kamkuemah, M; Kaplan, R; Myer, L, 2013)
"According to the European AIDS Clinical Society, tenofovir disoproxil fumarate can be used in HIV-infected pregnant women if started prior to pregnancy, although no data are available on the pharmacokinetics of tenofovir (TFV) during pregnancy."3.78Pregnancy-related effects on tenofovir pharmacokinetics: a population study with 186 women. ( Benaboud, S; Bouazza, N; Chappuy, H; Firtion, G; Foissac, F; Hirt, D; Launay, O; Pannier, E; Rey, E; Tréluyer, JM; Urien, S, 2012)
"To evaluate the association of tenofovir disoproxil fumarate (TDF) use during pregnancy with early growth parameters in HIV-exposed, uninfected (HEU) infants."3.78Safety of tenofovir use during pregnancy: early growth outcomes in HIV-exposed uninfected infants. ( DiMeglio, LA; Griner, R; Hazra, R; Jacobson, DL; Kacanek, D; Mendez, H; Miller, T; Mofenson, LM; Rich, KC; Seage, GR; Siberry, GK; Tassiopoulos, K; Watts, DH; Williams, PL, 2012)
"Tenofovir may be associated with a lower hazard or rate of pregnancy in women receiving HAART."3.78Tenofovir use and pregnancy among women initiating HAART. ( Firnhaber, C; Maskew, M; Sanne, I; Westreich, D, 2012)
"A TDF dosing regimen of 600 mg during labor and daily infant doses of 6 mg/kg maintains infant tenofovir plasma concentration above 50 ng/mL throughout the first week of life and should be used in the studies of TDF efficacy for HIV prevention of mother-to-child transmission and early infant treatment."2.79Pharmacokinetics and safety of tenofovir in HIV-infected women during labor and their infants during the first week of life. ( Emel, L; Eshleman, SH; Fowler, MG; George, K; Herron, C; Hudelson, SE; Joao, E; Kearney, B; Kreitchmann, R; Kumwenda, N; Mirochnick, M; Mofenson, L; Nielsen-Saines, K; Parsons, T; Pinto, J; Richardson, P; Santos, B; Sato, P; Taha, T, 2014)
"Although pharmacokinetic exposure of the NRTIs TDF and FTC during pregnancy is approximately 25% lower, this was not associated with virological failure in this study and did not result in mother-to-child transmission."2.78The pharmacokinetics, safety and efficacy of tenofovir and emtricitabine in HIV-1-infected pregnant women. ( Burger, DM; Colbers, AP; Giaquinto, C; Gingelmaier, A; Hawkins, DA; Ivanovic, J; Kabeya, K; Moltó, J; Rockstroh, JK; Sadiq, ST; Taylor, GP; Weizsäcker, K; Wyen, C, 2013)
"International Maternal Pediatric Adolescent AIDS Clinical Trials Group 1026s is a prospective, nonblinded, pharmacokinetic study of HIV-infected pregnant women taking antiretrovirals for clinical indications, including 2 cohorts (with or without tenofovir) receiving atazanavir/ritonavir 300/100 mg once daily during the second trimester, 400/100 mg during the third trimester, and 300/100 mg postpartum (PP)."2.78Pharmacokinetics of an increased atazanavir dose with and without tenofovir during the third trimester of pregnancy. ( Best, BM; Burchett, SK; Byroads, M; Caparelli, E; Cressey, TR; Hawkins, E; Kreitchmann, R; Mirochnick, M; Rossi, S; Shapiro, DE; Smith, E; Stek, A; Wang, J; Watts, DH, 2013)
"During follow-up, no bone fractures were reported to have occurred; 12/368 creatinines and seven out of 305 phosphates were grade one (16) or two (three) in 14 children with no effect of in utero tenofovir (p>0."2.77Pregnancy and infant outcomes among HIV-infected women taking long-term ART with and without tenofovir in the DART trial. ( Chidziva, E; Gibb, DM; Gilks, CF; Grosskurth, H; Hakim, J; Kizito, H; Kyomugisha, H; Munderi, P; Musoke, P; Nalumenya, R; Nathoo, K; Russell, EC; Spyer, M; Tumukunde, D; Walker, AS; Zalwango, E, 2012)
" All regimens were safe and well tolerated."2.76Pharmacokinetics and safety of single-dose tenofovir disoproxil fumarate and emtricitabine in HIV-1-infected pregnant women and their infants. ( Bardeguez, A; Cotter, A; Fiscus, SA; Flynn, PM; Heckman, B; Huang, S; Jean-Philippe, P; Kearney, B; Mirochnick, M; Mofenson, LM; Purswani, M; Robbins, B; Rodman, J; Rooney, JF; Shapiro, DE; Thorpe, E; Van Rompay, KK; Watts, DH, 2011)
"Should treatment of chronic hepatitis B virus infection be necessary during pregnancy, tenofovir, listed by the FDA as pregnancy category B drug, is to be preferred."2.49[Interdisciplinary aspects of and new drugs for chronic hepatitis B]. ( Horváth, G, 2013)
"Specialized treatment of CHB in pregnancy, coinfection, decompensated cirrhosis, and posttransplant is safe and effective."2.48New advances in chronic hepatitis B. ( Lee, WM; Tujios, SR, 2012)
" More comprehensive in vivo pharmacokinetic data are required to justify the potential use of these agents as safe and effective options during pregnancy."2.47Pharmacokinetics of antiretroviral drugs in anatomical sanctuary sites: the fetal compartment (placenta and amniotic fluid). ( Back, DJ; Else, LJ; Khoo, SH; Taylor, S, 2011)
" Secondary assessments included maternal HBV DNA reduction at delivery, and maternal or infant adverse events during follow up."1.56Efficacy and safety of tenofovir alafenamide fumarate for preventing mother-to-child transmission of hepatitis B virus: a national cohort study. ( Cao, L; Chen, B; Chen, R; Ding, Y; Fan, J; Gan, W; Huang, Y; Lin, C; Liu, Y; Pan, CQ; Sheng, Q; Wang, S; Wang, Y; Zhu, L, 2020)
"Pregnancy is a time of increased HIV acquisition risk and pregnancy reduces concentrations of antiretrovirals used for treatment."1.48Tenofovir and tenofovir-diphosphate concentrations during pregnancy among HIV-uninfected women using oral preexposure prophylaxis. ( Anderson, PL; Asiimwe, S; Baeten, JM; Bukusi, EA; Celum, C; Donnell, D; Haberer, JE; Heffron, R; Hendrix, CW; Katabira, E; Marzinke, MA; Mugo, NR; Mugwanya, K; Pyra, M; Thomas, KK, 2018)
"No increased risk of major birth defects including in non-live births was observed for pregnant women exposed to antivirals relevant to CHB treatment overall or to LAM or TDF compared to population-based controls."1.38Hepatitis B virus and human immunodeficiency virus drugs in pregnancy: findings from the Antiretroviral Pregnancy Registry. ( Aguilar, C; Brown, RS; Buti, M; Fagan, EA; Leu, CS; Pereira, MR; Tilson, HH; Verna, EC, 2012)
"New insights into the treatment of chronic hepatitis B with relevance for clinical practice have been adopted in these concise, revised guidelines."1.38The 2012 revised Dutch national guidelines for the treatment of chronic hepatitis B virus infection. ( Baak, BC; Bakker, CM; Beuers, UH; Brouwer, JT; Buster, EH; Drenth, JP; Honkoop, P; Janssen, HL; Kerbert-Dreteler, MJ; Koek, GH; Tan, AC; van der Spek, BW; van Erpecum, KJ; van Hoek, B; van Nieuwkerk, KM; van Soest, H; Vrolijk, JM, 2012)
"6-h half-life (30%)."1.35Population pharmacokinetics of emtricitabine in human immunodeficiency virus type 1-infected pregnant women and their neonates. ( Arrivé, E; Avit, D; Blanche, S; Coffié, P; Dabis, F; Ekouévi, DK; Hirt, D; Lalsab, S; Leang, SK; McIntyre, J; Nerrienet, E; Rey, E; Tréluyer, JM; Urien, S, 2009)
" The likelihood of renal toxicity (proximal renal tubular dysfunction [PRTD]) correlated with plasma drug concentrations, which depended on the dosage regimen and age-related changes in drug clearance."1.35Chronic administration of tenofovir to rhesus macaques from infancy through adulthood and pregnancy: summary of pharmacokinetics and biological and virological effects. ( Abel, K; Bischofberger, N; Brignolo, LL; Cihlar, T; Durand-Gasselin, L; Jerome, C; Kearney, BP; Marthas, ML; Moore, J; Ray, AS; Reiser, H; Spinner, A; Van Rompay, KK, 2008)

Research

Studies (62)

TimeframeStudies, this research(%)All Research%
pre-19902 (3.23)18.7374
1990's1 (1.61)18.2507
2000's8 (12.90)29.6817
2010's46 (74.19)24.3611
2020's5 (8.06)2.80

