Page last updated: 2024-11-01

nevirapine and Disease Exacerbation

nevirapine has been researched along with Disease Exacerbation in 23 studies

Nevirapine: A potent, non-nucleoside reverse transcriptase inhibitor used in combination with nucleoside analogues for treatment of HIV INFECTIONS and AIDS.
nevirapine : A dipyridodiazepine that is 5,11-dihydro-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepine which is substituted by methyl, oxo, and cyclopropyl groups at positions 4, 6, and 11, respectively. A non-nucleoside reverse transcriptase inhibitor with activity against HIV-1, it is used in combination with other antiretrovirals for the treatment of HIV infection.

Research Excerpts

ExcerptRelevanceReference
"HAART regimens including nevirapine are associated with faster liver fibrosis progression in HIV-infected patients with chronic hepatitis C."7.72Effect of antiretroviral drugs on liver fibrosis in HIV-infected patients with chronic hepatitis C: harmful impact of nevirapine. ( Castellano, V; García-García, JA; Gómez-Mateos, JM; Lozano, F; Macías, J; Merchante, N; Mira, JA; Palacios, RB; Pineda, JA; Sáez, C, 2004)
"The clinical significance of the reduced in vitro susceptibility of HIV to antiretroviral agents has been difficult to elucidate for nucleoside analogs such as zidovudine."6.17Resistance, drug failure, and disease progression. ( Richman, DD, 1994)
"Women randomized to valacyclovir suppressive therapy during pregnancy and postpartum had greater increases in CD4 counts and smaller increases in plasma HIV-1 RNA levels than women in the placebo arm."5.16Effects of valacyclovir on markers of disease progression in postpartum women co-infected with HIV-1 and herpes simplex virus-2. ( Drake, AL; Emery, S; Farquhar, C; John-Stewart, GC; Kiarie, JN; Matemo, DN; Ongecha-Owuor, F; Overbaugh, J; Richardson, B; Roxby, AC; Wald, A, 2012)
"HAART regimens including nevirapine are associated with faster liver fibrosis progression in HIV-infected patients with chronic hepatitis C."3.72Effect of antiretroviral drugs on liver fibrosis in HIV-infected patients with chronic hepatitis C: harmful impact of nevirapine. ( Castellano, V; García-García, JA; Gómez-Mateos, JM; Lozano, F; Macías, J; Merchante, N; Mira, JA; Palacios, RB; Pineda, JA; Sáez, C, 2004)
"We evaluated disease progression among HIV-infected women not on ART with CD4⁺ lymphocyte counts above 200 cells per microliter at delivery."2.78HIV disease progression in the first year after delivery among African women followed in the HPTN 046 clinical trial. ( Brown, ER; Chipato, T; Coovadia, H; Fawzi, W; Fowler, M; George, K; Herron, C; Maldonado, Y; Manji, K; Moodley, D; Nakabiito, C; Reddy, L; Richardson, P; Watts, DH; Zwerski, S, 2013)
" The safety profile of NVP XR was similar to NVP IR, but showed numerically fewer treatment-related adverse events."2.76Efficacy and safety of nevirapine extended-release once daily versus nevirapine immediate-release twice-daily in treatment-naive HIV-1-infected patients. ( Andrade-Villanueva, J; Bogner, J; Cahn, P; Drulak, M; Gathe, J; Horban, A; Nelson, M; Nguyen, T; Podzamczer, D; Quinson, AM; Santiago, S; Spencer, D; Yong, CL; Zhang, W, 2011)
"Differences in disease progression occurred from the third year on ART, whereas higher rates of switch to second-line treatment occurred in LCM from the second year."2.75Routine versus clinically driven laboratory monitoring of HIV antiretroviral therapy in Africa (DART): a randomised non-inferiority trial. ( Abaine, D; Aber, M; Ahimbisibwe, F; Akao, J; Akuma, S; Amuron, B; Amurwon, J; Angweng, E; Anywar, W; Atwiine, D; Atwiine, S; Awio, P; Babiker, A; Babiker, AG; Bafana, T; Bagaya, L; Bahendeka, S; Bakeinyaga, GT; Barungi, G; Bassett, M; Bohannon, J; Boocock, K; Borok, M; Bray, D; Breckenridge, A; Bulaya-Tembo, R; Buluma, E; Burke, A; Burke, C; Byakwaga, H; Byamukama, A; Byaruhanga, R; Chakonza, L; Chidziva, E; Chigwedere, E; Chimanzi, J; Chimbetete, C; Chirairo, H; Chirara, M; Chirema, O; Chitsungo, S; Chivhunga, T; Coutinho, A; Darbyshire, JH; Drasiku, A; Dunn, D; Enzama, R; Etukoit, B; Fadhiru, K; Ferrier, A; Florence, A; Foster, S; Gazzard, B; Generous, L; Gibb, DM; Gilks, C; Gilks, CF; Goodall, R; Grosskurth, H; Grundy, C; Haguma, W; Hakim, J; Hill, C; Hughes, P; Jamu, A; Jangano, M; Jones, S; Kabanda, J; Kabuye, G; Kagina, G; Kajungu, D; Kaleebu, P; Kambungu, A; Kankunda, R; Karungi, J; Kasirye, R; Katabira, E; Katabira, H; Katundu, P; Khauka, P; Kigozi, J; Kikaire, B; Kityo, C; Komugyena, J; Kulume, R; Kusiima, A; Kyomugisha, H; Labeja, O; Lara, AM; Latif, A; Levin, J; Lubwama, E; Lutwama, F; Lyagoba, F; Machingura, I; Machingura, J; Makota, S; Mambule, I; Mapinge, F; Mapuchere, C; Massa, R; Matenga, J; Matongo, M; Maweni, C; Mawora, A; McCormick, A; McLaren, A; Mdege, N; Moyo, K; Muchabaiwa, L; Mudzingwa, S; Mufuka-Kapuya, C; Muganzi, A; Mugisha, A; Mugurungi, O; Mugyenyi, P; Muhweezi, D; Muhwezi, A; Mukiibi, S; Mukose, A; Mulindwa, G; Mulindwa, M; Munderi, P; Murungi, S; Musana, H; Musoro, G; Mutowo, J; Mutsai, S; Muvirimi, C; Muyingo, S; Muzambi, M; Mwebesa, D; Mwesigwa, P; Nabankema, E; Nabongo, P; Naidoo, B; Nairuba, R; Nakahima, W; Nakazibwe, M; Nakiyingi, J; Nalumenya, R; Namale, L; Namara, W; Namata, I; Namazzi, A; Namuli, T; Namyalo, M; Nanfuka, A; Nanfuka, R; Nassuna, G; Ndembi, N; Newland, C; Ngorima, N; Nimwesiga, E; Nsibambi, D; Nyachwo, L; Nyiraguhirwa, D; Ochai, R; Ojiambo, H; Ojiambo, W; Oketta, F; Omony, W; Otim, T; Oyugi, J; Palfreeman, A; Pascoe, M; Pearce, G; Peto, L; Peto, T; Phiri, M; Pillay, D; Pozniak, A; Puddephatt, C; Rahim, S; Rauchenberger, M; Reid, A; Robertson, V; Ronald, A; Rooney, J; Ruberantwari, A; Rutikarayo, N; Sabiiti, J; Sadik, F; Sematala, F; Serwadda, D; Sheehan, S; Simango, M; Smith, M; Snowden, W; Spencer-Drake, C; Spyer, M; Ssali, F; Steens, JM; Svovanapasis, P; Takubwa, J; Taylor, K; Taziwa, F; Tinago, G; Todd, J; Tugume, S; Tukamushaba, J; Tumukunde, D; Tumusiime, C; Twijukye, C; Vere, L; Waita, R; Wakholi, BN; Walker, AS; Walusimbi, J; Wangati, K; Wanyama, J; Wapakhabulo, AC; Warambwa, C; Warara, R; Wavamunno, P; Weller, I; Whitworth, J; Wilkes, H; Winogron, D; Yirrell, D; Zalwango, A; Zalwango, E; Zawedde, C; Zengeza, E, 2010)
"Disease progression was particularly rapid, 85% infants meeting WHO criteria for ART within 6 months."2.73High frequency of rapid immunological progression in African infants infected in the era of perinatal HIV prophylaxis. ( Blanckenberg, N; Goulder, P; Kiepiela, P; McCarthy, N; Mkhwanazi, N; Mphatswe, W; Prendergast, A; Thobakgale, C; Tudor-Williams, G; Walker, BD, 2007)
"Rates of disease progression or death were 23% (11/47), 25% (13/53), and 12% (6/51) for the zidovudine plus nevirapine, zidovudine plus didanosine, and triple drug therapy groups, respectively (P=."2.69A randomized, double-blind trial comparing combinations of nevirapine, didanosine, and zidovudine for HIV-infected patients: the INCAS Trial. Italy, The Netherlands, Canada and Australia Study. ( Conway, B; Cooper, D; Hall, D; Harris, M; Lange, JM; Montaner, JS; Myers, M; Reiss, P; Robinson, P; Smith, D; Vella, S; Wainberg, MA, 1998)
"Risk for disease progression did not differ between the two groups (relative hazard of the triple-combination group, 1."2.68Nevirapine, zidovudine, and didanosine compared with zidovudine and didanosine in patients with HIV-1 infection. A randomized, double-blind, placebo-controlled trial. National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group Protoco ( Basgoz, N; D'Aquila, RT; Fischl, MA; Hirsch, MS; Hughes, MD; Johnson, VA; Liou, SH; Myers, M; Niu, M; Sommadossi, JP; Timpone, J, 1996)
"In a multivariate model, risk for disease progression was reduced by 56% (95% CI, 8% to 79% [P = 0."2.68Monitoring plasma HIV-1 RNA levels in addition to CD4+ lymphocyte count improves assessment of antiretroviral therapeutic response. ACTG 241 Protocol Virology Substudy Team. ( Basgoz, N; Bremer, JW; D'Aquila, RT; Elbeik, T; Erice, A; Fischl, MA; Hirsch, MS; Hughes, MD; Johnson, VA; Kuritzkes, DR; Scott, WA; Spector, SA, 1997)
" However, there are challenges to initiation of ART in early life, including the possibility of drug resistance in the context of prevention of mother-to-child transmission (PMTCT) programs, a paucity of drug choices , uncertain dosing for some medications and long-term toxicities."2.50Optimisation of antiretroviral therapy in HIV-infected children under 3 years of age. ( Abrams, E; Muhe, LM; Penazzato, M; Prendergast, AJ; Tindyebwa, D, 2014)
" However, there are challenges to initiate ART in early life, including the possibility of drug resistance in the context of prevention of mother-to-child transmission (PMTCT) programs, a paucity of drug choices , uncertain dosing for some medications and long-term toxicities."2.48Effectiveness of antiretroviral therapy in HIV-infected children under 2 years of age. ( Cotton, M; Gibb, D; Penazzato, M; Prendergast, A; Tierney, J, 2012)
"The surrogate markers of HIV/AIDS progression include CD4 T cell count and plasma viral load."1.40MicroRNA-150 is a potential biomarker of HIV/AIDS disease progression and therapy. ( Holla, P; Jameel, S; Munshi, SU; Panda, H; Rewari, BB, 2014)

