HIV Prevention Trial in Breastfeeding Mothers Across 14 Sites

Featuring results from a randomized strategy trial comparing maternal antiretroviral therapy (mART) versus infant nevirapine prophylaxis (iNVP) for preventing mother-to-child HIV transmission during breastfeeding. The trial enrolled 2431 mother-infant pairs across 14 sites in Sub-Saharan Africa and India between June 2011 and October 2014. The primary outcome was confirmed infant HIV-1 infection, with high infant HIV-free survival rates of 97.1% (mART) and 97.7% (iNVP) at 24 months.

Use Cases

• Compare the hazard ratio for infant HIV infection between the mART and iNVP prophylaxis arms using the primary efficacy outcome data.
• Analyze the relationship between maternal screening CD4 count (median 686 cells/mm) and infant HIV-free survival across the two trial strategies.
• Model the time to breastfeeding cessation (median 16 months) as a function of treatment arm and maternal clinical stage (97% WHO Stage I).
• Assess the incidence rates of severe, life-threatening, or fatal adverse events (14 and 42 per 100 person-years for mothers and infants) by treatment strategy.

Strengths

• Data from a large-scale randomized trial with 2431 enrolled mother-infant pairs.
• High infant HIV-free survival rates at 24 months (97.1% and 97.7%) provide a strong outcome signal.
• Trial conducted across 14 diverse sites in Sub-Saharan Africa and India, offering geographic breadth.
• Detailed baseline characteristics reported, including median maternal CD4 count (686 cells/mm) and infant birth weight (2.9 kg).

Limitations

• The dataset's specific variables, column structure, and sample data are unavailable for review.
• Trial population was primarily WHO Clinical Stage I women (97%), limiting generalizability to more advanced HIV cases.
• Data collection ended in 2014, so findings may not reflect current antiretroviral regimens or breastfeeding practices.

Provenance

Source

International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) Statistical and Data Analysis Center.

Collection Method

Randomized, open-label strategy trial conducted at 14 clinical sites.

Time Range

Enrollment from June 2011 to October 2014, with follow-up through 24 months postpartum.

Freshness

Last metadata update was 2026-02-09, but the underlying trial data covers 2011-2014.

Geography

Fourteen sites in Sub-Saharan Africa and India.