Nevirapine Plus Zidovudine to Prevent Perinatal HIV in Thailand

Phase 3

Completed

• Conditions: HIV Infections; Pregnancy
• Interventions: Drug: Single dose placebo to the mother and to the child; Drug: Single dose nevirapine to the mother and to the child; Drug: Single dose nevirapine to the mother and placebo to the child

• Registration Number: NCT00398684
• Lead Sponsor: Institut de Recherche pour le Developpement

Brief 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%.

Study Timeline

• Study Start: 2001-01
• Study Completion: 2004-06
• Study First Submitted: 2006-11-13
• Study First Submitted QC: 2006-11-13
• Study First Posted: 2006-11-14
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-02
• Last Update Posted: 2008-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1792

Inclusion Criteria

Not provided

Exclusion Criteria

• evidence of pre-existing fetal anomalies incompatible with life;
• known hypersensitivity to any benzodiazepine or to NVP;
• receipt of antiretroviral agent other than ZDV;
• receipt of non-allowed concomitant treatment;
• uncontrolled hypertension;
• concurrent participation in another clinical trial;
• women with a CD4 count <200/µL or history of oral candidiasis if they were not receiving PCP prophylaxis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Single dose placebo to the mother and to the child	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. (Placebo-Placebo)
1	Single dose nevirapine to the mother and to the child	One dose maternal NVP treatment at onset of labor, and one dose of infant NVP treatment 48-72 hours after birth (NVP-NVP)
2	Single dose nevirapine to the mother and placebo to the child	One dose maternal NVP treatment at onset of labor, and one dose of infant placebo 48-72 hours after birth. (NVP-Placebo)

Primary Outcome Measures

Name	Time	Method
Definitive HIV infection in infants as assessed by positive HIV DNA PCR on two peripheral blood samples

Secondary Outcome Measures

Name	Time	Method
Tolerance of nevirapine, in particular rashes.

Trial Locations

Locations (1)

Phpt - Ird 174; 🇹🇭 Chiang Mai, Thailand