Research

Studies (23)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's5 (21.74)18.2507
2000's9 (39.13)29.6817
2010's9 (39.13)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Watts, DH1
Brown, ER1
Maldonado, Y1
Herron, C1
Chipato, T1
Reddy, L1
Moodley, D1
Nakabiito, C1
Manji, K1
Fawzi, W1
George, K1
Richardson, P1
Zwerski, S1
Coovadia, H1
Fowler, M1
Gupta-Wright, A1
Wood, R1
Bekker, LG1
Lawn, SD1
Munshi, SU1
Panda, H1
Holla, P1
Rewari, BB1
Jameel, S1
Penazzato, M2
Prendergast, AJ1
Muhe, LM1
Tindyebwa, D1
Abrams, E1
Guidozzi, F1
Black, V1
Mugyenyi, P4
Walker, AS3
Hakim, J3
Munderi, P3
Gibb, DM3
Kityo, C3
Reid, A3
Grosskurth, H4
Darbyshire, JH5
Ssali, F3
Bray, D2
Katabira, E3
Babiker, AG3
Gilks, CF2
Kabuye, G1
Nsibambi, D2
Kasirye, R1
Zalwango, E1
Nakazibwe, M1
Kikaire, B1
Nassuna, G1
Massa, R1
Fadhiru, K2
Namyalo, M1
Zalwango, A1
Generous, L1
Khauka, P2
Rutikarayo, N1
Nakahima, W1
Mugisha, A1
Todd, J1
Levin, J1
Muyingo, S1
Ruberantwari, A1
Kaleebu, P2
Yirrell, D2
Ndembi, N2
Lyagoba, F2
Hughes, P1
Aber, M1
Lara, AM2
Foster, S2
Amurwon, J2
Wakholi, BN2
Whitworth, J1
Wangati, K1
Amuron, B1
Kajungu, D1
Nakiyingi, J1
Omony, W1
Tumukunde, D1
Otim, T1
Kabanda, J1
Musana, H1
Akao, J1
Kyomugisha, H1
Byamukama, A1
Sabiiti, J1
Komugyena, J1
Wavamunno, P1
Mukiibi, S1
Drasiku, A1
Byaruhanga, R1
Labeja, O1
Katundu, P2
Tugume, S2
Awio, P1
Namazzi, A1
Bakeinyaga, GT1
Katabira, H1
Abaine, D1
Tukamushaba, J1
Anywar, W1
Ojiambo, W1
Angweng, E1
Murungi, S2
Haguma, W1
Atwiine, S1
Kigozi, J3
Namale, L1
Mukose, A1
Mulindwa, G1
Atwiine, D1
Muhwezi, A1
Nimwesiga, E1
Barungi, G1
Takubwa, J1
Mwebesa, D1
Kagina, G1
Mulindwa, M1
Ahimbisibwe, F1
Mwesigwa, P1
Akuma, S1
Zawedde, C1
Nyiraguhirwa, D1
Tumusiime, C1
Bagaya, L1
Namara, W1
Karungi, J1
Kankunda, R1
Enzama, R1
Latif, A2
Robertson, V2
Chidziva, E1
Bulaya-Tembo, R1
Musoro, G1
Taziwa, F1
Chimbetete, C1
Chakonza, L1
Mawora, A1
Muvirimi, C1
Tinago, G1
Svovanapasis, P1
Simango, M1
Chirema, O1
Machingura, J1
Mutsai, S1
Phiri, M1
Bafana, T1
Chirara, M2
Muchabaiwa, L2
Muzambi, M2
Mutowo, J1
Chivhunga, T1
Chigwedere, E1
Pascoe, M1
Warambwa, C1
Zengeza, E1
Mapinge, F1
Makota, S1
Jamu, A1
Ngorima, N1
Chirairo, H1
Chitsungo, S1
Chimanzi, J1
Maweni, C1
Warara, R1
Matongo, M1
Mudzingwa, S1
Jangano, M1
Moyo, K1
Vere, L1
Mdege, N1
Machingura, I1
Ronald, A1
Kambungu, A1
Lutwama, F1
Mambule, I1
Nanfuka, A1
Walusimbi, J1
Nabankema, E1
Nalumenya, R1
Namuli, T1
Kulume, R1
