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Sponsors and Collaborators: |
Institut de Recherche pour le Developpement Harvard School of Public Health Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Agence Nationale de Recherche sur le SIDA (ANRS), France |
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Information provided by: | Institut de Recherche pour le Developpement |
ClinicalTrials.gov Identifier: | NCT00398684 |
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.
Condition | Intervention | Phase |
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HIV Infections Pregnancy |
Drug: Single dose nevirapine to the mother and to the child Drug: Single dose nevirapine to the mother and placebo to the child Drug: Single dose placebo to the mother and to the child |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Estimated Enrollment: | 1792 |
Study Start Date: | January 2001 |
Study Completion Date: | June 2004 |
Arms | Assigned Interventions |
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1: Experimental
One dose maternal NVP treatment at onset of labor, and one dose of infant NVP treatment 48-72 hours after birth (NVP-NVP)
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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]
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2: Experimental
One dose maternal NVP treatment at onset of labor, and one dose of infant placebo 48-72 hours after birth. (NVP-Placebo)
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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]
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3: Placebo Comparator
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)
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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]
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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%.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Pre-Entry Criteria
Women were eligible for the study if they:
Inclusion criteria
Women are eligible for the study if they:
Exclusion Criteria:
Thailand | |
Phpt - Ird 174 | |
Chiang Mai, Thailand, 50200 |
Principal Investigator: | Marc Lallemant, MD | Institut de recherche pour le Développement |
Study ID Numbers: | PHPT-2; R01-HD39615; ANRS 1208 |
Study First Received: | November 13, 2006 |
Last Updated: | May 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00398684 |
Health Authority: | Thailand: Ministry of Public Health |
Thailand Developing countries prophylaxis mother to child transmission |
HIV-1 HIV-1 infection HIV Seronegativity |
Virus Diseases Nevirapine Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Zidovudine Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |