adenine and Complications, Infectious Pregnancy
adenine has been researched along with Complications, Infectious Pregnancy in 62 studies
Research Excerpts
| Excerpt | Relevance | Reference |
|---|---|---|
| "When started in pregnancy, dolutegravir-containing regimens had superior virological efficacy at delivery compared with the efavirenz, emtricitabine, and tenofovir disoproxil fumarate regimen." | 9.41 | Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2 ( Amico, KR; Brummel, SS; Cassim, H; Chakhtoura, N; Chinula, L; Coletti, A; Currier, J; Fairlie, L; Frenkel, LM; Hanley, S; Hoffman, RM; Holmes, LB; Jean-Philippe, P; João, E; Johnston, B; Korutaro, V; Krotje, C; Lockman, S; Masheto, G; McCarthy, K; Mmbaga, BT; Momper, JD; Moyo, S; Purdue, L; Rooney, JF; Sax, PE; Shapiro, RL; Stranix-Chibanda, L; Stringer, JS; Thoofer, NK; Ziemba, L, 2021) |
| "Atazanavir exposure is reduced by pregnancy and by concomitant tenofovir use." | 9.15 | Atazanavir pharmacokinetics with and without tenofovir during pregnancy. ( Basar, M; Best, BM; Burchett, SK; Capparelli, EV; Hawkins, E; Hu, C; Mirochnick, M; Read, JS; Rossi, SS; Smith, E; Stek, AM, 2011) |
| "Tenofovir disoproxil fumarate (TDF) safety during pregnancy has important public health implications." | 8.89 | Safety of tenofovir during pregnancy for the mother and fetus: a systematic review. ( Bulterys, M; Ellington, S; Kourtis, AP; Legardy-Williams, J; Wang, L, 2013) |
| "We reviewed the published literature by conducting database searches of in vitro, animal and clinical studies, reported in journals and at conferences, using the search terms Tenofovir/gs4331/viread, pregnant/pregnancy, lactate, lactation, natal, reproduce/reproduction, placenta/placental, malformation, and teratogenicity/teratogenic." | 8.85 | 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) |
| " These pregnant females developed lamivudine (LAM)- or telbivudine (LdT)-resistant chronic hepatitis B and received tenofovir (TDF) therapy (300 mg/d), and its curative effect, maternal and perinatal adverse events, fetal growth and development, and neonatal prognosis were evaluated." | 7.81 | Tenofovir rescue therapy in pregnant females with chronic hepatitis B. ( Cai, HD; Cao, YJ; Hu, YH; Liu, M; Yi, W, 2015) |
| "To determine whether maternal use of tenofovir disoproxil fumarate for treatment of HIV in pregnancy predicts fetal and infant growth." | 7.79 | Infant growth outcomes after maternal tenofovir disoproxil fumarate use during pregnancy. ( Huo, Y; Livingston, EG; Patel, K; Ransom, CE; Scott, GB; Siberry, GK; Watts, HD; Williams, P, 2013) |
| "To evaluate the effects of tenofovir disoproxil fumarate (TDF) use during late pregnancy to reduce hepatitis B virus (HBV) transmission in highly viremic mothers." | 7.79 | Efficacy and safety of tenofovir disoproxil fumarate in pregnancy for the prevention of vertical transmission of HBV infection. ( Ay, M; Ayaz, C; Barcin, T; Celen, MK; Dal, MS; Dal, T; Gulsun, S; Kalkanli, S; Kaya, S; Mert, D; Yildirim, N, 2013) |
| "Tenofovir may be associated with a lower hazard or rate of pregnancy in women receiving HAART." | 7.78 | Tenofovir use and pregnancy among women initiating HAART. ( Firnhaber, C; Maskew, M; Sanne, I; Westreich, D, 2012) |
| "To evaluate the association of tenofovir disoproxil fumarate (TDF) use during pregnancy with early growth parameters in HIV-exposed, uninfected (HEU) infants." | 7.78 | Safety of tenofovir use during pregnancy: early growth outcomes in HIV-exposed uninfected infants. ( DiMeglio, LA; Griner, R; Hazra, R; Jacobson, DL; Kacanek, D; Mendez, H; Miller, T; Mofenson, LM; Rich, KC; Seage, GR; Siberry, GK; Tassiopoulos, K; Watts, DH; Williams, PL, 2012) |
| "According to the European AIDS Clinical Society, tenofovir disoproxil fumarate can be used in HIV-infected pregnant women if started prior to pregnancy, although no data are available on the pharmacokinetics of tenofovir (TFV) during pregnancy." | 7.78 | Pregnancy-related effects on tenofovir pharmacokinetics: a population study with 186 women. ( Benaboud, S; Bouazza, N; Chappuy, H; Firtion, G; Foissac, F; Hirt, D; Launay, O; Pannier, E; Rey, E; Tréluyer, JM; Urien, S, 2012) |
| "International Maternal Pediatric Adolescent AIDS Clinical Trials Group 1026s is a prospective, nonblinded, pharmacokinetic study of HIV-infected pregnant women taking antiretrovirals for clinical indications, including 2 cohorts (with or without tenofovir) receiving atazanavir/ritonavir 300/100 mg once daily during the second trimester, 400/100 mg during the third trimester, and 300/100 mg postpartum (PP)." | 6.78 | Pharmacokinetics of an increased atazanavir dose with and without tenofovir during the third trimester of pregnancy. ( Best, BM; Burchett, SK; Byroads, M; Caparelli, E; Cressey, TR; Hawkins, E; Kreitchmann, R; Mirochnick, M; Rossi, S; Shapiro, DE; Smith, E; Stek, A; Wang, J; Watts, DH, 2013) |
| "During follow-up, no bone fractures were reported to have occurred; 12/368 creatinines and seven out of 305 phosphates were grade one (16) or two (three) in 14 children with no effect of in utero tenofovir (p>0." | 6.77 | Pregnancy and infant outcomes among HIV-infected women taking long-term ART with and without tenofovir in the DART trial. ( Chidziva, E; Gibb, DM; Gilks, CF; Grosskurth, H; Hakim, J; Kizito, H; Kyomugisha, H; Munderi, P; Musoke, P; Nalumenya, R; Nathoo, K; Russell, EC; Spyer, M; Tumukunde, D; Walker, AS; Zalwango, E, 2012) |
| "When started in pregnancy, dolutegravir-containing regimens had superior virological efficacy at delivery compared with the efavirenz, emtricitabine, and tenofovir disoproxil fumarate regimen." | 5.41 | Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2 ( Amico, KR; Brummel, SS; Cassim, H; Chakhtoura, N; Chinula, L; Coletti, A; Currier, J; Fairlie, L; Frenkel, LM; Hanley, S; Hoffman, RM; Holmes, LB; Jean-Philippe, P; João, E; Johnston, B; Korutaro, V; Krotje, C; Lockman, S; Masheto, G; McCarthy, K; Mmbaga, BT; Momper, JD; Moyo, S; Purdue, L; Rooney, JF; Sax, PE; Shapiro, RL; Stranix-Chibanda, L; Stringer, JS; Thoofer, NK; Ziemba, L, 2021) |
| " The likelihood of renal toxicity (proximal renal tubular dysfunction [PRTD]) correlated with plasma drug concentrations, which depended on the dosage regimen and age-related changes in drug clearance." | 5.35 | Chronic administration of tenofovir to rhesus macaques from infancy through adulthood and pregnancy: summary of pharmacokinetics and biological and virological effects. ( Abel, K; Bischofberger, N; Brignolo, LL; Cihlar, T; Durand-Gasselin, L; Jerome, C; Kearney, BP; Marthas, ML; Moore, J; Ray, AS; Reiser, H; Spinner, A; Van Rompay, KK, 2008) |
| "Atazanavir exposure is reduced by pregnancy and by concomitant tenofovir use." | 5.15 | Atazanavir pharmacokinetics with and without tenofovir during pregnancy. ( Basar, M; Best, BM; Burchett, SK; Capparelli, EV; Hawkins, E; Hu, C; Mirochnick, M; Read, JS; Rossi, SS; Smith, E; Stek, AM, 2011) |
| "Tenofovir disoproxil fumarate (TDF) safety during pregnancy has important public health implications." | 4.89 | Safety of tenofovir during pregnancy for the mother and fetus: a systematic review. ( Bulterys, M; Ellington, S; Kourtis, AP; Legardy-Williams, J; Wang, L, 2013) |
| "We reviewed the published literature by conducting database searches of in vitro, animal and clinical studies, reported in journals and at conferences, using the search terms Tenofovir/gs4331/viread, pregnant/pregnancy, lactate, lactation, natal, reproduce/reproduction, placenta/placental, malformation, and teratogenicity/teratogenic." | 4.85 | 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) |
| "Tenofovir alafenamide (TAF) is a key component of HIV treatment, but pharmacokinetic data supporting the use of TAF during pregnancy are limited." | 4.12 | Pharmacokinetics of Tenofovir Alafenamide With Boosted Protease Inhibitors in Pregnant and Postpartum Women Living With HIV: Results From IMPAACT P1026s. ( Barr, E; Best, BM; Brooks, KM; Browning, R; Capparelli, EV; Chakhtoura, N; Deville, JG; Febo, IL; George, K; Knowles, K; Mirochnick, M; Paul, ME; Pinilla, M; Rungruengthanakit, K; Shapiro, DE; Stek, AM, 2022) |
| "To observe the clinical efficacy of combination therapy with peg-IFNalpha and adefovir (CPIA) in women who were hepatfis B virus (HBV) carriers and had just given birth and received telbivudine (LdT) during pregnancy for prevention of mother-to-child transmission." | 3.81 | [Efficacy of combination antiviral therapy following childbirth in pregnant HBV carriers receiving telbivudine for prevention of mother-to-child transmission]. ( Cao, ZH; Chen, XY; He, ZM; Jin, Y; Liu, YL; Lu, JF; Ma, LN; Zhang, SB, 2015) |
