HIVNET 012

A Phase IIB 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

Study Summary

What was HIVNET 012?

HIVNET 012 was a randomized clinical trial to evaluate the efficacy of two short-course antiretroviral drug regimens for the prevention of HIV transmission from infected mothers to their babies. The overall goal of the study was to identify a safe, effective means of preventing mother-to-infant HIV transmission that would be applicable and affordable in resource-limited settings.

Who participated in the study?

HIV-1 infected Ugandan women and their infants. The original study size was 1,500 mother-infant pairs. 642 evaluable mother/infant pairs were enrolled in the interim (phase IIB) study.

What happened during the study?

This study was originally designed as a randomized, double-blind, three-arm placebo-controlled trial to determine the efficacy of a short course of nevirapine and the efficacy of a short course of AZT for the prevention of mother to infant HIV transmission, with the goal of finding a safe, effective means of preventing mother-to-infant transmission that would be applicable and affordable in resource-limited countries. Soon after the study was initiated, results of another study were released which led to the placebo arm being dropped. Enrollment into the two active agent arms of the study (open-label Phase IIB component) was continued to provide preliminary screening data on the efficacy of the two antiretroviral regimens in an effort to select one of the two for inclusion in a re-designed efficacy trial comparing the selected regimen with an appropriate control.

Results

This landmark study found that a short intrapartum/neonatal regimen of nevirapine given to the mother at the onset of labor and to the infant within 72 hours of life reduced the risk of perinatal HIV transmission among breastfeeding women in Uganda by 47% at 14-16 weeks and by 41% at 18 months compared to a short intrapartum/neonatal regimen of AZT.