Authors

AuthorsStudies
Brooks, KM2
Pinilla, M1
Stek, AM2
Shapiro, DE3
Barr, E1
Febo, IL1
Paul, ME1
Deville, JG1
George, K2
Knowles, K1
Rungruengthanakit, K1
Browning, R1
Chakhtoura, N2
Capparelli, EV2
Mirochnick, M6
Best, BM3
Eke, AC1
Gebreyohannes, RD1
Sheffield, JS1
Dooley, KE1
Hui, PW1
Ng, C1
Cheung, KW1
Lai, CL1
Ding, Y1
Cao, L1
Zhu, L1
Huang, Y1
Lin, C1
Wang, Y1
Liu, Y1
Sheng, Q1
Wang, S1
Fan, J1
Chen, R1
Gan, W1
Chen, B1
Pan, CQ1
Lockman, S2
Brummel, SS1
Ziemba, L1
Stranix-Chibanda, L1
McCarthy, K1
Coletti, A1
Jean-Philippe, P2
Johnston, B1
Krotje, C1
Fairlie, L2
Hoffman, RM1
Sax, PE1
Moyo, S1
Stringer, JS3
Masheto, G1
Korutaro, V1
Cassim, H1
Mmbaga, BT1
João, E2
Hanley, S1
Purdue, L1
Holmes, LB1
Momper, JD1
Shapiro, RL1
Thoofer, NK1
Rooney, JF2
Frenkel, LM2
Amico, KR1
Chinula, L1
Currier, J1
Pyra, M1
Anderson, PL1
Hendrix, CW2
Heffron, R2
Mugwanya, K1
Haberer, JE1
Thomas, KK1
Celum, C2
Donnell, D1
Marzinke, MA1
Bukusi, EA1
Mugo, NR2
Asiimwe, S1
Katabira, E1
Baeten, JM2
Venter, WDF1
Moorhouse, M1
Sokhela, S1
Mashabane, N1
Masenya, M1
Serenata, C1
Akpomiemie, G1
Qavi, A1
Chandiwana, N1
Norris, S1
Chersich, M1
Clayden, P1
Abrams, E1
Arulappan, N1
Vos, A1
McCann, K1
Simmons, B1
Hill, A1
Horváth, G1
Taha, T1
Kreitchmann, R2
Nielsen-Saines, K1
Kumwenda, N1
Pinto, J1
Santos, B1
Parsons, T1
Kearney, B2
Emel, L1
Herron, C1
Richardson, P1
Hudelson, SE1
Eshleman, SH1
Fowler, MG1
Sato, P1
Mofenson, L1
Wang, L1
Kourtis, AP2
Ellington, S1
Legardy-Williams, J1
Bulterys, M2
Myer, L1
Kamkuemah, M1
Kaplan, R1
Bekker, LG1
Ransom, CE1
Huo, Y1
Patel, K1
Scott, GB1
Watts, HD1
Williams, P1
Siberry, GK2
Livingston, EG1
Celen, MK1
Mert, D1
Ay, M1
Dal, T1
Kaya, S1
Yildirim, N1
Gulsun, S1
Barcin, T1
Kalkanli, S1
Dal, MS1
Ayaz, C1
Nguyen, V2
Tan, PK2
Greenup, AJ2
Glass, A2
Davison, S2
Samarasinghe, D2
Holdaway, S2
Strasser, SI1
Chatterjee, U2
Jackson, K2
Locarnini, SA2
Levy, MT2
Price, AJ1
Kayange, M1
Zaba, B1
Chimbwandira, FM1
Jahn, A1
Chirwa, Z1
Dasgupta, AN1
Katundu, C1
Saul, JL1
Glynn, JR1
Koole, O1
Crampin, AC1
Gerlich, WH1
Matthews, LT1
Cohen, CR1
Bangsberg, DR1
Mistry, N1
Sereboe, L1
Oakeshott, P1
Hu, YH1
Liu, M1
Yi, W1
Cao, YJ1
Cai, HD1
Chen, HL1
Lee, CN1
Chang, CH1
Ni, YH1
Shyu, MK1
Chen, SM1
Hu, JJ1
Lin, HH1
Zhao, LL1
Mu, SC1
Lai, MW1
Lee, CL1
Lin, HM1
Tsai, MS1
Hsu, JJ1
Chen, DS1
Chan, KA1
Chang, MH1
Lu, JF1
Liu, YL1
Ma, LN1
Cao, ZH1
He, ZM1
Jin, Y1
Zhang, SB1
Chen, XY1
Chi, BH2
Chintu, N2
Cantrell, RA2
Kankasa, C1
Kruse, G1
Mbewe, F2
Sinkala, M2
Smith, PJ1
Stringer, EM2
Van Rompay, KK2
Durand-Gasselin, L1
Brignolo, LL1
Ray, AS1
Abel, K1
Cihlar, T1
Spinner, A1
Jerome, C1
Moore, J1
Kearney, BP1
Marthas, ML2
Reiser, H1
Bischofberger, N2
Hirt, D5
Urien, S5
Ekouévi, DK4
Rey, E3
Arrivé, E4
Blanche, S4
Amani-Bosse, C2
Nerrienet, E3
Gray, G2
Kone, M2
Leang, SK2
McIntyre, J4
Dabis, F4
Tréluyer, JM5
Coffié, P1
Lalsab, S1
Avit, D2
Foster, C1
Lyall, H1
Olmscheid, B1
Pearce, G1
Zhang, S1
Gibb, DM2
Ellis, GM1
Aldrovandi, GM1
Warrier, R1
Nakamura, K1
Pinnetti, C1
Baroncelli, S1
Villani, P1
Fantoni, M1
Tozzi, V1
De Luca, A1
Cauda, R1
Anzidei, G1
Cusato, M1
Regazzi, M1
Floridia, M1
Tamburrini, E1
Baleta, A1
Romanelli, F1
Murphy, B1
Hughes, MD1
Zheng, Y1
Chipato, T1
Conradie, F1
Sawe, F1
Asmelash, A1
Hosseinipour, MC2
Mohapi, L1
Stringer, E1
Mngqibisa, R1
Siika, A1
Atwine, D1
Hakim, J2
Shaffer, D1
Kanyama, C1
Wools-Kaloustian, K1
Salata, RA1
Hogg, E1
Alston-Smith, B1
Walawander, A1
Purcelle-Smith, E1
Eshleman, S1
Rooney, J1
Rahim, S1
Mellors, JW1
Schooley, RT1
Currier, JS1
Bygrave, H1
Ford, N1
van Cutsem, G1
Hilderbrand, K1
Jouquet, G1
Goemaere, E1
Vlahakis, N1
Triviño, L1
Makakole, L1
Kranzer, K1
Hu, C1
Burchett, SK2
Rossi, SS1
Hawkins, E2
Basar, M1
Smith, E2
Read, JS1
Pruvost, A2
Nyati, M2
Kruy, LS1
Legote, S1
Ek, ML1
Say, L1
Donnelly, J1
Giles, M1
Visvanathan, K1
Sasadeusz, J1
Flynn, PM1
Bardeguez, A1
Rodman, J1
Robbins, B1
Huang, S1
Fiscus, SA1
Mofenson, LM2
Watts, DH3
Heckman, B1
Thorpe, E1
Cotter, A1
Purswani, M1
Benaboud, S1
Launay, O1
Pannier, E1
Firtion, G1
Bouazza, N1
Foissac, F1
Chappuy, H1
Else, LJ1
Taylor, S1
Back, DJ1
Khoo, SH1
Williams, PL1
Mendez, H1
Seage, GR1
Jacobson, DL1
Hazra, R1
Rich, KC1
Griner, R1
Tassiopoulos, K1
Kacanek, D1
Miller, T1
DiMeglio, LA1
Friend, DR1
Tujios, SR1
Lee, WM1
Kuhn, L1
Kizito, H1
Russell, EC1
Chidziva, E1
Zalwango, E1
Nalumenya, R1
Spyer, M1
Tumukunde, D1
Nathoo, K1
Munderi, P1
Kyomugisha, H1
Grosskurth, H1
Gilks, CF1
Walker, AS1
Musoke, P1
Brown, RS1
Verna, EC1
Pereira, MR1
Tilson, HH1
Aguilar, C1
Leu, CS1
Buti, M1
Fagan, EA1
Johnson, DC1
Chasela, C1
Maliwichi, M1
Mwafongo, A1
Akinkuotu, A1
Moses, A1
Jamieson, DJ1
King, CC1
van der Horst, C1
Maskew, M1
Westreich, D1
Firnhaber, C1
Sanne, I1
Kinai, E1
Hosokawa, S1
Gomibuchi, H1
Gatanaga, H1
Kikuchi, Y1
Oka, S1
Buster, EH1
Baak, BC1
Bakker, CM1
Beuers, UH1
Brouwer, JT1
Drenth, JP1
van Erpecum, KJ1
van Hoek, B1
Honkoop, P1
Kerbert-Dreteler, MJ1
Koek, GH1
van Nieuwkerk, KM1
van Soest, H1
van der Spek, BW1
Tan, AC1
Vrolijk, JM1
Janssen, HL1
Colbers, AP1
Hawkins, DA1
Gingelmaier, A1
Kabeya, K1
Rockstroh, JK1
Wyen, C1
Weizsäcker, K1
Sadiq, ST1
Ivanovic, J1
Giaquinto, C1
Taylor, GP1
Moltó, J1
Burger, DM1
Coffin, CS1
Fung, SK1
Ma, MM1
Wang, J1
Stek, A1
Caparelli, E1
Rossi, S1
Byroads, M1
Cressey, TR1
Genc, MR1
Vardhana, S1
Delaney, ML1
Onderdonk, A1
Tuomala, R1
Norwitz, E1
Witkin, SS1
Sabbatini, F1
Prati, F1
Borghi, V1
Bedini, A1
Esposito, R1
Mussini, C1
Tarantal, AF1
Shaw, JP1
Cundy, K1
Brunell, P1
Light, IJ1
Linnemann, CC1

