nevirapine and Pregnancy 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.

Pregnancy: The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH.

Research Excerpts

Excerpt	Relevance	Reference
"To confirm whether 7 days of phenytoin, an enzyme inducer, would decrease the elimination half-life of single-dose nevirapine and to investigate its effect on the development of nevirapine resistance in pregnant, HIV-infected women."	9.17	Effect of 7 days of phenytoin on the pharmacokinetics of and the development of resistance to single-dose nevirapine for perinatal HIV prevention: a randomized pilot trial. ( Aitken, S; Burger, DM; Chunda, C; Fillekes, Q; Gibb, DM; Kankasa, C; Kisanga, ER; Muro, EP; Thomason, MJ; Walker, AS, 2013)
"Pharmacokinetic data for lopinavir in late pregnancy and in breastfeeding are limited, and no data for abacavir in breast milk are available."	9.17	Therapeutic levels of lopinavir in late pregnancy and abacavir passage into breast milk in the Mma Bana Study, Botswana. ( Capparelli, E; Essex, M; Leidner, J; Lockman, S; Makhema, J; Moffat, C; Moss, M; Moyo, S; Ogwu, A; Rossi, S; Shapiro, RL, 2013)
"Nevirapine (NVP) resistance emerges in up to 70% of women exposed to single-dose (sd) NVP for prevention of mother-to-child transmission of human immunodeficiency virus (HIV)."	9.17	Greater suppression of nevirapine resistance with 21- vs 7-day antiretroviral regimens after intrapartum single-dose nevirapine for prevention of mother-to-child transmission of HIV. ( Bonhomme, J; Chan, ES; Halvas, EK; Hitti, J; Hong, F; Hughes, MD; Kabanda, J; Klingman, KL; Kumarasamy, N; McMahon, DK; Mellors, JW; Taulo, F; Wallis, CL; Zheng, L, 2013)
"Intrapartum single-dose (SD) nevirapine (NVP) reduces perinatal transmission of human immunodeficiency virus (HIV) infection but selects for NVP-resistant virus, which compromises subsequent NVP-based therapy."	9.16	A comparison of 3 regimens to prevent nevirapine resistance mutations in HIV-infected pregnant women receiving a single intrapartum dose of nevirapine. ( Achalapong, J; Beck, IA; Britto, P; Chotivanich, N; Cressey, TR; Frenkel, L; Jourdain, G; Maupin, R; Mirochnick, M; Ngo-Giang-Huong, N; Prommas, S; Puthanakit, T; Rasri, W; Roongpisuthipong, A; Shapiro, DE; Van Dyke, RB; Yuthavisuthi, P, 2012)
"Daily nevirapine (NVP) prophylaxis to HIV-exposed infants significantly reduces breast-milk HIV transmission."	9.14	Nevirapine resistance and breast-milk HIV transmission: effects of single and extended-dose nevirapine prophylaxis in subtype C HIV-infected infants. ( Balasubramaniam, U; Bharadwaj, R; Bhore, AV; Bhosale, R; Bollinger, R; Gupta, A; Gupte, N; Kagal, A; Kulkarni, S; Kulkarni, V; Moorthy, A; Patil, S; Persaud, D; Sastry, J; Suryavanshi, N; Thakar, M; Tripathy, S; Venkataramani, V; Ziemniak, C, 2009)
"Nevirapine has been widely used in pregnancy for its efficacy, low pill burden, bioavailability and rapid transplacental transfer."	9.12	Safety of nevirapine in pregnancy. ( Anderson, J; de Ruiter, A; Edwards, SG; Hay, P; McDonald, C; Natarajan, U; Pym, A; Taylor, GP; Velisetty, P; Welch, J, 2007)
" We aimed to establish whether pregnancy rates differ between HIV-positive women who use various contraceptive methods and either efavirenz-based or nevirapine-based antiretroviral therapy (ART) regimens."	8.91	Pregnancy rates in HIV-positive women using contraceptives and efavirenz-based or nevirapine-based antiretroviral therapy in Kenya: a retrospective cohort study. ( Blat, C; Bukusi, EA; Cohen, CR; Gandhi, M; Hagey, J; Newmann, SJ; Onono, M; Patel, RC; Shade, SB; Vittinghoff, E, 2015)
" Further, the addition of single-dose TDF to single-dose nevirapine (SD-NVP) during delivery following maternal ZDV use during pregnancy significantly reduces the frequency of nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance."	8.85	Tenofovir 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)
"Clinical trials demonstrated intermittent preventive treatment in pregnancy with mefloquine (MQ) reduced malaria rates among pregnant women, yet an unexpected higher risk of mother-to-child transmission (MTCT) of HIV among HIV-positive women receiving MQ has also been observed."	7.88	Short Communication: Reduced Nevirapine Concentrations Among HIV-Positive Women Receiving Mefloquine for Intermittent Preventive Treatment for Malaria Control During Pregnancy. ( Desai, M; Dinh, C; Gonzalez, R; Haaland, RE; Heneine, W; Katana, A; Martin, A; Menendez, C; Otieno, K; Slutsker, L; Williamson, J, 2018)
" Patients were allocated to 2groups according to exposure to nevirapine during pregnancy."	7.83	[Hepatotoxicity in healthy infants exposed to nevirapine during pregnancy]. ( Figueras-Nadal, C; Fortuny-Guasch, C; Iveli, P; Martín-Nalda, A; Noguera-Julian, A; Rovira-Girabal, N; Soler-Palacín, P, 2016)
"Previous studies on nevirapine pharmacokinetics during pregnancy reported contradictory findings."	7.83	Pregnancy affects nevirapine pharmacokinetics: evidence from a CYP2B6 genotype-guided observational study. ( Back, D; Bolaji, O; Khoo, S; Neary, M; Olagunju, A; Owen, A, 2016)
"The objective of this study was to determine the prevalence of drug resistance mutations among HIV-positive women in Malawi 18 months after discontinuing nevirapine-based ART for the prevention of mother-to-child transmission."	7.81	Drug resistance mutations 18 months after discontinuation of nevirapine-based ART for prevention of mother-to-child transmission of HIV in Malawi. ( Amici, R; Andreotti, M; Galluzzo, CM; Giuliano, M; Jere, H; Liotta, G; Luhanga, R; Mancinelli, S; Marazzi, MC; Palombi, L; Sagno, JB; Vella, S, 2015)
"An exit interview was conducted one year post-partum for 85 HIV-infected women who participated in a study of HIV-1 transmission rates among NVP-experienced compared with NVP-naïve women in "The Nevirapine Repeat Pregnancy (NVP-RP) Study" at the Makerere University-Johns Hopkins University Research Collaboration, Kampala-Uganda, between June 2004 and June 2006."	7.81	A cross-sectional study of the magnitude, barriers, and outcomes of HIV status disclosure among women participating in a perinatal HIV transmission study, "the Nevirapine Repeat Pregnancy study". ( Bakaki, PM; Fowler, MG; Kiweewa, FM; Kusasira, F; McConnell, MS; Mubiru, MC; Musisi, M; Musoke, P; Nakayiwa, F; Nakintu, D; Namirembe, C, 2015)
"Data from a prospective multisite cohort study were used to examine the effect of HIV exposure, untreated HIV infection, and single-dose nevirapine on infant growth velocity."	7.80	HIV infection, viral load, low birth weight, and nevirapine are independent influences on growth velocity in HIV-exposed South African infants. ( Chhagan, M; Doherty, T; Fadnes, LT; Goga, AE; Jackson, DJ; Lombard, C; Ramokolo, V; Van den Broeck, J, 2014)
" We compared the pregnancy outcomes of women exposed to EFV and to nevirapine (NVP) during the first trimester."	7.77	Pregnancy outcomes in women exposed to efavirenz and nevirapine: an appraisal of the IeDEA West Africa and ANRS Databases, Abidjan, Côte d'Ivoire. ( Amani-Bosse, C; Anglaret, X; Coffie, PA; Dabis, F; Danel, C; Eholié, SP; Ekouevi, DK; Messou, E; Moh, R; Ouattara, E; Sissoko, M, 2011)
"Use of single dose nevirapine (sdNVP) to prevent HIV mother-to-child transmission is associated with the emergence of NVP resistance in many infants who are HIV infected despite prophylaxis."	7.75	In utero HIV infection is associated with an increased risk of nevirapine resistance in ugandan infants who were exposed to perinatal single dose nevirapine. ( Bagenda, D; Bakaki, P; Church, JD; Donnell, D; Eshleman, SH; Eure, C; Fowler, MG; Guay, LA; Jackson, JB; Matovu, F; McConnell, M; Musoke, P; Mwatha, A; Nakabiito, C; Omer, SB; Thigpen, MC, 2009)
"Single-dose nevirapine (SDNVP) for the prevention of mother-to-child HIV transmission (PMTCT) results in the selection of resistance mutants among HIV-infected mothers."	7.74	Reuse of single-dose nevirapine in subsequent pregnancies for the prevention of mother-to-child HIV transmission in Lusaka, Zambia: a cohort study. ( Aldrovandi, GM; Kankasa, C; Kuhn, L; Semrau, K; Sinkala, M; Thea, DM; Walter, J, 2008)
"Single-dose nevirapine (SDNVP) is widely used to prevent mother-to-child HIV transmission in resource-limited settings."	7.74	Effectiveness of repeat single-dose nevirapine for prevention of mother-to-child transmission of HIV-1 in repeat pregnancies in Uganda. ( Bagenda, D; Bakaki, P; Downing, R; Eure, C; Fowler, MG; Greenberg, AE; Matovu, F; McConnell, M; Mubiru, M; Thigpen, MC, 2007)
"To determine the impact of pregnancy on the pharmacokinetics (PK) of nevirapine (NVP) during chronic dosing in HIV-infected women and appropriate NVP dosing in this population."	7.74	Chronic administration of nevirapine during pregnancy: impact of pregnancy on pharmacokinetics. ( Aweeka, F; Best, B; Burchett, SK; Capparelli, EV; Foca, M; Hitti, J; Hu, C; Jimenez, E; Mirochnick, M; Nachman, S; Read, JS; Shearer, WT; Smith, E; Spector, SA; Stek, A; Thorpe, EM; Watts, H, 2008)
"Nelfinavir- or nevirapine-containing HAART regimens during pregnancy are well tolerated."	7.73	Nelfinavir and nevirapine side effects during pregnancy. ( Boer, K; de Wolf, F; Dieleman, J; Godfried, MH; Nellen, J; Schneider, ME; Sprenger, H; Tempelman, C; Timmermans, S; van der Ende, ME, 2005)
"The incidence of adverse events with nevirapine may be lower than previously reported (13% versus 29%) and may be primarily noted with initiating the drug late in pregnancy."	7.73	Third-trimester maternal toxicity with nevirapine use in pregnancy. ( Brady, MT; Fan-Havard, P; Hughes, L; Joy, S; Koletar, SL; Para, MF; Poi, M, 2005)
"To describe the maternal tolerability of nevirapine as part of combination antiretroviral therapy in pregnancy at three HIV centres in Dublin, Ireland and to determine risk factors for development of significant hepatotoxicity."	7.73	Maternal hepatotoxicity with nevirapine as part of combination antiretroviral therapy in pregnancy. ( Bergin, C; Geoghegan, J; Hopkins, S; Kelleher, B; Lyons, F; McCormick, PA; McGeary, A; Mulcahy, FM; Sheehan, G, 2006)
" We report the case of a pregnant human immunodeficiency virus type 1-infected woman who developed drug rash with eosinophilia and systemic symptoms syndrome and renal failure shortly after initiation of a nevirapine-containing antiretroviral regimen at 27 weeks' gestation."	7.72	Drug rash with eosinophilia and systemic symptoms syndrome and renal toxicity with a nevirapine-containing regimen in a pregnant patient with human immunodeficiency virus. ( Boswell, H; Fan-Havard, P; Knudtson, E; Para, M, 2003)
" The one adverse event associated with nelfinavir occurred in a subject with a CD4 cell count less than 250 cells/microL."	6.71	Maternal toxicity with continuous nevirapine in pregnancy: results from PACTG 1022. ( Baker, D; Foca, M; Frenkel, LM; Gandia, J; Gonzalez-Garcia, A; Hitti, J; Huang, S; McNamara, J; Nachman, SA; Paul, ME; Provisor, A; Stek, AM; Stevens, LM; Thorpe, EM; Watts, DH; Wei, LJ, 2004)
"The risk of adverse drug events associated with nevirapine (NVP) is suggested to be greater in pregnant women."	6.49	Adverse events associated with nevirapine use in pregnancy: a systematic review and meta-analysis. ( Andrieux-Meyer, I; Calmy, A; Ford, N; Hargreaves, S; Mills, EJ; Shubber, Z, 2013)
"To investigate if pregnancy is a risk factor for SJS among HIV-infected women taking NVP-containing regimens and registered within the Medunsa National Pharmacovigilance Centre database."	5.39	Risk of nevirapine-associated Stevens-Johnson syndrome among HIV-infected pregnant women: the Medunsa National Pharmacovigilance Centre, 2007 - 2012. ( Adewusi, E; Dube, N; Summers, R, 2013)
"Pregnancy has a moderate but significant lowering effect on NVP plasma concentrations."	5.35	Steady-state nevirapine plasma concentrations are influenced by pregnancy. ( Boer, K; Burger, DM; Damming, M; de Wolf, F; Godfried, MH; Nellen, JF; Prins, JM; van der Ende, ME; Wit, FW, 2008)
" The influence of gender, age, body weight and comedication on minimum and maximum concentrations (C(min), C(max)), area under the concentration-time curve (AUC), total clearance (CL(tot)), half-life (t(1/2)) and volume of distribution (V(d)) was analysed by multivariate techniques."	5.33	A comparison of the steady-state pharmacokinetics of nevirapine in men, nonpregnant women and women in late pregnancy. ( Carlebach, A; Gute, P; Haberl, A; Harder, S; Klauke, S; Knecht, G; Kurowski, M; Rohrbacher, M; Staszewski, S; Stocker, H; von Hentig, N, 2006)
"To confirm whether 7 days of phenytoin, an enzyme inducer, would decrease the elimination half-life of single-dose nevirapine and to investigate its effect on the development of nevirapine resistance in pregnant, HIV-infected women."	5.17	Effect of 7 days of phenytoin on the pharmacokinetics of and the development of resistance to single-dose nevirapine for perinatal HIV prevention: a randomized pilot trial. ( Aitken, S; Burger, DM; Chunda, C; Fillekes, Q; Gibb, DM; Kankasa, C; Kisanga, ER; Muro, EP; Thomason, MJ; Walker, AS, 2013)
"ART use did not affect risk of ovulation or pregnancy in women taking COCs, suggesting that nevirapine-containing ART does not interfere with COC contraceptive effectiveness."	5.17	Nevirapine-based antiretroviral therapy does not reduce oral contraceptive effectiveness. ( Delany-Moretlwe, S; Dubé, K; Edward, VA; Kwok, C; Lendvay, A; Mirembe, FM; Molife, L; Mpairwe, B; Nakubulwa, S; Nanda, K, 2013)
"Although substantiated by little evidence, concerns about zidovudine-related anaemia in pregnancy have influenced antiretroviral (ARV) regimen choice for preventing mother-to-child transmission of HIV-1, especially in settings where anaemia is common."	5.17	Maternal anaemia and duration of zidovudine in antiretroviral regimens for preventing mother-to-child transmission: a randomized trial in three African countries. ( Chersich, MF; Farley, TM; Luchters, S; Meda, N; Mwaura, M; Newell, ML; Sartorius, BK; Temmerman, M, 2013)
"Pharmacokinetic data for lopinavir in late pregnancy and in breastfeeding are limited, and no data for abacavir in breast milk are available."	5.17	Therapeutic levels of lopinavir in late pregnancy and abacavir passage into breast milk in the Mma Bana Study, Botswana. ( Capparelli, E; Essex, M; Leidner, J; Lockman, S; Makhema, J; Moffat, C; Moss, M; Moyo, S; Ogwu, A; Rossi, S; Shapiro, RL, 2013)
"Nevirapine (NVP) resistance emerges in up to 70% of women exposed to single-dose (sd) NVP for prevention of mother-to-child transmission of human immunodeficiency virus (HIV)."	5.17	Greater suppression of nevirapine resistance with 21- vs 7-day antiretroviral regimens after intrapartum single-dose nevirapine for prevention of mother-to-child transmission of HIV. ( Bonhomme, J; Chan, ES; Halvas, EK; Hitti, J; Hong, F; Hughes, MD; Kabanda, J; Klingman, KL; Kumarasamy, N; McMahon, DK; Mellors, JW; Taulo, F; Wallis, CL; Zheng, L, 2013)
"Extended nevirapine and cotrimoxazole prophylaxis through 6 months of age among HIV-exposed uninfected infants did not appear to increase the immediate or long-term risk of neutropenia, anemia or skin-rash."	5.16	Extended prophylaxis with nevirapine and cotrimoxazole among HIV-exposed uninfected infants is well tolerated. ( Aizire, J; Bolton, SG; Brown, ER; Coovadia, H; Fowler, MG; Kamateeka, M; Musoke, PM; Shetty, AK; Stranix-Chibanda, L; Wang, J, 2012)
"Intrapartum single-dose (SD) nevirapine (NVP) reduces perinatal transmission of human immunodeficiency virus (HIV) infection but selects for NVP-resistant virus, which compromises subsequent NVP-based therapy."	5.16	A comparison of 3 regimens to prevent nevirapine resistance mutations in HIV-infected pregnant women receiving a single intrapartum dose of nevirapine. ( Achalapong, J; Beck, IA; Britto, P; Chotivanich, N; Cressey, TR; Frenkel, L; Jourdain, G; Maupin, R; Mirochnick, M; Ngo-Giang-Huong, N; Prommas, S; Puthanakit, T; Rasri, W; Roongpisuthipong, A; Shapiro, DE; Van Dyke, RB; Yuthavisuthi, P, 2012)
"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."	5.16	Effects 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)
"In neonates whose mothers did not receive ART during pregnancy, prophylaxis with a two- or three-drug ART regimen is superior to zidovudine alone for the prevention of intrapartum HIV transmission; the two-drug regimen has less toxicity than the three-drug regimen."	5.16	Three postpartum antiretroviral regimens to prevent intrapartum HIV infection. ( Bastos, FI; Bethel, J; Bryson, YJ; Camarca, M; Ceriotto, M; Dickover, R; Fonseca, R; Gray, G; Grinsztejn, B; Joao, EC; Kreitchmann, R; Machado, D; Mirochnick, M; Mofenson, LM; Moreira, RI; Morgado, MG; Moye, J; Mussi-Pinhata, MM; Nielsen-Saines, K; Pilotto, JH; Pinto, J; Santos, B; Siberry, G; Theron, G; Veloso, VG; Watts, DH; Xu, J, 2012)
"Daily nevirapine (NVP) prophylaxis to HIV-exposed infants significantly reduces breast-milk HIV transmission."	5.14	Nevirapine resistance and breast-milk HIV transmission: effects of single and extended-dose nevirapine prophylaxis in subtype C HIV-infected infants. ( Balasubramaniam, U; Bharadwaj, R; Bhore, AV; Bhosale, R; Bollinger, R; Gupta, A; Gupte, N; Kagal, A; Kulkarni, S; Kulkarni, V; Moorthy, A; Patil, S; Persaud, D; Sastry, J; Suryavanshi, N; Thakar, M; Tripathy, S; Venkataramani, V; Ziemniak, C, 2009)
"For almost a decade, single-dose nevirapine (sdNVP) has been proven to be a safe and effective drug for the prevention of mother-to-child transmission (PMTCT) of HIV."	5.14	Is single-dose NVP relevant in the era of more efficacious PMTCT regimens? Lessons from Zambia. ( Bweupe, M; Dirks, R; Kabaso, M; Kasonde, P; Mandala, J; Sangiwa, G; Torpey, K, 2010)
