At a glance
ClinicalIndex Comparison Record- ✓Infant born to HIV-infected mother eligible for the study
- ✓Birth weight ≥2000 grams (4.4 lbs)
- ✓HIV DNA PCR negative at birth
- ✓Able to breastfeed with no condition preventing it
- ✕Infant HIV DNA PCR positive at birth
- ✕Infant ALT Grade 2 or higher at birth
- ✕Infant hemoglobin, absolute neutrophil count, or platelet count Grade 3 or higher at birth
- ✕Infant skin rash Grade 2B (urticaria), Grade 3, or above
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Trial to Determine the Efficacy and Safety of an Extended Regimen of Nevirapine in Infants Born to HIV-Infected Women to Prevent Vertical HIV Transmission During Breastfeeding
In Brief
A Phase 3 clinical trial evaluating Nevirapine and Nevirapine placebo for HIV Infections. Completed, enrolled 2,026 participants across 5 sites in 4 countries.
Detailed Summary
The many benefits of breastfeeding are well documented. However, because of the risk of mother-to-child transmission (MTCT) of HIV from an HIV infected mother to her infant, there is considerable concern over the practice, especially in developing countries. The purpose of this study is to determine the safety and effectiveness of the anti-HIV drug nevirapine (NVP) in preventing MTCT of HIV in breastfeeding infants born to HIV infected women in South Africa, Tanzania, Uganda, and Zimbabwe.
Study Details
Timeline
Interventions
10 mg/ml oral suspension taken once daily up to 6 months of age. Dosage will increase throughout study.
Oral suspension taken once daily up to 6 months of age