| " These pregnant females developed lamivudine (LAM)- or telbivudine (LdT)-resistant chronic hepatitis B and received tenofovir (TDF) therapy (300 mg/d), and its curative effect, maternal and perinatal adverse events, fetal growth and development, and neonatal prognosis were evaluated." | 3.81 | Tenofovir rescue therapy in pregnant females with chronic hepatitis B. ( Cai, HD; Cao, YJ; Hu, YH; Liu, M; Yi, W, 2015) |
| "To evaluate the effects of tenofovir disoproxil fumarate (TDF) use during late pregnancy to reduce hepatitis B virus (HBV) transmission in highly viremic mothers." | 3.79 | Efficacy and safety of tenofovir disoproxil fumarate in pregnancy for the prevention of vertical transmission of HBV infection. ( Ay, M; Ayaz, C; Barcin, T; Celen, MK; Dal, MS; Dal, T; Gulsun, S; Kalkanli, S; Kaya, S; Mert, D; Yildirim, N, 2013) |
| "To determine whether maternal use of tenofovir disoproxil fumarate for treatment of HIV in pregnancy predicts fetal and infant growth." | 3.79 | Infant growth outcomes after maternal tenofovir disoproxil fumarate use during pregnancy. ( Huo, Y; Livingston, EG; Patel, K; Ransom, CE; Scott, GB; Siberry, GK; Watts, HD; Williams, P, 2013) |
| "Emerging international guidelines for the prevention of mother-to-child transmission of HIV infection across sub-Saharan Africa call for the initiation of a triple-drug antiretroviral regimen containing tenofovir, a potentially nephrotoxic agent, in all HIV-infected pregnant women at the first antenatal clinic visit." | 3.79 | Low prevalence of renal dysfunction in HIV-infected pregnant women: implications for guidelines for the prevention of mother-to-child transmission of HIV. ( Bekker, LG; Kamkuemah, M; Kaplan, R; Myer, L, 2013) |
| "According to the European AIDS Clinical Society, tenofovir disoproxil fumarate can be used in HIV-infected pregnant women if started prior to pregnancy, although no data are available on the pharmacokinetics of tenofovir (TFV) during pregnancy." | 3.78 | Pregnancy-related effects on tenofovir pharmacokinetics: a population study with 186 women. ( Benaboud, S; Bouazza, N; Chappuy, H; Firtion, G; Foissac, F; Hirt, D; Launay, O; Pannier, E; Rey, E; Tréluyer, JM; Urien, S, 2012) |
| "To evaluate the association of tenofovir disoproxil fumarate (TDF) use during pregnancy with early growth parameters in HIV-exposed, uninfected (HEU) infants." | 3.78 | Safety of tenofovir use during pregnancy: early growth outcomes in HIV-exposed uninfected infants. ( DiMeglio, LA; Griner, R; Hazra, R; Jacobson, DL; Kacanek, D; Mendez, H; Miller, T; Mofenson, LM; Rich, KC; Seage, GR; Siberry, GK; Tassiopoulos, K; Watts, DH; Williams, PL, 2012) |
| "Tenofovir may be associated with a lower hazard or rate of pregnancy in women receiving HAART." | 3.78 | Tenofovir use and pregnancy among women initiating HAART. ( Firnhaber, C; Maskew, M; Sanne, I; Westreich, D, 2012) |
| "A TDF dosing regimen of 600 mg during labor and daily infant doses of 6 mg/kg maintains infant tenofovir plasma concentration above 50 ng/mL throughout the first week of life and should be used in the studies of TDF efficacy for HIV prevention of mother-to-child transmission and early infant treatment." | 2.79 | Pharmacokinetics and safety of tenofovir in HIV-infected women during labor and their infants during the first week of life. ( Emel, L; Eshleman, SH; Fowler, MG; George, K; Herron, C; Hudelson, SE; Joao, E; Kearney, B; Kreitchmann, R; Kumwenda, N; Mirochnick, M; Mofenson, L; Nielsen-Saines, K; Parsons, T; Pinto, J; Richardson, P; Santos, B; Sato, P; Taha, T, 2014) |
| "Although pharmacokinetic exposure of the NRTIs TDF and FTC during pregnancy is approximately 25% lower, this was not associated with virological failure in this study and did not result in mother-to-child transmission." | 2.78 | The pharmacokinetics, safety and efficacy of tenofovir and emtricitabine in HIV-1-infected pregnant women. ( Burger, DM; Colbers, AP; Giaquinto, C; Gingelmaier, A; Hawkins, DA; Ivanovic, J; Kabeya, K; Moltó, J; Rockstroh, JK; Sadiq, ST; Taylor, GP; Weizsäcker, K; Wyen, C, 2013) |
| "International Maternal Pediatric Adolescent AIDS Clinical Trials Group 1026s is a prospective, nonblinded, pharmacokinetic study of HIV-infected pregnant women taking antiretrovirals for clinical indications, including 2 cohorts (with or without tenofovir) receiving atazanavir/ritonavir 300/100 mg once daily during the second trimester, 400/100 mg during the third trimester, and 300/100 mg postpartum (PP)." | 2.78 | Pharmacokinetics of an increased atazanavir dose with and without tenofovir during the third trimester of pregnancy. ( Best, BM; Burchett, SK; Byroads, M; Caparelli, E; Cressey, TR; Hawkins, E; Kreitchmann, R; Mirochnick, M; Rossi, S; Shapiro, DE; Smith, E; Stek, A; Wang, J; Watts, DH, 2013) |
| "During follow-up, no bone fractures were reported to have occurred; 12/368 creatinines and seven out of 305 phosphates were grade one (16) or two (three) in 14 children with no effect of in utero tenofovir (p>0." | 2.77 | Pregnancy and infant outcomes among HIV-infected women taking long-term ART with and without tenofovir in the DART trial. ( Chidziva, E; Gibb, DM; Gilks, CF; Grosskurth, H; Hakim, J; Kizito, H; Kyomugisha, H; Munderi, P; Musoke, P; Nalumenya, R; Nathoo, K; Russell, EC; Spyer, M; Tumukunde, D; Walker, AS; Zalwango, E, 2012) |
| " All regimens were safe and well tolerated." | 2.76 | Pharmacokinetics and safety of single-dose tenofovir disoproxil fumarate and emtricitabine in HIV-1-infected pregnant women and their infants. ( Bardeguez, A; Cotter, A; Fiscus, SA; Flynn, PM; Heckman, B; Huang, S; Jean-Philippe, P; Kearney, B; Mirochnick, M; Mofenson, LM; Purswani, M; Robbins, B; Rodman, J; Rooney, JF; Shapiro, DE; Thorpe, E; Van Rompay, KK; Watts, DH, 2011) |
| "Should treatment of chronic hepatitis B virus infection be necessary during pregnancy, tenofovir, listed by the FDA as pregnancy category B drug, is to be preferred." | 2.49 | [Interdisciplinary aspects of and new drugs for chronic hepatitis B]. ( Horváth, G, 2013) |
| "Specialized treatment of CHB in pregnancy, coinfection, decompensated cirrhosis, and posttransplant is safe and effective." | 2.48 | New advances in chronic hepatitis B. ( Lee, WM; Tujios, SR, 2012) |
| " More comprehensive in vivo pharmacokinetic data are required to justify the potential use of these agents as safe and effective options during pregnancy." | 2.47 | Pharmacokinetics of antiretroviral drugs in anatomical sanctuary sites: the fetal compartment (placenta and amniotic fluid). ( Back, DJ; Else, LJ; Khoo, SH; Taylor, S, 2011) |
| " Secondary assessments included maternal HBV DNA reduction at delivery, and maternal or infant adverse events during follow up." | 1.56 | Efficacy and safety of tenofovir alafenamide fumarate for preventing mother-to-child transmission of hepatitis B virus: a national cohort study. ( Cao, L; Chen, B; Chen, R; Ding, Y; Fan, J; Gan, W; Huang, Y; Lin, C; Liu, Y; Pan, CQ; Sheng, Q; Wang, S; Wang, Y; Zhu, L, 2020) |
| "Pregnancy is a time of increased HIV acquisition risk and pregnancy reduces concentrations of antiretrovirals used for treatment." | 1.48 | Tenofovir and tenofovir-diphosphate concentrations during pregnancy among HIV-uninfected women using oral preexposure prophylaxis. ( Anderson, PL; Asiimwe, S; Baeten, JM; Bukusi, EA; Celum, C; Donnell, D; Haberer, JE; Heffron, R; Hendrix, CW; Katabira, E; Marzinke, MA; Mugo, NR; Mugwanya, K; Pyra, M; Thomas, KK, 2018) |
| "No increased risk of major birth defects including in non-live births was observed for pregnant women exposed to antivirals relevant to CHB treatment overall or to LAM or TDF compared to population-based controls." | 1.38 | Hepatitis B virus and human immunodeficiency virus drugs in pregnancy: findings from the Antiretroviral Pregnancy Registry. ( Aguilar, C; Brown, RS; Buti, M; Fagan, EA; Leu, CS; Pereira, MR; Tilson, HH; Verna, EC, 2012) |
| "New insights into the treatment of chronic hepatitis B with relevance for clinical practice have been adopted in these concise, revised guidelines." | 1.38 | The 2012 revised Dutch national guidelines for the treatment of chronic hepatitis B virus infection. ( Baak, BC; Bakker, CM; Beuers, UH; Brouwer, JT; Buster, EH; Drenth, JP; Honkoop, P; Janssen, HL; Kerbert-Dreteler, MJ; Koek, GH; Tan, AC; van der Spek, BW; van Erpecum, KJ; van Hoek, B; van Nieuwkerk, KM; van Soest, H; Vrolijk, JM, 2012) |