"Pregnant HIV-1 seropositive women (CD4+ T-cell count >250 and <500 cells/mm3) electing to breastfeed in Nairobi, Kenya were randomized to highly active antiretroviral therapy (HAART; zidovudine [ZDV], lamivudine and nevirapine [NVP]) during pregnancy and 6 months post-partum or to short-course ZDV plus single-dose NVP (ZDV/NVP)."	5.13	Highly active antiretroviral therapy versus zidovudine/nevirapine effects on early breast milk HIV type-1 Rna: a phase II randomized clinical trial. ( Chung, MH; John-Stewart, GC; Kiarie, JN; Kinuthia, J; Lehman, DA; Njiri, F; Overbaugh, J; Richardson, BA, 2008)
"In a setting of high perinatal nevirapine use, acute chorioamnionitis was not associated with vertical HIV-1 transmission."	5.12	Acute and chronic chorioamnionitis and the risk of perinatal human immunodeficiency virus-1 transmission. ( Chi, BH; Goldenberg, RL; Levy, J; Mudenda, V; Sinkala, M; Stringer, JS, 2006)
"Nevirapine has been widely used in pregnancy for its efficacy, low pill burden, bioavailability and rapid transplacental transfer."	5.12	Safety of nevirapine in pregnancy. ( Anderson, J; de Ruiter, A; Edwards, SG; Hay, P; McDonald, C; Natarajan, U; Pym, A; Taylor, GP; Velisetty, P; Welch, J, 2007)
"Large numbers of women receive single-dose nevirapine (sdNVP) to prevent mother-to-child transmission (MTCT) of HIV; over time, an increasing proportion will return to prevention of MTCT programs for a second pregnancy."	5.12	Transmission rates in consecutive pregnancies exposed to single-dose nevirapine in Soweto, South Africa and Abidjan, Côte d'Ivoire. ( Becquet, R; Dabis, F; Dhlamini, P; Ekouevi, DK; Gray, GE; Leroy, V; Lupodwana, P; Martinson, NA; McIntyre, JA; Morris, L; Steyn, JG; Tonwe-Gold, B; Viho, I, 2007)
"We conducted a randomized, double-blind trial of three treatment regimens in Thai women who were receiving zidovudine therapy during the third trimester of pregnancy."	5.11	Single-dose perinatal nevirapine plus standard zidovudine to prevent mother-to-child transmission of HIV-1 in Thailand. ( Jourdain, G; Kanshana, S; Koetsawang, S; Lallemant, M; Le Coeur, S; Mary, JY; McIntosh, K; Ngo-Giang-Huong, N; Thaineua, V, 2004)
"We randomly assigned 1844 women in Thailand who received zidovudine during the third trimester of pregnancy to receive intrapartum nevirapine or placebo."	5.11	Intrapartum exposure to nevirapine and subsequent maternal responses to nevirapine-based antiretroviral therapy. ( Ariyadej, S; Bowonwatanuwong, C; Hammer, S; Jourdain, G; Kantipong, P; Lallemant, M; Le Coeur, S; Leechanachai, P; Leenasirimakul, P; Ngo-Giang-Huong, N, 2004)
" However, zidovudine administered with lamivudine and indinavir was associated with increased risk of preterm births, zidovudine administered with nevirapine was associated with increased risk of stillbirths, and lamivudine administered with stavudine and efavirenz was associated with increased risk of low birth weight."	4.98	Comparative safety and effectiveness of perinatal antiretroviral therapies for HIV-infected women and their children: Systematic review and network meta-analysis including different study designs. ( Antony, J; Ashoor, HM; Blondal, E; Finkelstein, Y; Ghassemi, M; Gough, K; Hemmelgarn, BR; Hutton, B; Ivory, JD; Khan, PA; Lillie, E; Straus, SE; Tricco, AC; Vafaei, A; Veroniki, AA, 2018)
" Second, we discuss the existing clinical data on this topic, including the observational study from Kenya showing women using implants plus efavirenz-based ART had three-fold higher rates of pregnancy than women using implants plus nevirapine-based ART."	4.95	Concomitant contraceptive implant and efavirenz use in women living with HIV: perspectives on current evidence and policy implications for family planning and HIV treatment guidelines. ( Cohen, CR; Kiarie, J; Morroni, C; Patel, RC; Scarsi, KK; Sripipatana, T, 2017)
" We aimed to establish whether pregnancy rates differ between HIV-positive women who use various contraceptive methods and either efavirenz-based or nevirapine-based antiretroviral therapy (ART) regimens."	4.91	Pregnancy rates in HIV-positive women using contraceptives and efavirenz-based or nevirapine-based antiretroviral therapy in Kenya: a retrospective cohort study. ( Blat, C; Bukusi, EA; Cohen, CR; Gandhi, M; Hagey, J; Newmann, SJ; Onono, M; Patel, RC; Shade, SB; Vittinghoff, E, 2015)
" Further, the addition of single-dose TDF to single-dose nevirapine (SD-NVP) during delivery following maternal ZDV use during pregnancy significantly reduces the frequency of nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance."	4.85	Tenofovir 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)
" Women appear to be at an especially high risk for lactic acidosis, nevirapine-associated rashes and hepatotoxicity, and fat redistribution after highly active antiretroviral therapy exposure."	4.82	Sex differences in antiretroviral therapy-associated intolerance and adverse events. ( Clark, R, 2005)
"Maternal HIV drug resistance and maternal viral load were independent risk factors for vertical transmission during breastfeeding, suggesting that nevirapine alone may be insufficient infant prophylaxis against drug-resistant variants in maternal breast milk."	4.12	Maternal Human Immunodeficiency Virus (HIV) Drug Resistance Is Associated With Vertical Transmission and Is Prevalent in Infected Infants. ( Beck, IA; Boyce, CL; DeMarrais, P; Flynn, PM; Fowler, MG; Frenkel, LM; Ko, D; Owor, M; Sils, T; Stranix-Chibanda, L; Styrchak, SM; Taha, TE; Tierney, C; Wong-On-Wing, A, 2022)
"Despite improved policies to prevent mother-to-child HIV transmission (MTCT), adherence to maternal antiretroviral therapy (ART) and infant Nevirapine prophylaxis (NVP) is low in South Africa."	3.91	Longitudinal adherence to maternal antiretroviral therapy and infant Nevirapine prophylaxis from 6 weeks to 18 months postpartum amongst a cohort of mothers and infants in South Africa. ( Ayalew, K; Cheyip, M; Chirinda, W; Dinh, TH; Goga, A; Jackson, D; Kindra, G; Larsen, A; Lombard, C; Magasana, V; Ngandu, N, 2019)
" This study utilized Bayesian logistic regression to examine maternal-level predictors of adherence to infant nevirapine prophylaxis, including intimate partner violence, maternal adherence, HIV serostatus disclosure reaction, recency of HIV diagnosis, and depression."	3.88	A Bayesian Analysis of Prenatal Maternal Factors Predicting Nonadherence to Infant HIV Medication in South Africa. ( Cook, RR; Jones, DL; Peltzer, K; Rodriguez, VJ; Weiss, SM, 2018)
"Clinical trials demonstrated intermittent preventive treatment in pregnancy with mefloquine (MQ) reduced malaria rates among pregnant women, yet an unexpected higher risk of mother-to-child transmission (MTCT) of HIV among HIV-positive women receiving MQ has also been observed."	3.88	Short Communication: Reduced Nevirapine Concentrations Among HIV-Positive Women Receiving Mefloquine for Intermittent Preventive Treatment for Malaria Control During Pregnancy. ( Desai, M; Dinh, C; Gonzalez, R; Haaland, RE; Heneine, W; Katana, A; Martin, A; Menendez, C; Otieno, K; Slutsker, L; Williamson, J, 2018)
"Syphilis is associated with increased human immunodeficiency virus acquisition and sexual transmission; we examined impact on human immunodeficiency virus mother-to-child transmission among mother-infant pairs enrolled in the India Six-Week Extended-Dose Nevirapine study."	3.85	Maternal Syphilis: An Independent Risk Factor for Mother to Infant Human Immunodeficiency Virus Transmission. ( Bharadwaj, R; Bhat, J; Bhosale, R; Bollinger, R; Gupta, A; Gupte, N; Kinikar, A; Kulkarni, V; Mave, V; McIntire, KN; Patil, S; Suryavanshi, N, 2017)
" Patients were allocated to 2groups according to exposure to nevirapine during pregnancy."	3.83	[Hepatotoxicity in healthy infants exposed to nevirapine during pregnancy]. ( Figueras-Nadal, C; Fortuny-Guasch, C; Iveli, P; Martín-Nalda, A; Noguera-Julian, A; Rovira-Girabal, N; Soler-Palacín, P, 2016)
" Antiretroviral treatment-naive women started a nevirapine-based triple combination regimen from the third trimester of pregnancy until at least 6 months of exclusive breastfeeding."	3.83	Antibodies against pneumococcal capsular polysaccharide in Malawian HIV-positive mothers and their HIV-exposed uninfected children. ( Amici, R; Andreotti, M; Baroncelli, S; Galluzzo, CM; Giuliano, M; Jere, H; Mancinelli, S; Marazzi, MC; Palombi, L; Vella, S, 2016)
" In the study, women with baseline CD4(+) <350/mm(3) received a combination of stavudine, lamivudine, and nevirapine during pregnancy (from week 25 of gestation) and continued it indefinitely after delivery."	3.83	Virological Response and Drug Resistance 1 and 2 Years Post-Partum in HIV-Infected Women Initiated on Life-Long Antiretroviral Therapy in Malawi. ( Amici, R; Andreotti, M; Galluzzo, CM; Giuliano, M; Jere, H; Liotta, G; Mancinelli, S; Marazzi, MC; Palombi, L; Pirillo, MF; Sagno, JB; Scarcella, P; Vella, S, 2016)
" We found that nevirapine use and pregnancy are independently associated with severe skin reaction."	3.83	Severe antiretroviral-associated skin reactions in South African patients: a case series and case-control analysis. ( Boulle, A; Cohen, K; de Waal, R; Lehloenya, R; Maartens, G; Stewart, A, 2016)
"The objective of this study was to determine the prevalence of drug resistance mutations among HIV-positive women in Malawi 18 months after discontinuing nevirapine-based ART for the prevention of mother-to-child transmission."	3.81	Drug resistance mutations 18 months after discontinuation of nevirapine-based ART for prevention of mother-to-child transmission of HIV in Malawi. ( Amici, R; Andreotti, M; Galluzzo, CM; Giuliano, M; Jere, H; Liotta, G; Luhanga, R; Mancinelli, S; Marazzi, MC; Palombi, L; Sagno, JB; Vella, S, 2015)
"An exit interview was conducted one year post-partum for 85 HIV-infected women who participated in a study of HIV-1 transmission rates among NVP-experienced compared with NVP-naïve women in "The Nevirapine Repeat Pregnancy (NVP-RP) Study" at the Makerere University-Johns Hopkins University Research Collaboration, Kampala-Uganda, between June 2004 and June 2006."	3.81	A cross-sectional study of the magnitude, barriers, and outcomes of HIV status disclosure among women participating in a perinatal HIV transmission study, "the Nevirapine Repeat Pregnancy study". ( Bakaki, PM; Fowler, MG; Kiweewa, FM; Kusasira, F; McConnell, MS; Mubiru, MC; Musisi, M; Musoke, P; Nakayiwa, F; Nakintu, D; Namirembe, C, 2015)
", maternal zidovudine and infant ARV prophylaxis) of the World Health Organization's 2010 guidelines, no studies have assessed adherence to ARVs during pregnancy up to the postpartum period."	3.81	Longitudinal adherence to antiretroviral drugs for preventing mother-to-child transmission of HIV in Zambia. ( Chirwa, M; Ishikawa, N; Jimba, M; Kapyata, H; Komada, K; Miyano, S; Msiska, CY; Okawa, S; Syakantu, G; Yasuoka, J, 2015)
"Data from a prospective multisite cohort study were used to examine the effect of HIV exposure, untreated HIV infection, and single-dose nevirapine on infant growth velocity."	3.80	HIV infection, viral load, low birth weight, and nevirapine are independent influences on growth velocity in HIV-exposed South African infants. ( Chhagan, M; Doherty, T; Fadnes, LT; Goga, AE; Jackson, DJ; Lombard, C; Ramokolo, V; Van den Broeck, J, 2014)
"Data from cost studies and other published sources were used to determine the cost, per woman and per cohort (1000 breastfeeding and 1000 non-breastfeeding women), of switching from Option B (maternal triple antiretroviral [ARV] regimen during pregnancy and breastfeeding plus daily nevirapine for the infant for 6 weeks) to Option B+ (maternal triple ARV regimen initiated during pregnancy and continued for life)."	3.80	The incremental cost of switching from Option B to Option B+ for the prevention of mother-to-child transmission of HIV. ( Abimbola, TO; O'Brien, L; Sangrujee, N; Shaffer, N, 2014)
" We compared the pregnancy outcomes of women exposed to EFV and to nevirapine (NVP) during the first trimester."	3.77	Pregnancy outcomes in women exposed to efavirenz and nevirapine: an appraisal of the IeDEA West Africa and ANRS Databases, Abidjan, Côte d'Ivoire. ( Amani-Bosse, C; Anglaret, X; Coffie, PA; Dabis, F; Danel, C; Eholié, SP; Ekouevi, DK; Messou, E; Moh, R; Ouattara, E; Sissoko, M, 2011)
"From the ATHENA cohort study, three scenarios were selected for which the guideline recommended TDM: 1) start of a combination of lopinavir/ritonavir + efavirenz or nevirapine (drug-drug interaction); 2) start of efavirenz (routine TDM); and 3) use of nelfinavir during pregnancy."	3.77	Adherence to HIV therapeutic drug monitoring guidelines in The Netherlands. ( Burger, DM; de Wolf, F; Franssen, EJ; Kroon, F; Richter, C; Rigter, IM; Smit, C; van Luin, M; Wit, FW, 2011)
" We compared five PMTCT regimens at a fixed level of PMTCT medication uptake: 1) no antenatal ARVs (comparator); 2) sdNVP; 3) WHO 2010 guidelines using "Option A" (zidovudine during pregnancy/infant NVP during breastfeeding for women without advanced HIV disease; lifelong 3-drug antiretroviral therapy (ART) for women with advanced disease); 4) WHO "Option B" (ART during pregnancy/breastfeeding without advanced disease; lifelong ART with advanced disease); and 5) "Option B+:" lifelong ART for all pregnant/breastfeeding, HIV-infected women."	3.77	WHO 2010 guidelines for prevention of mother-to-child HIV transmission in Zimbabwe: modeling clinical outcomes in infants and mothers. ( Chu, J; Ciaranello, AL; Dabis, F; Engelsmann, B; Freedberg, KA; Keatinge, J; Maruva, M; Mugwagwa, R; Mushavi, A; Perez, F; Walensky, RP, 2011)
" Patients were offered nevirapine-based triple ART initiated in pregnancy until 6 months postpartum."	3.77	Extended antenatal use of triple antiretroviral therapy for prevention of mother-to-child transmission of HIV-1 correlates with favorable pregnancy outcomes. ( Buonomo, E; Ceffa, S; Haswell, J; Liotta, G; Magid, NA; Marazzi, MC; Narciso, P; Nielsen-Saines, K; Palombi, L; Paturzo, G; Scarcella, P; Zimba, I, 2011)
" Unbooked HIV positive pregnant women, who had not received antiretroviral drugs during the antenatal period but received nevirapine in labour, referred to as untreated-maternal HIV infection, were compared with women who received HAART early in pregnancy."	3.77	Pregnancy outcome among HIV positive women receiving antenatal HAART versus untreated maternal HIV infection. ( Biodun, O; Joseph, O; Michael, E, 2011)
"Compare the risk of HIV drug resistance in women stopping suppressive nelfinavir (NFV)-based or Nevirapine (NVP)-based antiretroviral therapy (ART) after pregnancy."	3.77	Selection of HIV resistance associated with antiretroviral therapy initiated due to pregnancy and suspended postpartum. ( Ellis, GM; Frenkel, LM; Hitti, J; Huang, S, 2011)
" Baseline median CD4 T-cell count: 417 cell/ųl; 98% received antiretroviral drugs during pregnancy [2 nucleoside analogs plus either nevirapine (55%) or a protease inhibitor (32%)]."	3.77	HIV and pregnancy: maternal and neonatal evolution. ( Cecchini, D; Mecikovsky, D; Trinidad, P; Urueña, A; Vesperoni, F, 2011)
" All women received zidovudine and lamivudine during pregnancy; 76% also received nelfinavir and 8."	3.76	Postpartum antiretroviral drug resistance in HIV-1-infected women receiving pregnancy-limited antiretroviral therapy. ( Cheng, I; Kuritzkes, DR; Paredes, R; Tuomala, RE, 2010)
"Conflicting data exist regarding the effect of pregnancy on steady-state nevirapine pharmacokinetics (PK), although steady-state nevirapine concentrations during pregnancy have never been characterized in sub-Saharan Africa."	3.76	Suboptimal nevirapine steady-state pharmacokinetics during intrapartum compared with postpartum in HIV-1-seropositive Ugandan women. ( Back, DJ; Boffito, M; Byakika-Kibwika, P; Flaherty, JP; Khoo, S; Lamorde, M; Merry, C; Nakabiito, C; Namakula, R; Okaba-Kayom, V; Ryan, M; Scarsi, KK, 2010)
"Use of single dose nevirapine (sdNVP) to prevent HIV mother-to-child transmission is associated with the emergence of NVP resistance in many infants who are HIV infected despite prophylaxis."	3.75	In utero HIV infection is associated with an increased risk of nevirapine resistance in ugandan infants who were exposed to perinatal single dose nevirapine. ( Bagenda, D; Bakaki, P; Church, JD; Donnell, D; Eshleman, SH; Eure, C; Fowler, MG; Guay, LA; Jackson, JB; Matovu, F; McConnell, M; Musoke, P; Mwatha, A; Nakabiito, C; Omer, SB; Thigpen, MC, 2009)
"To estimate whether the association between nevirapine (NVP) and hepatotoxicity differs according to pregnancy status in HIV-infected women."	3.75	Increased risk of hepatotoxicity in HIV-infected pregnant women receiving antiretroviral therapy independent of nevirapine exposure. ( Brogly, SB; French, AL; Hershow, RC; Leighty, RM; Lu, M; Ouyang, DW; Shapiro, DE; Thompson, B; Tuomala, RE, 2009)
"Limited information is currently available on the metabolic profile of nevirapine in pregnancy."	3.75	Plasma lipid profile in pregnant women with HIV receiving nevirapine. ( Anzidei, G; Dalzero, S; Floridia, M; Guaraldi, G; Guerra, B; Meloni, AM; Molinari, A; Pinnetti, C; Ravizza, M; Tamburrini, E; Tibaldi, C; Vimercati, A, 2009)
"Single-dose nevirapine (SDNVP) for the prevention of mother-to-child HIV transmission (PMTCT) results in the selection of resistance mutants among HIV-infected mothers."	3.74	Reuse of single-dose nevirapine in subsequent pregnancies for the prevention of mother-to-child HIV transmission in Lusaka, Zambia: a cohort study. ( Aldrovandi, GM; Kankasa, C; Kuhn, L; Semrau, K; Sinkala, M; Thea, DM; Walter, J, 2008)