Clinical Trials (16)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants[NCT03048422]Phase 3643 participants (Actual)Interventional2018-01-19Completed
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
WRHI 060 (ADVANCE): A Randomised, Phase 3 Non-inferiority Study of DTG + TAF + FTC Compared With DTG + TDF + FTC and EFV + TDF + FTC in Patients Infected With HIV-1 Starting First-line Antiretroviral Therapy - Extension to 192 Weeks[NCT03122262]Phase 31,110 participants (Actual)Interventional2017-01-16Completed
Can the Weight Gain Associated With Use of Integrase Strand Inhibitors be Halted or Reversed With a Switch to Doravirine/Lamivudine/Tenofovir DF in Patients Living With HIV? (DeLiTE)[NCT04665375]Phase 425 participants (Anticipated)Interventional2021-04-26Enrolling by invitation
Prevention of Mother-to-child Transmission of Hepatitis B Virus: a One Arm, Open Label Intervention Study to Estimate the Optimal Timing of Tenofovir (TDF) in Pregnancy[NCT02995005]Phase 1/Phase 298 participants (Actual)Interventional2018-05-24Completed
Pilot of an mHealth-enhanced, Safer Conception Intervention to Reduce HIV-1 Risk Among Kenyan HIV-1 Serodiscordant Couples[NCT03030768]74 participants (Actual)Observational2016-02-29Completed
Chronic HBV Infection in Pregnant Women Taking TAF to Prevent Mother-to-child Transmission in the Third Trimester: a Multicenter, Prospective Study[NCT04237376]600 participants (Anticipated)Observational2019-04-09Recruiting
Addition of Single-dose, Maternal Tenofovir and Emtricitabine to Reduce Non-nucleoside Reverse Transcriptase Inhibitor Resistance Mutations in the Setting of Zidovudine and Nevirapine for Prevention of Mother-to-child HIV Transmission[NCT00204308]Phase 2400 participants (Actual)Interventional2005-03-31Completed
Study of Placental Transfer of Tenofovir and Its Factors of Variability Using the Human Placental Perfusion Model[NCT02020083]369 participants (Actual)Observational2013-02-28Completed
Phase II Trial, Multicentre, Opened Label Evaluating the Pharmacokinetics and the Safety and Toxicity of the Tenofovir-Emtricitabine Combination in Pregnant Women and Infants in Africa and Asia[NCT00334256]Phase 272 participants (Actual)Interventional2006-10-31Completed
Maternal and Infant Monitoring for Evidence of Toxicity Related to Tenofovir Exposure: The Bone and Kidney Health Substudy of the IMPAACT 1077 PROMISE Protocol (Promoting Maternal and Infant Survival Everywhere)[NCT01066858]1,765 participants (Actual)Observational2011-03-22Completed
Optimal Combination Therapy After Nevirapine Exposure[NCT00089505]Phase 3745 participants (Actual)Interventional2006-11-30Completed
Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum[NCT00042289]1,578 participants (Actual)Observational2003-06-09Completed
Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women[NCT01310023]3,400 participants (Anticipated)Observational2007-03-31Recruiting
PC4PrEP: Integrating Pre-Exposure Prophylaxis (PrEP) Into Primary Care[NCT03617874]22 participants (Actual)Interventional2020-02-28Completed
Study on Pharmacokinetics of Newly Developed ANtiretroviral Agents in HIV-infected pregNAnt Women (PANNA)[NCT00825929]176 participants (Anticipated)Observational2009-02-28Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change in Maternal Weight Antepartum

Change in maternal antepartum weight per week based on generalized estimating equations (NCT03048422)
Timeframe: Baseline through before delivery (up to one day prior)

Interventionkg/week (Mean)
Arm 1: Maternal DTG+FTC/TAF0.378
Arm 2: Maternal DTG+FTC/TDF0.319
Arm 3: Maternal EFV/FTC/TDF0.291

Change in Maternal Weight Overall

Change in maternal weight per week based on generalized estimating equations (NCT03048422)
Timeframe: Baseline to 50 weeks postpartum

Interventionkg/week (Mean)
Arm 1: Maternal DTG+FTC/TAF-0.027
Arm 2: Maternal DTG+FTC/TDF-0.050
Arm 3: Maternal EFV/FTC/TDF-0.084

Change in Maternal Weight Postpartum

Change in maternal postpartum weight per week based on generalized estimating equations (NCT03048422)
Timeframe: Delivery to 50 weeks postpartum

Interventionkg/week (Mean)
Arm 1: Maternal DTG+FTC/TAF0.014
Arm 2: Maternal DTG+FTC/TDF-0.008
Arm 3: Maternal EFV/FTC/TDF-0.032

Count of Infants With HIV-1 Antiretroviral Drug Resistance Mutations at the Time of Infant HIV Diagnosis

Count of infants with HIV-1 antiretroviral drug resistance mutations (to any antiretroviral drug) at the time of infant HIV diagnosis, based on laboratory blood test results. (NCT03048422)
Timeframe: From birth through 50 weeks postpartum

InterventionParticipants (Count of Participants)
Arm 1 Infants1
Arm 2 Infants0
Arm 3 Infants1

Cumulative Probability of Infant Deaths

The Kaplan-Meier estimate of the cumulative probability of infant deaths from birth through 50 weeks after birth. (NCT03048422)
Timeframe: Birth through 50 weeks after birth

InterventionCumulative probability per 100 persons (Number)
Arm 1 Infants1.0
Arm 2 Infants2.0
Arm 3 Infants6.9

Cumulative Probability of Infant HIV-infection

The Kaplan-Meier estimate of the cumulative probability of infants acquiring HIV-1 infection from birth through 50 weeks after birth based on nucleic acid test results. (NCT03048422)
Timeframe: Birth through 50 weeks after birth

InterventionCumulative probability per 100 persons (Number)
Arm 1 Infants0.98
Arm 2 Infants0.50
Arm 3 Infants0.55

Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event

The Kaplan-Meier estimate of the cumulative probability of infants experiencing grade 3 or higher adverse events, including events resulting in death due to any cause. (NCT03048422)
Timeframe: Birth through Week 50 postpartum

InterventionCumulative probability per 100 persons (Number)
Arms 1 and 2 Infants26.8
Arm 3 Infants30.9

Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event

The Kaplan-Meier estimate of the cumulative probability of infants experiencing grade 3 or higher adverse events, including events resulting in death due to any cause. (NCT03048422)
Timeframe: From birth through Week 50 postpartum

InterventionCumulative probability per 100 persons (Number)
Arm 1 Infants25.3
Arm 2 Infants28.6
Arm 3 Infants30.9

Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event

"The Kaplan-Meier estimate of the cumulative probability of women experiencing grade 3 or higher adverse events, including events resulting in death due to any cause.~Time to first maternal grade 3 or higher adverse event was defined as the first grade 3 or higher adverse event that occurred after randomization and before 74 weeks of follow-up. The timeframe of 74 weeks was determined by adding up 56 weeks of postpartum follow-up to the mean duration of antepartum follow-up, which was 18 weeks." (NCT03048422)
Timeframe: From randomization up to 74 weeks

,
InterventionCumulative probability per 100 persons (Number)
Arm 1: Maternal DTG+FTC/TAF25.1
Arm 2: Maternal DTG+FTC/TDF30.8
Arm 3: Maternal EFV/FTC/TDF27.9
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF27.9
Arm 3: Maternal EFV/FTC/TDF27.9

Maternal Change in Creatinine Clearance

Maternal change in creatinine clearance per week based on generalized estimating equations (NCT03048422)
Timeframe: Baseline to 50 weeks postpartum

InterventionmL/min (Mean)
Arm 1: Maternal DTG+FTC/TAF-0.980
Arm 2: Maternal DTG+FTC/TDF-0.887
Arm 3: Maternal EFV/FTC/TDF-0.935

Percentage of Infants Born Small for Gestational Age

Percentage of infants born small for gestational age (<10th percentile adjusted for sex assigned at birth) based on Intergrowth 21st Standards (NCT03048422)
Timeframe: Birth

Interventionpercentage of participants (Number)
Arm 1 Infants16.3
Arm 2 Infants22.5
Arm 3 Infants20.5

Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome

Percentage of mother-infant pairs with an adverse pregnancy outcome. Adverse pregnancy outcome includes spontaneous abortion (<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (<37 completed weeks), or small for gestational age (<10th percentile by INTERGROWTH 21st Standards) (NCT03048422)
Timeframe: Delivery

Interventionpercentage of mother-infant pairs (Number)
Arm 1: Maternal DTG+FTC/TAF24.1
Arm 2: Maternal DTG+FTC/TDF32.9
Arm 3: Maternal EFV/FTC/TDF32.7

