Trial reportJournal of acquired immune deficiency syndromes (1999)2018
Prevention of HIV-1 Transmission Through Breastfeeding: Efficacy and Safety of Maternal Antiretroviral Therapy Versus Infant Nevirapine Prophylaxis for Duration of Breastfeeding in HIV-1-Infected Women With High CD4 Cell Count (IMPAACT PROMISE): A Randomized, Open-Label, Clinical Trial.
Trial report in Journal of acquired immune deficiency syndromes (1999), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 94 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
94 citing papers in PubMed, 2 syntheses or guidelines pooled it, 208 citations in OpenAlex.
- Interventions to prevent mother-to-child transmission in breastfeeding mothers with HIV: a systematic review and meta-analysis of randomized controlled trials.Revista do Instituto de Medicina Tropical de Sao Paulo · 2024Pooled it
- Time-Trend, Regional and National Prevalence of Vertical Transmission of HIV-1 in Sub-Saharan Africa: A Systematic Review and Meta-Analysis.Journal of primary care & community healthPooled it
- Brief Report: Postpartum Maternal Monitoring for Renal Safety Related to Tenofovir Exposure During Breastfeeding in the PROMISE 1077BF Randomized Trial.Journal of acquired immune deficiency syndromes (1999) · 2026Trial
- Bone mineral density changes in breastfeeding women with HIV on antiretroviral therapy in Eastern and Southern Africa.AIDS (London, England) · 2025Trial
- Pregnancy Outcomes of Women Conceiving on Antiretroviral Therapy (ART) Compared to Those Commenced on ART During Pregnancy.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Trial
- SMS messaging to improve retention and viral suppression in prevention of mother-to-child HIV transmission (PMTCT) programs in Kenya: A 3-arm randomized clinical trial.PLoS medicine · 2021Trial
- Trial
- Trial
- Effectiveness of the baby-friendly community initiative in promoting exclusive breastfeeding among HIV negative and positive mothers: a randomized controlled trial in Koibatek Sub-County, Baringo, Kenya.International breastfeeding journal · 2020Trial
- Dolutegravir versus efavirenz in women starting HIV therapy in late pregnancy (DolPHIN-2): an open-label, randomised controlled trial.The lancet. HIV · 2020Trial
- Antenatal Intracellular Concentrations of Tenofovir Diphosphate and Emtricitabine Triphosphate and Associations Between Tenofovir Diphosphate and Severe Adverse Pregnancy Outcomes: IMPAACT-PROMISE (1077BF) Trial.Journal of acquired immune deficiency syndromes (1999) · 2020Trial
- Trial
- Association between HIV antiretroviral therapy and preterm birth based on antenatal ultrasound gestational age determination: a comparative analysis.AIDS (London, England) · 2019Trial
- Time to viral rebound and safety after antiretroviral treatment interruption in postpartum women compared with men.AIDS (London, England) · 2019Trial
- Trial
- HIV and Pregnancy in Türkiye: Gaps and Gains in the Era of Modern ART: A Multicenter Cohort Study.AIDS and behavior · 2026Article
- Associations of Plasma and Breast Milk HIV RNA and Tenofovir Concentrations With Risk of Postnatal HIV Transmission During Breastfeeding Among Women With and Without ARV Exposure.Journal of acquired immune deficiency syndromes (1999) · 2026Article
- "I love my baby more than they do": infant feeding decision-making among mothers living with HIV in the United States.AIDS care · 2026Article
- Oral Lamivudine for Extended HIV Postnatal Prophylaxis.Paediatric drugs · 2026Review
- Viral load suppression among pregnant and breastfeeding women living with HIV in Ghana: a prospective longitudinal study.BMC infectious diseases · 2026Article
34 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
28 authors at 19 institutions in 7 countries.
Funding
Abstract
backgroundNo randomized trial has directly compared the efficacy of prolonged infant antiretroviral prophylaxis versus maternal antiretroviral therapy (mART) for prevention of mother-to-child transmission throughout the breastfeeding period.
settingFourteen sites in Sub-Saharan Africa and India.
methodsA randomized, open-label strategy trial was conducted in HIV-1-infected women with CD4 counts ≥350 cells/mm (or ≥country-specific ART threshold if higher) and their breastfeeding HIV-1-uninfected newborns. Randomization at 6-14 days postpartum was to mART or infant nevirapine (iNVP) prophylaxis continued until 18 months after delivery or breastfeeding cessation, infant HIV-1 infection, or toxicity, whichever occurred first. The primary efficacy outcome was confirmed infant HIV-1 infection. Efficacy analyses included all randomized mother-infant pairs except those with infant HIV-1 infection at entry.
resultsBetween June 2011 and October 2014, 2431 mother-infant pairs were enrolled; 97% of women were World Health Organization Clinical Stage I, median screening CD4 count 686 cells/mm. Median infant gestational age/birth weight was 39 weeks/2.9 kilograms. Seven of 1219 (0.57%) and 7 of 1211 (0.58%) analyzed infants in the mART and iNVP arms, respectively, were HIV-infected (hazard ratio 1.0, 96% repeated confidence interval 0.3-3.1); infant HIV-free survival was high (97.1%, mART and 97.7%, iNVP, at 24 months). There were no significant differences between arms in median time to breastfeeding cessation (16 months) or incidence of severe, life-threatening, or fatal adverse events for mothers or infants (14 and 42 per 100 person-years, respectively).
conclusionsBoth mART and iNVP prophylaxis strategies were safe and associated with very low breastfeeding HIV-1 transmission and high infant HIV-1-free survival at 24 months.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.