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About
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.
Full description
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:
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%.
Sex
Volunteers
Inclusion and exclusion criteria
Pre-Entry Criteria
Women were eligible for the study if they:
Inclusion criteria
Women are eligible for the study if they:
Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
1,792 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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