"a retrospective study was performed between January 2003 and December 2006 analysing all women prescribed nevirapine in pregnancy."	3.74	[Evaluation of the adverse effects of nevirapine in HIV-infected pregnant women in a South Brazilian University Hospital]. ( Astori, Ade A; Fernandes, Rde B; Gomes, Sel-K; Kondo, W; Sasaki, Md; Sbalqueiro, RL, 2008)
"Single-dose nevirapine (SDNVP) is widely used to prevent mother-to-child HIV transmission in resource-limited settings."	3.74	Effectiveness of repeat single-dose nevirapine for prevention of mother-to-child transmission of HIV-1 in repeat pregnancies in Uganda. ( Bagenda, D; Bakaki, P; Downing, R; Eure, C; Fowler, MG; Greenberg, AE; Matovu, F; McConnell, M; Mubiru, M; Thigpen, MC, 2007)
"To determine the impact of pregnancy on the pharmacokinetics (PK) of nevirapine (NVP) during chronic dosing in HIV-infected women and appropriate NVP dosing in this population."	3.74	Chronic administration of nevirapine during pregnancy: impact of pregnancy on pharmacokinetics. ( Aweeka, F; Best, B; Burchett, SK; Capparelli, EV; Foca, M; Hitti, J; Hu, C; Jimenez, E; Mirochnick, M; Nachman, S; Read, JS; Shearer, WT; Smith, E; Spector, SA; Stek, A; Thorpe, EM; Watts, H, 2008)
"In the Western Cape province of South Africa, an intensified regimen for the prevention-of-mother-to-child-transmission-of-HIV consisting of zidovudine (AZT) from 34 weeks of pregnancy plus single dose (sd) nevirapine (NVP) during labor was instituted in 2004."	3.74	Zidovudine with nevirapine for the prevention of HIV mother-to-child transmission reduces nevirapine resistance in mothers from the Western Cape, South Africa. ( Claassen, M; Cotton, MF; Engelbrecht, S; Laten, JD; Preiser, W; Theron, GB; van Zyl, GU, 2008)
"This study used Markov modeling to define the circumstances under which the following interventions would be cost-effective: BF for 6 months with daily infant nevirapine (NVP) prophylaxis; maternal combination antiretroviral therapy (ART) during pregnancy and for 6 months of BF; and maternal combination ART only for women who meet CD4 criteria."	3.73	Potential cost-effectiveness of maternal and infant antiretroviral interventions to prevent mother-to-child transmission during breast-feeding. ( Maclean, CC; Stringer, JS, 2005)
"Nelfinavir- or nevirapine-containing HAART regimens during pregnancy are well tolerated."	3.73	Nelfinavir and nevirapine side effects during pregnancy. ( Boer, K; de Wolf, F; Dieleman, J; Godfried, MH; Nellen, J; Schneider, ME; Sprenger, H; Tempelman, C; Timmermans, S; van der Ende, ME, 2005)
"The incidence of adverse events with nevirapine may be lower than previously reported (13% versus 29%) and may be primarily noted with initiating the drug late in pregnancy."	3.73	Third-trimester maternal toxicity with nevirapine use in pregnancy. ( Brady, MT; Fan-Havard, P; Hughes, L; Joy, S; Koletar, SL; Para, MF; Poi, M, 2005)
"To describe the maternal tolerability of nevirapine as part of combination antiretroviral therapy in pregnancy at three HIV centres in Dublin, Ireland and to determine risk factors for development of significant hepatotoxicity."	3.73	Maternal hepatotoxicity with nevirapine as part of combination antiretroviral therapy in pregnancy. ( Bergin, C; Geoghegan, J; Hopkins, S; Kelleher, B; Lyons, F; McCormick, PA; McGeary, A; Mulcahy, FM; Sheehan, G, 2006)
" We report the case of a pregnant human immunodeficiency virus type 1-infected woman who developed drug rash with eosinophilia and systemic symptoms syndrome and renal failure shortly after initiation of a nevirapine-containing antiretroviral regimen at 27 weeks' gestation."	3.72	Drug rash with eosinophilia and systemic symptoms syndrome and renal toxicity with a nevirapine-containing regimen in a pregnant patient with human immunodeficiency virus. ( Boswell, H; Fan-Havard, P; Knudtson, E; Para, M, 2003)
" The majority of the HIV positive mothers received nevirapine in labour while 35% had combination ARV drugs in pregnancy."	3.72	Prevention of mother-to-child transmission of HIV at Maiduguri, Nigeria. ( Audu, BM; Chama, CM; Kyari, O, 2004)
"The following were determined using data from eight African countries: national program costs and impact on infant infections; reductions in adult HIV prevalence and unintended pregnancies among HIV-infected women that would have equivalent impact on infant HIV infections averted as the nevirapine intervention; and the cost threshold for drugs with greater efficacy than nevirapine yielding an equivalent cost per DALY saved."	3.72	Cost-effectiveness of nevirapine to prevent mother-to-child HIV transmission in eight African countries. ( de Zoysa, I; Denison, J; O'Reilly, KR; Schmid, GP; Sweat, MD, 2004)
"To describe the experience of four London HIV centres prescribing nevirapine (NVP) to HIV-1 infected pregnant women with respect to immunological and virological response, tolerability and pregnancy outcome."	3.71	Experience of nevirapine use in a London cohort of HIV-infected pregnant women. ( de Ruiter, A; Easterbrook, P; Edwards, SG; Hay, P; Larbalestier, N; Taylor, GP; Welch, J, 2001)
"Results of ACTG 076, a clinical trial funded by the National Institute of Allergy and Infectious Disease (NIAID), indicate that perinatal HIV transmission rates could be significantly reduced by treating HIV-positive pregnant women with an intensive zidovudine (AZT) regimen during the second half of pregnancy and during labor and delivery, and by treating the infants for the first six weeks of life."	3.69	Preventing HIV infection in infants in developing countries: NIAID's role. National Institute of Allergy and Infectious Diseases. ( , 1997)
"Nevirapine exposure was assessed in all patients with available blood samples and safety was assessed in all participants."	3.01	Pharmacokinetics and safety of early nevirapine-based antiretroviral therapy for neonates at high risk for perinatal HIV infection: a phase 1/2 proof of concept study. ( Bryson, Y; Bwakura-Dangarembizi, M; Capparelli, EV; Chadwick, EG; Coletti, A; Cotton, MF; Hazra, R; Jean-Philippe, P; LeBlanc, R; Mirochnick, M; Naidoo, KL; Nelson, BS; Persaud, D; Reding, C; Ruel, TD; Spector, SA; Tierney, C; Zimmer, B, 2021)
"Nevirapine (NVP) is a key component of antiretroviral prophylaxis and treatment for neonates."	2.84	Assessment of Nevirapine Prophylactic and Therapeutic Dosing Regimens for Neonates. ( Aarons, L; Borkird, T; Capparelli, EV; Cressey, TR; Jittayanun, K; Jourdain, G; Lallemant, M; Le Coeur, S; Luvira, A; Phanomcheong, S; Puangsombat, A; Punyawudho, B; Saenjum, C; Sukrakanchana, PO; Urien, S, 2017)
"Levonorgestrel implants were inserted at baseline in all women."	2.82	Unintended Pregnancies Observed With Combined Use of the Levonorgestrel Contraceptive Implant and Efavirenz-based Antiretroviral Therapy: A Three-Arm Pharmacokinetic Evaluation Over 48 Weeks. ( Back, DJ; Buzibye, A; Byakika-Kibwika, P; Cohn, SE; Darin, KM; Dilly Penchala, S; Else, LJ; Lamorde, M; Merry, C; Nakalema, S; Scarsi, KK, 2016)
" In a pharmacokinetic investigation, breast milk and plasma samples of mothers and newborns were collected."	2.78	Population pharmacokinetic analysis of a nevirapine-based HIV-1 prevention of mother-to-child transmission program in Uganda to assess the impact of different dosing regimens for newborns. ( Frank, M; Harms, G; Kloft, C; Kunz, A, 2013)
"We evaluated disease progression among HIV-infected women not on ART with CD4⁺ lymphocyte counts above 200 cells per microliter at delivery."	2.78	HIV 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 primary efficacy endpoint was HIV-1 infection in infants at 6 months and safety endpoints were adverse reactions in both groups."	2.77	Efficacy and safety of an extended nevirapine regimen in infant children of breastfeeding mothers with HIV-1 infection for prevention of postnatal HIV-1 transmission (HPTN 046): a randomised, double-blind, placebo-controlled trial. ( Andrew, P; Brown, ER; Chetty, V; Chipato, T; Coovadia, HM; Eshleman, SH; Fawzi, W; Fowler, MG; George, K; Guay, L; Kisenge, R; Lynn, DJ; Maldonado, Y; Manji, K; Mofenson, LM; Moodley, D; Msweli, L; Musoke, P; Mwatha, A; Nakabiito, C; Richardson, P; Stranix-Chibanda, L; Zwerski, S, 2012)
"Lamivudine resistance was detected by ASP in only 1 of 51 women who received CBV."	2.77	Short-course Combivir after single-dose nevirapine reduces but does not eliminate the emergence of nevirapine resistance in women. ( Boltz, VF; Chow, JY; Coffin, JM; Gray, GE; Hall, DB; Hopley, MJ; Maldarelli, F; Martinson, NA; Mayers, D; McIntyre, JA; Mellors, JW; Palmer, S; Robinson, P, 2012)
"46%), underweight (27% vs."	2.77	Growth patterns among HIV-exposed infants receiving nevirapine prophylaxis in Pune, India. ( Bollinger, RC; Gupta, A; Gupte, N; Khandave, M; Kinikar, AA; Nayak, U; Ram, M; Sastry, J; Shankar, AV, 2012)
" A one-compartment model was used for mothers and neonates; the absorption rate constants for mothers and neonates were 0."	2.76	Population pharmacokinetics of nevirapine in HIV-1-infected pregnant women and their neonates. ( Arrivé, E; Avit, D; Benaboud, S; Blanche, S; Dabis, F; Ekouévi, DK; Gray, G; Hirt, D; McIntyre, J; Nerrienet, E; Rey, E; Sim, KL; Tréluyer, JM; Urien, S, 2011)
"Birth defects were evaluated among infants on the Pediatric AIDS Clinical Trials Group 316 trial that studied addition of peripartum nevirapine to established ARV regimen for prevention of mother-to-child transmission."	2.76	Birth defects among a cohort of infants born to HIV-infected women on antiretroviral medication. ( Culnane, M; Cunningham, CK; Delfraissy, JF; Huang, S; Kaiser, KA; Mandelbrot, L; Mofenson, L; Newell, ML; Scheuerle, A; Stanley, K; Watts, DH, 2011)
" Similarly, the proportion of serious adverse events in the HIVIGLOB/sdNVP and sdNVP arms, respectively, for mothers (18."	2.76	Safety and efficacy of HIV hyperimmune globulin for prevention of mother-to-child HIV transmission in HIV-1-infected pregnant women and their infants in Kampala, Uganda (HIVIGLOB/NVP STUDY). ( Antelman, G; Falksveden, L; Fowler, MG; Guay, L; Jackson, JB; Mmiro, F; Moulton, LH; Mubiru, M; Musoke, P; Nakabiito, C; Omer, SB; Onyango-Makumbi, C; Wahren, B; Wigzell, H; Zwerski, S, 2011)
"However, neutropenia was no longer associated with antenatal exposure to HAART after 1 month of age."	2.73	Hematologic and hepatic toxicities associated with antenatal and postnatal exposure to maternal highly active antiretroviral therapy among infants. ( Bae, WH; Essex, M; Lockman, S; Onyait, K; Shapiro, RL; Smeaton, LM; Thior, I; Wester, C, 2008)
" Mothers in the usZDV/sdNVP group received a loading dose of zidovudine (600 mg administered orally) and continued to receive 300-mg doses of zidovudine orally every 3 h while in labor, and their infants received zidovudine at a dosage of 2 mg per kg of body weight 4 times per day orally for 72 h."	2.73	A randomized, double-blind, placebo-controlled trial of combined nevirapine and zidovudine compared with nevirapine alone in the prevention of perinatal transmission of HIV in Zimbabwe. ( Arbess, G; Boyle, E; Chipato, T; Chitsike, I; Glazier, RH; Gottesman, M; Pilon, R; Silverman, M; Simor, A; Spitzer, RF; Thistle, P, 2007)
"Nevirapine was detected in the cord blood of 244 of 259 (94%) infants whose mothers reported they took nevirapine in labor more than 1 h before delivery and in 12 of 13 (92%) infants whose mothers reported they took nevirapine less than 1 h before delivery."	2.72	Association of cord blood nevirapine concentration with reported timing of dose and HIV-1 transmission. ( Donnell, D; Fleming, T; Fowler, MG; Guay, L; Jackson, JB; Mirochnick, M; Mmiro, F; Mofenson, L; Musoke, P; Nakabiito, C; Parsons, T, 2006)
" Lower predose nevirapine concentrations were associated with lower cord blood concentrations and a shorter interval between maternal dosing and delivery."	2.71	Predose infant nevirapine concentration with the two-dose intrapartum neonatal nevirapine regimen: association with timing of maternal intrapartum nevirapine dose. ( Blanchard, S; Culnane, M; Cunningham, CK; Dorenbaum, A; Gelber, RD; Mirochnick, M; Mofenson, L; Sullivan, JL, 2003)
"Nevirapine was associated with a 41% (95% CI 16-59) reduction in relative risk of transmission through to age 18 months."	2.71	Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: 18-month follow-up of the HIVNET 012 randomised trial. ( Allen, M; Bagenda, D; Bakaki, P; Bray, D; Deseyve, M; Ducar, C; Duefield, C; Emel, L; Fleming, T; Fowler, MG; Gigliotti, M; Guay, LA; Jackson, JB; Miotti, P; Mirochnick, M; Mmiro, F; Mofenson, L; Musoke, P; Mwatha, A; Nakabiito, C; Owor, M; Sherman, J, 2003)
" Our data indicate that NVP prophylaxis for 6 months was safe and well tolerated in infants."	2.71	Safety and trough concentrations of nevirapine prophylaxis given daily, twice weekly, or weekly in breast-feeding infants from birth to 6 months. ( Abdool Karim, SS; Bassett, MT; Coovadia, HM; Emel, L; Eshleman, SH; Fleming, T; George, K; Jones, SA; Katzenstein, DA; Maldonado, Y; Maponga, CC; Mirochnick, MM; Mofenson, LM; Mwatha, A; Shetty, AK; Wells, J, 2003)
" The one adverse event associated with nelfinavir occurred in a subject with a CD4 cell count less than 250 cells/microL."	2.71	Maternal toxicity with continuous nevirapine in pregnancy: results from PACTG 1022. ( Baker, D; Foca, M; Frenkel, LM; Gandia, J; Gonzalez-Garcia, A; Hitti, J; Huang, S; McNamara, J; Nachman, SA; Paul, ME; Provisor, A; Stek, AM; Stevens, LM; Thorpe, EM; Watts, DH; Wei, LJ, 2004)
"The median NVP level fell to 68 ng/mL (range: <50-228, n = 43) 8 to 14 days after dosing and to 51 ng/mL (range: <50-166, n = 25) between 15 and 21 days."	2.71	Persistence of nevirapine exposure during the postpartum period after intrapartum single-dose nevirapine in addition to zidovudine prophylaxis for the prevention of mother-to-child transmission of HIV-1. ( Capparelli, E; Cressey, TR; Jackson, JB; Jourdain, G; Kunkeaw, S; Lallemant, MJ; Mirochnick, M; Musoke, P, 2005)
"Nevirapine resistance was more frequent in infants with subtype C than with subtypes A and D (87 versus 50%, P = 0."	2.71	Resistance after single-dose nevirapine prophylaxis emerges in a high proportion of Malawian newborns. ( Chen, S; Eshleman, SH; Fiscus, SA; Guay, LA; Hoover, DR; Hudelson, SE; Jackson, JB; Kumwenda, N; Mmiro, F; Musoke, P; Mwatha, A; Taha, T, 2005)
"Pediatric AIDS Clinical Trials Group protocol 316 was an international, multicenter, placebo-controlled trial comparing single-dose oral nevirapine (200 mg to mother and 2 mg/kg to infant) with placebo in human immunodeficiency virus (HIV)-infected pregnant women receiving standard antiretroviral therapy."	2.70	Development of resistance mutations in women receiving standard antiretroviral therapy who received intrapartum nevirapine to prevent perinatal human immunodeficiency virus type 1 transmission: a substudy of pediatric AIDS clinical trials group protocol 3 ( Bazin, B; Britto, P; Chaix, ML; Cunningham, CK; Delfraissy, JF; Dorenbaum, A; Gelber, RD; Mofenson, L; Rekacewicz, C; Rouzioux, C; Sullivan, JL, 2002)
" Initial dose pharmacokinetic profiles in the pregnant women were similar to those seen in nonpregnant adults."	2.70	Nevirapine pharmacokinetics in pregnant women and in their infants after in utero exposure. ( Fenton, T; Lugo, M; Mirochnick, M; Siminski, S; Sullivan, JL, 2001)
"As part of an on-going clinical trial in Malawi, infants born to women who received (early presenters) or did not receive (late presenters) standard intrapartum nevirapine (NVP) dosing were randomized to receive orally either single dose NVP alone or NVP plus zidovudine (twice daily for 1 week)."	2.70	Effect of HIV-1 antiretroviral prophylaxis on hepatic and hematological parameters of African infants. ( Broadhead, R; Fiscus, S; Gibbons, A; Hoover, D; Kumwenda, N; Lema, V; Liomba, G; Mukiibi, J; Taha, TE, 2002)
"Nevirapine elimination was prolonged in both mothers and infants, with median half-lives ranging from 36."	2.69	Pharmacokinetics of nevirapine in human immunodeficiency virus type 1-infected pregnant women and their neonates. Pediatric AIDS Clinical Trials Group Protocol 250 Team. ( Beckerman, K; Fenton, T; Gagnier, P; Gwynne, M; Jimenez, E; Mirochnick, M; Pav, J; Siminski, S; Spector, SA; Sperling, RS; Sullivan, JL; Yogev, R, 1998)
"Nevirapine, 200 mg, was given as a single dose during labor to 21 HIV-1-infected pregnant Ugandan women."	2.69	A phase I/II study of the safety and pharmacokinetics of nevirapine in HIV-1-infected pregnant Ugandan women and their neonates (HIVNET 006). ( Allen, M; Bagenda, D; Dransfield, K; Elliott, T; Fleming, T; Fowler, MG; Guay, LA; Hom, D; Horton, S; Jackson, JB; Mirochnick, M; Mmiro, F; Mofenson, L; Murarka, A; Musoke, P; Nakabiito, C; Pav, JW, 1999)
"Drugs most likely to interact with combined oral contraceptives, transdermal and implant contraceptives include protease inhibitors, the NNRTIs efavirenz and nevirapine, and cobicistat-boosted elvitegravir."	2.49	Drug interactions between antiretrovirals and hormonal contraceptives. ( Hills-Nieminen, C; Tseng, A, 2013)
"The risk of adverse drug events associated with nevirapine (NVP) is suggested to be greater in pregnant women."	2.49	Adverse events associated with nevirapine use in pregnancy: a systematic review and meta-analysis. ( Andrieux-Meyer, I; Calmy, A; Ford, N; Hargreaves, S; Mills, EJ; Shubber, Z, 2013)