Namata, I1
Nyachwo, L1
Florence, A1
Kusiima, A1
Lubwama, E1
Nairuba, R1
Oketta, F1
Buluma, E1
Waita, R1
Ojiambo, H1
Sadik, F1
Wanyama, J1
Nabongo, P1
Oyugi, J1
Sematala, F1
Muganzi, A1
Twijukye, C1
Byakwaga, H1
Ochai, R1
Muhweezi, D1
Coutinho, A1
Etukoit, B1
Gilks, C2
Boocock, K1
Puddephatt, C1
Grundy, C1
Bohannon, J1
Winogron, D1
Burke, A1
Babiker, A2
Wilkes, H1
Rauchenberger, M1
Sheehan, S1
Spencer-Drake, C1
Taylor, K1
Spyer, M1
Ferrier, A1
Naidoo, B1
Dunn, D2
Goodall, R2
Peto, L1
Nanfuka, R1
Mufuka-Kapuya, C1
Pillay, D1
McCormick, A1
Weller, I1
Bahendeka, S1
Bassett, M1
Wapakhabulo, AC1
Gazzard, B1
Mapuchere, C1
Mugurungi, O1
Burke, C1
Jones, S1
Newland, C1
Pearce, G1
Rahim, S1
Rooney, J1
Smith, M1
Snowden, W1
Steens, JM1
Breckenridge, A1
McLaren, A1
Hill, C1
Matenga, J1
Pozniak, A1
Serwadda, D1
Peto, T1
Palfreeman, A1
Borok, M1
Gathe, J1
Andrade-Villanueva, J1
Santiago, S1
Horban, A1
Nelson, M1
Cahn, P1
Bogner, J1
Spencer, D1
Podzamczer, D3
Yong, CL1
Nguyen, T1
Zhang, W1
Drulak, M1
Quinson, AM1
Roxby, AC1
Drake, AL1
Ongecha-Owuor, F1
Kiarie, JN1
Richardson, B1
Matemo, DN1
Overbaugh, J1
Emery, S1
John-Stewart, GC1
Wald, A1
Farquhar, C1
Prendergast, A2
Tierney, J1
Cotton, M1
Gibb, D1
Martínez, E2
Arnaiz, JA2
Dalmau, D2
Ribera, E2
Domingo, P2
Knobel, H2
Riera, M1
Pedrol, E2
Force, L2
Llibre, JM1
Segura, F1
Richart, C1
Cortés, C1
Javaloyas, M1
Aranda, M1
Cruceta, A1
de Lazzari, E2
Gatell, JM2
van Leth, F1
Wit, FW1
Reiss, P2
Schattenkerk, JK1
van der Ende, ME1
Schneider, MM1
Mulder, JW1
Frissen, PH1
de Wolf, F1
Lange, JM2
Macías, J1
Castellano, V1
Merchante, N1
Palacios, RB1
Mira, JA1
Sáez, C1
García-García, JA1
Lozano, F1
Gómez-Mateos, JM1
Pineda, JA1
Leyes, M1
Asboe, D1
Williams, IG1
Goodall, RL1
Hooker, MH1
Mphatswe, W1
Blanckenberg, N1
Tudor-Williams, G1
Thobakgale, C1
Mkhwanazi, N1
McCarthy, N1
Walker, BD1
Kiepiela, P1
Goulder, P1
Leng, LK1
Pancharoen, C1
Bunupuradah, T1
Thisyakorn, U1
Trinavarat, P1
Sosothikul, D1
Ananworanich, J1
Berenguer, J1
Bellón, JM1
Miralles, P1
Alvarez, E1
Castillo, I1
Cosín, J1
López, JC1
Sánchez Conde, M1
Padilla, B1
Resino, S1
Richman, DD1
D'Aquila, RT2
Hughes, MD2
Johnson, VA2
Fischl, MA2
Sommadossi, JP1
Liou, SH1
Timpone, J1
Myers, M2
Basgoz, N2
Niu, M1
Hirsch, MS2
Bremer, JW1
Elbeik, T1
Erice, A1
Kuritzkes, DR1
Scott, WA1
Spector, SA1
Montaner, JS1
Cooper, D1
Vella, S1
Harris, M1
Conway, B1
Wainberg, MA1
Smith, D1
Robinson, P1
Hall, D1
Doepel, L1
Folkers, G1