| "6-h half-life (30%)." | 1.35 | Population pharmacokinetics of emtricitabine in human immunodeficiency virus type 1-infected pregnant women and their neonates. ( Arrivé, E; Avit, D; Blanche, S; Coffié, P; Dabis, F; Ekouévi, DK; Hirt, D; Lalsab, S; Leang, SK; McIntyre, J; Nerrienet, E; Rey, E; Tréluyer, JM; Urien, S, 2009) |
| " The likelihood of renal toxicity (proximal renal tubular dysfunction [PRTD]) correlated with plasma drug concentrations, which depended on the dosage regimen and age-related changes in drug clearance." | 1.35 | Chronic administration of tenofovir to rhesus macaques from infancy through adulthood and pregnancy: summary of pharmacokinetics and biological and virological effects. ( Abel, K; Bischofberger, N; Brignolo, LL; Cihlar, T; Durand-Gasselin, L; Jerome, C; Kearney, BP; Marthas, ML; Moore, J; Ray, AS; Reiser, H; Spinner, A; Van Rompay, KK, 2008) |
Research
Studies (62)
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 2 (3.23) | 18.7374 |
| 1990's | 1 (1.61) | 18.2507 |
| 2000's | 8 (12.90) | 29.6817 |
| 2010's | 46 (74.19) | 24.3611 |
| 2020's | 5 (8.06) | 2.80 |
Authors
| Authors | Studies |
|---|---|
| Brooks, KM | 2 |
| Pinilla, M | 1 |
| Stek, AM | 2 |
| Shapiro, DE | 3 |
| Barr, E | 1 |
| Febo, IL | 1 |
| Paul, ME | 1 |
| Deville, JG | 1 |
| George, K | 2 |
| Knowles, K | 1 |
| Rungruengthanakit, K | 1 |
| Browning, R | 1 |
| Chakhtoura, N | 2 |
| Capparelli, EV | 2 |
| Mirochnick, M | 6 |
| Best, BM | 3 |
| Eke, AC | 1 |
| Gebreyohannes, RD | 1 |
| Sheffield, JS | 1 |
| Dooley, KE | 1 |
| Hui, PW | 1 |
| Ng, C | 1 |
| Cheung, KW | 1 |
| Lai, CL | 1 |
| Ding, Y | 1 |
| Cao, L | 1 |
| Zhu, L | 1 |
| Huang, Y | 1 |
| Lin, C | 1 |
| Wang, Y | 1 |
| Liu, Y | 1 |
| Sheng, Q | 1 |
| Wang, S | 1 |
| Fan, J | 1 |
| Chen, R | 1 |
| Gan, W | 1 |
| Chen, B | 1 |
| Pan, CQ | 1 |
| Lockman, S | 2 |
| Brummel, SS | 1 |
| Ziemba, L | 1 |
| Stranix-Chibanda, L | 1 |
| McCarthy, K | 1 |
| Coletti, A | 1 |
| Jean-Philippe, P | 2 |
| Johnston, B | 1 |
| Krotje, C | 1 |
| Fairlie, L | 2 |
| Hoffman, RM | 1 |
| Sax, PE | 1 |
| Moyo, S | 1 |
| Stringer, JS | 3 |
| Masheto, G | 1 |
| Korutaro, V | 1 |
| Cassim, H | 1 |
| Mmbaga, BT | 1 |
| João, E | 2 |
| Hanley, S | 1 |
| Purdue, L | 1 |
| Holmes, LB | 1 |
| Momper, JD | 1 |
| Shapiro, RL | 1 |
| Thoofer, NK | 1 |
| Rooney, JF | 2 |
| Frenkel, LM | 2 |
| Amico, KR | 1 |
| Chinula, L | 1 |
| Currier, J | 1 |
| Pyra, M | 1 |
| Anderson, PL | 1 |
| Hendrix, CW | 2 |
| Heffron, R | 2 |
| Mugwanya, K | 1 |
| Haberer, JE | 1 |
| Thomas, KK | 1 |
| Celum, C | 2 |
| Donnell, D | 1 |
| Marzinke, MA | 1 |
| Bukusi, EA | 1 |
| Mugo, NR | 2 |
| Asiimwe, S | 1 |
| Katabira, E | 1 |
| Baeten, JM | 2 |
| Venter, WDF | 1 |
| Moorhouse, M | 1 |
| Sokhela, S | 1 |
| Mashabane, N | 1 |
| Masenya, M | 1 |
| Serenata, C | 1 |
| Akpomiemie, G | 1 |
| Qavi, A | 1 |
| Chandiwana, N | 1 |
| Norris, S | 1 |
| Chersich, M | 1 |
| Clayden, P | 1 |
| Abrams, E | 1 |
| Arulappan, N | 1 |
| Vos, A | 1 |
| McCann, K | 1 |
| Simmons, B | 1 |
| Hill, A | 1 |
| Horváth, G | 1 |
| Taha, T | 1 |
| Kreitchmann, R | 2 |
| Nielsen-Saines, K | 1 |
| Kumwenda, N | 1 |
| Pinto, J | 1 |
| Santos, B | 1 |
| Parsons, T | 1 |
| Kearney, B | 2 |
| Emel, L | 1 |
| Herron, C | 1 |
| Richardson, P | 1 |
| Hudelson, SE | 1 |
| Eshleman, SH | 1 |
| Fowler, MG | 1 |
| Sato, P | 1 |
| Mofenson, L | 1 |
| Wang, L | 1 |
| Kourtis, AP | 2 |
| Ellington, S | 1 |
| Legardy-Williams, J | 1 |
| Bulterys, M | 2 |
| Myer, L | 1 |
| Kamkuemah, M | 1 |
| Kaplan, R | 1 |
| Bekker, LG | 1 |
| Ransom, CE | 1 |
| Huo, Y | 1 |
| Patel, K | 1 |
| Scott, GB | 1 |
| Watts, HD | 1 |
| Williams, P | 1 |
| Siberry, GK | 2 |
| Livingston, EG | 1 |
| Celen, MK | 1 |
| Mert, D | 1 |
| Ay, M | 1 |
| Dal, T | 1 |
| Kaya, S | 1 |
| Yildirim, N | 1 |
| Gulsun, S | 1 |
| Barcin, T | 1 |
| Kalkanli, S | 1 |
| Dal, MS | 1 |
| Ayaz, C | 1 |
| Nguyen, V | 2 |
| Tan, PK | 2 |
| Greenup, AJ | 2 |
| Glass, A | 2 |
| Davison, S | 2 |
| Samarasinghe, D | 2 |
| Holdaway, S | 2 |
| Strasser, SI | 1 |
| Chatterjee, U | 2 |
| Jackson, K | 2 |
| Locarnini, SA | 2 |
| Levy, MT | 2 |
| Price, AJ | 1 |
| Kayange, M | 1 |
| Zaba, B | 1 |
| Chimbwandira, FM | 1 |
| Jahn, A | 1 |
| Chirwa, Z | 1 |
| Dasgupta, AN | 1 |
| Katundu, C | 1 |
| Saul, JL | 1 |
| Glynn, JR | 1 |
| Koole, O | 1 |
| Crampin, AC | 1 |
| Gerlich, WH | 1 |
| Matthews, LT | 1 |
| Cohen, CR | 1 |
| Bangsberg, DR | 1 |
| Mistry, N | 1 |
| Sereboe, L | 1 |
| Oakeshott, P | 1 |
| Hu, YH | 1 |
| Liu, M | 1 |
| Yi, W | 1 |
| Cao, YJ | 1 |
| Cai, HD | 1 |
| Chen, HL | 1 |
| Lee, CN | 1 |
| Chang, CH | 1 |
| Ni, YH | 1 |
| Shyu, MK | 1 |
| Chen, SM | 1 |
| Hu, JJ | 1 |
| Lin, HH | 1 |
| Zhao, LL | 1 |
| Mu, SC | 1 |
| Lai, MW | 1 |
| Lee, CL | 1 |
| Lin, HM | 1 |
| Tsai, MS | 1 |
| Hsu, JJ | 1 |
| Chen, DS | 1 |
| Chan, KA | 1 |
| Chang, MH | 1 |
| Lu, JF | 1 |
| Liu, YL | 1 |
| Ma, LN | 1 |
| Cao, ZH | 1 |
| He, ZM | 1 |
| Jin, Y | 1 |
| Zhang, SB | 1 |
| Chen, XY | 1 |
| Chi, BH | 2 |
| Chintu, N | 2 |
| Cantrell, RA | 2 |
| Kankasa, C | 1 |
| Kruse, G | 1 |
| Mbewe, F | 2 |
| Sinkala, M | 2 |
| Smith, PJ | 1 |
| Stringer, EM | 2 |
| Van Rompay, KK | 2 |
| Durand-Gasselin, L | 1 |
| Brignolo, LL | 1 |
| Ray, AS | 1 |
| Abel, K | 1 |
| Cihlar, T | 1 |
| Spinner, A | 1 |
| Jerome, C | 1 |
| Moore, J | 1 |
| Kearney, BP | 1 |
| Marthas, ML | 2 |
| Reiser, H | 1 |
| Bischofberger, N | 2 |
| Hirt, D | 5 |
| Urien, S | 5 |
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Clinical Trials (16)
Trial Overview
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants[NCT03048422] | Phase 3 | 643 participants (Actual) | Interventional | 2018-01-19 | Completed | ||
| Changes in Weight and Body Composition After Switch to Dolutegravir/Lamivudine Compared to Continued Dolutegravir/Abacavir/Lamivudine for Virologically Suppressed HIV Infection: A Randomized Open-label Superiority Trial: AVERTAS-1[NCT04904406] | Phase 4 | 95 participants (Anticipated) | Interventional | 2020-10-22 | Recruiting | ||
| WRHI 060 (ADVANCE): A Randomised, Phase 3 Non-inferiority Study of DTG + TAF + FTC Compared With DTG + TDF + FTC and EFV + TDF + FTC in Patients Infected With HIV-1 Starting First-line Antiretroviral Therapy - Extension to 192 Weeks[NCT03122262] | Phase 3 | 1,110 participants (Actual) | Interventional | 2017-01-16 | Completed | ||
| Can the Weight Gain Associated With Use of Integrase Strand Inhibitors be Halted or Reversed With a Switch to Doravirine/Lamivudine/Tenofovir DF in Patients Living With HIV? (DeLiTE)[NCT04665375] | Phase 4 | 25 participants (Anticipated) | Interventional | 2021-04-26 | Enrolling by invitation | ||
| Prevention of Mother-to-child Transmission of Hepatitis B Virus: a One Arm, Open Label Intervention Study to Estimate the Optimal Timing of Tenofovir (TDF) in Pregnancy[NCT02995005] | Phase 1/Phase 2 | 98 participants (Actual) | Interventional | 2018-05-24 | Completed | ||
| Pilot of an mHealth-enhanced, Safer Conception Intervention to Reduce HIV-1 Risk Among Kenyan HIV-1 Serodiscordant Couples[NCT03030768] | 74 participants (Actual) | Observational | 2016-02-29 | Completed | |||
| Chronic HBV Infection in Pregnant Women Taking TAF to Prevent Mother-to-child Transmission in the Third Trimester: a Multicenter, Prospective Study[NCT04237376] | 600 participants (Anticipated) | Observational | 2019-04-09 | Recruiting | |||
| 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 | ||
| Study of Placental Transfer of Tenofovir and Its Factors of Variability Using the Human Placental Perfusion Model[NCT02020083] | 369 participants (Actual) | Observational | 2013-02-28 | 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 | |||
| Optimal Combination Therapy After Nevirapine Exposure[NCT00089505] | Phase 3 | 745 participants (Actual) | Interventional | 2006-11-30 | Completed | ||
| Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum[NCT00042289] | 1,578 participants (Actual) | Observational | 2003-06-09 | Completed | |||
| Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women[NCT01310023] | 3,400 participants (Anticipated) | Observational | 2007-03-31 | Recruiting | |||
| PC4PrEP: Integrating Pre-Exposure Prophylaxis (PrEP) Into Primary Care[NCT03617874] | 22 participants (Actual) | Interventional | 2020-02-28 | Completed | |||
| Study on Pharmacokinetics of Newly Developed ANtiretroviral Agents in HIV-infected pregNAnt Women (PANNA)[NCT00825929] | 176 participants (Anticipated) | Observational | 2009-02-28 | Recruiting | |||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Trial Outcomes
Change in Maternal Weight Antepartum
Change in maternal antepartum weight per week based on generalized estimating equations (NCT03048422)