"We reviewed studies comparing serious adverse NVP-related events among ART-naive pregnant women who commenced therapy at higher v."	2.48	Safety of nevirapine in HIV-infected pregnant women initiating antiretroviral therapy at higher CD4 counts: a systematic review and meta-analysis. ( Bera, E; Mia, R, 2012)
" The first trial began in April 1991 and assessed zidovudine (ZDV) versus placebo and since then, the type, dosage and duration of drugs to be compared has been modified in each subsequent trial."	2.47	Antiretrovirals for reducing the risk of mother-to-child transmission of HIV infection. ( Brocklehurst, P; Siegfried, N; Sint, TT; van der Merwe, L, 2011)
" More comprehensive in vivo pharmacokinetic data are required to justify the potential use of these agents as safe and effective options during pregnancy."	2.47	Pharmacokinetics of antiretroviral drugs in anatomical sanctuary sites: the fetal compartment (placenta and amniotic fluid). ( Back, DJ; Else, LJ; Khoo, SH; Taylor, S, 2011)
" Sources included adverse event reports from pharmaceutical manufacturers and the US FDA, reports from peer-reviewed journals/scientific meetings and the Research on Adverse Drug events And Reports (RADAR) project."	2.45	Hepatotoxicity associated with long- versus short-course HIV-prophylactic nevirapine use: a systematic review and meta-analysis from the Research on Adverse Drug events And Reports (RADAR) project. ( Bennett, CL; Chandler, KL; Differding, V; Johnson, S; McKoy, JM; Obadina, E; Palella, F; Parada, JP; Raisch, DW; Scarsi, KK; Scheetz, MH; Sutton, S; Yarnold, PR, 2009)
" The first trial began in April 1991 and assessed zidovudine (ZDV) versus placebo and since then, the type, dosage and duration of drugs to be compared has been modified in each subsequent trial."	2.44	Antiretrovirals for reducing the risk of mother-to-child transmission of HIV infection. ( Brocklehurst, P; Siegfried, NL; van der Merwe, L; Volmink, J, 2007)
"Nevirapine resistance has been detected in a considerable proportion of women after single-dose nevirapine (SD-NVP) for the prevention of mother-to-child human immunodeficiency virus-1 transmission."	2.44	Use of single-dose nevirapine for the prevention of mother-to-child transmission of HIV-1: does development of resistance matter? ( Eshleman, SH; Kourtis, AP; McConnell, MS; Stringer, JS; Weidle, PJ, 2007)
" Based on current knowledge, the immense benefits of antiretroviral prophylaxis in reducing the risk of MTCT, far outweigh the potential for adverse effects."	2.43	The safety of antiretroviral drugs in pregnancy. ( Newell, ML; Thorne, C, 2005)
" To minimize toxicity, clinicians must adhere to dosing guidelines, avoid prescribing the drug in patients with known increased risk of toxicity, and promptly recognize toxicities, which are mainly cutaneous and hepatic."	2.43	Nevirapine toxicity. ( Taiwo, BO, 2006)
"Nevirapine is a potent non-nucleoside inhibitor of HIV-1 reverse transcriptase."	2.41	Nevirapine: pharmacokinetic considerations in children and pregnant women. ( Clarke, DF; Dorenbaum, A; Mirochnick, M, 2000)
" Although possessing a common mechanism of action, these agents can be differentiated by both molecular and pharmacokinetic characteristics."	2.41	Clinical pharmacokinetics of non-nucleoside reverse transcriptase inhibitors. ( DiCenzo, R; Morse, GD; Smith, PF, 2001)
"Lopinavir was mostly requested in patients when adherence measures did not correlate with the clinical picture, suspected non-adherence, lopinavir-rifampicin interactions and for neonatal safety monitoring."	1.56	Pediatric Antiretroviral Therapeutic Drug Monitoring: A Five and a Half Year Experience from a South African Tertiary Hospital. ( Decloedt, EH; Engelbrecht, AE; Norman, J; Rabie, H; Wiesner, L, 2020)
"A physiologically-based pharmacokinetic (PBPK) model for nevirapine, which is metabolized by the cytochrome P450 (CYP) 3A4, 2B6 and 2D6 pathways, was developed to predict maternal and fetal pharmacokinetics (PK)."	1.46	A Physiologically-Based Pharmacokinetic Model to Predict Human Fetal Exposure for a Drug Metabolized by Several CYP450 Pathways. ( Benaboud, S; Blanche, S; Bouazza, N; De Sousa Mendes, M; Foissac, F; Hirt, D; Lui, G; Pressiat, C; Treluyer, JM; Urien, S; Valade, E; Zheng, Y, 2017)
"Universal multi drug antiretroviral treatment in pregnancy is a global priority in our bid to eliminate paediatric HIV infections although few studies have documented the impact of antiretroviral coverage on overall pregnancy outcomes."	1.43	Improved pregnancy outcomes with increasing antiretroviral coverage in South Africa. ( Maharaj, N; Moodley, D; Moodley, T; Sartorius, B; Sebitloane, M, 2016)
" We investigated the frequency and severity of adverse events (AE) in infants receiving multiple drug prophylaxis compared to ZDV alone."	1.42	Serious adverse events are uncommon with combination neonatal antiretroviral prophylaxis: a retrospective case review. ( Barr, E; Davies, J; Forster, JE; Kinzie, K; Levin, MJ; McFarland, EJ; Pappas, J; Paul, S; Smith, C; Weinberg, A, 2015)
"Nevirapine was the offending drug in 21/22 (95%) cases."	1.42	Stevens Johnson Syndrome and Toxic Epidermal Necrolysis: Maternal and Foetal Outcomes in Twenty-Two Consecutive Pregnant HIV Infected Women. ( Knight, L; Lehloenya, RJ; Matjila, M; Muloiwa, R; Todd, G, 2015)
"Only zidovudine has adequate dosing recommendations for treating term and preterm infants and has an intravenous formulation, essential if feeding intolerance occurs."	1.42	The last and first frontier--emerging challenges for HIV treatment and prevention in the first week of life with emphasis on premature and low birth weight infants. ( Cotton, MF; Holgate, S; Mirochnick, M; Nelson, A; Rabie, H; Wedderburn, C, 2015)
"To investigate if pregnancy is a risk factor for SJS among HIV-infected women taking NVP-containing regimens and registered within the Medunsa National Pharmacovigilance Centre database."	1.39	Risk of nevirapine-associated Stevens-Johnson syndrome among HIV-infected pregnant women: the Medunsa National Pharmacovigilance Centre, 2007 - 2012. ( Adewusi, E; Dube, N; Summers, R, 2013)
" Mice were dosed twice daily until PND 28."	1.39	Toxicology and Carcinogenesis Studies of Mixtures of 3'-Azido-3'-Deoxythymidine (AZT), Lamivudine (3TC), and Nevirapine (NVP) (CAS Nos. 30516-87-1, 134678-17-4, 129618-40-2) in Genetically Modified C3B6.129F1-Trp53(tm1Brd) N12 Haploinsufficient Mice (in u ( , 2013)
"Demographic, treatment and pregnancy related data were collected."	1.38	Hcv coinfection, an important risk factor for hepatotoxicity in pregnant women starting antiretroviral therapy. ( Boer, K; de Wolf, F; Godfried, MH; Nellen, JF; Smit, C; Snijdewind, IJ; van der Ende, ME, 2012)
"We compared adverse events among breast-feeding neonates born to Kenyan mothers receiving triple-antiretroviral therapy, including either nevirapine or nelfinavir."	1.38	Rash, hepatotoxicity and hyperbilirubinemia among Kenyan infants born to HIV-infected women receiving triple-antiretroviral drugs for the prevention of mother-to-child HIV transmission. ( Akoth, B; Angira, F; Masaba, R; Mills, LA; Minniear, TD; Ndivo, R; Oyaro, B; Peters, PJ; Polle, N; Thomas, TK; Zeh, C, 2012)
"Nevirapine was given at delivery to 93/135 (69%) women, and to 128/135 (95%) children."	1.38	HIV-1 mother-to-child transmission, post-test counselling, and antiretroviral prophylaxis in Northern Viet Nam: a prospective observational study. ( Anh, NM; Bao, NH; Cam, PD; Caridha, R; Ehrnst, A; Gaseitsiwe, S; Ha, TT; Hien, NT; Tuan, PL, 2012)
" Our study suggests that NVP dosing of preterm infants as soon as possible after birth without maternal intrapartum dosing may be as effective as combined maternal and infant dosing."	1.37	Nevirapine plasma concentrations in premature infants exposed to single-dose nevirapine for prevention of mother-to-child transmission of HIV-1. ( Cotton, MF; Els, I; Hall, D; Madsen, R; Mirochnick, M; Mugabo, P; Rabie, H; Smith, J; Smith, P; Steyn, W, 2011)
" Pharmacokinetic parameter estimates and model-predicted HIV-1 transmission rates were very consistent with other studies."	1.37	Quantifying the impact of nevirapine-based prophylaxis strategies to prevent mother-to-child transmission of HIV-1: a combined pharmacokinetic, pharmacodynamic, and viral dynamic analysis to predict clinical outcomes. ( Frank, M; Harms, G; Kloft, C; Kunz, A; Schütte, C; von Kleist, M, 2011)
"Nevirapine is widely used to treat HIV-1 infection to prevent mother-to-child transmission; unfortunately adverse drug reactions have been reported."	1.36	Nevirapine-induced hepatotoxicity and pharmacogenetics: a retrospective study in a population from Mozambique. ( Altan, AM; Borgiani, P; Bramanti, P; Ceffa, S; Ciccacci, C; Marazzi, MC; Novelli, G; Palombi, L; Paturzo, G; Sirianni, E, 2010)
"To investigate uptake and provision of antenatal care (ANC) services in the Uzazi Bora project: a demonstration-intervention project for Safe Motherhood and prevention of mother-to-child transmission of HIV in Kenya."	1.36	A Safe Motherhood project in Kenya: assessment of antenatal attendance, service provision and implications for PMTCT. ( Chersich, MF; Delva, W; Luchters, S; Muigai, E; Oyier, V; Temmerman, M; Yard, E, 2010)
"Predictors of adverse events (AE) associated with nevirapine use are needed to better understand reports of severe rash or liver enzyme elevation (LEE) in HIV+ women."	1.36	Adverse events in a cohort of HIV infected pregnant and non-pregnant women treated with nevirapine versus non-nevirapine antiretroviral medication. ( Aaron, E; Bachmann, LH; Criniti, S; Gracely, E; Kempf, MC; Kumar, R; Tedaldi, E; Warriner, A, 2010)
"Zidovudine was not detectable in any infant plasma samples obtained after the day of delivery, while the median concentrations in infant plasma samples from postpartum weeks 2, 6, and 14 were 67 ng/ml, 32 ng/ml, and 24 ng/ml for lamivudine and 987 ng/ml, 1,032 ng/ml, and 734 ng/ml for nevirapine, respectively."	1.35	Antiretroviral concentrations in breast-feeding infants of mothers receiving highly active antiretroviral therapy. ( Capparelli, E; Fowler, MG; Holland, D; Masaba, R; Mirochnick, M; Odhiambo, P; Thigpen, MC; Thomas, T; Weidle, PJ; Zeh, C, 2009)
"Non-nevirapine regimens were initiated following biochemical and symptomatic improvement; symptoms did not recur."	1.35	Incidence of nevirapine-associated hepatitis in an antenatal clinic. ( Black, V; Rees, H, 2008)
"Pregnancy has a moderate but significant lowering effect on NVP plasma concentrations."	1.35	Steady-state nevirapine plasma concentrations are influenced by pregnancy. ( Boer, K; Burger, DM; Damming, M; de Wolf, F; Godfried, MH; Nellen, JF; Prins, JM; van der Ende, ME; Wit, FW, 2008)
" The objectives were to compare NVP levels, adverse events, and 36-week efficacy of NVP-based ART between patients who did not receive FLU (group A) and those who received FLU 200 mg/day or 400 mg/day (group B)."	1.34	Plasma nevirapine levels, adverse events and efficacy of antiretroviral therapy among HIV-infected patients concurrently receiving nevirapine-based antiretroviral therapy and fluconazole. ( Athichathanabadi, C; Manosuthi, W; Phoorisri, T; Sungkanuparph, S; Uttayamakul, S, 2007)
" Neutropenia (usually transient) was the most common severe adverse event."	1.34	Safety of HIV-1 Perinatal Transmission Prophylaxis With Zidovudine and Nevirapine in Rural South India. ( Bethel, J; Dharmarajan, S; Jacob, SM; Junankar, V; Parameshwari, S; Read, JS; Samuel, NM; Stoszek, SK; Van Hook, HM; Xu, J, 2007)
"Nevirapine was quantifiable for up to 17 days after discontinuation of therapy; total nevirapine concentrations remained above the 90% inhibitory concentration for 6 days, and no differences were observed between breasts."	1.34	Persistence of nevirapine in breast milk after discontinuation of treatment. ( Acosta, EP; Aldrovandi, GM; Ashouri, N; Bennetto-Hood, C; King, JR; Woodman, K, 2007)
"Transmission prophylaxis in offspring of HIV-positive mothers may give rise to adverse effects."	1.34	[Side effects of antiretroviral treatment for transmission prophylaxis in preterm and near-term infants]. ( Bauer, K; Dunsch, D; Haberl, A; Linde, R; Reitter, A; Schlösser, R, 2007)
"All nevirapine side effects were developed in less than seven weeks."	1.34	Nevirapine-induced side effects in pregnant women: experience of a Brazilian university hospital. ( Carraro, EA; Cornelsen, TC; Dias, JM; Kondo, W; Macedo, RL; Perini, J; Prandel, E; Sasaki, Md; Sbalquiero, R, 2007)
"Zidovudine (AZT) was provided antenatally from week 34 of gestation and during labour."	1.33	Effectiveness of the first district-wide programme for the prevention of mother-to-child transmission of HIV in South Africa. ( Abdullah, F; Boulle, A; Coetzee, D; Draper, B; Goemaere, E; Hilderbrand, K, 2005)
" Multivariate logistic regression was used to test independent association of CD4 and hepatitis C virus (HCV) infection related to the outcome of toxic effects of NVP."	1.33	Nevirapine toxicity in a cohort of HIV-1-infected pregnant women. ( Calvet, GA; Cruz, ML; D'Ippolito, MM; João, EC; Matos, HJ; Menezes, JA; Salgado, LA, 2006)
" In a multivariate model, K103N detection was associated with HIV-1 subtype (C > A), after adjusting for log10 delivery viral load, the number of days between NVP dosing and sample collection, age, and parity."	1.33	Quantitative analysis of HIV-1 variants with the K103N resistance mutation after single-dose nevirapine in women with HIV-1 subtypes A, C, and D. ( Chen, S; Church, JD; Eshleman, SH; Fiscus, SA; Flys, TS; Guay, LA; Hoover, DR; Jackson, JB; Jones, DC; Kumwenda, N; Mmiro, F; Musoke, P; Mwatha, A; Taha, TE, 2006)
" A pre-dose to 6 h post-dose steady-state pharmacokinetic analysis (n = 35) of the drugs on the day of the scheduled Caesarean section was performed."	1.33	Placental transfer and pharmacokinetics of lopinavir and other protease inhibitors in combination with nevirapine at delivery. ( Belohradsky, BH; Eberle, J; Friese, K; Gingelmaier, A; Grubert, TA; Kästner, R; Kurowski, M; Mylonas, I, 2006)
"To assess the incidence and consequences of adverse reactions among African HIV-positive pregnant women treated with fixed-dose combinations of a nevirapine-containing antiretroviral (ARV) triple therapy."	1.33	Safety of nevirapine-containing antiretroviral triple therapy regimens to prevent vertical transmission in an African cohort of HIV-1-infected pregnant women. ( da Cruz Gomes, A; Germano, P; Guidotti, G; Liotta, G; Loureiro, S; Mancinelli, S; Marazzi, MC; Narciso, P; Palombi, L; Perno, CF; Valls Blazquez, MC, 2006)
"To reduce mother-to-child transmission (MTCT) of HIV, we assessed the stability of nevirapine suspension in an oral dosing syringe over a range of storage conditions."	1.33	Stability of nevirapine suspension in prefilled oral syringes used for reduction of mother-to-child HIV transmission. ( Dreyfuss, ML; Gray, RH; Hamzeh, FM; Li, X; Parsons, TL; Rexroad, VE; Stamper, PD, 2006)
" The influence of gender, age, body weight and comedication on minimum and maximum concentrations (C(min), C(max)), area under the concentration-time curve (AUC), total clearance (CL(tot)), half-life (t(1/2)) and volume of distribution (V(d)) was analysed by multivariate techniques."	1.33	A comparison of the steady-state pharmacokinetics of nevirapine in men, nonpregnant women and women in late pregnancy. ( Carlebach, A; Gute, P; Haberl, A; Harder, S; Klauke, S; Knecht, G; Kurowski, M; Rohrbacher, M; Staszewski, S; Stocker, H; von Hentig, N, 2006)
"In HIV-infected women receiving prenatal care and ART, adverse events were uncommon."	1.32	Maternal toxicity and pregnancy complications in human immunodeficiency virus-infected women receiving antiretroviral therapy: PACTG 316. ( Balasubramanian, R; Culnane, M; Cunningham, CK; Delfraissy, JF; Delke, I; Dorenbaum, A; Fiore, S; Gelber, RD; Maupin, RT; Mofenson, LM; Newell, ML; Watts, DH, 2004)
" Labor ward dosing to enhance nevirapine coverage should be considered as an adjunct to antenatal nevirapine administration for prevention of mother-to-child transmission of HIV."	1.32	Universal nevirapine upon presentation in labor to prevent mother-to-child HIV transmission in high prevalence settings. ( Acosta, EP; Aldrovandi, GM; Goldenberg, RL; Kumwenda, R; Sinkala, M; Stout, JP; Stringer, JS; Vermund, SH, 2004)
"Nevirapine was provided to HIV-1-seropositive women and condoms distributed to all participants."	1.32	Antenatal couple counseling increases uptake of interventions to prevent HIV-1 transmission. ( Farquhar, C; John, FN; John-Stewart, GC; Kabura, MN; Kiarie, JN; Mbori-Ngacha, DA; Nduati, RW; Richardson, BA, 2004)
"Mass treatment of nevirapine would increase access to antiretroviral drugs among pregnant women because they can access nevirapine without volunteer counseling and testing, which 31% of pregnant women in developing countries refused to accept due to the fear of stigmatization."	1.31	Mass treatment with nevirapine to prevent mother-to-child transmission of HIV/AIDS in sub-Saharan African countries. ( Hashimoto, H; Kapiga, SH; Murata, Y, 2002)
" Nevirapine is well absorbed during labor, and sufficient drug for prophylaxis against perinatal transmission crosses the placenta if an oral dose is administered to the mother at least 1 hour before delivery."	1.31	Antiretroviral pharmacology in pregnant women and their newborns. ( Mirochnick, M, 2000)
"Nevirapine is a non-nucleoside HIV reverse transcriptase inhibitor."	1.29	Nevirapine: ethical dilemmas and care for HIV-infected mothers. ( Benson, M; Shannon, M, 1995)