Percentage of Mother-Infant Pairs With an Adverse Pregnancy Outcome

Percentage of mother-infant pairs with an adverse pregnancy outcome. Adverse pregnancy outcome includes spontaneous abortion (<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (<37 completed weeks), or small for gestational age (<10th percentile per INTERGROWTH 21st Standards) (NCT03048422)
Timeframe: Delivery

Interventionpercentage of mother-infant pairs (Number)
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF28.4
Arm 3: Maternal EFV/FTC/TDF32.7

Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome or Major Congenital Anomaly

Percentage of mother-infant pairs with an adverse pregnancy outcome or major congenital anomaly. Adverse pregnancy outcomes include spontaneous abortions (<20 weeks gestation), stillbirths (≥20 weeks gestation), preterm deliveries (<37 weeks gestation), and infants small for gestational age (<10th percentile per INTERGROWTH 21st Standards). Major congenital anomaly was defined consistent with the definition of malformation provided by Holmes and Westgate (i.e., a structural abnormality with surgical, medical, or cosmetic importance) and evaluated by an internal study team blinded to treatment arm. (NCT03048422)
Timeframe: Delivery through 50 weeks postpartum

Interventionpercentage of mother-infant pairs (Number)
Arm 1: Maternal DTG+FTC/TAF24.1
Arm 2: Maternal DTG+FTC/TDF32.9
Arm 3: Maternal EFV/FTC/TDF33.2

Percentage of Mother-Infant Pairs With Preterm Deliveries

Percentage of mother-infant pairs with preterm deliveries (<37 weeks gestation) resulting in live born infant (NCT03048422)
Timeframe: Delivery

Interventionpercentage of participants (Number)
Arm 1: Maternal DTG+FTC/TAF5.8
Arm 2: Maternal DTG+FTC/TDF9.4
Arm 3: Maternal EFV/FTC/TDF12.1

Percentage of Mothers With HIV-1 ARV Drug Resistance Mutations at the Time of Maternal Virologic Failure

Percentage of mothers with HIV-1 antiretroviral (ARV) drug resistance mutations at the time of maternal virologic failure. Virologic failure was defined as two consecutive plasma HIV-1 RNA viral loads <200 copies/mL on or after 24 weeks on study. Drug resistance mutations were assessed using the Stanford algorithm, and all ARV regimens were assessed for mutations. (NCT03048422)
Timeframe: From 24 weeks after randomization through Week 50 postpartum

Interventionpercentage of participants (Number)
Arm 1: Maternal DTG+FTC/TAF0.92
Arm 2: Maternal DTG+FTC/TDF1.86
Arm 3: Maternal EFV/FTC/TDF6.16

Percentage of Mothers With HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum

Percentage of mothers with HIV-1 RNA less than 200 copies/mL at 50 weeks postpartum using real-time test results obtained from site laboratories (NCT03048422)
Timeframe: 50 weeks postpartum

Interventionpercentage of participants (Number)
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF96.3
Arm 3: Maternal EFV/FTC/TDF96.4

Percentage of Mothers With HIV-1 RNA Less Than 50 Copies/mL at Delivery Measured at Central Laboratory

Percentage of mothers with HIV-1 RNA less than 50 copies/mL at delivery using batched test results obtained from central laboratory (NCT03048422)
Timeframe: Delivery

Interventionpercentage of participants (Number)
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF94.4
Arm 3: Maternal EFV/FTC/TDF78.8

Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum Based on FDA Snapshot Algorithm

Percentage of mothers with virologic success of HIV-1 RNA less than 200 copies/mL at 50 weeks postpartum based on FDA snapshot algorithm using real-time test results obtained from site laboratories (NCT03048422)
Timeframe: 50 weeks postpartum

Interventionpercentage of participants (Number)
Arm 1: Maternal DTG+FTC/TAF75.6
Arm 2: Maternal DTG+FTC/TDF77.7
Arm 3: Maternal EFV/FTC/TDF76.3

Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at Delivery Based on FDA Snapshot Algorithm

Percentage of mothers with virologic success of HIV-1 RNA less than 200 copies/mL at delivery based on FDA snapshot algorithm using real-time test results obtained from site laboratories (NCT03048422)
Timeframe: Delivery

Interventionpercentage of participants (Number)
Arm 1: Maternal DTG+FTC/TAF88.9
Arm 2: Maternal DTG+FTC/TDF92.6
Arm 3: Maternal EFV/FTC/TDF81.0

Time to First HIV-1 RNA Less Than 200 Copies/mL Through Delivery

Time to first viral HIV-1 RNA less than 200 copies/mL through delivery, determined using real-time results obtained from site laboratories (NCT03048422)
Timeframe: Randomization to delivery

Interventionweeks (Mean)
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF4.26
Arm 3: Maternal EFV/FTC/TDF6.49

Infant Creatinine Clearance

Infant creatinine clearance based on Schwartz formula (NCT03048422)
Timeframe: Delivery and 26 weeks postpartum

,,
InterventionmL/min (Mean)
Delivery26 Weeks Postpartum
Arm 1 Infants52.7134.8
Arm 2 Infants53.1123.6
Arm 3 Infants49.0135.0

Percentage of Mothers With HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery

Percentage of mothers with plasma HIV-1 RNA viral load less than 200 copies/mL at delivery determined using real-time test results obtained at site laboratories. This outcome was evaluated in the non-inferiority (primary outcome) and superiority (secondary outcome) analyses. The intention-to-treat analysis included all randomized women who had viral load data available. The per-protocol analysis excluded women who modified randomized treatment (stopped, paused, switched, added any treatment) before viral load evaluation at delivery, with the exception of women who modified randomized treatment for use of a concomitant medication. (NCT03048422)
Timeframe: Delivery

,
InterventionPercentage of participants (Number)
Intention-to-Treat AnalysisPer-Protocol Analysis
Arm 3: Maternal EFV/FTC/TDF91.091.4
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF97.597.5

Number of Participants Who Experienced HIV-related Disease Progression or Death

Worsening to WHO stage III/IV (among subjects who had WHO stage I/II at baseline) and death were the composite secondary endpoint. WHO Disease Staging System for HIV Infection and Disease in Adults and Adolescents is an approach for use in resource limited settings in studies of progression to symptomatic HIV disease. There are 4 stages of disease staging, 1 being the least severe and 4 being the most severe disease stage based on the HIV related symptoms and diagnoses. Please refer to the following web page for detailed staging criteria: http://www.who.int/docstore/hiv/scaling/anex1.html (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.

Interventionparticipants (Number)
NVP/NVP6
NVP/LPV_r4
NoNVP/NVP19
NoNVP/LPV_r26

Number of Participants Who Experienced Treatment-related Toxicity That Led to Discontinuation of Randomized Regimen.

The outcome is defined as treatment-related toxicity (as evaluated by sites), regardless of grade, that led to discontinuation of randomized regimen. For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.

Interventionparticipants (Number)
NVP/NVP15
NVP/LPV_r0
NoNVP/NVP35
NoNVP/LPV_r0

Number of Participants Who Experienced Virologic Failure or Died.

Virologic failure (VF) is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.

Interventionparticipants (Number)
NVP/NVP32
NVP/LPV_r10
NoNVP/NVP42
NoNVP/LPV_r50

Number of Participants Who Received NVP-containing Regimens at Randomization and Experienced NVP-associated Rash or Grade 2+ Liver Lab Abnormality

Any grade of rash or grade 2+ liver lab abnormality events that were claimed to be NVP associated (definitely, probably, or possibly) by site investigators were evaluated. Grade 2+ liver lab abnormality is defined as aspartate aminotransferase (AST)>=2.6 x ULN or alanine aminotransferase (ALT)>=2.6 x ULN. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP arm. Throughout study for NoNVP/NVP arm.

Interventionparticipants (Number)
NVP/NVP20
NoNVP/NVP51

CD4 Count Change From Randomization

Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (last CD4 before/on treatment start date). For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r. Week 48 and 96.

,,,
Interventioncells/mm^3 (Median)
Week 48 CD4 count change from randomizationWeek 96 CD4 count change from randomization
NoNVP/LPV_r172256
NoNVP/NVP172223
NVP/LPV_r201278
NVP/NVP191291

Percent of Participants Who Experienced Virologic Failure or Died

Results report cumulative percent of participants reaching virologic failure (VF) or death by week 48 and week 96 calculated using the Kaplan-Meier method. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms.

,,,
InterventionPercent of participants (Number)
week 48 percent of virologic failure or deathweek 96 percent of virologic failure or death
NoNVP/LPV_r1420
NoNVP/NVP1417
NVP/LPV_r412
NVP/NVP2331

Percent of Participants Who Reported to Never Missed Any of the Study Drug Regimen in the Past Month

Self-reported adherence at week 48 and 96 while participants remained on randomized regimen. Adherence interviews for each antiretroviral drug drug the participant is taking was performed by site personnel every 24 weeks. For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms.

,,,
Interventionpercent of participants (Number)
week 48 percent of full adherence in past monthweek 96 percent of full adherence in past month
NoNVP/LPV_r8687
NoNVP/NVP9093
NVP/LPV_r8895
NVP/NVP8994

Time From Randomization to Virologic Failure or Death for Participants Who Had SD NVP Exposure Prior to Study Entry

5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) with median follow-up 72 weeks and range from 0 to 144 weeks.

