Common TitlePACTG 316
Official Title A Phase III Randomized, Blinded Study of Nevirapine for the Prevention of Maternal-Fetal Transmission in Pregnant HIV-Infected Women
Phase Phase III
ClinicalTrials.gov NCT00000869
Treatments
Nevirapine
Nevirapine
Tradename:ViramuneOther Names:NVPClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Pregnancy/WomenResistance/Virological FailurePediatricsPharmacologyAdverse Effects
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Cunningham CK, Balasubramanian R, Delke I, et al. The impact of race/ethnicity on mother-to-child HIV transmission in the United States in Pediatric AIDS Clinical Trials Group Protocol 316. J Acquir Immune Defic Syndr. 2004;36:800-7.
- Cunningham CK, Chaix ML, Rekacewicz C, et al. 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 316. J Infect Dis. 2002;186:181-8.
- Dorenbaum A, Cunningham CK, Gelber RD, et al. Two-dose intrapartum/newborn nevirapine and standard antiretroviral therapy to reduce perinatal HIV transmission: a randomized trial. JAMA. 2003;288:189-98.
- Newell ML, Huang S, Fiore S, et al. Characteristics and management of HIV-1-infected pregnant women enrolled in a randomised trial: differences between Europe and the USA. BMC Infect Dis. 2007;7:60.
- Watts DH, Balasubramanian R, Maupin RT Jr, et al. Maternal toxicity and pregnancy complications in human immunodeficiency virus-infected women receiving antiretroviral therapy: PACTG 316. Am J Obstet Gynecol. 2004;190:506-16.