Research

Studies (667)

Authors

Clinical Trials (64)

Trial Overview

Trial Outcomes

Frequency and Severity of Adverse Reactions Among Participating Infants

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	38 (5.70)	18.2507
2000's	386 (57.87)	29.6817
2010's	221 (33.13)	24.3611
2020's	22 (3.30)	2.80

Authors	Studies
Yeh, RF	1
Rezk, NL	1
Kashuba, AD	2
Dumond, JB	1
Tappouni, HL	1
Tien, HC	1
Chen, YC	1
Vourvahis, M	1
Horton, AL	1
Fiscus, SA	13
Patterson, KB	1
Boyce, CL	1
Sils, T	1
Ko, D	1
Wong-On-Wing, A	1
Beck, IA	5
Styrchak, SM	1
DeMarrais, P	1
Tierney, C	2
Stranix-Chibanda, L	6
Flynn, PM	3
Taha, TE	14
Owor, M	7
Fowler, MG	30
Frenkel, LM	9
Chaúque, S	1
Mohole, J	1
Zucula, H	1
Lambo, L	1
Lisboa, A	1
Ferreira, D	1
Nguyen, H	1
Chowdhary, H	1
Macmillian, B	1
Elias, B	1
Seni, A	1
Buck, WC	1
Dollfus, C	1
Le Chenadec, J	1
Mandelbrot, L	2
Tubiana, R	1
Faye, A	2
Brossard, M	1
Frange, P	1
Blanche, S	5
Warszawski, J	1
Cuco, RM	1
Loquiha, O	1
Juga, A	1
Couto, A	1
Meggi, B	1
Vubil, A	1
Sevene, E	1
Osman, N	2
Temermam, M	1
Degomme, O	1
Sidat, M	2
Bhatt, N	1
Stalter, RM	1
Amorim, G	1
Mocello, AR	1
Jakait, B	2
Shepherd, BE	2
Musick, B	1
Bernard, C	1
Bukusi, EA	3
Wools-Kaloustian, K	2
Cohen, CR	4
Yiannoutsos, CT	1
Patel, RC	4
Jao, J	2
Sun, S	1
Bonner, LB	1
Legbedze, J	1
Mmasa, KN	1
Makhema, J	7
Mmalane, M	1
Kgole, S	1
Masasa, G	1
Moyo, S	4
Gerschenson, M	1
Mohammed, T	1
Abrams, EJ	10
Kurland, IJ	2
Geffner, ME	2
Powis, KM	1
Namara-Lugolobi, E	1
Namukwaya, Z	2
Ouma, J	1
Namale-Matovu, J	1
Nakabiito, C	14
Ndugwa, C	1
Musoke, P	30
Penazzato, M	2
Kasirye, I	1
Ruel, T	1
Mukui, I	1
Bekker, A	1
Archary, M	1
Essajee, S	1
Siberry, GK	2
Mahy, M	1
Simnoue, D	1
Simione, B	1
Zech, JM	1
Mushavi, A	2
Larsen, A	1
Magasana, V	1
Dinh, TH	2
Ngandu, N	1
Lombard, C	3
Cheyip, M	1
Ayalew, K	1
Chirinda, W	1
Kindra, G	1
Jackson, D	2
Goga, A	2
Onyango-Makumbi, C	2
Owora, AH	1
Mwiru, RS	1
Mwatha, A	14
Young, AM	1
Moodley, D	13
Coovadia, HM	5
Manji, K	3
Maldonado, Y	6
Richardson, P	3
Andrew, P	2
George, K	4
Fawzi, W	3
Hompe, ED	1
Jacobson, DL	1
Eudailey, JA	1
Butler, K	2
Edwards, W	1
Pollara, J	1
Brummel, SS	1
Fouda, GG	1
Chinula, L	1
Kamanga, M	1
Kinikar, A	3
Permar, SR	2
Engelbrecht, AE	1
Wiesner, L	2
Norman, J	1
Rabie, H	5
Decloedt, EH	1
Venkatesh, KK	2
Farhad, M	1
Fenton, T	4
Naik, S	1
Fairlie, L	1
Stringer, JSA	1
Chi, BH	14
Lallemant, M	10
Amzal, B	1
Sripan, P	1
Urien, S	4
Cressey, TR	7
Ngo-Giang-Huong, N	9
Klinbuayaem, V	2
Rawangban, B	1
Sabsanong, P	3
Siriwachirachai, T	1
Jarupanich, T	2
Kanjanavikai, P	2
Wanasiri, P	1
Koetsawang, S	4
Jourdain, G	11
Le Coeur, S	7
Suryavanshi, N	5
Kadam, A	1
Gupte, N	7
Hegde, A	1
Kanade, S	1
Sivalenka, S	1
Kumar, VS	1
Gupta, A	8
Bollinger, RC	6
Shankar, A	2
McKenzie-White, J	1
Mave, V	3
Napyo, A	1
Tylleskär, T	1
Mukunya, D	1
Tumuhamye, J	1
Musaba, MW	1
Ojok Arach, AA	1
Waako, P	1
Tumwine, JK	1
Ndeezi, G	1
Bhattacharya, D	1
Guo, R	1
Tseng, CH	1
Emel, L	5
Sun, R	1
Chiu, SH	1
Chipato, T	6
Mohtashemi, NZ	1
Kintu, K	1
Manji, KP	1
Thio, CL	1
Currier, JS	3
Waitt, C	1
Myer, L	1
Khoo, S	3
Ruel, TD	1
Capparelli, EV	4
Nelson, BS	1
Coletti, A	1
Bryson, Y	2
Cotton, MF	6
Spector, SA	3
Mirochnick, M	20
LeBlanc, R	1
Reding, C	1
Zimmer, B	1
Persaud, D	3
Bwakura-Dangarembizi, M	2
Naidoo, KL	1
Hazra, R	1
Jean-Philippe, P	2
Chadwick, EG	1
Celerino da Silva, R	1
Segat, L	1
Kuhn, L	14
Chies, JAB	1
Crovella, S	1
Menegotto, M	1
Magdaleno, AM	1
da Silva, CLO	1
Friedrich, L	1
da Silva, CH	1
Aguti, I	1
Kimbugwe, C	1
Apai, P	1
Munyaga, S	1
Nyeko, R	1
Bitarakwate, E	2
Ashburn, K	1
Kazooba, P	1
Khamasi, R	1
Natumanya, E	1
Herrera, N	1
Owomugisha, B	1
Malkin, RA	2
Kisaakye, L	1
Hirt, D	3
Kubota Kilengelela, J	1
Jarreau, PH	1
Tréluyer, JM	3
Marcou, V	1
Kebaya, LMN	1
Wamalwa, D	1
Kariuki, N	1
Admani, B	1
Ayieko, P	1
Nduati, R	1
Cababasay, M	1
Mofenson, LM	12
Fiscus, S	4
Coutsoudis, A	2
Gnanashanmugam, D	2
Chakhtoura, N	1
McCarthy, K	1
Frenkel, L	4
Beck, I	2
Mukuzunga, C	1
Makanani, B	1
Nematadzira, T	1
Kusakara, B	1
Patil, S	5
Vhembo, T	1
Bobat, R	3
Mmbaga, BT	2
Masenya, M	1
Nyati, M	1
Theron, G	3
Mulenga, H	1
Shapiro, DE	6
Girma, M	1
Wendaferash, R	1
Shibru, H	1
Berhane, Y	1
Hoelscher, M	1
Kroidl, A	1
McIlleron, H	1
Denti, P	1
Cohn, S	1
Mashabela, F	1
Hoffmann, JD	1
Shembe, S	1
Msandiwa, R	1
Velaphi, S	1
Lala, SG	2
Chaisson, RE	1
Martinson, N	7
Dooley, KE	1
Punyawudho, B	1
Saenjum, C	1
Jittayanun, K	1
Phanomcheong, S	1
Luvira, A	1
Borkird, T	1
Puangsombat, A	1
Aarons, L	1
Sukrakanchana, PO	1
Bhat, J	1
Bharadwaj, R	3
Kulkarni, V	4
Bhosale, R	7
McIntire, KN	1
Bollinger, R	2
Morroni, C	1
Scarsi, KK	4
Sripipatana, T	2
Kiarie, J	4
Birlie, B	1
Braekers, R	1
Awoke, T	1
Kasim, A	1
Shkedy, Z	1
Mwau, M	1
Bwana, P	1
Kithinji, L	1
Ogollah, F	1
Ochieng, S	1
Akinyi, C	1
Adhiambo, M	1
Ogumbo, F	1
Sirengo, M	1
Boeke, C	1
Cook, RR	1
Peltzer, K	2
Weiss, SM	1
Rodriguez, VJ	1
Jones, DL	1
Veroniki, AA	1
Antony, J	1
Straus, SE	1
Ashoor, HM	1
Finkelstein, Y	1
Khan, PA	1
Ghassemi, M	1
Blondal, E	1
Ivory, JD	1
Hutton, B	1
Gough, K	1
Hemmelgarn, BR	1
Lillie, E	1
Vafaei, A	1
Tricco, AC	1
Nkenfou, CN	1
Temgoua, ES	1
Ndzi, EN	1
Mekue, LCM	1
Ngoufack, MN	1
Dambaya, B	1
Anoubissi, JD	1
Domkam, I	2
Elong, E	1
Fainguem, N	1
Thèze, J	1
Colizzi, V	2
Bissek, ACZK	1
Ndjolo, A	1
Haaland, RE	1
Otieno, K	1
Martin, A	1
Katana, A	1
Dinh, C	1
Slutsker, L	1
Menendez, C	2
Gonzalez, R	1
Williamson, J	1
Heneine, W	4
Desai, M	1
Ogalo, EA	1
Adina, JO	1
Ooko, H	1
Batuka, J	1
Kimaiyo, S	1
Torimiro, JN	1
Nanfack, A	1
Takang, W	1
Keou, CK	1
Joyce, AN	1
Njefi, K	1
Agyingi, K	1
Takou, D	1
Moudourou, S	1
Sosso, S	1
Mbu, RE	2
Liu, JX	1
Shen, J	1
Wilson, N	1
Janumpalli, S	1
Stadler, P	1
Padian, N	1
Wang, X	2
Guo, G	1
Zheng, J	1
Lu, L	1
Potty, RS	1
Sinha, A	1
Sethumadhavan, R	1
Isac, S	1
Washington, R	1
Apangu, P	1
Izudi, J	1
Bajunirwe, F	2
Mulogo, E	1
Batwala, V	1
Strehlau, R	2
Paximadis, M	1
Patel, F	1
Burke, M	1
Technau, KG	1
Shiau, S	2
Sherman, GG	3
Hunt, G	1
Ledwaba, J	2
Mazanderani, AH	1
Tiemessen, CT	4
Thomas, K	1
Yiannoutsos, C	1
Onono, M	2
Wools-Kaloustian, KK	1
Tseng, A	1
Hills-Nieminen, C	1
Ton, Q	1
Frank, M	2
Harms, G	7
Kunz, A	7
Kloft, C	2
Reynolds, HW	2
Gachuno, O	1
Kayita, J	2
Hays, MA	1
Otterness, C	1
Rakwar, J	1
Darak, S	1
Darak, T	1
Kulkarni, S	3
Parchure, R	1
Hutter, I	1
Janssen, F	1
Wang, R	1
Weng, J	1
Pain, D	1
Barr, CD	1
Maruapula, D	1
Mongwato, D	1
Novitsky, V	3
Essex, M	8
Audureau, E	1
Kahn, JG	5
Besson, MH	1
Saba, J	1
Ladner, J	1
Vardhanabhuti, S	1
Acosta, EP	7
Ribaudo, HJ	2
Severe, P	1
Lalloo, U	1
Kumarasamy, N	2
Taulo, F	2
Kabanda, J	2
Oneko, O	1
Ive, P	1
Sambarey, P	2
Chan, ES	2
Hitti, J	7
Hong, F	2
McMahon, D	1
Haas, DW	1
Kourtis, AP	7
Wiener, J	4
Kayira, D	5
Chasela, C	3
Ellington, SR	3
Hyde, L	1
Hosseinipour, M	1
van der Horst, C	6
Jamieson, DJ	6
Werayingyong, P	1
Phanuphak, N	2
Chokephaibulkit, K	1
Tantivess, S	1
Kullert, N	1
Tosanguan, K	1
Butchon, R	1
Voramongkol, N	1
Boonsuk, S	1
Pilasant, S	1
Kulpeng, W	1
Teerawattananon, Y	1
Bendle, M	1
Bajpai, S	1
Choudhary, A	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
PHPT-5 Second Phase: Perinatal Antiretroviral Intensification for the Prevention of Mother-to-child Transmission of HIV in Thai Women Having Received Less Than 8 Weeks of HAART During Pregnancy[NCT01511237]	Phase 3	379 participants (Actual)	Interventional	2011-12-31	Completed
A Phase III Trial to Determine the Efficacy and Safety of an Extended Regimen of Nevirapine in Infants Born to HIV-Infected Women to Prevent Vertical HIV Transmission During Breastfeeding[NCT00074412]	Phase 3	2,026 participants (Actual)	Interventional	2007-01-31	Completed
Very Early Intensive Treatment of HIV-Infected Infants to Achieve HIV Remission: A Phase I/II Proof of Concept Study[NCT02140255]	Phase 1/Phase 2	905 participants (Anticipated)	Interventional	2015-01-23	Recruiting
Short Duration Exclusive Breastfeeding With Abrupt Weaning to Reduce the Risk of Mother-to-Child HIV Transmission[NCT00310726]		1,435 participants (Actual)	Interventional	2001-05-31	Completed
Evaluation of Conditional Cash Transfers to Increase Retention in PMTCT Services in Akwa Ibom State, Nigeria[NCT02447159]		554 participants (Actual)	Interventional	2015-08-31	Completed
The Effect of Phenytoin on the Pharmacokinetics of Nevirapine and the Development of Nevirapine Resistance After a Single Dose Nevirapine (VIramune®), Which is Part of ARV Prophylaxis for PMTCT in Moshi, TAnzania, and in Lusaka, Zambia (VITA2 Trial)[NCT01187719]	Phase 2	66 participants (Actual)	Interventional	2010-05-31	Completed
Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women[NCT00993031]	Phase 3	389 participants (Actual)	Interventional	2009-12-15	Completed
Interactions Between Antiretrovirals and Combined Oral Contraceptive Pills[NCT00829114]	Phase 4	370 participants (Anticipated)	Interventional	2009-03-31	Completed
PROMISE EBF: Promoting Infant Health and Nutrition in Sub-Saharan Africa: Safety and Efficacy of Exclusive Breastfeeding Promotion in the Era of HIV[NCT00397150]		2,579 participants (Actual)	Interventional	2006-11-30	Completed
Maternal and Infant Peripartum Nevirapine, Versus Infant Only Peripartum Nevirapine, or Maternal Lopinavir/Ritonavir in Addition to Standard Zidovudine Prophylaxis for the Prevention of Perinatal HIV in Thailand.[NCT00409591]	Phase 3	435 participants (Actual)	Interventional	2008-07-31	Terminated (stopped due to Change in National PMTCT guidelines in Thailand)
A Pharmacokinetic Evaluation of Levonorgestrel Implant and Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Based Antiretroviral Therapy in HIV-infected Ugandan Women[NCT01789879]	Phase 2	60 participants (Actual)	Interventional	2014-03-04	Completed
Optimizing Integrated PMTCT Services in Rural North-Central Nigeria: A Cluster Randomized Trial[NCT01805752]		369 participants (Actual)	Interventional	2013-03-31	Completed
Role of Pharmacogenetics in Efavirenz and Nevirapine Pharmacokinetics, Efficacy and Safety in Mother-infant Pairs During Pregnancy and Lactation[NCT02269462]		460 participants (Actual)	Observational	2012-12-31	Completed
Breastfeeding Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere)[NCT01061151]	Phase 3	3,747 participants (Actual)	Interventional	2011-03-01	Completed
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 2	400 participants (Actual)	Interventional	2005-03-31	Completed
Effect of Intermittent Preventive Treatment (IPTp) With Sulfadoxine-Pyrimethamine Plus Insecticide Treated Nets, Delivered Through Antenatal Clinics for the Prevention of Malaria in Mozambican Pregnant Women[NCT00209781]		1,028 participants	Interventional	2003-08-31	Active, not recruiting
Prevention of Maternal to Infant HIV Transmission in India[NCT00061321]	Phase 3	770 participants (Actual)	Interventional	2002-08-31	Completed
Nevirapine (NVP) Use to Prevent Maternal-Infant HIV Transmission: A Randomized Clinical Trial of Two Doses of NVP Compared to Six Weeks of NVP for the Prevention of Maternal-Infant HIV Transmission in the Breastfeeding Infant[NCT00074399]	Phase 3	775 participants (Actual)	Interventional	2001-02-28	Completed
A Phase III Randomized Clinical Trial of the Standard Two Dose Nevirapine (NVP) Regimen With the Addition of HIV Immune Globulin(HIVIGLOB) or Extended Infant NVP Dosing Compared With the Standard NVP Regimen Alone for the Prevention of Maternal-Infant HIV[NCT00639938]	Phase 3	722 participants (Actual)	Interventional	2004-07-31	Completed
Presumptive and Definitive Virologic HIV Diagnosis in Hospitalized Malawian Infants[NCT01388452]		300 participants (Actual)	Interventional	2011-06-30	Completed
ARVs to Prevent Breastmilk HIV:Viral and Immune Responses[NCT00167674]	Phase 2	58 participants (Actual)	Interventional	2003-05-31	Completed
A Cohort Study To Assess The Impact Of A Breastfeeding Counselling And Support Strategy To Promote Exclusive Breastfeeding On Post-Natal Transmission Of HIV In African Women[NCT01948557]		3,465 participants (Actual)	Interventional	2001-10-31	Completed