Timeframe: Baseline through before delivery (up to one day prior)
| Intervention | kg/week (Mean) |
|---|---|
| Arm 1: Maternal DTG+FTC/TAF | 0.378 |
| Arm 2: Maternal DTG+FTC/TDF | 0.319 |
| Arm 3: Maternal EFV/FTC/TDF | 0.291 |
Change in Maternal Weight Overall
Change in maternal weight per week based on generalized estimating equations (NCT03048422)
Timeframe: Baseline to 50 weeks postpartum
| Intervention | kg/week (Mean) |
|---|---|
| Arm 1: Maternal DTG+FTC/TAF | -0.027 |
| Arm 2: Maternal DTG+FTC/TDF | -0.050 |
| Arm 3: Maternal EFV/FTC/TDF | -0.084 |
Change in Maternal Weight Postpartum
Change in maternal postpartum weight per week based on generalized estimating equations (NCT03048422)
Timeframe: Delivery to 50 weeks postpartum
| Intervention | kg/week (Mean) |
|---|---|
| Arm 1: Maternal DTG+FTC/TAF | 0.014 |
| Arm 2: Maternal DTG+FTC/TDF | -0.008 |
| Arm 3: Maternal EFV/FTC/TDF | -0.032 |
Count of Infants With HIV-1 Antiretroviral Drug Resistance Mutations at the Time of Infant HIV Diagnosis
Count of infants with HIV-1 antiretroviral drug resistance mutations (to any antiretroviral drug) at the time of infant HIV diagnosis, based on laboratory blood test results. (NCT03048422)
Timeframe: From birth through 50 weeks postpartum
| Intervention | Participants (Count of Participants) |
|---|---|
| Arm 1 Infants | 1 |
| Arm 2 Infants | 0 |
| Arm 3 Infants | 1 |
Cumulative Probability of Infant Deaths
The Kaplan-Meier estimate of the cumulative probability of infant deaths from birth through 50 weeks after birth. (NCT03048422)
Timeframe: Birth through 50 weeks after birth
| Intervention | Cumulative probability per 100 persons (Number) |
|---|---|
| Arm 1 Infants | 1.0 |
| Arm 2 Infants | 2.0 |
| Arm 3 Infants | 6.9 |
Cumulative Probability of Infant HIV-infection
The Kaplan-Meier estimate of the cumulative probability of infants acquiring HIV-1 infection from birth through 50 weeks after birth based on nucleic acid test results. (NCT03048422)
Timeframe: Birth through 50 weeks after birth
| Intervention | Cumulative probability per 100 persons (Number) |
|---|---|
| Arm 1 Infants | 0.98 |
| Arm 2 Infants | 0.50 |
| Arm 3 Infants | 0.55 |
Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event
The Kaplan-Meier estimate of the cumulative probability of infants experiencing grade 3 or higher adverse events, including events resulting in death due to any cause. (NCT03048422)
Timeframe: Birth through Week 50 postpartum
| Intervention | Cumulative probability per 100 persons (Number) |
|---|---|
| Arms 1 and 2 Infants | 26.8 |
| Arm 3 Infants | 30.9 |
Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event
The Kaplan-Meier estimate of the cumulative probability of infants experiencing grade 3 or higher adverse events, including events resulting in death due to any cause. (NCT03048422)
Timeframe: From birth through Week 50 postpartum
| Intervention | Cumulative probability per 100 persons (Number) |
|---|---|
| Arm 1 Infants | 25.3 |
| Arm 2 Infants | 28.6 |
| Arm 3 Infants | 30.9 |
Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event
"The Kaplan-Meier estimate of the cumulative probability of women experiencing grade 3 or higher adverse events, including events resulting in death due to any cause.~Time to first maternal grade 3 or higher adverse event was defined as the first grade 3 or higher adverse event that occurred after randomization and before 74 weeks of follow-up. The timeframe of 74 weeks was determined by adding up 56 weeks of postpartum follow-up to the mean duration of antepartum follow-up, which was 18 weeks." (NCT03048422)
Timeframe: From randomization up to 74 weeks
| Intervention | Cumulative probability per 100 persons (Number) |
|---|---|
| Arm 1: Maternal DTG+FTC/TAF | 25.1 |
| Arm 2: Maternal DTG+FTC/TDF | 30.8 |
| Arm 3: Maternal EFV/FTC/TDF | 27.9 |
| Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | 27.9 |
| Arm 3: Maternal EFV/FTC/TDF | 27.9 |
Maternal Change in Creatinine Clearance
Maternal change in creatinine clearance per week based on generalized estimating equations (NCT03048422)
Timeframe: Baseline to 50 weeks postpartum
| Intervention | mL/min (Mean) |
|---|---|
| Arm 1: Maternal DTG+FTC/TAF | -0.980 |
| Arm 2: Maternal DTG+FTC/TDF | -0.887 |
| Arm 3: Maternal EFV/FTC/TDF | -0.935 |
Percentage of Infants Born Small for Gestational Age
Percentage of infants born small for gestational age (<10th percentile adjusted for sex assigned at birth) based on Intergrowth 21st Standards (NCT03048422)
Timeframe: Birth
| Intervention | percentage of participants (Number) |
|---|---|
| Arm 1 Infants | 16.3 |
| Arm 2 Infants | 22.5 |
| Arm 3 Infants | 20.5 |
Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome
Percentage of mother-infant pairs with an adverse pregnancy outcome. Adverse pregnancy outcome includes spontaneous abortion (<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (<37 completed weeks), or small for gestational age (<10th percentile by INTERGROWTH 21st Standards) (NCT03048422)
Timeframe: Delivery
| Intervention | percentage of mother-infant pairs (Number) |
|---|---|
| Arm 1: Maternal DTG+FTC/TAF | 24.1 |
| Arm 2: Maternal DTG+FTC/TDF | 32.9 |
| Arm 3: Maternal EFV/FTC/TDF | 32.7 |
Percentage of Mother-Infant Pairs With an Adverse Pregnancy Outcome
Percentage of mother-infant pairs with an adverse pregnancy outcome. Adverse pregnancy outcome includes spontaneous abortion (<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (<37 completed weeks), or small for gestational age (<10th percentile per INTERGROWTH 21st Standards) (NCT03048422)
Timeframe: Delivery
| Intervention | percentage of mother-infant pairs (Number) |
|---|---|
| Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | 28.4 |
| Arm 3: Maternal EFV/FTC/TDF | 32.7 |
Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome or Major Congenital Anomaly
Percentage of mother-infant pairs with an adverse pregnancy outcome or major congenital anomaly. Adverse pregnancy outcomes include spontaneous abortions (<20 weeks gestation), stillbirths (≥20 weeks gestation), preterm deliveries (<37 weeks gestation), and infants small for gestational age (<10th percentile per INTERGROWTH 21st Standards). Major congenital anomaly was defined consistent with the definition of malformation provided by Holmes and Westgate (i.e., a structural abnormality with surgical, medical, or cosmetic importance) and evaluated by an internal study team blinded to treatment arm. (NCT03048422)
Timeframe: Delivery through 50 weeks postpartum
| Intervention | percentage of mother-infant pairs (Number) |
|---|---|
| Arm 1: Maternal DTG+FTC/TAF | 24.1 |
| Arm 2: Maternal DTG+FTC/TDF | 32.9 |
| Arm 3: Maternal EFV/FTC/TDF | 33.2 |
Percentage of Mother-Infant Pairs With Preterm Deliveries
Percentage of mother-infant pairs with preterm deliveries (<37 weeks gestation) resulting in live born infant (NCT03048422)
Timeframe: Delivery
| Intervention | percentage of participants (Number) |
|---|---|
| Arm 1: Maternal DTG+FTC/TAF | 5.8 |
| Arm 2: Maternal DTG+FTC/TDF | 9.4 |
| Arm 3: Maternal EFV/FTC/TDF | 12.1 |
Percentage of Mothers With HIV-1 ARV Drug Resistance Mutations at the Time of Maternal Virologic Failure
Percentage of mothers with HIV-1 antiretroviral (ARV) drug resistance mutations at the time of maternal virologic failure. Virologic failure was defined as two consecutive plasma HIV-1 RNA viral loads <200 copies/mL on or after 24 weeks on study. Drug resistance mutations were assessed using the Stanford algorithm, and all ARV regimens were assessed for mutations. (NCT03048422)
Timeframe: From 24 weeks after randomization through Week 50 postpartum
| Intervention | percentage of participants (Number) |
|---|---|
| Arm 1: Maternal DTG+FTC/TAF | 0.92 |
| Arm 2: Maternal DTG+FTC/TDF | 1.86 |
| Arm 3: Maternal EFV/FTC/TDF | 6.16 |
Percentage of Mothers With HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum
Percentage of mothers with HIV-1 RNA less than 200 copies/mL at 50 weeks postpartum using real-time test results obtained from site laboratories (NCT03048422)
Timeframe: 50 weeks postpartum
| Intervention | percentage of participants (Number) |
|---|---|
| Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | 96.3 |
| Arm 3: Maternal EFV/FTC/TDF | 96.4 |
Percentage of Mothers With HIV-1 RNA Less Than 50 Copies/mL at Delivery Measured at Central Laboratory
Percentage of mothers with HIV-1 RNA less than 50 copies/mL at delivery using batched test results obtained from central laboratory (NCT03048422)
Timeframe: Delivery
