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Nevirapine Plus Zidovudine to Prevent Perinatal HIV in Thailand

NCT00398684 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1792

Last updated 2008-05-07

No results posted yet for this study

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.

Conditions

  • HIV Infections
  • Pregnancy

Interventions

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. \[Infants less than 2,500g received only 0.2mL/kg\]

Sponsors & Collaborators

  • Harvard School of Public Health (HSPH)

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • ANRS, Emerging Infectious Diseases

    collaborator OTHER_GOV

  • Institut de Recherche pour le Developpement

    lead OTHER_GOV

Principal Investigators

  • Marc Lallemant, MD · Institut de Recherche pour le Developpement

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Completion
2004-06-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00398684 on ClinicalTrials.gov