Trial reportJournal of acquired immune deficiency syndromes (1999)2014
Efficacy and safety of an extended nevirapine regimen in infants of breastfeeding mothers with HIV-1 infection for prevention of HIV-1 transmission (HPTN 046): 18-month results of a randomized, double-blind, placebo-controlled trial.
Trial report in Journal of acquired immune deficiency syndromes (1999), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.
What it found
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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.
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Who cites it
14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 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
- HIV-free survival at 12-24 months in breastfed infants of HIV-infected women on antiretroviral treatment.Tropical medicine & international health : TM & IH · 2016Pooled it
- Article
- Optimizing the World Health Organization algorithm for HIV vertical transmission risk assessment by adding maternal self-reported antiretroviral therapy adherence.BMC public health · 2022Article
- Pediatric AIDS-Therapeutic Successes Built on a Foundation of Pediatric Clinical Pharmacology with Pharmacokinetic-Pharmacodynamic Modeling.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2022Article
- Correlates and determinants of Early Infant Diagnosis outcomes in North-Central Nigeria.AIDS research and therapy · 2019Article
- Identifying high or low risk of mother to child transmission of HIV: How Harare City, Zimbabwe is doing?PloS one · 2019Article
- Systemic administration of an HIV-1 broadly neutralizing dimeric IgA yields mucosal secretory IgA and virus neutralization.Mucosal immunology · 2017Article
- The History of the HIV/AIDS Epidemic in Africa.Current HIV/AIDS reports · 2016Review
- Maternal Highly Active Antiretroviral Therapy and Child HIV-Free Survival in Malawi, 2004-2009.Maternal and child health journal · 2016Article
- Sexuality and Reproduction in HIV-Positive Women: A Meta-Synthesis.AIDS patient care and STDs · 2016Review
- Engagement of Traditional Healers and Birth Attendants as a Controversial Proposal to Extend the HIV Health Workforce.Current HIV/AIDS reports · 2015Review
- Prevention of mother-to-child transmission of HIV type 1: the role of neonatal and infant prophylaxis.Expert review of anti-infective therapy · 2015Review
- The association between the ratio of monocytes: lymphocytes and risk of tuberculosis among HIV-infected postpartum women.Journal of acquired immune deficiency syndromes (1999) · 2014Article
Corrections and comments
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Authors and funding
25 authors at 14 institutions in 5 countries.
Funding
Abstract
backgroundHPTN 046 compared the efficacy and safety of infant nevirapine (NVP) among HIV-exposed breastfed infants randomized at 6 weeks to 6 months to t NVP or placebo to prevent postnatal infection: we report final 18-month outcomes.
methodsRandomized, placebo-controlled trial in 4 African countries. Infant diagnostic HIV testing was performed regularly from birth through 18 months. Kaplan-Meier analysis was used to assess 18-month cumulative infant HIV infection, HIV infection/or death, and mortality rates.
resultsBetween 6 weeks and 6 months, postnatal HIV infection rates were significantly lower among infants receiving daily NVP from 6 weeks to 6 months 1.1% [95% confidence interval (CI): 0.2% to 1.8%], compared with placebo 2.4% (95% CI: 1.3% to 2.6%), P = 0.049, but not significantly lower thereafter. Eighteen-month postnatal infection rates were low: 2.2% (95% CI: 1.1% to 3.3%) versus 3.1% (95% CI: 1.9% to 4.4%), respectively, P = 0.28. Mortality and HIV infection/death did not differ between arms at any age. Infants of women receiving antiretroviral therapy (ART) for their own health had the lowest 18-month postnatal infection rates (0.5%, 95% CI: 0.0% to 1.1%). However, HIV infection/death rates at 18 months were not significantly different for infants of mothers on ART (3.7%, 95% CI: 1.9% to 5.5%), and infants of mothers with CD4 counts of ≥ 350 cells per cubic millimeter not receiving ART (4.8%, 95% CI: 2.7% to 6.8%; P = 0.46). There were no differences in adverse events between study arms.
conclusionsThis trial demonstrated early but not late differences in postnatal HIV transmission among infants randomized at age 6 weeks to extended NVP or placebo, underscoring the importance of continued prophylaxis throughout breastfeeding.
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