| Intervention | percentage of participants (Number) |
|---|---|
| Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | 94.4 |
| Arm 3: Maternal EFV/FTC/TDF | 78.8 |
Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum Based on FDA Snapshot Algorithm
Percentage of mothers with virologic success of HIV-1 RNA less than 200 copies/mL at 50 weeks postpartum based on FDA snapshot algorithm using real-time test results obtained from site laboratories (NCT03048422)
Timeframe: 50 weeks postpartum
| Intervention | percentage of participants (Number) |
|---|---|
| Arm 1: Maternal DTG+FTC/TAF | 75.6 |
| Arm 2: Maternal DTG+FTC/TDF | 77.7 |
| Arm 3: Maternal EFV/FTC/TDF | 76.3 |
Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at Delivery Based on FDA Snapshot Algorithm
Percentage of mothers with virologic success of HIV-1 RNA less than 200 copies/mL at delivery based on FDA snapshot algorithm using real-time test results obtained from site laboratories (NCT03048422)
Timeframe: Delivery
| Intervention | percentage of participants (Number) |
|---|---|
| Arm 1: Maternal DTG+FTC/TAF | 88.9 |
| Arm 2: Maternal DTG+FTC/TDF | 92.6 |
| Arm 3: Maternal EFV/FTC/TDF | 81.0 |
Time to First HIV-1 RNA Less Than 200 Copies/mL Through Delivery
Time to first viral HIV-1 RNA less than 200 copies/mL through delivery, determined using real-time results obtained from site laboratories (NCT03048422)
Timeframe: Randomization to delivery
| Intervention | weeks (Mean) |
|---|---|
| Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | 4.26 |
| Arm 3: Maternal EFV/FTC/TDF | 6.49 |
Infant Creatinine Clearance
Infant creatinine clearance based on Schwartz formula (NCT03048422)
Timeframe: Delivery and 26 weeks postpartum
| Intervention | mL/min (Mean) | |
|---|---|---|
| Delivery | 26 Weeks Postpartum | |
| Arm 1 Infants | 52.7 | 134.8 |
| Arm 2 Infants | 53.1 | 123.6 |
| Arm 3 Infants | 49.0 | 135.0 |
Percentage of Mothers With HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery
Percentage of mothers with plasma HIV-1 RNA viral load less than 200 copies/mL at delivery determined using real-time test results obtained at site laboratories. This outcome was evaluated in the non-inferiority (primary outcome) and superiority (secondary outcome) analyses. The intention-to-treat analysis included all randomized women who had viral load data available. The per-protocol analysis excluded women who modified randomized treatment (stopped, paused, switched, added any treatment) before viral load evaluation at delivery, with the exception of women who modified randomized treatment for use of a concomitant medication. (NCT03048422)
Timeframe: Delivery
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| Intention-to-Treat Analysis | Per-Protocol Analysis | |
| Arm 3: Maternal EFV/FTC/TDF | 91.0 | 91.4 |
| Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | 97.5 | 97.5 |
Number of Participants Who Experienced HIV-related Disease Progression or Death
Worsening to WHO stage III/IV (among subjects who had WHO stage I/II at baseline) and death were the composite secondary endpoint. WHO Disease Staging System for HIV Infection and Disease in Adults and Adolescents is an approach for use in resource limited settings in studies of progression to symptomatic HIV disease. There are 4 stages of disease staging, 1 being the least severe and 4 being the most severe disease stage based on the HIV related symptoms and diagnoses. Please refer to the following web page for detailed staging criteria: http://www.who.int/docstore/hiv/scaling/anex1.html (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.
| Intervention | participants (Number) |
|---|---|
| NVP/NVP | 6 |
| NVP/LPV_r | 4 |
| NoNVP/NVP | 19 |
| NoNVP/LPV_r | 26 |
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.
| Intervention | participants (Number) |
|---|---|
| NVP/NVP | 15 |
| NVP/LPV_r | 0 |
| NoNVP/NVP | 35 |
| NoNVP/LPV_r | 0 |
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.
| Intervention | participants (Number) |
|---|---|
| NVP/NVP | 32 |
| NVP/LPV_r | 10 |
| NoNVP/NVP | 42 |
| NoNVP/LPV_r | 50 |
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.
| Intervention | participants (Number) |
|---|---|
| NVP/NVP | 20 |
| NoNVP/NVP | 51 |
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.
| 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 |
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.
| 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 |
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.
| 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 |
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.
| Intervention | weeks (Number) | ||
|---|---|---|---|
| 5th percentile | 10th percentile | 25th percentile | |
| NVP/LPV_r | 60 | 84 | NA |
| NVP/NVP | 12 | 12 | 60 |
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.
| Intervention | weeks (Number) | ||
|---|---|---|---|
| 5th percentile | 10th percentile | 25th percentile | |
| NoNVP/LPV_r | 12 | 36 | 132 |
| NoNVP/NVP | 24 | 36 | NA |
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.
| Intervention | hour (Median) |
|---|---|
| DTG 50mg q.d. | 32.8 |
| EVG/COBI 150/150mg q.d. | 7.6 |
| DRV/COBI 800/150 mg q.d. | NA |
| EFV 600 mg q.d. (Outside THA) | 65.6 |
PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (IQR) for ARVs and TB Drugs
Cord blood and maternal plasma concentrations were collected and measured at delivery, and compared as a ratio. (NCT00042289)
Timeframe: Measured at time of delivery with single cord blood and single maternal plasma sample.
| Intervention | unitless (Median) |
|---|---|
| DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d. | 0.15 |
| DTG 50mg q.d. | 1.25 |
| EVG/COBI 150/150mg q.d. | 0.91 |
| DRV/COBI 800/150 mg q.d. | 0.07 |
| ATV/COBI 300/150 mg q.d. | 0.07 |
| TFV 300mg q.d. | 0.88 |
PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (Range) for ARVs and TB Drugs
Cord blood and maternal plasma concentrations were collected and measured at delivery, and compared as a ratio. For arms with zero overall participants analyzed, samples were below the limit of quantification and ratios could not be calculated. (NCT00042289)
Timeframe: Measured at time of delivery with single cord blood and single maternal plasma sample.
| Intervention | unitless (Median) |
|---|---|
| TAF 10mg q.d. w/COBI | 0.97 |
| EFV 600 mg q.d. (Outside THA) | 0.67 |
| EFV 600mg q.d. | 0.49 |
| LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. | 0.2 |
| RAL 400mg b.i.d. | 1.5 |
| ETR 200mg b.i.d. | 0.52 |
| MVC 150 or 300mg b.i.d. | 0.33 |
| ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d. | 0.14 |
| TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d. | 0.16 |
| NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d. | 0.19 |
| IDV/RTV Arm 2: 400/100mg q.d. (Only THA) | 0.12 |
| RPV 25mg q.d. | 0.55 |
| ATV/RTV 300/100mg q.d. or TFV/ATV/RTV 300/300/100mg q.d. | 0.18 |
| DRV/RTV 800/100mg q.d. or DRV/RTV 600/100mg b.i.d. | 0.18 |
Plasma Concentration for Contraceptives
Serum concentrations of the contraceptives. Note that no historical controls were provided by team pharmacologists and thus no comparisons were done for contraceptive concentrations in women using hormonal contraceptives and selected ARV drugs as compared to historical controls not using those ARV drugs. (NCT00042289)
Timeframe: Measured at 6-7 weeks after contraceptive initiation postpartum
| Intervention | pg/mL (Median) |
|---|---|
| ATV/RTV/TFV 300/100/300mg q.d. With ENG | 604 |
| LPV/RTV 400/100 b.i.d. With ENG | 428 |
| EFV 600mg q.d. With ENG | 125 |
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.
| Intervention | mcg*hr/mL (Median) | |
|---|---|---|
| Before contraceptive initiation | After contraceptive initiation | |
| LPV/RTV 400/100 b.i.d. With ENG | 115.97 | 100.20 |
Area Under the Curve From 0 to 24 Hours (AUC24) of ARVs for Contraceptive Arms
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8, 12, and 24 hours post dosing.
| Intervention | mcg*hr/mL (Median) | |
|---|---|---|
| Before contraceptive initiation | After contraceptive initiation | |
| ATV/RTV/TFV 300/100/300mg q.d. With ENG | 53.96 | 55.25 |
| EFV 600mg q.d. With ENG | 53.64 | 56.65 |
Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC (area under the curve) were determined using the linear trapezoidal rule. See PK target in the Protocol Appendix V. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| 3rd Trimester | Postpartum | |
| EFV 600mg q.d. | 20 | 21 |
| MVC 150 or 300mg b.i.d. | 8 | 7 |
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.
