Trial reportJournal of acquired immune deficiency syndromes (1999)2018
Pediatric Neurodevelopmental Functioning After In Utero Exposure to Triple-NRTI vs. Dual-NRTI + PI ART in a Randomized Trial, Botswana.
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 7 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.
- Early neurodevelopment of HIV-exposed uninfected children in the era of antiretroviral therapy: a systematic review and meta-analysis.The Lancet. Child & adolescent health · 2022Pooled it
- Growth, clinical and neurodevelopmental outcomes at school age are similar for children who received 1-year lamivudine or lopinavir/ritonavir HIV prophylaxis in early life.Scientific reports · 2021Trial
- Association of maternal and infant inflammation with neurodevelopment in HIV-exposed uninfected children in a South African birth cohort.Brain, behavior, and immunity · 2021Article
- Epilepsy management in pregnant HIV+ women in sub-Saharan Africa, clinical aspects to consider: a scoping review.BMC medicine · 2020Article
- Contemporary Issues in Pregnancy (and Offspring) in the Current HIV Era.Current HIV/AIDS reports · 2019Review
- In Utero Efavirenz Exposure and Neurodevelopmental Outcomes in HIV-exposed Uninfected Children in Botswana.The Pediatric infectious disease journal · 2019Article
- Contribution of Maternal Antiretroviral Therapy and Breastfeeding to 24-Month Survival in Human Immunodeficiency Virus-Exposed Uninfected Children: An Individual Pooled Analysis of African and Asian Studies.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018Article
Corrections and comments
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Authors and funding
14 authors at 8 institutions in 2 countries.
Funding
Abstract
backgroundIn utero exposure to nucleoside reverse transcriptase inhibitor (NRTI)-containing antiretroviral treatment (ART) regimens may be associated with poor neurodevelopmental functioning in children of HIV-infected mothers. We investigated neurodevelopmental outcomes of HIV-exposed uninfected (HEU) children of HIV-infected women enrolled in a randomized trial of abacavir/zidovudine/lamivudine (triple-NRTI regimen) vs. lopinavir/ritonavir/zidovudine/lamivudine [dual-NRTI + protease inhibitor (PI) regimen].
settingThe Mma Bana randomized trial was conducted in urban and rural sites in Botswana.
methodsThe Mma Bana study randomized HIV-infected pregnant women with CD4 ≥200 cells per mm to a triple-NRTI vs. dual-NRTI + PI regimen from 26- to 34-week gestation through planned weaning at 6-month postpartum. Partway through the study, neurodevelopmental assessments were added at 24 months of age, including the Developmental Milestones Checklist, the Bayley Scales of Infant and Toddler Development third edition, Ten Questions Questionnaire, and Profile of Social Emotional Development. We evaluated differences in mean scores between the 2 arms using unadjusted and adjusted linear regression.
resultsA total of 197 HEU infants (48% male) completed a neurodevelopmental assessment (101 in triple-NRTI arm and 96 in dual-NRTI + PI-exposed arm). Mean values for all neurodevelopmental outcomes were similar for children of mothers randomized to either ART regimen, with no significant differences in either unadjusted or adjusted models (estimated effect sizes ranging from -0.12 to 0.14).
conclusionsNeurodevelopmental outcomes in 24-month-old HEU children of HIV-infected mothers with baseline CD4 ≥200 were similar in those randomized to a dual-NRTI + PI-based vs. a triple-NRTI-based ART regimen, suggestive of lack of short-term toxicity. Monitoring of long-term toxicity and newer regimens is warranted.
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