NCT00398684

Nevirapine Plus Zidovudine to Prevent Perinatal HIV in Thailand

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,792 (planned)
• Sponsor: Institut de Recherche pour le Developpement · Other Government
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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: 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%.

Conditions

• HIV Infections
• Pregnancy

Interventions

Type	Name	Description
DRUG	Single dose nevirapine to the mother and to the child	One maternal 200 mg NVP dose at the onset of labor, and one dose of infant NVP (0.6 ml/6mg) between 48-72 hours after birth. \[Infants less than 2,500g received only 0.2mL/kg\]
DRUG	Single dose nevirapine to the mother and placebo to the child	One maternal 200 mg NVP dose at the onset of labor, and one dose of infant placebo (0.6 ml) between 48-72 hours after birth. \[Infants less than 2,500g received only 0.2mL/kg\]
DRUG	Single dose placebo to the mother and to the child	One maternal placebo dose at the onset of labor, and one dose of infant placebo (0.6 ml) between 48-72 hours after birth. \[Infants less than 2,500g received only 0.2mL/kg\]

Timeline

• Start date: 2001-01-01
• Completion: 2004-06-01
• First posted: 2006-11-14
• Last updated: 2008-05-07

Locations

1 site across 1 country: Thailand