HIV Infections Clinical Trial
The purpose of this study was to assess the efficacy of a single dose of the drug nevirapine (NVP) given to pregnant women at onset of labor and to their infant 48-72 hours after birth in addition to standard oral zidovudine (ZDV or AZT) prophylaxis for the prevention of mother-to-child transmission of HIV-1.
Multicenter, randomized, three arms, double-blind, controlled study. Study population was
HIV-infected pregnant women who were on ZDV prophylaxis for more than two weeks and gave
informed consent. If eligible, women completed a baseline check-up. Women meeting selection
criteria were randomly assigned to receive one of three study regimens, in addition to ZDV
prophylaxis:
1. One dose maternal NVP treatment at onset of labor, and one dose of infant NVP treatment
48-72 hours after birth
2. One dose maternal NVP treatment at onset of labor, and one dose of infant placebo 48-72
hours after birth
3. One dose maternal placebo at onset of labor, and one dose of infant placebo 48-72 hours
after birth. This was the reference study arm.
Follow-up of women and infants was carried out on an outpatient basis except for delivery
and the first three days after delivery.
AMENDMENT
After the first interim analysis, enrollment in Placebo-Placebo arm was terminated on May 2,
2002, according to the recommendation of the Data and Safety Monitoring Board. The target
sample size was increased to 660, instead of 510, in each of the two remaining arms (N-N and
N-P) to ensure enough power to test for non-inferiority between these arms with a limit of
2.5%.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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