Trial reportJournal of the Pediatric Infectious Diseases Society2026
Growth Outcomes After 48 Weeks of Dolutegravir in Children and Adolescents With HIV-1 in IMPAACT P1093 and IMPAACT 2019.
Trial report in Journal of the Pediatric Infectious Diseases Society, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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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.
Phase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of Dolutegravir, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents
Phase I/II Study of the Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age
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12 authors.
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Abstract
backgroundWe evaluated growth outcomes in children and adolescents with HIV-1 initiating or switching to dolutegravir-based antiretroviral therapy (ART) in the single-arm International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network studies P1093 and IMPAACT 2019.
methodsWe performed descriptive post hoc analyses of body mass index-for-age (BAZ), weight-for-age (WAZ), and length/height-for-age z scores (L/HAZ) for each trial through Week 48. Changes in BAZ were assessed using a mixed model for repeated measures.
resultsWe included data from 181 and 57 participants from P1093 and IMPAACT 2019, respectively (10% [23/238] were adolescents). Baseline mean BAZ was -0.1 in P1093 and -0.7 in IMPAACT 2019. At Week 48, adjusted mean BAZ increased significantly in P1093 (0.3; 95% CI, 0.03, 0.49; P < .05) and non-significantly in IMPAACT 2019 (0.3; 95% CI, -0.03, 0.58; P = .074). Mean BAZ was in the normal range at Week 48 in both trials. Marked increases in BAZ were observed among subgroups with baseline BAZ <-2. By Week 48, 65% (117/181) of participants in P1093 and 74% (42/57) in IMPAACT 2019 remained in the same BAZ category. Improvements from severe or moderate malnutrition/thinness to normal weight occurred in 6% (10/181) and 7% (4/57) of participants in P1093 and IMPAACT 2019, respectively, while increases to overweight or obesity were observed in 9% (16/181) and 5% (3/57). Small changes were observed in overall mean WAZ and L/HAZ through Week 48 in both trials.
conclusionSmall overall increases in BAZ were observed over 1 year among pediatric participants on dolutegravir-based ART, with most participants remaining in their baseline BAZ category. CLINICAL TRIAL INFORMATION: ClinicalTrials.gov, NCT01302847 and NCT03760458.
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