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 2	72 participants (Actual)	Interventional	2006-10-31	Completed
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)	Observational	2011-03-22	Completed
Phase III Trial of Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission[NCT00021671]	Phase 3	3,720 participants	Interventional		Completed
HIV Exposure, Disease Acquisition and Progression Among Children: Role of Maternal Immunogenetics, Viral Genetic Diversity, HAART Exposure, Co-morbidities and Psycho-Social Status: (UZ-CHS Birth Cohort)[NCT04087239]		1,200 participants (Actual)	Observational	2016-01-26	Active, not recruiting
An Open-label Study Evaluating the Resistance Profile of Single Dose Nevirapine(NVP) When Combined With a 4 or 7 Day Course of Combivir® (ZDV/3TC) Compared to Single Dose Nevirapine for the Prevention of Mother to Child Transmission (pMTCT) of HIV - Treat[NCT00144183]	Phase 3	407 participants	Interventional	2003-01-31	Completed
Optimizing the Delivery of Maternal and Child Health Services to Strengthen the Primary Health Care System in Rural South Africa[NCT02626351]		3,172 participants (Actual)	Interventional	2015-07-15	Completed
A Phase 2, One Arm, Open Label, Feasibility Study Assessing One Month Zidovudine/Didanosine Postpartum Prophylaxis to Prevent Resistance Mutations in Mothers Exposed to Single Dose Nevirapine to Prevent Mother to Child Transmission of HIV[NCT00142337]	Phase 2	244 participants (Actual)	Interventional	2004-12-31	Completed
Observational Cohort of HIV Infected Adults and Children in the PHPT Network Hospitals in Thailand[NCT00433030]		2,816 participants (Actual)	Observational	2007-01-31	Completed
HIV Infection and Breastfeeding: Interventions for Maternal and Infant Health[NCT00164736]	Phase 3	2,369 participants (Actual)	Interventional	2004-03-31	Completed
Pharmacokinetics and Safety of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants[NCT04862975]		200 participants (Anticipated)	Observational	2024-01-08	Not yet recruiting
Lopinavir/Ritonavir/Combivir vs. Abacavir/Zidovudine/Lamivudine for Virologic Efficacy and the Prevention of Mother-to-Child HIV Transmission Among Breastfeeding Women With CD4 Counts Greater Than or Equal to 200 Cells/mm3 in Botswana[NCT00270296]	Phase 2	730 participants (Actual)	Interventional	2006-06-30	Completed
Z 1303 - Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children[NCT02682810]		4,000 participants (Actual)	Interventional	2016-02-29	Completed
Nevirapine Pharmacodynamics and Resistance Among HIV-Infected Mothers in Lilongwe, Malawi[NCT00164762]		126 participants (Actual)	Observational	2005-06-30	Completed
Optimal Combination Therapy After Nevirapine Exposure[NCT00089505]	Phase 3	745 participants (Actual)	Interventional	2006-11-30	Completed
Phase II, Parallel, Randomized, Clinical Trials Comparing the Responses to Initiation of NNRTI-Based Versus PI-Based Antiretroviral Therapy in HIV Infected Infants Who Have and Have Not Previously Received Single Dose Nevirapine for Prevention of Mother-t[NCT00307151]	Phase 2	452 participants (Actual)	Interventional	2005-12-31	Completed
A Pharmacokinetics Study Comparing Lopinavir Plasma Exposure When Given as Lopinavir/Ritonavir (1:1) in the Presence of Rifampicin and Lopinavir/Ritonavir (4:1) Without Rifampicin in HIV and TB Co-infected Children in South Africa.[NCT02348177]	Phase 4	96 participants (Actual)	Interventional	2013-01-31	Completed
A Phase I/II, Open-Label Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Etravirine (ETR) in Antiretroviral (ARV) Treatment-Experienced HIV-1 Infected Infants and Children, Aged ≥ 2 Months to < 6 Years[NCT01504841]	Phase 1/Phase 2	26 participants (Actual)	Interventional	2013-03-14	Completed
The Effect of Single Dose Carbamazepine on the Pharmacokinetics of Single Dose Nevirapine (Viramune, NVP) and Development of NVP Resistance, PMTCT Program of Moshi, Tanzania (VITA1)[NCT00294892]	Phase 2	144 participants (Actual)	Interventional	2006-02-28	Completed
[NCT00398684]	Phase 3	1,792 participants	Interventional	2001-01-31	Completed
Phase II Study of the Pharmacokinetics of Nevirapine and the Incidence of Nevirapine Resistance Mutations in HIV-Infected Women Receiving a Single Intrapartum Dose of Nevirapine With the Concomitant Administration of Zidovudine/Didanosine or Zidovudine/Di[NCT00109590]	Phase 2	175 participants (Actual)	Interventional	2006-06-30	Completed
HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding[NCT00530777]	Phase 2	148 participants (Actual)	Interventional	2008-04-30	Completed
Phase III Randomized Trial of the Safety and Efficacy of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV-1 Transmission[NCT00099359]	Phase 3	1,735 participants (Actual)	Interventional	2004-02-29	Completed
A Phase I Trial to Evaluate the Safety and Pharmacokinetics of Raltegravir in HIV-1-Exposed Neonates at Risk of Acquiring HIV-1 Infection[NCT01780831]	Phase 1	52 participants (Actual)	Interventional	2014-01-28	Completed
Maintaining Options for Mothers Study (MOMS): A Phase II Randomized Comparison of Three Antiretroviral Strategies Administered for 7 or 21 Days to Reduce the Emergence of Nevirapine Resistant HIV-1 Following a Single Intrapartum Dose of Nevirapine[NCT00099632]	Phase 2	484 participants (Actual)	Interventional	2006-03-31	Completed
A Phase III Randomized, Blinded Study of Nevirapine for the Prevention of Maternal-Fetal Transmission in Pregnant HIV-Infected Women[NCT00000869]	Phase 3	2,009 participants	Interventional		Completed
A Phase III Placebo-Controlled Trial to Determine the Efficacy of Oral AZT and the Efficacy of Oral Nevirapine for the Prevention of Vertical Transmission of HIV-1 Infection in Pregnant Ugandan Women and Their Neonates[NCT00006396]	Phase 3	1,500 participants	Interventional		Completed
A Phase III Randomized Trial of the Safety and Antiretroviral Effects of Zidovudine/Lamivudine/Abacavir Versus Zidovudine/Lamivudine/Lopinavir/Ritonavir in the Prevention of Perinatal Transmission of HIV[NCT00086359]	Phase 3	19 participants (Actual)	Interventional	2004-07-31	Completed
Assessment of Safety and Toxicity Among Infants Born to HIV-1-Infected Women Enrolled in Antiretroviral Treatment Protocols in Diverse Areas of the World[NCT00100867]		236 participants (Actual)	Observational	2006-06-30	Completed
Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum[NCT00042289]		1,578 participants (Actual)	Observational	2003-06-09	Completed
Phase I/II Study to Assess the Safety and Plasma Concentrations of Nevirapine Given Daily, Twice a Week or Weekly as Prophylaxis in Breastfeeding Infants From Birth to 6 Months[NCT00006279]	Phase 1	75 participants	Interventional		Completed
A Phase III Randomized, Double-Blinded Study of Nevirapine for the Prevention of Maternal-Fetal Transmission in Pregnant HIV-Infected Women[NCT00001135]	Phase 3	2,009 participants	Interventional		Completed
A Phase III Randomized, Double-Blinded Study of Nevirapine for the Prevention of Maternal-Fetal Transmission in Pregnant HIV-Infected Women[NCT00000942]	Phase 3	1,244 participants	Interventional		Completed
Randomized Trial of Protease Inhibitor-Including vs. Protease Inhibitor-Sparing Regimens for Women Who Initiate Therapy of HIV Infection During Pregnancy[NCT00017719]	Phase 3	440 participants	Interventional	2002-05-31	Completed
An Open-Label, Pilot Study to Characterize the Pharmacokinetics of a 400mg Oral Dose of Raltegravir in the Cervicovaginal Fluids of HIV-Infected Pre-menopausal Women[NCT00961272]		6 participants (Actual)	Observational	2009-07-31	Completed
A Phase IV, Open-Label, Single-Sequence Pilot Study to Characterize the Pharmacokinetics of a 400mg Oral Dose of Raltegravir in the Cervicovaginal Fluids of HIV-Infected Women[NCT00774683]		1 participants (Actual)	Observational	2008-08-31	Completed
A Phase IV, Open-Label Study to Characterize the First-Dose and Multiple-Dose Pharmacokinetics of Raltegravir in the Gastrointestinal Tract of Healthy Male Volunteers[NCT01325051]	Phase 1	15 participants (Actual)	Interventional	2011-04-30	Completed
A Phase I Study of the Safety, Tolerance, and Pharmacokinetics of Tenofovir Disoproxil Fumarate (TDF) and the Combination of TDF Plus Emtricitabine in HIV-1 Infected Pregnant Women and Their Infants[NCT00076791]	Phase 1	66 participants (Actual)	Interventional	2004-03-31	Completed
"Prevention of Milk-Borne Transmission of HIV-1C in Botswana (Mashi)"[NCT00197587]		1,200 participants (Actual)	Interventional	2002-08-31	Completed
ART Readiness in HIV-infected Pregnant Women: From Formative Qualitative Research to Individual Randomized Trial[NCT02459678]		454 participants (Actual)	Interventional	2015-05-31	Completed
Pilot Evaluation of Pulmonary Tuberculosis Screening in Antenatal Clinics in Lusaka, Zambia[NCT02053129]		5,033 participants (Actual)	Interventional	2011-11-30	Completed
A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers[NCT00000808]	Phase 1	49 participants	Interventional		Completed
Mother-Infant Rapid Intervention at Delivery (MIRIAD)[NCT00046436]		7,500 participants	Observational		Terminated
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

For those infants who were randomized at 6 weeks and who initiated study drug we looked at the frequency and severity of adverse reactions through 18 months of study. The severity of all AEs was graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. The term severity is described as the intensity grade or level for specific event (i.e. mild, moderate, severe, or life-threatening). Severity is not the same as seriousness. (NCT00074412)
Timeframe: 6 weeks through 18 months

HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study

Infant Survival Rates (Mortality Regardless of HIV Infection) in the Two Arms

Proportion of Infants Who Are Alive and HIV-uninfected in the Two Arms

Relative Rates of HIV Infection in the Two Arms

ART Levels in Hair Samples at Delivery

Intervention	Number of Adverse Events (Number)
	Death	Life-Threatening	Severe	Moderate	Mild
Nevirapine	26	87	375	694	832
Placebo	30	87	332	677	838

Intervention	participants (Number)
	# of HIV infections at 6 months	# of Infants at risk for HIV infection at 6 months
Nevirapine	8	700
Placebo	18	699

Intervention	participants (Number)
	# Infant Deaths at 18 months	# Infants at risk of death at 18 months
Nevirapine	26	678
Placebo	30	684

Intervention	participants (Number)
	Number of Infants Alive and HIV-free at 6 months	Number of Infants Alive and HIV-free at 18 months
Nevirapine	689	629
Placebo	683	616

Intervention	participants (Number)
	# of infants with HIV infection at 18 months	# of infants @ risk for HIV infection at 18 months
Nevirapine	16	664
Placebo	23	663

antiretroviral hair concentrations (per doubling) (NCT00993031)
Timeframe: delivery

Change in Maternal CD4 Cell Counts

Intervention	antiretroviral hair concentration(ng/mg) (Mean)
Without Protease Inhibitor	5.7
With Protease Inhibitor	6.6

CD4 cell count recovery efavirenz at delivery (NCT00993031)
Timeframe: Time of randomization to delivery, an average of 20 weeks

Incidence of Pre-eclampsia Defined by Hypertension > 140/90 on Two Occasions Measured > 6 Hours Apart With ≥1+ Proteinuria on Clean Catch Urine Dipstick

Intervention	CD4 cell count (Median)
Without Protease Inhibitor	-7
With Protease Inhibitor	57

Pre-eclampsia Defined by Hypertension > 140/90 on Two Occasions Measured > 6 Hours Apart With ≥1+ Proteinuria on Clean Catch Urine Dipstick (NCT00993031)
Timeframe: Time from randomization until delivery

Maternal Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk After Pregnancy

Intervention	Participants (Count of Participants)
Without Protease Inhibitor	0
With Protease Inhibitor	0