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile
NVP/LPV_r6084NA
NVP/NVP121260

Time From Randomization to Virologic Failure or Death for Participants Without SD NVP Exposure Prior to Study Entry

5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. (NCT00089505)
Timeframe: Throughout study with median follow-up 72 weeks and range from 0 to 180 weeks.

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile
NoNVP/LPV_r1236132
NoNVP/NVP2436NA

Pharmacokinetic (PK) Parameter: Infant Plasma Washout Half-life (T1/2) of ARVs and TB Drugs

Infant plasma concentrations were collected and measured during the first 9 days of life. Half-life is defined as 0.693/k, where k, the elimination rate constant, is the slope of the decline in concentrations. (NCT00042289)
Timeframe: Infant plasma samples at 2-10, 18-28, 36-72 hours and 5-9 days after birth.

Interventionhour (Median)
DTG 50mg q.d.32.8
EVG/COBI 150/150mg q.d.7.6
DRV/COBI 800/150 mg q.d.NA
EFV 600 mg q.d. (Outside THA)65.6

PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (IQR) for ARVs and TB Drugs

Cord blood and maternal plasma concentrations were collected and measured at delivery, and compared as a ratio. (NCT00042289)
Timeframe: Measured at time of delivery with single cord blood and single maternal plasma sample.

Interventionunitless (Median)
DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.0.15
DTG 50mg q.d.1.25
EVG/COBI 150/150mg q.d.0.91
DRV/COBI 800/150 mg q.d.0.07
ATV/COBI 300/150 mg q.d.0.07
TFV 300mg q.d.0.88

PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (Range) for ARVs and TB Drugs

Cord blood and maternal plasma concentrations were collected and measured at delivery, and compared as a ratio. For arms with zero overall participants analyzed, samples were below the limit of quantification and ratios could not be calculated. (NCT00042289)
Timeframe: Measured at time of delivery with single cord blood and single maternal plasma sample.

Interventionunitless (Median)
TAF 10mg q.d. w/COBI0.97
EFV 600 mg q.d. (Outside THA)0.67
EFV 600mg q.d.0.49
LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.0.2
RAL 400mg b.i.d.1.5
ETR 200mg b.i.d.0.52
MVC 150 or 300mg b.i.d.0.33
ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.0.14
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.0.16
NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.0.19
IDV/RTV Arm 2: 400/100mg q.d. (Only THA)0.12
RPV 25mg q.d.0.55
ATV/RTV 300/100mg q.d. or TFV/ATV/RTV 300/300/100mg q.d.0.18
DRV/RTV 800/100mg q.d. or DRV/RTV 600/100mg b.i.d.0.18

Plasma Concentration for Contraceptives

Serum concentrations of the contraceptives. Note that no historical controls were provided by team pharmacologists and thus no comparisons were done for contraceptive concentrations in women using hormonal contraceptives and selected ARV drugs as compared to historical controls not using those ARV drugs. (NCT00042289)
Timeframe: Measured at 6-7 weeks after contraceptive initiation postpartum

Interventionpg/mL (Median)
ATV/RTV/TFV 300/100/300mg q.d. With ENG604
LPV/RTV 400/100 b.i.d. With ENG428
EFV 600mg q.d. With ENG125

Area Under the Curve From 0 to 12 Hours (AUC12) of ARVs for Contraceptive Arms

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12h (area-under-the-curve from 0 to 12 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8 and 12 hours post dosing.

Interventionmcg*hr/mL (Median)
Before contraceptive initiationAfter contraceptive initiation
LPV/RTV 400/100 b.i.d. With ENG115.97100.20

Area Under the Curve From 0 to 24 Hours (AUC24) of ARVs for Contraceptive Arms

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8, 12, and 24 hours post dosing.

,
Interventionmcg*hr/mL (Median)
Before contraceptive initiationAfter contraceptive initiation
ATV/RTV/TFV 300/100/300mg q.d. With ENG53.9655.25
EFV 600mg q.d. With ENG53.6456.65

Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC (area under the curve) were determined using the linear trapezoidal rule. See PK target in the Protocol Appendix V. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.

,
InterventionParticipants (Count of Participants)
3rd TrimesterPostpartum
EFV 600mg q.d.2021
MVC 150 or 300mg b.i.d.87

Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC (area under the curve) were determined using the linear trapezoidal rule. See PK target in the Protocol Appendix V. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.

,,,,,,,,,,,,,,,,,,,,,,
InterventionParticipants (Count of Participants)
2nd Trimester3rd TrimesterPostpartum
ATV/RTV Arm 1: 300/100mg q.d.11212
DRV/COBI 800/150 mg q.d.3414
DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.71622
DRV/RTV 600/100mg b.i.d.71922
DRV/RTV 800/100mg q.d.91922
DTG 50mg q.d.92023
EFV 600 mg q.d. (Outside THA)123334
ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.82927
ETR 200mg b.i.d.5137
EVG/COBI 150/150mg q.d.81018
FPV/RTV 700/100mg b.i.d.82622
IDV/RTV Arm 2: 400/100mg q.d. (Only THA)101926
LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.93027
ATV/COBI 300/150 mg q.d.125
NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.NA1514
RAL 400mg b.i.d.113330
RPV 25mg q.d.142625
TAF 10mg q.d. w/COBI152322
TAF 25mg q.d.132324
TAF 25mg q.d. w/COBI or RTV Boosting102418
TFV 300mg q.d.22727
TFV/ATV/RTV Arm 1: 300/300/100mg q.d.11112
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.72332

Pharmacokinetic (PK) Parameter: Infant Plasma Washout Concentration of ARVs and TB Drugs

Infant plasma concentrations were collected and measured during the first 9 days of life. (NCT00042289)
Timeframe: Blood samples were collected at 2-10, 18-28, 36-72 hours and 5-9 days after birth.

,,,
Interventionmcg/mL (Median)
2-10 hours after birth18-28 hours after birth36-72 hours after birth5-9 days after birth
DRV/COBI 800/150 mg q.d.0.351.431.871.72
DTG 50mg q.d.1.731.531.000.06
EFV 600 mg q.d. (Outside THA)1.11.00.90.4
EVG/COBI 150/150mg q.d.0.1320.0320.0050.005

PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Geometric Mean (95% CI) for ARVs and TB Drugs

Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing. (NCT00042289)
Timeframe: Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.

Interventionng*hour/mL (Geometric Mean)
2nd Trimester3rd TrimesterPostpartum
MVC 150 or 300mg b.i.d.NA27173645

PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12 (area under the curve from 0 to 12 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.

,,,
Interventionmg*hour/L (Median)
2nd Trimester3rd TrimesterPostpartum
DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.55.151.879.6
DRV/RTV 600/100mg b.i.d.45.845.961.7
FPV/RTV 700/100mg b.i.d.43.5032.1551.60
NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.NA34.233.5

PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12 (area under the curve from 0 to 12 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.

,,,
Interventionmg*hour/L (Median)
2nd Trimester3rd TrimesterPostpartum
ETR 200mg b.i.d.4.58.35.3
IDV/RTV Arm 2: 400/100mg q.d. (Only THA)14.916.127.1
LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.7296133
RAL 400mg b.i.d.6.65.411.6

PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (IQR) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24 (area under the curve from 0 to 24 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.

,,,,,,,,,,,,,
Interventionmg*hour/L (Median)
2nd Trimester3rd TrimesterPostpartum
ATV/COBI 300/150 mg q.d.25.3318.8536.20
ATV/RTV Arm 1: 300/100mg q.d.88.241.957.9
ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.30.645.748.8
DRV/COBI 800/150 mg q.d.50.0042.0595.55
DRV/RTV 800/100mg q.d.64.663.5103.9
DTG 50mg q.d.47.649.265.0
EFV 600 mg q.d. (Outside THA)47.3060.0262.70
EVG/COBI 150/150mg q.d.15.314.021.0
TAF 10mg q.d. w/COBI0.1970.2060.216
TAF 25mg q.d.0.1710.2120.271
TAF 25mg q.d. w/COBI or RTV Boosting0.1810.2570.283
TFV 300mg q.d.1.92.43.0
TFV/ATV/RTV Arm 1: 300/300/100mg q.d.14.528.839.6
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.26.237.758.7

PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.

Interventionmg*hour/L (Median)
3rd TrimesterPostpartum
EFV 600mg q.d.55.458.3

PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.