Clinical Trials (3)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Randomised, Double Blind, Double Dummy, Parallel Group, Active Controlled Trial to Evaluate the Antiviral Efficacy of 400 mg QD neVirapine Extended Release Formulation in Comparison to 200 mg BID neVirapinE Immediate Release in Combination With Truvada®[NCT00561925]Phase 31,068 participants (Actual)Interventional2007-11-30Completed
A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine[NCT00000770]Phase 2400 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
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Comparison of CD4+ Cell Count (Cells/Cubic Millimeter) Change From Baseline at Week 144, Full Analysis Set Population

(NCT00561925)
Timeframe: baseline, week 144

Interventioncells/cubic millimeter (Mean)
NVP IR 200mg BID239.3
NVP XR 400mg QD270.7

Comparison of HIV-1 Viral Load (log10 Copies/mL) Change From Baseline at Week 144, Full Analysis Set Population

(NCT00561925)
Timeframe: baseline, week 144

Interventionlog10 copies/mL (Mean)
NVP IR 200mg BID-2.7
NVP XR 400mg QD-2.8

Occurrence of Hepatic Events

Frequency of patients with hepatitis symptoms (NCT00561925)
Timeframe: until last patient completed 144 weeks (up to 193 weeks)

Interventionparticipants (Number)
NVP IR10
NVP XR8
IR-IR/XR2
XR-IR/XR0

Relative Bioavailability Trough C_pre,ss,1

Relative bioavailability measured of trough concentrations. Analysis based on adjusted by-treatment geometric means, the adjusted geometric mean ratio of NVP XR : NVP IR and it's 90% confidence interval with p-value and the inter-individual geometric coefficient of variation. (NCT00561925)
Timeframe: week 132

Interventionng/mL (Geometric Mean)
NVP IR4567.03
NVP XR3634.26

Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population

Primary endpoint was the number of patients with a sustained virologic response through week 48 using LLOQ = 50 copies/mL (NCT00561925)
Timeframe: week 48

,
Interventionparticipants (Number)
ResponderNon responder
NVP IR 200mg BID384122
NVP XR 400mg QD40996

Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events

(NCT00561925)
Timeframe: week 0 to 72

,
Interventioncumulative probability (Number)
Interval Week 0 to <2Interval Week 2 to <4Interval Week 4 to <6Interval Week 6 to <8Interval Week 8 to <12Interval Week 12 to <16Interval Week 16 to <24Interval Week 24 to <32Interval Week 32 to <40Interval Week 40 to <48Interval Week 48 to <60Interval Week 60 to <72Interval Week >=72
NVP IR0.0000.0000.0120.0220.0240.0260.0260.0260.0260.0290.0290.0320.038
NVP XR0.0000.0020.0100.0160.0180.0180.0180.0200.0220.0220.0220.0220.026

Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities

(NCT00561925)
Timeframe: week 0 to 72

,
Interventioncumulative probability (Number)
Interval Week 0 to <2Interval Week 2 to <4Interval Week 4 to <6Interval Week 6 to <8Interval Week 8 to <12Interval Week 12 to <16Interval Week 16 to <24Interval Week 24 to <32Interval Week 32 to <40Interval Week 40 to <48Interval Week 48 to <60Interval Week 60 to <72Interval Week >=72
NVP IR0.0000.0000.0120.0490.0590.0630.0630.0670.0700.0760.0760.0760.076
NVP XR0.0000.0020.0140.0260.0340.0360.0360.0430.0490.0560.0580.0580.070

Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities

(NCT00561925)
Timeframe: week 0 to 72

,
Interventioncumulative probability (Number)
Interval Week 0 to <2Interval Week 2 to <4Interval Week 4 to <6Interval Week 6 to <8Interval Week 8 to <12Interval Week 12 to <16Interval Week 16 to <24Interval Week 24 to <32Interval Week 32 to <40Interval Week 40 to <48Interval Week 48 to <60Interval Week 60 to <72Interval Week >=72
NVP IR0.0000.0000.0060.0270.0330.0390.0390.0420.0440.0530.0530.0530.053
NVP XR0.0000.0000.0020.0060.0080.0080.0080.0150.0190.0280.0310.0330.033

Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash

(NCT00561925)
Timeframe: week 0 to 72

,
Interventioncumulative probability (Number)
Interval Week 0 to <2Interval Week 2 to <4Interval Week 4 to <6Interval Week 6 to <8Interval Week 8 to <12Interval Week 12 to <16Interval Week 16 to <24Interval Week 24 to <32Interval Week 32 to <40Interval Week 40 to <48Interval Week 48 to <60Interval Week 60 to <72Interval Week >=72
NVP IR0.0000.0000.0020.0040.0040.0040.0040.0040.0040.0040.0040.0040.004
NVP XR0.0000.0000.0060.0080.0100.0100.0100.0100.0100.0100.0100.0100.010

Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication

(NCT00561925)
Timeframe: week 0 to 144

,
Interventioncumulative probability (Number)
Interval Week 0 to <2Interval Week 2 to <4Interval Week 4 to <6Interval Week 6 to <8Interval Week 8 to <12Interval Week 12 to <16Interval Week 16 to <24Interval Week 24 to <32Interval Week 32 to <40Interval Week 40 to <48Interval Week 48 to <60Interval Week 60 to <72Interval Week 72 to <84Interval Week 84 to <96Interval Week 96 to <108Interval Week 108 to <120Interval Week 120 to <132Interval Week 132 to <144
NVP IR0.0000.0000.0340.0670.0810.0930.1130.1300.1560.1720.1920.2020.2130.2290.2430.2670.2750.289
NVP XR0.0000.0000.0260.0460.0590.0670.0830.1150.1390.1560.1620.1760.1880.2060.2180.2320.2360.244

Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population

(NCT00561925)
Timeframe: week 0 to 144

,
Interventionproportion of participants (Number)
Interval Week 0 to <2Interval Week 2 to <4Interval Week 4 to <6Interval Week 6 to <8Interval Week 8 to <12Interval Week 12 to <16Interval Week 16 to <24Interval Week 24 to <32Interval Week 32 to <40Interval Week 40 to <48Interval Week 48 to <60Interval Week 60 to <72Interval Week 72 to <84Interval Week 84 to <96Interval Week 96 to <108Interval Week 108 to <120Interval Week 120 to <132Interval Week 132 to <144Interval Week 144 to <168
NVP IR 200mg BID00.0060.0060.0230.0290.0290.0310.040.0420.0470.0470.0520.0540.0540.0570.0570.060.060.062
NVP XR 400mg QD00.0020.0060.0080.010.0190.0210.0250.0250.0270.0270.0320.0350.040.040.0450.0470.0470.047

Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population

(NCT00561925)
Timeframe: week 0 to 144

,
Interventionproportion of participants (Number)
Interval Week 0 to <2Interval Week 2 to <4Interval Week 4 to <6Interval Week 6 to <8Interval Week 8 to <12Interval Week 12 to <16Interval Week 16 to <24Interval Week 24 to <32Interval Week 32 to <40Interval Week 40 to <48Interval Week 48 to <60Interval Week 60 to <72Interval Week 72 to <84Interval Week 84 to <96Interval Week 96 to <108Interval Week 108 to <120Interval Week 120 to <132Interval Week 132 to <144Interval Week 144 to <168
NVP IR 200mg BID10.840.8380.8340.8340.8320.830.8220.8060.7920.7770.7590.7330.7130.6860.6620.650.630.61
NVP XR 400mg QD10.8650.8650.8650.8630.8610.8590.8480.8320.8160.8080.7880.7660.7450.7190.6970.6810.6710.66

Occurrence of Elevations in Laboratory Measurement by DAIDS Grade

(NCT00561925)
Timeframe: until last patient completed 144 weeks (up to 193 weeks)

,,,
Interventionparticipants (Number)
DAIDS grade 3 or 4 AEsDAIDS grade 4 AEs
IR-IR/XR7111
NVP IR5317
NVP XR11125
XR-IR/XR83