(NCT00993031)
Timeframe: Number of treatments given for clinical malaria based on postive blood smear from time from delivery until 24 months after delivery or cessation of breastfeeding

Maternal Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk During Pregnancy

Intervention	treatments (Number)
Group A	21
Group B	13

(NCT00993031)
Timeframe: Number of treatments given for clinical malaria based on postive blood smear from time from randomization until 24 months after delivery or cessation of breastfeeding

Number of Participants With Grade 3 or 4 Toxicity in the Two Treatment Groups in Women

Number of Participants With Maternal HIV RNA Suppression of <400 Copies/mL

Intervention	treatments (Number)
With Protease Inhibitor	17
Without Protease Inhibitor	17

Intervention	Participants (Count of Participants)
Without Protease Inhibitor	12
With Protease Inhibitor	8

Virologic suppression was defined as plasma HIV-1 RNA 400 copies/ml or less based on the lower limit of detection of the available test. (NCT00993031)
Timeframe: Time from randomization until delivery, an average of 20 weeks

Number of Participants With Maternal to Child Transmission of HIV, Measured by Infant HIV DNA PCR

Number of Participants With Severe Maternal Anemia Defined by Hemoglobin < 8g/dl at Any Point During the Trial in Each Treatment Group

Intervention	Participants (Count of Participants)
Without Protease Inhibitor	166
With Protease Inhibitor	153

Intervention	Participants (Count of Participants)
Without Protease Inhibitor	0
With Protease Inhibitor	2

Proportion of women with severe maternal Anemia (hemoglobin < 8g/dl by hemacue or CBC) at any point during the trial in Each Treatment Group (NCT00993031)
Timeframe: Time from randomization until one year follow up

Placental Malaria Defined as Positive Placental RDT

Intervention	Participants (Count of Participants)
Without Protease Inhibitor	11
With Protease Inhibitor	11

Number of participants with positive placental RDT for malaria. Malaria rapid diagnostic tests (RDTs) assist in the diagnosis of malaria by detecting evidence of malaria parasites (antigens) in human blood. RDTs permit a reliable detection of malaria infections particularly in remote areas with limited access to good quality microscopy services. (NCT00993031)
Timeframe: Delivery

Placental Malaria Defined Placental Histopathologic Analysis

Intervention	participants (Number)
With Protease Inhibitor	6
Without Protease Inhibitor	7

Number of participants with positive placental histopathology slide for malaria (NCT00993031)
Timeframe: Delivery

Prevalence of Composite Clinical Outcome Defined by LBW, Stillbirth(Intrauterine Fetal Demise >20wks GA), Late Spontaneous Abortion(Miscarriage 12-20wks GA), Preterm Delivery(<37wks Gestation), Neonatal Death(Death of Liveborn Infant Within First 28days)

Intervention	participants (Number)
With Protease Inhibitor	62
Without Protease Inhibitor	47

Percent of evaluated participants with composite clinical outcome defined by LBW, stillbirth (intrauterine fetal demise >20wks GA), late spontaneous abortion(miscarriage 12-20wks GA), preterm delivery(<37wks gestation), neonatal death(death of live-born infant within first 28 days) (NCT00993031)
Timeframe: Time from randomization until 24 months postpartum or cessation of breastfeeding

Prevalence of Malaria Defined as Positive Placental Blood PCR

Intervention	% of evaluated participants with outcome (Number)
With Protease Inhibitor	33.9
Without Protease Inhibitor	27.8

Number of participants with positive placental blood PCR for malaria (NCT00993031)
Timeframe: Delivery

Prevalence of Malaria Defined as Positive Placental Blood Smear

Intervention	participants (Number)
With Protease Inhibitor	6
Without Protease Inhibitor	7

Number of participants with positive placental blood smear for malaria (NCT00993031)
Timeframe: Delivery

Exclusive Breastfeeding Rates in Burkina Faso

Intervention	participants (Number)
With Protease Inhibitor	5
Without Protease Inhibitor	6

The EBF prevalences (24-h recall) at 12 weeks in the intervention and control clusters. (NCT00397150)
Timeframe: at 3 months of age

Exclusive Breastfeeding Rates in South Africa

Intervention	participants (Number)
Intervention	310
No Intervention	161

The EBF prevalences based on 24-h recall at 12 weeks in the intervention and control clusters. (NCT00397150)
Timeframe: at 3 months of age

Exclusive Breastfeeding Rates in Uganda

Intervention	participants (Number)
Intervention	56
No Intervention	30

The EBF prevalences (24-h recall) at 12 weeks in the intervention and control clusters. (NCT00397150)
Timeframe: at 3 months of age

Infant Morbidity, 2 Week Diarrhoea Prevalence

Antepartum Component: Number of Confirmed Infant HIV Infections

Intervention	participants (Number)
Intervention	323
No Intervention	161

Intervention	participants (Number)
Intervention	104
No Intervention	101

Defined as HIV nucleic acid test (NAT) positivity of the specimen drawn at either the birth (Day 0-5) or Week 1 (Day 6-14) visit, confirmed by HIV NAT positivity of a second specimen collected at a different time point (NCT01061151)
Timeframe: Measured at birth or Week 1 study visit

Antepartum Component: Number of Infant HIV Infections

Intervention	Participants (Count of Participants)
Antepartum Arm A	25
Antepartum Arm B	7
Antepartum Arm C	2

Detected by HIV NAT positivity (NCT01061151)
Timeframe: Measured at the birth (<= 3 days postpartum) visit

Maternal Health Component: Incidence of AIDS-defining Illness

Intervention	Participants (Count of Participants)
Antepartum Arm A	22
Antepartum Arm B	4
Antepartum Arm C	2

"AIDS-defining illness refers to the WHO Clinical Stage 4 illnesses listed in Appendix IV. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group." (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Maternal Health Component: Incidence of Death

Intervention	New cases per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)	0.08
Maternal Health Arm B (Discontinue Triple ARVs)	0.25

Number of women who died during the maternal health component; that is, who had been randomized to either continue or discontinue ART after risk of HIV vertical transmission through breastfeeding was over. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Maternal Health Component: Incidence of HIV/AIDS-related Event or Death

Intervention	New cases per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)	0.24
Maternal Health Arm B (Discontinue Triple ARVs)	0.43

"HIV/AIDS-related event refers to the WHO Clinical Stage 4 illnesses, pulmonary tuberculosis, and other serious bacterial infections listed in Appendix IV of the protocol. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group." (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Maternal Health Component: Incidence of HIV/AIDS-related Event or World Health Organization (WHO) Clinical Stage 2 or 3 Events

Intervention	New cases per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)	1.30
Maternal Health Arm B (Discontinue Triple ARVs)	1.43

Maternal Health Component: Incidence of HIV/AIDS-related Events

Intervention	New cases per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)	3.47
Maternal Health Arm B (Discontinue Triple ARVs)	5.61

Maternal Health Component: Incidence of Progression to AIDS-defining Illness or Death

Intervention	New cases per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)	1.14
Maternal Health Arm B (Discontinue Triple ARVs)	1.24

AIDS-defining illness refers to the WHO Clinical Stage 4 illnesses in Appendix IV of the protocol. These events were reviewed and confirmed by an Endpoint review group. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Maternal Health Component: Incidence of Tuberculosis

Intervention	New cases per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)	0.24
Maternal Health Arm B (Discontinue Triple ARVs)	0.49

Incidence of tuberculosis. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Maternal Health Component: Incidence Rate of Cardiovascular or Other Metabolic Events

Intervention	New cases per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)	0.40
Maternal Health Arm B (Discontinue Triple ARVs)	0.31

"Cardiovascular or metabolic events of particular concern were included in this analysis. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates.~Metabolic events considered were diabetes mellitus, lipodystrophy, or dyslipidemia. Cardiovascular events considered were hypertension, congestive heart failure, stroke, Transient Ischemia Event (TIA), pulmonary embolism, myocardial infarction (whether acute symptomatic or silent), coronary artery disease, deep vein thrombosis, peripheral vascular disease, or symptomatic HIV-associated cardiomyopathy." (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Maternal Health Component: Incidence Rate of Death or Any Condition of Particular Concern

Intervention	events per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)	2.9
Maternal Health Arm B (Discontinue Triple ARVs)	5.7

Particular events were targeted as those of particular concern. This outcome considered all such events: death, events defining WHO stages II, III, or IV, targeted cardiovascular adverse events, other targeted adverse events, or cancers which were not AIDS-defining. A complete list can be found in Appendix IV of the Protocol. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Maternal Health Component: Incidence Rate of Progression to AIDS-defining Illness, Death, or a Serious Non-AIDS Cardiovascular, Hepatic, or Renal Event

Intervention	events per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)	9.0
Maternal Health Arm B (Discontinue Triple ARVs)	14.0

"This outcome included AIDS-defining illnesses or cardiovascular, hepatic, or renal adverse events of particular concern which were evaluated as serious. Serious outcomes were both those defined as serious according to the International Conference on Harmonization (ICH) definition, or outcomes with grades equal to or worse than 3 (Severe). A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates. Cardiovascular events considered were hypertension, congestive heart failure, stroke, Transient Ischemia Event (TIA), pulmonary embolism, myocardial infarction (whether acute symptomatic or silent), coronary artery disease, deep vein thrombosis, peripheral vascular disease, or symptomatic HIV-associated cardiomyopathy. Hepatic events considered were cirrhosis and idiopathic sclerosing cholangitis. Renal events considered were renal insufficiency, acute or chronic." (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Maternal Health Component: Other Targeted Medical Conditions

Intervention	events per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)	0.5
Maternal Health Arm B (Discontinue Triple ARVs)	0.9

Other (non-cardiologic) medical conditions of particular concern were included in this outcome. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates. Events included were metabolic events, hepatic events, renal events, infections such as pulmonary tuberculosis, malaria, or other serious bacterial infections, and others. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Maternal Health Component: Toxicity: Incidence of Grade 3 or Greater Laboratory Results or Signs and Symptoms and Selected Grade 2 Hematologic, Renal, and Hepatic Laboratory Results

Intervention	events per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)	4.0
Maternal Health Arm B (Discontinue Triple ARVs)	4.6

The maternal safety endpoints summarized include grade 2, 3 or 4 hematologies (hemoglobin (Hb), White Blood Cells (WBC), Absolute Neutrophil Count (ANC), platelet count), chemistries (Alanine Aminotransferase (ALT or SGPT), serum creatinine), and grade 3 or 4 signs and symptoms that occurred post-randomization. These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Postpartum Component: Incidence of Confirmed Infant HIV Infection

Intervention	New cases per 100 person-years (Number)
Maternal Health Arm A (Continue Triple ARVs)	15.3
Maternal Health Arm B (Discontinue Triple ARVs)	13.9

Defined as infant HIV NAT positivity of a specimen drawn at any post-randomization visit (i.e., any visit after the Week 1 [Day 6-14] visit), confirmed by HIV NAT positivity of a second specimen drawn at a different time point. Analyses were conducted at the Mother-Infant (M-I) pair level, hence the worst outcome for multiple births was counted as a single event. (NCT01061151)
Timeframe: Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first

Postpartum Component: Incidence of Grade 3 or Higher Adverse Events and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events

Intervention	New cases per 100 person-years (Number)
Postpartum Arm A (Maternal Prophylaxis)	0.56
Postpartum Arm B (Infant Prophylaxis)	0.55

These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). (NCT01061151)
Timeframe: Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first

Postpartum Component: Proportion of Mother-Infant Pairs With no Death or HIV Diagnosis Through 24 Months Post-delivery

Intervention	New cases per 100 person-years (Number)
Postpartum Arm A (Maternal Prophylaxis)	14.4
Postpartum Arm B (Infant Prophylaxis)	14.1

Defined as infant HIV NAT positivity of a specimen drawn at any post-randomization visit, confirmed by HIV NAT positivity of a second specimen drawn at a different time point, or infant death. Analyses (Kaplan-Meier probabilities) were conducted at the Mother-Infant (M-I) pair level, hence the worst outcome for multiple births was counted as a single event. (NCT01061151)
Timeframe: Measured through 24 months post-delivery

Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies)

Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events

Intervention	Probability (Number)
Postpartum Arm A (Maternal Prophylaxis)	0.971
Postpartum Arm B (Infant Prophylaxis)	0.977

Intervention	Participants (Count of Participants)
	Period 2
Antepartum Arm C	111

Intervention	Participants (Count of Participants)
	Periods 1 and 2	Period 2
Antepartum Arm A	389	91
Antepartum Arm B	563	123

Intervention	Participants (Count of Participants)
	Period 2
Antepartum Arm C	60

Antepartum Component: Number of Mothers With Obstetrical Complications

Intervention	Participants (Count of Participants)
	Periods 1 and 2	Period 2
Antepartum Arm A	261	59
Antepartum Arm B	318	61

"Complications included deaths, diagnoses, signs/symptoms, chemistry lab tests, or hematological lab tests, with grades of 3 (Severe) or worse. Obstetrical complications were those classified by the MedDra coding system as Pregnancy, puerperium and perinatal conditions, except if the condition was the death of the fetus: Abortions not specified as induced or spontaneous, Abortions spontaneous, or Stillbirth and foetal death." (NCT01061151)
Timeframe: Measured through the Week 1 postpartum study visit

Antepartum Component: Number of Mothers With Obstetrical Complications

Intervention	Participants (Count of Participants)
	Period 2
Antepartum Arm C	23

Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component)

Intervention	Participants (Count of Participants)
	Periods 1 and 2	Period 2
Antepartum Arm A	89	20
Antepartum Arm B	75	12

For overall survival, failure was defined to be death. For HIV-free survival, failure was defined to be either death or developing HIV. The probability of living, or living without HIV infection, at 104 weeks was calculated by Kaplan-Meier estimation of the survival function. (NCT01061151)
Timeframe: Measured from birth through 104 weeks of age

Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component)

Postpartum Component: Proportion of Infants Alive Through 12 and 24 Months Post-delivery

Analyses (Kaplan-Meier probabilities) conducted for all individual infants (rather than M-I pair) (NCT01061151)
Timeframe: Measured at 12 and 24 months post-delivery

Antepartum Component: Maternal HIV RNA Less Than 400 Copies/mL at Delivery

Analysis used the principle of intent to treat. (NCT01061151)
Timeframe: Measured at the time of delivery

Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures

"Adherence is by maternal report; adherence through hair analysis is not included here.~The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since adherence was not a focus of the study." (NCT01061151)
Timeframe: Week 6 visit (14 days - 9 weeks postpartum); Week 14 visit (10-19 weeks postpartum); Week 26 visit (20 to 31 weeks postpartum); Week 50 visit (44 to 55 weeks postpartum); and Week 74 visit (68 to 80 weeks postpartum).

Number of HIV+ Infants

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

Number of Participants With Virologic Suppression

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

Change in CD4 Percent From Entry to Week 48

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

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

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

Percent of Participants Experiencing Virologic Failure

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

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

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

Time From Randomization to Death

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

Time From Randomization to HIV-related Disease Progression or Death

HIV-related disease progression was defined as progression in WHO clinical stage from stage at entry or death. For subjects in WHO Stage IV at entry, disease progression was defined as death. (NCT00307151)
Timeframe: Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)

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

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

Time From Randomization to Virologic Failure

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

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

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

Area Under the Plasma Concentration-Time Curve Over 12 Hours of ETR

Geometric Mean (Standard Deviation) of the area under the plasma concentration-time curve over 12 hours (AUC12h) of ETR. (NCT01504841)
Timeframe: Pre-dose, 1, 2, 4, 6, 9, and 12 hours post-dose measured at intensive PK visit (within 7-10 days after last dose of study drug administration)

Decline in Absolute CD4 Percent of Greater Than 5 Percent Any Time After 12 Weeks of Therapy

Number (%) of participants with a >5% decline in absolute CD4 percent from baseline at weeks 12, 24, and 48, by Cohort, including Clopper-Pearson confidence intervals. (NCT01504841)
Timeframe: Measured at baseline and at Weeks 12, 24, and 48

HIV-1 RNA Virologic Failure Status at Weeks 24 and 48

Number (%) of participants with confirmed Virologic Failure, defined as: failure to suppress plasma HIV-1 RNA to fewer than 400 copies/ml and failure to achieve at least a 2-log10 reduction (from baseline) in HIV-1 RNA at Weeks 24 or 48, by Cohort, with Clopper-Pearson confidence intervals. The initial HIV-1 RNA results that met the Virologic Failure definition were each confirmed by a second result obtained within 1 to 4 weeks of the initial result obtained at Week 24 and/or 48. (NCT01504841)
Timeframe: Baseline, Week 24, and Week 48

Area Under the Curve Pharmacokinetic Outcome for LPV/r. (AUC ug*hr/mL)

Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test. (NCT00109590)
Timeframe: Within 72 hours postpartum and during the first 30 days postpartum

Four (4) Hour Concentration Pharmacokinetic Outcome for LPV/r (C4hour ug/mL).

Maximum Concentration Pharmacokinetic Outcome for LPV/r (Cmax ug/mL) .

Median HIV-1 Viral Load at 24 Weeks Postpartum in Women

Number of Women With Grade >=3 Events After Start of Study Treatment

Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading > the Severity of Adult and Pediatric Adverse Events (December 2004). All grade 3 and higher signs, symptoms, and laboratory toxicities (and events of any grade that led to a change in study treatment) were included. (NCT00109590)
Timeframe: After start of study Treatment (postpartum)

Pre-dose Concentration Pharmacokinetic Outcome for LPV/r (Cpredose ug/mL).

Resistance Mutations in HIV Infected Infants

Resistance mutations as identified by consensus sequencing or OLA (NCT00109590)
Timeframe: 24 weeks postpartum

The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay (OLA) in Plasma

The incidence of new NVP resistance mutations at day 10 or week 6 postpartum in each randomized arm. Samples with viral load <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml it was conservatively imputed as resistant in the primary analysis. (NCT00109590)
Timeframe: at Day 10 or Week 6 postpartum.

The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations for the Subgroup of Women With Plasma HIV RNA >= 500 Copies/ml At Entry

The Proportion of Women Who Develop One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay in Plasma (Sampling Was Done at Days 10,21,30, and Weeks 5,6, and 8 Postpartum).