Interventionmg*hour/L (Median)
2nd Trimester3rd TrimesterPostpartum
RPV 25mg q.d.1.9691.6692.387

PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

Interventionmg/L (Median)
3rd TrimesterPostpartum
EFV 600mg q.d.5.445.10

PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

,,,,,,,,,,,,,,
Interventionmg/L (Median)
2nd Trimester3rd TrimesterPostpartum
ATV/COBI 300/150 mg q.d.2.822.203.90
ATV/RTV Arm 1: 300/100mg q.d.NA3.64.1
ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.3.114.514.52
DRV/COBI 800/150 mg q.d.4.593.677.04
DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.6.226.558.96
DRV/RTV 600/100mg b.i.d.5.645.537.78
DRV/RTV 800/100mg q.d.6.775.788.11
DTG 50mg q.d.3.623.544.85
EFV 600 mg q.d. (Outside THA)3.875.134.41
FPV/RTV 700/100mg b.i.d.5.615.126.75
IDV/RTV Arm 2: 400/100mg q.d. (Only THA)3.893.625.37
NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.NA5.15.0
TFV 300mg q.d.0.2500.2450.298
TFV/ATV/RTV Arm 1: 300/300/100mg q.d.1.22.54.1
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.2.733.565.43

PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

,,,
Interventionmg/L (Median)
2nd Trimester3rd TrimesterPostpartum
ETR 200mg b.i.d.0.701.010.63
LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.8.410.714.6
RAL 400mg b.i.d.2.2501.7703.035
RPV 25mg q.d.0.1450.1340.134

PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (95% CI) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

Interventionng/mL (Median)
3rd TrimesterPostpartum
MVC 150 or 300mg b.i.d.448647

PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (IQR) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

,,,
Interventionng/mL (Median)
2nd Trimester3rd TrimesterPostpartum
EVG/COBI 150/150mg q.d.1447.11432.81713.1
TAF 10mg q.d. w/COBI80.491.298.2
TAF 25mg q.d.69.796133
TAF 25mg q.d. w/COBI or RTV Boosting87.8107141

PK Parameter: Trough Concentration (C12) With Geometric Mean (95% CI) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 12 hrs after an observed dose.

Interventionng/mL (Geometric Mean)
3rd TrimesterPostpartum
MVC 150 or 300mg b.i.d.108128

PK Parameter: Trough Concentration (C12) With Median (IQR) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose.

,,,
Interventionmg/L (Median)
2nd Trimester3rd TrimesterPostpartum
DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.2.842.524.51
DRV/RTV 600/100mg b.i.d.2.122.222.51
FPV/RTV 700/100mg b.i.d.2.121.642.87
NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.NA0.470.52

PK Parameter: Trough Concentration (C12) With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose.

,,,
Interventionmg/L (Median)
2nd Trimester3rd TrimesterPostpartum
ETR 200mg b.i.d.0.360.480.38
IDV/RTV Arm 2: 400/100mg q.d. (Only THA)0.130.130.28
LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.3.75.17.2
RAL 400mg b.i.d.0.06210.0640.0797

PK Parameter: Trough Concentration (C24) With Median (IQR) for ARVs and TB Drugs

"Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose.~For the TAF 25 mg q.d., 10 mg q.d. w/COBI, and 25 mg q.d. w/COBI or RTV boosting arms, samples were all below the limit of quantification and statistical analyses were not conducted." (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.

,,,,,,,,,,,,,
Interventionmg/L (Median)
2nd Trimester3rd TrimesterPostpartum
ATV/COBI 300/150 mg q.d.0.210.210.61
ATV/RTV Arm 1: 300/100mg q.d.2.00.71.2
ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.0.490.710.90
DRV/COBI 800/150 mg q.d.0.330.271.43
DRV/RTV 800/100mg q.d.0.991.172.78
DTG 50mg q.d.0.730.931.28
EFV 600 mg q.d. (Outside THA)1.491.481.94
EVG/COBI 150/150mg q.d.0.02580.04870.3771
TAF 10mg q.d. w/COBI0.001950.001950.00195
TAF 25mg q.d.0.001950.001950.00195
TAF 25mg q.d. w/COBI or RTV Boosting0.001950.001950.00195
TFV 300mg q.d.0.0390.0540.061
TFV/ATV/RTV Arm 1: 300/300/100mg q.d.0.30.50.8
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.0.440.571.26

PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.

Interventionmg/L (Median)
3rd TrimesterPostpartum
EFV 600mg q.d.1.602.05

PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.

Interventionmg/L (Median)
2nd Trimester3rd TrimesterPostpartum
RPV 25mg q.d.0.0630.0560.081

Reviews

9 reviews available for adenine and Complications, Infectious Pregnancy

ArticleYear
Tenofovir alafenamide use in pregnant and lactating women living with HIV.
    Expert opinion on drug metabolism & toxicology, 2020, Volume: 16, Issue:4

    Topics: Adenine; Alanine; Anti-HIV Agents; Female; HIV Infections; Humans; Lactation; Pregnancy; Pregnancy C

2020
[Interdisciplinary aspects of and new drugs for chronic hepatitis B].
    Orvosi hetilap, 2013, Jul-21, Volume: 154, Issue:29

    Topics: Adenine; Antiviral Agents; Comorbidity; Drug Interactions; Drug Therapy, Combination; Female; Gastro

2013
Safety of tenofovir during pregnancy for the mother and fetus: a systematic review.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2013, Volume: 57, Issue:12

    Topics: Adenine; Animals; Female; Fetal Development; HIV Infections; Humans; Infant, Newborn; Organophosphon

2013
Tenofovir disoproxil fumarate in pregnancy and prevention of mother-to-child transmission of HIV-1: is it time to move on from zidovudine?
    HIV medicine, 2009, Volume: 10, Issue:7

    Topics: Adenine; Adult; Africa South of the Sahara; Animals; Anti-HIV Agents; Antiretroviral Therapy, Highly

2009
Systemic preexposure prophylaxis for human immunodeficiency virus infection.
    Pharmacotherapy, 2010, Volume: 30, Issue:10

    Topics: Adenine; Animals; Anti-HIV Agents; Antiviral Agents; Deoxycytidine; Emtricitabine; Female; HIV; HIV

2010
Antiviral therapy for hepatitis B infection during pregnancy and breastfeeding.
    Antiviral therapy, 2011, Volume: 16, Issue:5

    Topics: Adenine; Antiviral Agents; Breast Feeding; Female; Guanine; Hepatitis B; Hepatitis B virus; Hepatiti

2011
Pharmacokinetics of antiretroviral drugs in anatomical sanctuary sites: the fetal compartment (placenta and amniotic fluid).
    Antiviral therapy, 2011, Volume: 16, Issue:8

    Topics: Adenine; Adult; Amniotic Fluid; Anti-HIV Agents; Cyclohexanes; Enfuvirtide; Female; Fetal Blood; Fet

2011
Drug delivery in multiple indication (multipurpose) prevention technologies: systems to prevent HIV-1 transmission and unintended pregnancies or HSV-2 transmission.
    Expert opinion on drug delivery, 2012, Volume: 9, Issue:4

    Topics: Adenine; Administration, Intravaginal; Anti-Infective Agents; Antiviral Agents; Biopharmaceutics; Co

2012
New advances in chronic hepatitis B.
    Current opinion in gastroenterology, 2012, Volume: 28, Issue:3

    Topics: Adenine; Antiviral Agents; Coinfection; Disease Progression; Drug Resistance, Viral; Female; Guanine

2012

Trials

18 trials available for adenine and Complications, Infectious Pregnancy

ArticleYear
Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2
    Lancet (London, England), 2021, 04-03, Volume: 397, Issue:10281

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Drug Therapy, Combination; Emtricitabine; Female; Gestatio

2021
Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV.
    The New England journal of medicine, 2019, 08-29, Volume: 381, Issue:9

    Topics: Adenine; Adolescent; Adult; Anti-Retroviral Agents; Bone Density; CD4 Lymphocyte Count; Drug Therapy

2019
Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV.
    The New England journal of medicine, 2019, 08-29, Volume: 381, Issue:9

    Topics: Adenine; Adolescent; Adult; Anti-Retroviral Agents; Bone Density; CD4 Lymphocyte Count; Drug Therapy

2019
Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV.
    The New England journal of medicine, 2019, 08-29, Volume: 381, Issue:9

    Topics: Adenine; Adolescent; Adult; Anti-Retroviral Agents; Bone Density; CD4 Lymphocyte Count; Drug Therapy

2019
Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV.
    The New England journal of medicine, 2019, 08-29, Volume: 381, Issue:9

    Topics: Adenine; Adolescent; Adult; Anti-Retroviral Agents; Bone Density; CD4 Lymphocyte Count; Drug Therapy

2019
Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV.
    The New England journal of medicine, 2019, 08-29, Volume: 381, Issue:9

    Topics: Adenine; Adolescent; Adult; Anti-Retroviral Agents; Bone Density; CD4 Lymphocyte Count; Drug Therapy

2019
Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV.
    The New England journal of medicine, 2019, 08-29, Volume: 381, Issue:9

    Topics: Adenine; Adolescent; Adult; Anti-Retroviral Agents; Bone Density; CD4 Lymphocyte Count; Drug Therapy

2019
Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV.
    The New England journal of medicine, 2019, 08-29, Volume: 381, Issue:9

    Topics: Adenine; Adolescent; Adult; Anti-Retroviral Agents; Bone Density; CD4 Lymphocyte Count; Drug Therapy

2019
Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV.
    The New England journal of medicine, 2019, 08-29, Volume: 381, Issue:9

    Topics: Adenine; Adolescent; Adult; Anti-Retroviral Agents; Bone Density; CD4 Lymphocyte Count; Drug Therapy

2019
Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV.
    The New England journal of medicine, 2019, 08-29, Volume: 381, Issue:9

    Topics: Adenine; Adolescent; Adult; Anti-Retroviral Agents; Bone Density; CD4 Lymphocyte Count; Drug Therapy