Occurrence of Rashes

Frequency of patients with drug related rash events by functional grouping (NCT00561925)
Timeframe: until last patient completed 144 weeks (up to 193 weeks)

,,,
Interventionparticipants (Number)
rash group Irash group IIrash group IIArash group IIIrash group IV
IR-IR/XR63100
NVP IR96430
NVP XR1113550
XR-IR/XR00000

Proportion of Sustained Virologic Response at Week 144 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population

Endpoint was the number of patients with a sustained virologic response through week 144 using LLOQ = 50 copies/mL (NCT00561925)
Timeframe: week 144

,
Interventionparticipants (Number)
ResponderNon responder
NVP IR 200mg BID296210
NVP XR 400mg QD321184

Reviews

3 reviews available for nevirapine and Disease Exacerbation

ArticleYear
Optimisation of antiretroviral therapy in HIV-infected children under 3 years of age.
    The Cochrane database of systematic reviews, 2014, May-22, Issue:5

    Topics: Anti-HIV Agents; CD4 Lymphocyte Count; Disease Progression; Drug Administration Schedule; Drug Combi

2014
Effectiveness of antiretroviral therapy in HIV-infected children under 2 years of age.
    The Cochrane database of systematic reviews, 2012, Jul-11, Issue:7

    Topics: Anti-HIV Agents; CD4 Lymphocyte Count; Disease Progression; Drug Administration Schedule; Drug Combi

2012
Resistance, drug failure, and disease progression.
    AIDS research and human retroviruses, 1994, Volume: 10, Issue:8

    Topics: Antiviral Agents; Disease Progression; Drug Resistance, Microbial; Drug Therapy, Combination; HIV; H

1994

Trials

13 trials available for nevirapine and Disease Exacerbation

ArticleYear
HIV disease progression in the first year after delivery among African women followed in the HPTN 046 clinical trial.
    Journal of acquired immune deficiency syndromes (1999), 2013, Nov-01, Volume: 64, Issue:3

    Topics: Adolescent; Adult; Anti-HIV Agents; Breast Feeding; CD4 Lymphocyte Count; Disease Progression; Doubl

2013
Routine versus clinically driven laboratory monitoring of HIV antiretroviral therapy in Africa (DART): a randomised non-inferiority trial.
    Lancet (London, England), 2010, Jan-09, Volume: 375, Issue:9709

    Topics: Adenine; Adolescent; Adult; Africa; Aged; Anemia; Anti-Retroviral Agents; CD4 Lymphocyte Count; Crea

2010
Nevirapine/zidovudine/lamivudine has superior immunological and virological responses not reflected in clinical outcomes in a 48-week randomized comparison with abacavir/zidovudine/lamivudine in HIV-infected Ugandan adults with low CD4 cell counts.
    HIV medicine, 2010, Volume: 11, Issue:5

    Topics: Adult; Body Weight; CD4 Lymphocyte Count; Dideoxynucleosides; Disease Progression; Double-Blind Meth

2010
Efficacy and safety of nevirapine extended-release once daily versus nevirapine immediate-release twice-daily in treatment-naive HIV-1-infected patients.
    Antiviral therapy, 2011, Volume: 16, Issue:5

    Topics: Adult; Anti-HIV Agents; CD4 Lymphocyte Count; Disease Progression; Double-Blind Method; Drug Adminis

2011
Effects of valacyclovir on markers of disease progression in postpartum women co-infected with HIV-1 and herpes simplex virus-2.
    PloS one, 2012, Volume: 7, Issue:6

    Topics: Acyclovir; Antiviral Agents; Biomarkers; CD4 Antigens; Disease Progression; Female; Herpes Genitalis

2012
Substitution of nevirapine, efavirenz, or abacavir for protease inhibitors in patients with human immunodeficiency virus infection.
    The New England journal of medicine, 2003, Sep-11, Volume: 349, Issue:11

    Topics: Adult; Aged; Alkynes; Benzoxazines; Cyclopropanes; Dideoxynucleosides; Disease Progression; Drug The

2003
Three-year follow-up of protease inhibitor-based regimen simplification in HIV-infected patients.
    AIDS (London, England), 2007, Jan-30, Volume: 21, Issue:3

    Topics: Alkynes; Antiretroviral Therapy, Highly Active; Benzoxazines; Cyclopropanes; Dideoxynucleosides; Dis

2007
A virological benefit from an induction/maintenance strategy: the Forte trial.
    Antiviral therapy, 2007, Volume: 12, Issue:1

    Topics: Adult; Antiretroviral Therapy, Highly Active; CD4 Lymphocyte Count; Didanosine; Disease Progression;

