Trial reportThe Pediatric infectious disease journal2025
Efficacy, Safety and Tolerability of Dispersible and Immediate Release Abacavir/Dolutegravir/Lamivudine Tablets in Children With HIV: IMPAACT 2019 Week 48 Results.
Trial report in The Pediatric infectious disease journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The trial behind it
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Who cites it
1 citing paper in PubMed.
- Early outcomes of South African children with persistent viral non-suppression following switch to dolutegravir-based antiretroviral therapy.Southern African journal of HIV medicine · 2026Article
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Authors and funding
28 authors.
Funding
Abstract
backgroundDispersible and immediate-release fixed-dose combinations (FDC) of abacavir, dolutegravir, and lamivudine are priority first-line antiretroviral therapy (ART) in children with HIV-1 (CWHIV). We report safety, efficacy and tolerability of these regimens through 48 weeks of treatment.
methodsIMPAACT 2019 was a phase I/II, international, multisite, open-label, noncomparative study of dispersible and immediate-release FDC abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in participants with HIV-1 <12 years of age weighing 6 to <40 kg. At entry, participants were ART-naive or ART-experienced and virally suppressed on stable ART for ≥6 months. Participants received weight-banded dosing and enrolled across 5 weight bands in parallel. Follow-up visits were completed at weeks 1, 4, 12, 24, 36 and 48.
resultsFifty-seven participants were enrolled; 2 participants withdrew due to poor drug tolerability. Fifty-four of 55 participants on the study at week 48 remained on the study drug. All 54 participants who remained on study drug through week 48 had viral loads of <200 copies/mL. CD4-lymphocyte counts remained stable with age over 48 weeks. Mean change (95% confidence interval) in body mass index Z-scores was 0.4 (0.2-0.6). Nine study drug-related adverse events were reported. One drug-induced liver injury attributed to abacavir and dolutegravir led to the permanent discontinuation of the study drug.
conclusionsDispersible FDC ABC/DTG/3TC is the first dispersible dolutegravir-containing single tablet regimen for CWHIV. Dispersible- and immediate-release ABC/DTG/3TC was observed to be generally safe, effective and well-tolerated in CWHIV through 48 weeks.
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