2019
Pharmacokinetics and safety of tenofovir in HIV-infected women during labor and their infants during the first week of life.
    Journal of acquired immune deficiency syndromes (1999), 2014, Jan-01, Volume: 65, Issue:1

    Topics: Adenine; Adolescent; Adult; Anti-HIV Agents; Drug Administration Schedule; Female; Fetal Blood; HIV

2014
High medication adherence during periconception periods among HIV-1-uninfected women participating in a clinical trial of antiretroviral pre-exposure prophylaxis.
    Journal of acquired immune deficiency syndromes (1999), 2014, Sep-01, Volume: 67, Issue:1

    Topics: Adenine; Adolescent; Adult; Anti-HIV Agents; Cohort Studies; Double-Blind Method; Female; Fertilizat

2014
Efficacy of maternal tenofovir disoproxil fumarate in interrupting mother-to-infant transmission of hepatitis B virus.
    Hepatology (Baltimore, Md.), 2015, Volume: 62, Issue:2

    Topics: Adenine; Adult; DNA, Viral; Female; Follow-Up Studies; Gestational Age; Hepatitis B virus; Hepatitis

2015
Addition of single-dose tenofovir and emtricitabine to intrapartum nevirapine to reduce perinatal HIV transmission.
    Journal of acquired immune deficiency syndromes (1999), 2008, Jun-01, Volume: 48, Issue:2

    Topics: Adenine; Adolescent; Adult; Anti-HIV Agents; Deoxycytidine; Drug Therapy, Combination; Emtricitabine

2008
Population pharmacokinetics of tenofovir in HIV-1-infected pregnant women and their neonates (ANRS 12109).
    Clinical pharmacology and therapeutics, 2009, Volume: 85, Issue:2

    Topics: Adenine; Female; HIV Infections; HIV-1; Humans; Infant, Newborn; Maternal-Fetal Exchange; Organophos

2009
Population pharmacokinetics of tenofovir in HIV-1-infected pregnant women and their neonates (ANRS 12109).
    Clinical pharmacology and therapeutics, 2009, Volume: 85, Issue:2

    Topics: Adenine; Female; HIV Infections; HIV-1; Humans; Infant, Newborn; Maternal-Fetal Exchange; Organophos

2009
Population pharmacokinetics of tenofovir in HIV-1-infected pregnant women and their neonates (ANRS 12109).
    Clinical pharmacology and therapeutics, 2009, Volume: 85, Issue:2

    Topics: Adenine; Female; HIV Infections; HIV-1; Humans; Infant, Newborn; Maternal-Fetal Exchange; Organophos

2009
Population pharmacokinetics of tenofovir in HIV-1-infected pregnant women and their neonates (ANRS 12109).
    Clinical pharmacology and therapeutics, 2009, Volume: 85, Issue:2

    Topics: Adenine; Female; HIV Infections; HIV-1; Humans; Infant, Newborn; Maternal-Fetal Exchange; Organophos

2009
Intrapartum tenofovir and emtricitabine reduces low-concentration drug resistance selected by single-dose nevirapine for perinatal HIV prevention.
    AIDS research and human retroviruses, 2009, Volume: 25, Issue:11

    Topics: Adenine; Anti-HIV Agents; Deoxycytidine; Dose-Response Relationship, Drug; Drug Administration Sched

2009
Antiretroviral therapies in women after single-dose nevirapine exposure.
    The New England journal of medicine, 2010, Oct-14, Volume: 363, Issue:16

    Topics: Adenine; Adult; Anti-HIV Agents; Anti-Retroviral Agents; CD4 Lymphocyte Count; Deoxycytidine; Drug T

2010
Atazanavir pharmacokinetics with and without tenofovir during pregnancy.
    Journal of acquired immune deficiency syndromes (1999), 2011, Apr-15, Volume: 56, Issue:5

    Topics: Adenine; Anti-HIV Agents; Atazanavir Sulfate; Drug Administration Schedule; Drug Monitoring; Drug Th

2011
Very high concentrations of active intracellular phosphorylated emtricitabine in neonates (ANRS 12109 trial, step 2).
    Antimicrobial agents and chemotherapy, 2011, Volume: 55, Issue:6

    Topics: Acquired Immunodeficiency Syndrome; Adenine; Adult; Antiviral Agents; Deoxycytidine; Emtricitabine;

2011
Plasma and intracellular tenofovir pharmacokinetics in the neonate (ANRS 12109 trial, step 2).
    Antimicrobial agents and chemotherapy, 2011, Volume: 55, Issue:6

    Topics: Acquired Immunodeficiency Syndrome; Adenine; Anti-HIV Agents; Female; HIV-1; Humans; Infant, Newborn

2011
Pharmacokinetics and safety of single-dose tenofovir disoproxil fumarate and emtricitabine in HIV-1-infected pregnant women and their infants.
    Antimicrobial agents and chemotherapy, 2011, Volume: 55, Issue:12

    Topics: Adenine; Adult; Anti-HIV Agents; Deoxycytidine; Dose-Response Relationship, Drug; Drug Therapy, Comb

2011
Pregnancy and infant outcomes among HIV-infected women taking long-term ART with and without tenofovir in the DART trial.
    PLoS medicine, 2012, Volume: 9, Issue:5

    Topics: Abortion, Spontaneous; Adenine; Adult; Anti-HIV Agents; Body Height; Body Weight; Breast Feeding; Bu

2012
Tenofovir use and renal insufficiency among pregnant and general adult population of HIV-infected, ART-naïve individuals in Lilongwe, Malawi.
    PloS one, 2012, Volume: 7, Issue:7

    Topics: Adenine; Adolescent; Adult; Alkynes; Anti-HIV Agents; Benzoxazines; Body Mass Index; CD4 Lymphocyte

2012
The pharmacokinetics, safety and efficacy of tenofovir and emtricitabine in HIV-1-infected pregnant women.
    AIDS (London, England), 2013, Mar-13, Volume: 27, Issue:5

    Topics: Adenine; Adult; Anti-HIV Agents; Deoxycytidine; Emtricitabine; Europe; Female; Fetal Blood; HIV Infe

2013
Pharmacokinetics of an increased atazanavir dose with and without tenofovir during the third trimester of pregnancy.
    Journal of acquired immune deficiency syndromes (1999), 2013, May-01, Volume: 63, Issue:1

    Topics: Adenine; Adolescent; Adult; Anti-HIV Agents; Atazanavir Sulfate; Dose-Response Relationship, Drug; D

2013
Antiviral drugs for the neonate--the risk-benefit ledger.
    The Journal of pediatrics, 1975, Volume: 86, Issue:2

    Topics: Adenine; Animals; Antiviral Agents; Arabinose; Brain; Brain Diseases; Clinical Trials as Topic; Cyta

1975

Other Studies

35 other studies available for adenine and Complications, Infectious Pregnancy

ArticleYear
Pharmacokinetics of Tenofovir Alafenamide With Boosted Protease Inhibitors in Pregnant and Postpartum Women Living With HIV: Results From IMPAACT P1026s.
    Journal of acquired immune deficiency syndromes (1999), 2022, 07-01, Volume: 90, Issue:3

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Antiviral Agents; Female; HIV Infections; Humans; Postpart

2022
Acceptance of antiviral treatment and enhanced service model for pregnant patients carrying hepatitis B.
    Hong Kong medical journal = Xianggang yi xue za zhi, 2020, Volume: 26, Issue:4

    Topics: Adenine; Adult; Antiviral Agents; DNA, Viral; Female; Hepatitis B; Hepatitis B Surface Antigens; Hep

2020
Efficacy and safety of tenofovir alafenamide fumarate for preventing mother-to-child transmission of hepatitis B virus: a national cohort study.
    Alimentary pharmacology & therapeutics, 2020, Volume: 52, Issue:8

    Topics: Abnormalities, Drug-Induced; Adenine; Adult; Alanine; Chemoprevention; China; Cohort Studies; DNA, V

2020
Tenofovir and tenofovir-diphosphate concentrations during pregnancy among HIV-uninfected women using oral preexposure prophylaxis.
    AIDS (London, England), 2018, 08-24, Volume: 32, Issue:13

    Topics: Adenine; Administration, Oral; Adult; Anti-HIV Agents; Blood Chemical Analysis; Chemoprevention; Fem

2018
Low prevalence of renal dysfunction in HIV-infected pregnant women: implications for guidelines for the prevention of mother-to-child transmission of HIV.
    Tropical medicine & international health : TM & IH, 2013, Volume: 18, Issue:11

    Topics: Adenine; Adult; Age Factors; Anti-HIV Agents; CD4 Lymphocyte Count; Contraindications; Creatinine; F

2013
Infant growth outcomes after maternal tenofovir disoproxil fumarate use during pregnancy.
    Journal of acquired immune deficiency syndromes (1999), 2013, Dec-01, Volume: 64, Issue:4

    Topics: Adenine; Adolescent; Anti-HIV Agents; Child Development; Female; Humans; Infant; Organophosphonates;

2013
Efficacy and safety of tenofovir disoproxil fumarate in pregnancy for the prevention of vertical transmission of HBV infection.
    World journal of gastroenterology, 2013, Dec-28, Volume: 19, Issue:48