2007
High frequency of rapid immunological progression in African infants infected in the era of perinatal HIV prophylaxis.
    AIDS (London, England), 2007, Jun-19, Volume: 21, Issue:10

    Topics: Anti-HIV Agents; CD4 Lymphocyte Count; Disease Progression; Drug Administration Schedule; Drug Thera

2007
Resistance, drug failure, and disease progression.
    AIDS research and human retroviruses, 1994, Volume: 10, Issue:8

    Topics: Antiviral Agents; Disease Progression; Drug Resistance, Microbial; Drug Therapy, Combination; HIV; H

1994
Nevirapine, zidovudine, and didanosine compared with zidovudine and didanosine in patients with HIV-1 infection. A randomized, double-blind, placebo-controlled trial. National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group Protoco
    Annals of internal medicine, 1996, Jun-15, Volume: 124, Issue:12

    Topics: Adult; CD4 Lymphocyte Count; Didanosine; Disease Progression; Double-Blind Method; Drug Therapy, Com

1996
Monitoring plasma HIV-1 RNA levels in addition to CD4+ lymphocyte count improves assessment of antiretroviral therapeutic response. ACTG 241 Protocol Virology Substudy Team.
    Annals of internal medicine, 1997, Jun-15, Volume: 126, Issue:12

    Topics: Acquired Immunodeficiency Syndrome; Adult; Anti-HIV Agents; CD4 Lymphocyte Count; Didanosine; Diseas

1997
A randomized, double-blind trial comparing combinations of nevirapine, didanosine, and zidovudine for HIV-infected patients: the INCAS Trial. Italy, The Netherlands, Canada and Australia Study.
    JAMA, 1998, Mar-25, Volume: 279, Issue:12

    Topics: Adult; Anti-HIV Agents; CD4 Lymphocyte Count; Didanosine; Disease Progression; Double-Blind Method;

1998

Other Studies

8 other studies available for nevirapine and Disease Exacerbation

ArticleYear
Temporal association between incident tuberculosis and poor virological outcomes in a South African antiretroviral treatment service.
    Journal of acquired immune deficiency syndromes (1999), 2013, Nov-01, Volume: 64, Issue:3

    Topics: Adult; AIDS-Related Opportunistic Infections; Alkynes; Anti-HIV Agents; Benzoxazines; CD4 Lymphocyte

2013
MicroRNA-150 is a potential biomarker of HIV/AIDS disease progression and therapy.
    PloS one, 2014, Volume: 9, Issue:5

    Topics: Acquired Immunodeficiency Syndrome; Adult; Alkynes; Antiretroviral Therapy, Highly Active; Benzoxazi

2014
The obstetric face and challenge of HIV/AIDS.
    Clinical obstetrics and gynecology, 2009, Volume: 52, Issue:2

    Topics: Acquired Immunodeficiency Syndrome; AIDS-Related Opportunistic Infections; Anti-HIV Agents; Anti-Inf

2009
Differential CD4 T-cell response in HIV-1-infected patients using protease inhibitor-based or nevirapine-based highly active antiretroviral therapy.
    HIV medicine, 2004, Volume: 5, Issue:2

    Topics: Adult; Antiretroviral Therapy, Highly Active; CD4 Lymphocyte Count; CD4-Positive T-Lymphocytes; Coho

2004
Effect of antiretroviral drugs on liver fibrosis in HIV-infected patients with chronic hepatitis C: harmful impact of nevirapine.
    AIDS (London, England), 2004, Mar-26, Volume: 18, Issue:5

    Topics: Adult; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Cross-Sectional Studies; Disease Prog

2004
Regression of a cervical spinal mass following highly active antiretroviral therapy (HAART) in child with advanced human immunodeficiency virus (HIV) disease.
    Journal of the Medical Association of Thailand = Chotmaihet thangphaet, 2007, Volume: 90, Issue:9

    Topics: Anti-Retroviral Agents; Antiretroviral Therapy, Highly Active; Cervical Vertebrae; Child; Disease Pr

2007
Association between exposure to nevirapine and reduced liver fibrosis progression in patients with HIV and hepatitis C virus coinfection.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2008, Jan-01, Volume: 46, Issue:1

    Topics: Adult; Alkynes; Anti-HIV Agents; Benzoxazines; Cross-Sectional Studies; Cyclopropanes; Disease Progr

2008
NIAID researchers present new findings at retrovirus meeting. National Institute of Allergy and Infectious Diseases.
    NIAID AIDS agenda, 1997

    Topics: Anti-HIV Agents; CD4 Lymphocyte Count; CD4-Positive T-Lymphocytes; Chemokines; Clinical Trials as To

1997