The incidence of new NVP resistance mutation in plasma HIV within 8 weeks postpartum in each randomized arm was estimated using an exact binomial confidence interval. If a resistance mutation was detected at any of the timepoints then an endpoint was met. Samples with VL <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml (e.g.missed visit), it was conservatively imputed as resistant in the primary analysis. (NCT00109590)
Timeframe: within 8 weeks postpartum.

Proportion of Women With New NVP Resistance Mutation Within 8 Weeks Postpartum Who Had a NVP Resistance Mutation Detected at 72 Weeks Postpartum.

Resistance mutations as identified by OLA in plasma samples or PBMC at 72 weeks postpartum amongst women who had new NVP resistance mutations within 8 weeks postpatrum. These results were based on the 13 women who developed a new NVP resistance mutation in the first 8 weeks postpartum. For the primary outcome measure 1, one particpant in arm A was unavailable for follow-up after week 5 and was conservatively imputed to have developed resistance mutation. (NCT00109590)
Timeframe: within 72 weeks postpartum

The Proportion of Women With Any New ZDV, ddI, or LPV/r Resistance Mutations.

(NCT00109590)
Timeframe: At Week 5 postpartum (ZDV) and at the first timepoint with viral load >=500 copies/ml after treatment discontinuation (ddI and LPV/r).

Mean Change in HIV-1 Levels in Plasma Between 34 and 38 Weeks Gestation

Calculated as log10 plasma viral load at 34 weeks gestation - log10 plasma viral load at 38 weeks gestation (NCT00530777)
Timeframe: 4 weeks

Vertical HIV-1 Transmission

Infant HIV Infection Status

Infant HIV-1 Infection Status

Participant Deaths

Participants With Serious Adverse Events

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

3TC and NFV Pharmacokinetics

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

NVP Pharmacokinetics

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

Risk Factors for Perinatal HIV-1 Transmission

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

AUC24 for Cohort 1 RAL Dose #1 (Within 48 Hours of Birth)

Area Under the Concentration-time Curve at 24-hour interval (AUC24) based on intensive PK sampling around Cohort 1 RAL dose #1 (within 48 hours of birth) (NCT01780831)
Timeframe: Cohort 1 RAL dose #1 (within 48 hours of birth) intensive PK sampling: within 30 min pre-dose; and 1-2, 4-8, 12 (±1), 24 (±1) hours post-dose.

AUC24 for Cohort 2 Initial RAL Dose (Within 48 and 12-60 Hours of Birth for RAL-naive and RAL-exposed Groups, Respectively)

Area Under the Concentration-time Curve at the 24-hour interval (AUC24) for Cohort 2 initial RAL dose (within 48 and between 12-60 hours of birth for RAL-naive and RAL-exposed, respectively). (NCT01780831)
Timeframe: Cohort 2 initial dose (within 48 and between 12-60 hours of birth for RAL-naive and RAL-exposed, respectively) intensive PK sampling: within 1 hour pre-dose; and 1-2, 6-10, 20-24 hours post-dose.

Clast for Cohort 2 Initial RAL Dose (Within 48 and Between 12-60 Hours of Birth for RAL-naïve and RAL-exposed Groups, Respectively)

Last concentration of the drug (Clast) at 24 hour interval post dosing for the Cohort 2 initial RAL dose (within 48 and at 12-60 hours of birth for RAL-naive and RAL-exposed, respectively). This is the plasma RAL concentration from a sample collected at or close to 24 hours post dose. (NCT01780831)
Timeframe: Cohort 2 initial dose (within 48 and between 12-60 hours of birth for RAL-naive and RAL-exposed groups, respectively) intensive PK sampling: within 1 hour pre-dose; and 1-2, 6-10, 20-24 hours post-dose.

Cmax for Cohort 1 RAL Dose #1 (Within 48 Hours of Birth)

Maximum concentration (Cmax) for Cohort 1 dose #1 (within 48 hours of birth) (NCT01780831)
Timeframe: Cohort 1 dose #1(within 48 hours of birth) intensive PK sampling: within 30 min pre-dose; and 1-2, 4-8, 12 (±1), 24 (±1) hours post-dose.

Cohort 1 Dose #1 Neonatal RAL Elimination (CL/F) by UGT1A1 Genotype Group

Cohort 1 Dose #1 neonatal RAL elimination was represented by Clearance (CL/F), which is the volume of plasma cleared of the drug per unit time. Genotyping for polymorphisms of UGT1A1 were performed on infants who were eligible for PK sampling and were consented by their mothers/guardians (i.e. genotyping was optional) . (NCT01780831)
Timeframe: Cohort 1 Dose #1 Intensive PK sampling: within 30 min pre-dose; and 1-2, 4-8, 12, 24 hours post-dose. Samples for UGT1A1 genotype testing were collected at study entry.

Cohort 2 Initial Dose Neonatal RAL Elimination (CL/F) by UGT1A1 Genotype Group

Cohort 2 initial dose neonatal RAL elimination was represented by Clearance (CL/F), which is defined as the volume of plasma cleared of the drug per unit time. Genotyping for polymorphisms of UGT1A1 were performed on infants who were eligible for PK sampling and were consented by their mothers/guardians (i.e. genotyping was optional) . (NCT01780831)
Timeframe: Intensive PK sampling for Cohort 2 initial dose: within 1 hour pre-dose; and 1-2, 6-10, 20-24 hours post-dose. Samples for UGT1A1 genotype testing were collected at study entry.

Cohort 2 Neonatal RAL Elimination (CL/F) at 15-18 Days of Life by UGT1A1 Genotype Group

Cohort 2 15-18 days of life dose neonatal RAL elimination was represented by Clearance (CL/F), which is defined as the volume of plasma cleared of the drug per unit time at 15-18 days of life when RAL dosing would have been 3 mg/kg twice daily. Genotyping for polymorphisms of UGT1A1 were performed on infants who were eligible for PK sampling and were consented by their mothers/guardians(i.e. genotyping was optional) . (NCT01780831)
Timeframe: Intensive PK sampling for Cohort 2 at 15-18 days of life: within 1 hour pre-dose; and 1-2 hours post-dose, 4-6, 8-12 hours post-dose. Samples for UGT1A1 genotype testing were collected at study entry.

Number of Infants Who Died or Had Grade 3/4 Adverse Event Through 24 Weeks of Life

Number of infants who died or had adverse events (AEs) of Grade 3 or 4 as defined in DAIDS AE Grading Table. Events with onset dates prior to first RAL dosing and congenital anomalies assessed as baseline by the study team were considered baseline events and not AEs. (NCT01780831)
Timeframe: From first RAL dose through 24 weeks of life

Number of Infants Who Died or Had Grade 3/4 Adverse Event Through 6 Weeks of Life

Number of Infants Who Died or Had SADR of Grade 3 or 4 Through 24 Weeks of Life

"Number of infants who died or had Suspected Adverse Drug Reaction (SADR) of Grade 3 or 4 as defined in DAIDS AE Grading Table.~Events with onset dates prior to the first RAL dosing and congenital anomalies assessed as baseline by the study team were considered baseline events and not AEs. SADRs are AEs assessed as definitely related, probably related or possibly related to RAL." (NCT01780831)
Timeframe: From first RAL dose through 24 weeks of life

Number of Infants Who Died or Had SADR of Grade 3 or 4 Through 6 Weeks of Life

RAL AUC12 for Cohort 2 at 15-18 Days of Life

Area Under the Concentration-time Curve at 12-hour interval (AUC12) of RAL for Cohort 2 at 15-18 days of life. (NCT01780831)
Timeframe: Intensive PK sampling for Cohort 2 at 15-18 days of life: within 1 hour pre-dose; and 1-2, 4-6, 8-12 hours post-dose.

RAL C12 for Cohort 2 at 15-18 Days of Life

RAL concentration at 12 hours (C12) for Cohort 2 at 15-18 days of life. (NCT01780831)
Timeframe: Intensive PK sampling for Cohort 2 at 15-18 days of life: within 1 hour pre-dose; and 1-2, 4-6, 8-12 hours post-dose.

Number of Participants Who Discontinued Study Treatment Prematurely

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

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

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

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

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

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

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

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

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.

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.

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.

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

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.

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.

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.

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

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.

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.

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.

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

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.

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.

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.

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.

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

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

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

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

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.

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.

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.

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.

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.

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.

Intervention	Proportional probability (Number)
	Overall survival, period 2 group	HIV-free survival, period 2 group
Antepartum Arm C	0.942	0.921

Intervention	Proportional probability (Number)
	Overall survival, Periods 1 & 2 group (arms A & B only)	Overall survival, period 2 group	HIV-free survival, Periods 1&2 group (arms A&B only)	HIV-free survival, period 2 group
Antepartum Arm A	0.959	0.951	0.937	0.936
Antepartum Arm B	0.967	0.982	0.947	0.940

Intervention	Probability (Number)
	12 months post delivery	24 months post delivery
Postpartum Arm A (Maternal Prophylaxis)	0.988	0.978
Postpartum Arm B (Infant Prophylaxis)	0.989	0.987

Intervention	Participants (Count of Participants)			Participants (Count of Participants)
	Periods 1 and 272329519		Periods 1 and 272329520	Period 272329520	Period 272329519	Period 272329521
	HIV RNA < 400 copies/mL	HIV RNA >= 400 copies/mL
Antepartum Arm A	415
Antepartum Arm B	1092
Antepartum Arm A	929
Antepartum Arm B	275
Antepartum Arm A	102
Antepartum Arm B	259
Antepartum Arm C	225
Antepartum Arm A	210
Antepartum Arm B	62
Antepartum Arm C	79

Intervention	Participants (Count of Participants)
	Week 6 visit72329524				Week 6 visit72329525	Week 14 visit72329524	Week 14 visit72329525	Week 26 visit72329524	Week 26 visit72329525	Week 50 visit72329524	Week 50 visit72329525	Week 74 visit72329524	Week 74 visit72329525
	Missed dose over 1 month ago	Never missed a dose	Missed dose 2-4 weeks ago	Missed dose within last 2 weeks
Postpartum Arm A (Maternal Prophylaxis)	1003
Postpartum Arm B (Infant Prophylaxis)	1104
Postpartum Arm A (Maternal Prophylaxis)	12
Postpartum Arm A (Maternal Prophylaxis)	17
Postpartum Arm B (Infant Prophylaxis)	4
Postpartum Arm A (Maternal Prophylaxis)	140
Postpartum Arm B (Infant Prophylaxis)	74
Postpartum Arm A (Maternal Prophylaxis)	956
Postpartum Arm B (Infant Prophylaxis)	1081
Postpartum Arm A (Maternal Prophylaxis)	20
Postpartum Arm B (Infant Prophylaxis)	0
Postpartum Arm A (Maternal Prophylaxis)	35
Postpartum Arm A (Maternal Prophylaxis)	112
Postpartum Arm B (Infant Prophylaxis)	50
Postpartum Arm A (Maternal Prophylaxis)	888
Postpartum Arm B (Infant Prophylaxis)	1035
Postpartum Arm A (Maternal Prophylaxis)	48
Postpartum Arm A (Maternal Prophylaxis)	31
Postpartum Arm B (Infant Prophylaxis)	8
Postpartum Arm A (Maternal Prophylaxis)	103
Postpartum Arm B (Infant Prophylaxis)	47
Postpartum Arm A (Maternal Prophylaxis)	716
Postpartum Arm B (Infant Prophylaxis)	841
Postpartum Arm A (Maternal Prophylaxis)	37
Postpartum Arm A (Maternal Prophylaxis)	34
Postpartum Arm B (Infant Prophylaxis)	7
Postpartum Arm A (Maternal Prophylaxis)	64
Postpartum Arm B (Infant Prophylaxis)	30
Postpartum Arm A (Maternal Prophylaxis)	311
Postpartum Arm B (Infant Prophylaxis)	377
Postpartum Arm A (Maternal Prophylaxis)	15
Postpartum Arm B (Infant Prophylaxis)	2
Postpartum Arm B (Infant Prophylaxis)	1
Postpartum Arm B (Infant Prophylaxis)	9

Intervention	cells/mm^3 (Median)
	Week 48 CD4 count change from randomization	Week 96 CD4 count change from randomization
NoNVP/LPV_r	172	256
NoNVP/NVP	172	223
NVP/LPV_r	201	278
NVP/NVP	191	291

Intervention	Percent of participants (Number)
	week 48 percent of virologic failure or death	week 96 percent of virologic failure or death
NoNVP/LPV_r	14	20
NoNVP/NVP	14	17
NVP/LPV_r	4	12
NVP/NVP	23	31

Intervention	percent of participants (Number)
	week 48 percent of full adherence in past month	week 96 percent of full adherence in past month
NoNVP/LPV_r	86	87
NoNVP/NVP	90	93
NVP/LPV_r	88	95
NVP/NVP	89	94

Intervention	weeks (Number)
	5th percentile	10th percentile	25th percentile
NVP/LPV_r	60	84	NA
NVP/NVP	12	12	60

Intervention	Percent of CD4 (Mean)
Coh I: NVP	13.9
Coh I: LPV/r	12.0
Coh II: NVP	15.2
Coh II: LPV/r	14.3

Intervention	Percent of participants (Number)
Coh I: NVP	27.4
Coh I: LPV/r	10.4
Coh II: NVP	28.6
Coh II: LPV/r	12.9

Intervention	Percent of participants (Number)
Coh I: NVP	39.6
Coh I: LPV/r	21.7
Coh II: NVP	40.8
Coh II: LPV/r	19.3

Intervention	ng*h/mL (Geometric Mean)
Cohort I: Treatment Experienced, 2 to 6 Years of Age	5512.85
Cohort II: Treatment Experienced, 1 to 2 Years of Age	4821.76

Intervention	Participants (Count of Participants)
	Week 1272045667		Week 1272045668	Week 2472045667	Week 2472045668	Week 4872045667	Week 4872045668
	>5% decline in CD4 % from baseline	Increase or <5% decline in CD4 % from baseline
Cohort I: Treatment Experienced, 2 to 6 Years of Age	1
Cohort II: Treatment Experienced, 1 to 2 Years of Age	2
Cohort I: Treatment Experienced, 2 to 6 Years of Age	10
Cohort II: Treatment Experienced, 1 to 2 Years of Age	1
Cohort II: Treatment Experienced, 1 to 2 Years of Age	3
Cohort I: Treatment Experienced, 2 to 6 Years of Age	2
Cohort I: Treatment Experienced, 2 to 6 Years of Age	9

Intervention	log10 copies/mL (Median)
Arm A : LPV/r x 7d	4.3
Arm B : no LPV/r	3.9
Arm C: LPV/r x 30d	4.0

Intervention	percent of participants (Number)
Arm A : LPV/r x 7d	3.6
Arm B : no LPV/r	7.1
Arm C : LPV/r x 30d	5.3

Intervention	percent of participants (Number)
Arm A: LPV/r x 7d	4.9
Arm B: no LPV/r	9.5
Arm C : LPV/r x 30d	7.0

Intervention	percent of participants (Number)
Arm A : LPV/r x 7d	7.1
Arm B : no LPV/r	12.5
Arm C: LPV/r x 30d	5.3

Intervention	participants (Number)
	OLA in plasma samples	OLA in PBMC
Arm A : LPV/r x 7d	0	0
Arm B : no LPV/r	0	0
Arm C: LPV/r x 30d	0	1

Intervention	percent of participants (Number)
	The proportion of women with new ZDV resistance	The proportion of women with new ddI resistance	The proportion of women with new LPV/r resistance
Arm A : LPV/r x 7d	0	0	0
Arm B : no LPV/r	1.78	0	0
Arm C: LPV/r x 30d	0	0	0

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

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

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

Intervention	ug*h/mL (Median)
	(NFV-AUC-12h) 4-7 day	(NFV-AUC-12h) 10-14 day	(3TC-AUC-12 h) 4-7 day	(3TC-AUC-12h) 10-14 day
ARM C (ZDV + 3TC/NFV)	20.7	25.5	4.0	7.9

Intervention	ng/mL (Median)
	NVP conc prior to 3rd dose	NVP peak conc (Cmax) post 3rd dose	NVP conc 3-5 day post 3rd dose	NVP conc 7 day post 3rd dose
ARM B (ZDV + NVP)	362	2286	459	76

Intervention	participants (Number)
	Treatment Arm C (ZDV+3TC/NFV)	Treatment Arm B (ZDV+NFV)	Treatment Arm A (ZDV only)	Illegal Substance Abuse during pregnancy
Infected	12	11	24	7
Uninfected	516	523	505	130

Intervention	mg*h/L (Geometric Mean)
Cohort 1 RAL-naive: 3 mg/kg for First Dose	53.88
Cohort 1 RAL-naive: 2 mg/kg for First Dose	44.26
Cohort 1 RAL-exposed 1.5 mg/kg	37.42

Intervention	mg*h/L (Geometric Mean)
Cohort 2 RAL-naive: 1.5 mg/kg Once Daily on Days 1-7 of Life	38.2
Cohort 2 RAL-exposed: 1.5mg/kg Once Daily on Days 1-7 of Life	42.89

Intervention	ng/mL (Geometric Mean)
Cohort 2 RAL-naive: 1.5 mg/kg Once Daily on Days 1-7 of Life	947.90
Cohort 2 RAL-exposed: 1.5 mg/kg Once Daily on Days 1-7 of Life	946.24

Intervention	ng/mL (Geometric Mean)
Cohort 1 RAL-naive: 3 mg/kg for First Dose	3360.89
Cohort 1 RAL-naive: 2 mg/kg for First Dose	3405.24
Cohort 1 RAL-exposed: 1.5 mg/kg for First Dose	2188.82

Intervention	Participants (Count of Participants)
Cohort 1 RAL-naive	2
Cohort 1 RAL-exposed	2
Cohort 1 Total	4
Cohort 2 RAL-naive	11
Cohort 2 RAL-exposed	4
Cohort 2 Total	15