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| 2nd Trimester | 3rd Trimester | Postpartum | |
| ATV/RTV Arm 1: 300/100mg q.d. | 1 | 12 | 12 |
| DRV/COBI 800/150 mg q.d. | 3 | 4 | 14 |
| DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d. | 7 | 16 | 22 |
| DRV/RTV 600/100mg b.i.d. | 7 | 19 | 22 |
| DRV/RTV 800/100mg q.d. | 9 | 19 | 22 |
| DTG 50mg q.d. | 9 | 20 | 23 |
| EFV 600 mg q.d. (Outside THA) | 12 | 33 | 34 |
| ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d. | 8 | 29 | 27 |
| ETR 200mg b.i.d. | 5 | 13 | 7 |
| EVG/COBI 150/150mg q.d. | 8 | 10 | 18 |
| FPV/RTV 700/100mg b.i.d. | 8 | 26 | 22 |
| IDV/RTV Arm 2: 400/100mg q.d. (Only THA) | 10 | 19 | 26 |
| LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. | 9 | 30 | 27 |
| ATV/COBI 300/150 mg q.d. | 1 | 2 | 5 |
| NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d. | NA | 15 | 14 |
| RAL 400mg b.i.d. | 11 | 33 | 30 |
| RPV 25mg q.d. | 14 | 26 | 25 |
| TAF 10mg q.d. w/COBI | 15 | 23 | 22 |
| TAF 25mg q.d. | 13 | 23 | 24 |
| TAF 25mg q.d. w/COBI or RTV Boosting | 10 | 24 | 18 |
| TFV 300mg q.d. | 2 | 27 | 27 |
| TFV/ATV/RTV Arm 1: 300/300/100mg q.d. | 1 | 11 | 12 |
| TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d. | 7 | 23 | 32 |
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.
| Intervention | mcg/mL (Median) | |||
|---|---|---|---|---|
| 2-10 hours after birth | 18-28 hours after birth | 36-72 hours after birth | 5-9 days after birth | |
| DRV/COBI 800/150 mg q.d. | 0.35 | 1.43 | 1.87 | 1.72 |
| DTG 50mg q.d. | 1.73 | 1.53 | 1.00 | 0.06 |
| EFV 600 mg q.d. (Outside THA) | 1.1 | 1.0 | 0.9 | 0.4 |
| EVG/COBI 150/150mg q.d. | 0.132 | 0.032 | 0.005 | 0.005 |
PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Geometric Mean (95% CI) for ARVs and TB Drugs
Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing. (NCT00042289)
Timeframe: Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.
| Intervention | ng*hour/mL (Geometric Mean) | ||
|---|---|---|---|
| 2nd Trimester | 3rd Trimester | Postpartum | |
| MVC 150 or 300mg b.i.d. | NA | 2717 | 3645 |
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.
| Intervention | mg*hour/L (Median) | ||
|---|---|---|---|
| 2nd Trimester | 3rd Trimester | Postpartum | |
| DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d. | 55.1 | 51.8 | 79.6 |
| DRV/RTV 600/100mg b.i.d. | 45.8 | 45.9 | 61.7 |
| FPV/RTV 700/100mg b.i.d. | 43.50 | 32.15 | 51.60 |
| NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d. | NA | 34.2 | 33.5 |
PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (Range) for ARVs and TB Drugs
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12 (area under the curve from 0 to 12 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.
| Intervention | mg*hour/L (Median) | ||
|---|---|---|---|
| 2nd Trimester | 3rd Trimester | Postpartum | |
| ETR 200mg b.i.d. | 4.5 | 8.3 | 5.3 |
| IDV/RTV Arm 2: 400/100mg q.d. (Only THA) | 14.9 | 16.1 | 27.1 |
| LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. | 72 | 96 | 133 |
| RAL 400mg b.i.d. | 6.6 | 5.4 | 11.6 |
PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (IQR) for ARVs and TB Drugs
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24 (area under the curve from 0 to 24 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.
| Intervention | mg*hour/L (Median) | ||
|---|---|---|---|
| 2nd Trimester | 3rd Trimester | Postpartum | |
| ATV/COBI 300/150 mg q.d. | 25.33 | 18.85 | 36.20 |
| ATV/RTV Arm 1: 300/100mg q.d. | 88.2 | 41.9 | 57.9 |
| ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d. | 30.6 | 45.7 | 48.8 |
| DRV/COBI 800/150 mg q.d. | 50.00 | 42.05 | 95.55 |
| DRV/RTV 800/100mg q.d. | 64.6 | 63.5 | 103.9 |
| DTG 50mg q.d. | 47.6 | 49.2 | 65.0 |
| EFV 600 mg q.d. (Outside THA) | 47.30 | 60.02 | 62.70 |
| EVG/COBI 150/150mg q.d. | 15.3 | 14.0 | 21.0 |
| TAF 10mg q.d. w/COBI | 0.197 | 0.206 | 0.216 |
| TAF 25mg q.d. | 0.171 | 0.212 | 0.271 |
| TAF 25mg q.d. w/COBI or RTV Boosting | 0.181 | 0.257 | 0.283 |
| TFV 300mg q.d. | 1.9 | 2.4 | 3.0 |
| TFV/ATV/RTV Arm 1: 300/300/100mg q.d. | 14.5 | 28.8 | 39.6 |
| TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d. | 26.2 | 37.7 | 58.7 |
PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.
| Intervention | mg*hour/L (Median) | |
|---|---|---|
| 3rd Trimester | Postpartum | |
| EFV 600mg q.d. | 55.4 | 58.3 |
PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.
| Intervention | mg*hour/L (Median) | ||
|---|---|---|---|
| 2nd Trimester | 3rd Trimester | Postpartum | |
| RPV 25mg q.d. | 1.969 | 1.669 | 2.387 |
PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.
| Intervention | mg/L (Median) | |
|---|---|---|
| 3rd Trimester | Postpartum | |
| EFV 600mg q.d. | 5.44 | 5.10 |
PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.
| Intervention | mg/L (Median) | ||
|---|---|---|---|
| 2nd Trimester | 3rd Trimester | Postpartum | |
| ATV/COBI 300/150 mg q.d. | 2.82 | 2.20 | 3.90 |
| ATV/RTV Arm 1: 300/100mg q.d. | NA | 3.6 | 4.1 |
| ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d. | 3.11 | 4.51 | 4.52 |
| DRV/COBI 800/150 mg q.d. | 4.59 | 3.67 | 7.04 |
| DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d. | 6.22 | 6.55 | 8.96 |
| DRV/RTV 600/100mg b.i.d. | 5.64 | 5.53 | 7.78 |
| DRV/RTV 800/100mg q.d. | 6.77 | 5.78 | 8.11 |
| DTG 50mg q.d. | 3.62 | 3.54 | 4.85 |
| EFV 600 mg q.d. (Outside THA) | 3.87 | 5.13 | 4.41 |
| FPV/RTV 700/100mg b.i.d. | 5.61 | 5.12 | 6.75 |
| IDV/RTV Arm 2: 400/100mg q.d. (Only THA) | 3.89 | 3.62 | 5.37 |
| NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d. | NA | 5.1 | 5.0 |
| TFV 300mg q.d. | 0.250 | 0.245 | 0.298 |
| TFV/ATV/RTV Arm 1: 300/300/100mg q.d. | 1.2 | 2.5 | 4.1 |
| TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d. | 2.73 | 3.56 | 5.43 |
PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (Range) for ARVs and TB Drugs
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.
| Intervention | mg/L (Median) | ||
|---|---|---|---|
| 2nd Trimester | 3rd Trimester | Postpartum | |
| ETR 200mg b.i.d. | 0.70 | 1.01 | 0.63 |
| LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. | 8.4 | 10.7 | 14.6 |
| RAL 400mg b.i.d. | 2.250 | 1.770 | 3.035 |
| RPV 25mg q.d. | 0.145 | 0.134 | 0.134 |
PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (95% CI) for ARVs and TB Drugs
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.
| Intervention | ng/mL (Median) | |
|---|---|---|
| 3rd Trimester | Postpartum | |
| MVC 150 or 300mg b.i.d. | 448 | 647 |
PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (IQR) for ARVs and TB Drugs
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.
| Intervention | ng/mL (Median) | ||
|---|---|---|---|
| 2nd Trimester | 3rd Trimester | Postpartum | |
| EVG/COBI 150/150mg q.d. | 1447.1 | 1432.8 | 1713.1 |
| TAF 10mg q.d. w/COBI | 80.4 | 91.2 | 98.2 |
| TAF 25mg q.d. | 69.7 | 96 | 133 |
| TAF 25mg q.d. w/COBI or RTV Boosting | 87.8 | 107 | 141 |
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.
| Intervention | ng/mL (Geometric Mean) | |
|---|---|---|
| 3rd Trimester | Postpartum | |
| MVC 150 or 300mg b.i.d. | 108 | 128 |
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.
| Intervention | mg/L (Median) | ||
|---|---|---|---|
| 2nd Trimester | 3rd Trimester | Postpartum | |
| DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d. | 2.84 | 2.52 | 4.51 |
| DRV/RTV 600/100mg b.i.d. | 2.12 | 2.22 | 2.51 |
| FPV/RTV 700/100mg b.i.d. | 2.12 | 1.64 | 2.87 |
| NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d. | NA | 0.47 | 0.52 |
PK Parameter: Trough Concentration (C12) With Median (Range) for ARVs and TB Drugs
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose.
| Intervention | mg/L (Median) | ||
|---|---|---|---|
| 2nd Trimester | 3rd Trimester | Postpartum | |
| ETR 200mg b.i.d. | 0.36 | 0.48 | 0.38 |
| IDV/RTV Arm 2: 400/100mg q.d. (Only THA) | 0.13 | 0.13 | 0.28 |
| LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. | 3.7 | 5.1 | 7.2 |
| RAL 400mg b.i.d. | 0.0621 | 0.064 | 0.0797 |
PK Parameter: Trough Concentration (C24) With Median (IQR) for ARVs and TB Drugs
"Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose.~For the TAF 25 mg q.d., 10 mg q.d. w/COBI, and 25 mg q.d. w/COBI or RTV boosting arms, samples were all below the limit of quantification and statistical analyses were not conducted." (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.