    Topics: Adenine; Antiviral Agents; Biomarkers; DNA, Viral; Female; Hepatitis B; Hepatitis B e Antigens; Hepa

2013
Anti-viral therapy for prevention of perinatal HBV transmission: extending therapy beyond birth does not protect against post-partum flare.
    Alimentary pharmacology & therapeutics, 2014, Volume: 39, Issue:10

    Topics: Adenine; Adult; Antiviral Agents; Female; Follow-Up Studies; Hepatitis B e Antigens; Hepatitis B vir

2014
Uptake of prevention of mother-to-child-transmission using Option B+ in northern rural Malawi: a retrospective cohort study.
    Sexually transmitted infections, 2014, Volume: 90, Issue:4

    Topics: Adenine; Adult; Alkynes; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Benzoxazines; Chemo

2014
Efficacy and safety of tenofovir disoproxil fumarate in pregnancy to prevent perinatal transmission of hepatitis B virus.
    Journal of hepatology, 2014, Volume: 61, Issue:3

    Topics: Adenine; Adult; Antiviral Agents; Cohort Studies; Female; Gastrointestinal Diseases; Hepatitis B; He

2014
Reduction of infectivity in chronic hepatitis B virus carriers among healthcare providers and pregnant women by antiviral therapy.
    Intervirology, 2014, Volume: 57, Issue:3-4

    Topics: Adenine; Antiviral Agents; DNA, Viral; Female; Guanine; Health Personnel; Hepatitis B e Antigens; He

2014
HIV testing in pregnancy.
    Sexually transmitted infections, 2014, Volume: 90, Issue:8

    Topics: Adenine; Anti-HIV Agents; Benzoxazines; Female; HIV Infections; Humans; Infectious Disease Transmiss

2014
Tenofovir rescue therapy in pregnant females with chronic hepatitis B.
    World journal of gastroenterology, 2015, Feb-28, Volume: 21, Issue:8

    Topics: Adenine; Adult; Antiviral Agents; Apgar Score; Biomarkers; Birth Weight; China; DNA, Viral; Drug Res

2015
[Efficacy of combination antiviral therapy following childbirth in pregnant HBV carriers receiving telbivudine for prevention of mother-to-child transmission].
    Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology, 2015, Volume: 23, Issue:11

    Topics: Adenine; Alanine Transaminase; Antiviral Agents; Carrier State; DNA, Viral; Drug Therapy, Combinatio

2015
Chronic administration of tenofovir to rhesus macaques from infancy through adulthood and pregnancy: summary of pharmacokinetics and biological and virological effects.
    Antimicrobial agents and chemotherapy, 2008, Volume: 52, Issue:9

    Topics: Adenine; Age Factors; Animals; Anti-HIV Agents; Disease Models, Animal; Female; HIV Infections; HIV-

2008
Population pharmacokinetics of emtricitabine in human immunodeficiency virus type 1-infected pregnant women and their neonates.
    Antimicrobial agents and chemotherapy, 2009, Volume: 53, Issue:3

    Topics: Adenine; Anti-HIV Agents; Area Under Curve; Clinical Trials as Topic; Deoxycytidine; Emtricitabine;

2009
Rapid HIV-RNA decline following addition of raltegravir and tenofovir to ongoing highly active antiretroviral therapy in a woman presenting with high-level HIV viraemia at week 38 of pregnancy.
    The Journal of antimicrobial chemotherapy, 2010, Volume: 65, Issue:9

    Topics: Adenine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Female; HIV Infections; Humans; Org

2010
Antiretroviral vaginal gel shows promise against HIV.
    Lancet (London, England), 2010, Jul-31, Volume: 376, Issue:9738

    Topics: Adenine; Adult; Anti-HIV Agents; Anti-Retroviral Agents; Clinical Trials as Topic; Female; Gels; HIV

2010
Implementing a tenofovir-based first-line regimen in rural Lesotho: clinical outcomes and toxicities after two years.
    Journal of acquired immune deficiency syndromes (1999), 2011, Mar-01, Volume: 56, Issue:3

    Topics: Adenine; Adult; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Cohort Studies; Female; HIV

2011
Battles with donors cloud Malawi's HIV prevention plan.
    Lancet (London, England), 2011, Jul-16, Volume: 378, Issue:9787

    Topics: Acquired Immunodeficiency Syndrome; Adenine; Alkynes; Anti-HIV Agents; Benzoxazines; CD4 Lymphocyte

2011
Microbicide might protect pregnant women from HIV. Susceptibility is high for them.
    AIDS alert, 2011, Volume: 26, Issue:9

    Topics: Adenine; Disease Susceptibility; Female; HIV Infections; Humans; Organophosphonates; Pregnancy; Preg

2011
Pregnancy-related effects on tenofovir pharmacokinetics: a population study with 186 women.
    Antimicrobial agents and chemotherapy, 2012, Volume: 56, Issue:2

    Topics: Adenine; Adolescent; Adult; Anti-HIV Agents; Drug Monitoring; Female; HIV Infections; HIV-1; Humans;

2012
Safety of tenofovir use during pregnancy: early growth outcomes in HIV-exposed uninfected infants.
    AIDS (London, England), 2012, Jun-01, Volume: 26, Issue:9

    Topics: Adenine; Anti-HIV Agents; Body Size; Child Development; Drug Therapy, Combination; Female; HIV Infec

2012
Does maternal use of tenofovir during pregnancy affect growth of HIV-exposed uninfected infants?
    AIDS (London, England), 2012, Jun-01, Volume: 26, Issue:9

    Topics: Adenine; Anti-HIV Agents; Body Size; Female; HIV Infections; Humans; Infant, Newborn; Male; Organoph

2012
Hepatitis B virus and human immunodeficiency virus drugs in pregnancy: findings from the Antiretroviral Pregnancy Registry.
    Journal of hepatology, 2012, Volume: 57, Issue:5

    Topics: Adenine; Adult; Antiviral Agents; Congenital Abnormalities; Female; Hepatitis B; Hepatitis B virus;

2012
Research. Fetuses unaffected by tenofovir, 1-year-olds appear slightly smaller.
    AIDS policy & law, 2012, Volume: 27, Issue:7

    Topics: Adenine; Female; Fetus; Growth; HIV Infections; Humans; Infant; Organophosphonates; Pregnancy; Pregn

2012
Interim guidance for clinicians considering the use of preexposure prophylaxis for the prevention of HIV infection in heterosexually active adults.
    MMWR. Morbidity and mortality weekly report, 2012, Aug-10, Volume: 61, Issue:31

    Topics: Adenine; Administration, Oral; Adult; Anti-Retroviral Agents; Centers for Disease Control and Preven

2012
Tenofovir use and pregnancy among women initiating HAART.
    AIDS (London, England), 2012, Nov-28, Volume: 26, Issue:18

    Topics: Adenine; Adolescent; Adult; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; CD4 Lymphocyte C

2012
Blunted fetal growth by tenofovir in late pregnancy.
    AIDS (London, England), 2012, Oct-23, Volume: 26, Issue:16

    Topics: Adenine; Adult; Anti-HIV Agents; Asian People; Bone Density; Female; Fetal Growth Retardation; Hepat

2012
The 2012 revised Dutch national guidelines for the treatment of chronic hepatitis B virus infection.
    The Netherlands journal of medicine, 2012, Volume: 70, Issue:8

    Topics: Adenine; Antiviral Agents; Drug Approval; Drug Resistance, Viral; Female; Guanine; Hepatitis B, Chro

2012
Management of chronic hepatitis B: Canadian Association for the Study of the Liver consensus guidelines.
    Canadian journal of gastroenterology = Journal canadien de gastroenterologie, 2012, Volume: 26, Issue:12

    Topics: Adenine; Allied Health Personnel; Antibodies, Viral; Antiviral Agents; Canada; Coinfection; Drug Res

2012
Relationship between a toll-like receptor-4 gene polymorphism, bacterial vaginosis-related flora and vaginal cytokine responses in pregnant women.
    European journal of obstetrics, gynecology, and reproductive biology, 2004, Oct-15, Volume: 116, Issue:2

    Topics: Adenine; Adult; Enzyme-Linked Immunosorbent Assay; Female; Genotype; Guanine; Humans; Interleukin-1;

2004
Congenital pyelectasis in children born from mothers on tenofovir containing therapy during pregnancy: report of two cases.
    Infection, 2007, Volume: 35, Issue:6

    Topics: Adenine; Adult; Anti-HIV Agents; Female; HIV Infections; Humans; Infant, Newborn; Italy; Kidney; Mal

2007
Administration of 9-[2-(R)-(phosphonomethoxy)propyl]adenine (PMPA) to gravid and infant rhesus macaques (Macaca mulatta): safety and efficacy studies.
    Journal of acquired immune deficiency syndromes and human retrovirology : official publication of the International Retrovirology Association, 1999, Apr-01, Volume: 20, Issue:4

    Topics: Adenine; Animals; Animals, Newborn; Antiviral Agents; Biological Transport; Body Weight; Female; Imm

1999
Neonatal herpes simplex infection following delivery by cesarean section.
    Obstetrics and gynecology, 1974, Volume: 44, Issue:4

    Topics: Adenine; Anti-Infective Agents; Arabinose; Cesarean Section; Extraembryonic Membranes; Female; Herpe

1974