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

Sponsors: Division of AIDS, US National Institute of Allergy and Infectious Diseases (DAIDS, NIAD)
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
US National Institutes of Health (NIH)

Protocol Summary: HPTN/IMPAACT 046 was a phase III, multi-site, randomized, double-blind, placebo-controlled trial that sought to evaluate the efficacy and safety of an extended regimen of nevirapine (NVP) from 6 weeks to 6 months or through cessation of breastfeeding, whichever is earliest, for prevention of mother-to-child transmission of HIV through breast milk compared with placebo among infants who are provided nevirapine for the first 6 weeks (through Day 42) of life and are HIV-uninfected at age 6 weeks.

Years: 2007 – 2011

Investigator: Tsungai Chipato, MBChB, FRCOG, MCE

Location: Seke North and St. Mary’s CRSs


Completed Study


Coovadia HM, Brown ER, Fowler ER, Chipato T, Moodley D, et al. (2012) 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 randomized, double-blind, placebo-controlled trial. Lancet; 379 (9812): 221-8.

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