| Intervention | mg/L (Median) | ||
|---|---|---|---|
| 2nd Trimester | 3rd Trimester | Postpartum | |
| ATV/COBI 300/150 mg q.d. | 0.21 | 0.21 | 0.61 |
| ATV/RTV Arm 1: 300/100mg q.d. | 2.0 | 0.7 | 1.2 |
| ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d. | 0.49 | 0.71 | 0.90 |
| DRV/COBI 800/150 mg q.d. | 0.33 | 0.27 | 1.43 |
| DRV/RTV 800/100mg q.d. | 0.99 | 1.17 | 2.78 |
| DTG 50mg q.d. | 0.73 | 0.93 | 1.28 |
| EFV 600 mg q.d. (Outside THA) | 1.49 | 1.48 | 1.94 |
| EVG/COBI 150/150mg q.d. | 0.0258 | 0.0487 | 0.3771 |
| TAF 10mg q.d. w/COBI | 0.00195 | 0.00195 | 0.00195 |
| TAF 25mg q.d. | 0.00195 | 0.00195 | 0.00195 |
| TAF 25mg q.d. w/COBI or RTV Boosting | 0.00195 | 0.00195 | 0.00195 |
| TFV 300mg q.d. | 0.039 | 0.054 | 0.061 |
| TFV/ATV/RTV Arm 1: 300/300/100mg q.d. | 0.3 | 0.5 | 0.8 |
| TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d. | 0.44 | 0.57 | 1.26 |
PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.
| Intervention | mg/L (Median) | |
|---|---|---|
| 3rd Trimester | Postpartum | |
| EFV 600mg q.d. | 1.60 | 2.05 |
PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.
| Intervention | mg/L (Median) | ||
|---|---|---|---|
| 2nd Trimester | 3rd Trimester | Postpartum | |
| RPV 25mg q.d. | 0.063 | 0.056 | 0.081 |
Reviews
9 reviews available for adenine and Complications, Infectious Pregnancy
| Article | Year |
|---|---|
Tenofovir alafenamide use in pregnant and lactating women living with HIV.
Topics: Adenine; Alanine; Anti-HIV Agents; Female; HIV Infections; Humans; Lactation; Pregnancy; Pregnancy C | 2020 |
[Interdisciplinary aspects of and new drugs for chronic hepatitis B].
Topics: Adenine; Antiviral Agents; Comorbidity; Drug Interactions; Drug Therapy, Combination; Female; Gastro | 2013 |
Safety of tenofovir during pregnancy for the mother and fetus: a systematic review.
Topics: Adenine; Animals; Female; Fetal Development; HIV Infections; Humans; Infant, Newborn; Organophosphon | 2013 |
Tenofovir disoproxil fumarate in pregnancy and prevention of mother-to-child transmission of HIV-1: is it time to move on from zidovudine?
Topics: Adenine; Adult; Africa South of the Sahara; Animals; Anti-HIV Agents; Antiretroviral Therapy, Highly | 2009 |
Systemic preexposure prophylaxis for human immunodeficiency virus infection.
Topics: Adenine; Animals; Anti-HIV Agents; Antiviral Agents; Deoxycytidine; Emtricitabine; Female; HIV; HIV | 2010 |
Antiviral therapy for hepatitis B infection during pregnancy and breastfeeding.
Topics: Adenine; Antiviral Agents; Breast Feeding; Female; Guanine; Hepatitis B; Hepatitis B virus; Hepatiti | 2011 |
Pharmacokinetics of antiretroviral drugs in anatomical sanctuary sites: the fetal compartment (placenta and amniotic fluid).
Topics: Adenine; Adult; Amniotic Fluid; Anti-HIV Agents; Cyclohexanes; Enfuvirtide; Female; Fetal Blood; Fet | 2011 |
Drug delivery in multiple indication (multipurpose) prevention technologies: systems to prevent HIV-1 transmission and unintended pregnancies or HSV-2 transmission.
Topics: Adenine; Administration, Intravaginal; Anti-Infective Agents; Antiviral Agents; Biopharmaceutics; Co | 2012 |
New advances in chronic hepatitis B.
Topics: Adenine; Antiviral Agents; Coinfection; Disease Progression; Drug Resistance, Viral; Female; Guanine | 2012 |
Trials
18 trials available for adenine and Complications, Infectious Pregnancy
| Article | Year |
|---|---|
Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2
Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Drug Therapy, Combination; Emtricitabine; Female; Gestatio | 2021 |
Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV.
Topics: Adenine; Adolescent; Adult; Anti-Retroviral Agents; Bone Density; CD4 Lymphocyte Count; Drug Therapy | 2019 |
Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV.
Topics: Adenine; Adolescent; Adult; Anti-Retroviral Agents; Bone Density; CD4 Lymphocyte Count; Drug Therapy | 2019 |
Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV.
Topics: Adenine; Adolescent; Adult; Anti-Retroviral Agents; Bone Density; CD4 Lymphocyte Count; Drug Therapy | 2019 |
Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV.
Topics: Adenine; Adolescent; Adult; Anti-Retroviral Agents; Bone Density; CD4 Lymphocyte Count; Drug Therapy | 2019 |
Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV.
Topics: Adenine; Adolescent; Adult; Anti-Retroviral Agents; Bone Density; CD4 Lymphocyte Count; Drug Therapy | 2019 |
Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV.
Topics: Adenine; Adolescent; Adult; Anti-Retroviral Agents; Bone Density; CD4 Lymphocyte Count; Drug Therapy | 2019 |
Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV.
Topics: Adenine; Adolescent; Adult; Anti-Retroviral Agents; Bone Density; CD4 Lymphocyte Count; Drug Therapy | 2019 |
Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV.
Topics: Adenine; Adolescent; Adult; Anti-Retroviral Agents; Bone Density; CD4 Lymphocyte Count; Drug Therapy | 2019 |
Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV.
Topics: Adenine; Adolescent; Adult; Anti-Retroviral Agents; Bone Density; CD4 Lymphocyte Count; Drug Therapy | 2019 |
Pharmacokinetics and safety of tenofovir in HIV-infected women during labor and their infants during the first week of life.
Topics: Adenine; Adolescent; Adult; Anti-HIV Agents; Drug Administration Schedule; Female; Fetal Blood; HIV | 2014 |
High medication adherence during periconception periods among HIV-1-uninfected women participating in a clinical trial of antiretroviral pre-exposure prophylaxis.
Topics: Adenine; Adolescent; Adult; Anti-HIV Agents; Cohort Studies; Double-Blind Method; Female; Fertilizat | 2014 |
Efficacy of maternal tenofovir disoproxil fumarate in interrupting mother-to-infant transmission of hepatitis B virus.
Topics: Adenine; Adult; DNA, Viral; Female; Follow-Up Studies; Gestational Age; Hepatitis B virus; Hepatitis | 2015 |
Addition of single-dose tenofovir and emtricitabine to intrapartum nevirapine to reduce perinatal HIV transmission.
Topics: Adenine; Adolescent; Adult; Anti-HIV Agents; Deoxycytidine; Drug Therapy, Combination; Emtricitabine | 2008 |
Population pharmacokinetics of tenofovir in HIV-1-infected pregnant women and their neonates (ANRS 12109).
Topics: Adenine; Female; HIV Infections; HIV-1; Humans; Infant, Newborn; Maternal-Fetal Exchange; Organophos | 2009 |
Population pharmacokinetics of tenofovir in HIV-1-infected pregnant women and their neonates (ANRS 12109).
Topics: Adenine; Female; HIV Infections; HIV-1; Humans; Infant, Newborn; Maternal-Fetal Exchange; Organophos | 2009 |
Population pharmacokinetics of tenofovir in HIV-1-infected pregnant women and their neonates (ANRS 12109).
Topics: Adenine; Female; HIV Infections; HIV-1; Humans; Infant, Newborn; Maternal-Fetal Exchange; Organophos | 2009 |
Population pharmacokinetics of tenofovir in HIV-1-infected pregnant women and their neonates (ANRS 12109).
Topics: Adenine; Female; HIV Infections; HIV-1; Humans; Infant, Newborn; Maternal-Fetal Exchange; Organophos | 2009 |
Intrapartum tenofovir and emtricitabine reduces low-concentration drug resistance selected by single-dose nevirapine for perinatal HIV prevention.
Topics: Adenine; Anti-HIV Agents; Deoxycytidine; Dose-Response Relationship, Drug; Drug Administration Sched | 2009 |
Antiretroviral therapies in women after single-dose nevirapine exposure.
Topics: Adenine; Adult; Anti-HIV Agents; Anti-Retroviral Agents; CD4 Lymphocyte Count; Deoxycytidine; Drug T | 2010 |
Atazanavir pharmacokinetics with and without tenofovir during pregnancy.
Topics: Adenine; Anti-HIV Agents; Atazanavir Sulfate; Drug Administration Schedule; Drug Monitoring; Drug Th | 2011 |
Very high concentrations of active intracellular phosphorylated emtricitabine in neonates (ANRS 12109 trial, step 2).
Topics: Acquired Immunodeficiency Syndrome; Adenine; Adult; Antiviral Agents; Deoxycytidine; Emtricitabine; | 2011 |
Plasma and intracellular tenofovir pharmacokinetics in the neonate (ANRS 12109 trial, step 2).
Topics: Acquired Immunodeficiency Syndrome; Adenine; Anti-HIV Agents; Female; HIV-1; Humans; Infant, Newborn | 2011 |
Pharmacokinetics and safety of single-dose tenofovir disoproxil fumarate and emtricitabine in HIV-1-infected pregnant women and their infants.
Topics: Adenine; Adult; Anti-HIV Agents; Deoxycytidine; Dose-Response Relationship, Drug; Drug Therapy, Comb | 2011 |
Pregnancy and infant outcomes among HIV-infected women taking long-term ART with and without tenofovir in the DART trial.
