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Nevirapine for the Prevention of Maternal-Fetal Transmission in Pregnant HIV-Infected Women
NCT00001135Phase 3
Key facts
- Status
- Completed
- Countries
- 2
- Sponsor
- National Institute of Allergy and Infectious Diseases
- Modality
- Small Molecules
- Drugs
- nevirapine
- Conditions
- human immunodeficiency virus infection (HIV)
01
Overview
Phase 3, randomised, double-blind trial in human immunodeficiency virus infection (HIV) comparing Nevirapine + Zidovudine with Placebo + Zidovudine (2 arms). Primary endpoint: Rate of maternal-fetal HIV transmission at 6 months. Status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Nevirapine + Zidovudine
Mothers receive a single oral dose of NVP during labor. Infants receive a single oral dose of NVP between 48 and 72 hours of life. Both receive ZDV.
Placebo + Zidovudine
Mothers receive a single oral dose of placebo during labor. Infants receive a single oral dose of placebo between 48 and 72 hours of life. Both receive ZDV.
03
Who it enrols
HIV-positive pregnant women (>= 28 weeks gestation) who are taking Zidovudine, do not intend to breast-feed, and have no liver disorders or prior NNRTI use.
04
Endpoints
Primary
Rate of maternal-fetal HIV transmission
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