1. Pediatric Neurodevelopmental Functioning After In Utero Exposure to Triple-NRTI vs. Dual-NRTI + PI ART in a Randomized Trial, Botswana
- Author
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Tebogo Madidimalo, Deborah Kacanek, Betsy Kammerer, Shahin Lockman, Penny Holding, Gloria Mayondi, Joseph Makhema, Jean Leidner, Paige L. Williams, Kebaiphe Moabi, Sharon Nichols, Haruna Jibril, Vicki Tepper, and Roger L. Shapiro
- Subjects
Adult ,Pediatrics ,medicine.medical_specialty ,Anti-HIV Agents ,HIV Infections ,Article ,law.invention ,Nucleoside Reverse Transcriptase Inhibitor ,03 medical and health sciences ,Zidovudine ,Young Adult ,0302 clinical medicine ,Pharmacotherapy ,Child Development ,Randomized controlled trial ,law ,immune system diseases ,Pregnancy ,030225 pediatrics ,Antiretroviral Therapy, Highly Active ,medicine ,Humans ,Pharmacology (medical) ,030212 general & internal medicine ,Young adult ,Pregnancy Complications, Infectious ,Maternal-Fetal Exchange ,reproductive and urinary physiology ,Botswana ,business.industry ,Infant, Newborn ,Lamivudine ,virus diseases ,Infant ,Lopinavir ,HIV Protease Inhibitors ,Infectious Diseases ,In utero ,Neurodevelopmental Disorders ,Reverse Transcriptase Inhibitors ,Female ,business ,medicine.drug - Abstract
BACKGROUND: In 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+PI regimen). SETTING: The Mma Bana randomized trial was conducted in urban and rural sites in Botswana. METHODS: The Mma Bana study randomized HIV-infected pregnant women with CD4 ≥ 200 cells/mm(3) to a triple-NRTI vs. dual-NRTI+PI regimen from 26–34 weeks gestation through planned weaning at 6 months 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 3(rd) edition, Ten Questions Questionnaire, and Profile of Social Emotional Development. We evaluated differences in mean scores between the two arms using unadjusted and adjusted linear regression. RESULTS: A total of 197 HEU infants (48% male) completed a neurodevelopmental assessment (101 in triple-NRTI arm; 96 in dual-NRTI+PI-exposed arm). Means 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). CONCLUSION: Neurodevelopmental 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 versus a triple-NRTI-based ART regimen, suggestive of lack of short term toxicity. Monitoring of long term toxicity and newer regimens is warranted.
- Published
- 2018