Topics: Abortion, Spontaneous; Adenine; Adult; Anti-HIV Agents; Body Height; Body Weight; Breast Feeding; Bu | 2012 |
Tenofovir use and renal insufficiency among pregnant and general adult population of HIV-infected, ART-naïve individuals in Lilongwe, Malawi.
Topics: Adenine; Adolescent; Adult; Alkynes; Anti-HIV Agents; Benzoxazines; Body Mass Index; CD4 Lymphocyte | 2012 |
The pharmacokinetics, safety and efficacy of tenofovir and emtricitabine in HIV-1-infected pregnant women.
Topics: Adenine; Adult; Anti-HIV Agents; Deoxycytidine; Emtricitabine; Europe; Female; Fetal Blood; HIV Infe | 2013 |
Pharmacokinetics of an increased atazanavir dose with and without tenofovir during the third trimester of pregnancy.
Topics: Adenine; Adolescent; Adult; Anti-HIV Agents; Atazanavir Sulfate; Dose-Response Relationship, Drug; D | 2013 |
Antiviral drugs for the neonate--the risk-benefit ledger.
Topics: Adenine; Animals; Antiviral Agents; Arabinose; Brain; Brain Diseases; Clinical Trials as Topic; Cyta | 1975 |
Other Studies
35 other studies available for adenine and Complications, Infectious Pregnancy
| Article | Year |
|---|---|
Pharmacokinetics of Tenofovir Alafenamide With Boosted Protease Inhibitors in Pregnant and Postpartum Women Living With HIV: Results From IMPAACT P1026s.
Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Antiviral Agents; Female; HIV Infections; Humans; Postpart | 2022 |
Acceptance of antiviral treatment and enhanced service model for pregnant patients carrying hepatitis B.
Topics: Adenine; Adult; Antiviral Agents; DNA, Viral; Female; Hepatitis B; Hepatitis B Surface Antigens; Hep | 2020 |
Efficacy and safety of tenofovir alafenamide fumarate for preventing mother-to-child transmission of hepatitis B virus: a national cohort study.
Topics: Abnormalities, Drug-Induced; Adenine; Adult; Alanine; Chemoprevention; China; Cohort Studies; DNA, V | 2020 |
Tenofovir and tenofovir-diphosphate concentrations during pregnancy among HIV-uninfected women using oral preexposure prophylaxis.
Topics: Adenine; Administration, Oral; Adult; Anti-HIV Agents; Blood Chemical Analysis; Chemoprevention; Fem | 2018 |
Low prevalence of renal dysfunction in HIV-infected pregnant women: implications for guidelines for the prevention of mother-to-child transmission of HIV.
Topics: Adenine; Adult; Age Factors; Anti-HIV Agents; CD4 Lymphocyte Count; Contraindications; Creatinine; F | 2013 |
Infant growth outcomes after maternal tenofovir disoproxil fumarate use during pregnancy.
Topics: Adenine; Adolescent; Anti-HIV Agents; Child Development; Female; Humans; Infant; Organophosphonates; | 2013 |
Efficacy and safety of tenofovir disoproxil fumarate in pregnancy for the prevention of vertical transmission of HBV infection.
Topics: Adenine; Antiviral Agents; Biomarkers; DNA, Viral; Female; Hepatitis B; Hepatitis B e Antigens; Hepa | 2013 |
Anti-viral therapy for prevention of perinatal HBV transmission: extending therapy beyond birth does not protect against post-partum flare.
Topics: Adenine; Adult; Antiviral Agents; Female; Follow-Up Studies; Hepatitis B e Antigens; Hepatitis B vir | 2014 |
Uptake of prevention of mother-to-child-transmission using Option B+ in northern rural Malawi: a retrospective cohort study.
Topics: Adenine; Adult; Alkynes; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Benzoxazines; Chemo | 2014 |
Efficacy and safety of tenofovir disoproxil fumarate in pregnancy to prevent perinatal transmission of hepatitis B virus.
Topics: Adenine; Adult; Antiviral Agents; Cohort Studies; Female; Gastrointestinal Diseases; Hepatitis B; He | 2014 |
Reduction of infectivity in chronic hepatitis B virus carriers among healthcare providers and pregnant women by antiviral therapy.
Topics: Adenine; Antiviral Agents; DNA, Viral; Female; Guanine; Health Personnel; Hepatitis B e Antigens; He | 2014 |
HIV testing in pregnancy.
Topics: Adenine; Anti-HIV Agents; Benzoxazines; Female; HIV Infections; Humans; Infectious Disease Transmiss | 2014 |
Tenofovir rescue therapy in pregnant females with chronic hepatitis B.
Topics: Adenine; Adult; Antiviral Agents; Apgar Score; Biomarkers; Birth Weight; China; DNA, Viral; Drug Res | 2015 |
[Efficacy of combination antiviral therapy following childbirth in pregnant HBV carriers receiving telbivudine for prevention of mother-to-child transmission].
Topics: Adenine; Alanine Transaminase; Antiviral Agents; Carrier State; DNA, Viral; Drug Therapy, Combinatio | 2015 |
Chronic administration of tenofovir to rhesus macaques from infancy through adulthood and pregnancy: summary of pharmacokinetics and biological and virological effects.
Topics: Adenine; Age Factors; Animals; Anti-HIV Agents; Disease Models, Animal; Female; HIV Infections; HIV- | 2008 |
Population pharmacokinetics of emtricitabine in human immunodeficiency virus type 1-infected pregnant women and their neonates.
Topics: Adenine; Anti-HIV Agents; Area Under Curve; Clinical Trials as Topic; Deoxycytidine; Emtricitabine; | 2009 |
Rapid HIV-RNA decline following addition of raltegravir and tenofovir to ongoing highly active antiretroviral therapy in a woman presenting with high-level HIV viraemia at week 38 of pregnancy.
Topics: Adenine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Female; HIV Infections; Humans; Org | 2010 |
Antiretroviral vaginal gel shows promise against HIV.
Topics: Adenine; Adult; Anti-HIV Agents; Anti-Retroviral Agents; Clinical Trials as Topic; Female; Gels; HIV | 2010 |
Implementing a tenofovir-based first-line regimen in rural Lesotho: clinical outcomes and toxicities after two years.
Topics: Adenine; Adult; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Cohort Studies; Female; HIV | 2011 |
Battles with donors cloud Malawi's HIV prevention plan.
Topics: Acquired Immunodeficiency Syndrome; Adenine; Alkynes; Anti-HIV Agents; Benzoxazines; CD4 Lymphocyte | 2011 |
Microbicide might protect pregnant women from HIV. Susceptibility is high for them.
Topics: Adenine; Disease Susceptibility; Female; HIV Infections; Humans; Organophosphonates; Pregnancy; Preg | 2011 |
Pregnancy-related effects on tenofovir pharmacokinetics: a population study with 186 women.
Topics: Adenine; Adolescent; Adult; Anti-HIV Agents; Drug Monitoring; Female; HIV Infections; HIV-1; Humans; | 2012 |
Safety of tenofovir use during pregnancy: early growth outcomes in HIV-exposed uninfected infants.
Topics: Adenine; Anti-HIV Agents; Body Size; Child Development; Drug Therapy, Combination; Female; HIV Infec | 2012 |
Does maternal use of tenofovir during pregnancy affect growth of HIV-exposed uninfected infants?
Topics: Adenine; Anti-HIV Agents; Body Size; Female; HIV Infections; Humans; Infant, Newborn; Male; Organoph | 2012 |
Hepatitis B virus and human immunodeficiency virus drugs in pregnancy: findings from the Antiretroviral Pregnancy Registry.
Topics: Adenine; Adult; Antiviral Agents; Congenital Abnormalities; Female; Hepatitis B; Hepatitis B virus; | 2012 |
Research. Fetuses unaffected by tenofovir, 1-year-olds appear slightly smaller.
Topics: Adenine; Female; Fetus; Growth; HIV Infections; Humans; Infant; Organophosphonates; Pregnancy; Pregn | 2012 |
Interim guidance for clinicians considering the use of preexposure prophylaxis for the prevention of HIV infection in heterosexually active adults.
Topics: Adenine; Administration, Oral; Adult; Anti-Retroviral Agents; Centers for Disease Control and Preven | 2012 |
Tenofovir use and pregnancy among women initiating HAART.
Topics: Adenine; Adolescent; Adult; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; CD4 Lymphocyte C | 2012 |
Blunted fetal growth by tenofovir in late pregnancy.
Topics: Adenine; Adult; Anti-HIV Agents; Asian People; Bone Density; Female; Fetal Growth Retardation; Hepat | 2012 |
The 2012 revised Dutch national guidelines for the treatment of chronic hepatitis B virus infection.
Topics: Adenine; Antiviral Agents; Drug Approval; Drug Resistance, Viral; Female; Guanine; Hepatitis B, Chro | 2012 |
Management of chronic hepatitis B: Canadian Association for the Study of the Liver consensus guidelines.
Topics: Adenine; Allied Health Personnel; Antibodies, Viral; Antiviral Agents; Canada; Coinfection; Drug Res | 2012 |
Relationship between a toll-like receptor-4 gene polymorphism, bacterial vaginosis-related flora and vaginal cytokine responses in pregnant women.
Topics: Adenine; Adult; Enzyme-Linked Immunosorbent Assay; Female; Genotype; Guanine; Humans; Interleukin-1; | 2004 |
Congenital pyelectasis in children born from mothers on tenofovir containing therapy during pregnancy: report of two cases.
Topics: Adenine; Adult; Anti-HIV Agents; Female; HIV Infections; Humans; Infant, Newborn; Italy; Kidney; Mal | 2007 |
Administration of 9-[2-(R)-(phosphonomethoxy)propyl]adenine (PMPA) to gravid and infant rhesus macaques (Macaca mulatta): safety and efficacy studies.
Topics: Adenine; Animals; Animals, Newborn; Antiviral Agents; Biological Transport; Body Weight; Female; Imm | 1999 |
Neonatal herpes simplex infection following delivery by cesarean section.
Topics: Adenine; Anti-Infective Agents; Arabinose; Cesarean Section; Extraembryonic Membranes; Female; Herpe | 1974 |