Peer-reviewed article
Growth Outcomes After 48 Weeks of Dolutegravir in Children and Adolescents with HIV-1 in IMPAACT P1093 and IMPAACT 2019
Michael McKenna, Zrinka Lulic, Ann M. Buchanan, Cynthia Brothers, Lionel K. K. Tan et al. ·
Summary
Written by AI, not yet AICS's view · claude-sonnet-5This study looked at growth in children and teenagers with HIV who started or switched to a drug called dolutegravir as part of their HIV treatment. Researchers tracked their weight and height for one year using two clinical trials. On average, children's body mass index scores improved slightly and moved into a healthier range by week 48. However, most children stayed in the same weight category they started in, and some children who were underweight became overweight rather than reaching a normal healthy weight.
Key points
- 181 and 57 participants were included from the two trials, with 10% being adolescents.
- Average BMI-for-age z-score increased significantly in one trial (0.3) and improved but not significantly in the other trial by week 48.
- 65% and 74% of participants in the two trials stayed in the same weight category throughout the study.
- 6-7% of participants moved from malnutrition/thinness to normal weight, while 5-9% moved to overweight or obesity.
- Height and overall weight-for-age showed only small changes over the study period.
Limitations
This is a summary of an abstract only, so full study details on methodology and confounding factors are not available. Both trials lacked a comparison group not receiving dolutegravir, making it hard to know if growth changes were due to the drug itself.
Abstract
BACKGROUND: We evaluated growth outcomes in children and adolescents with HIV-1 initiating or switching to dolutegravir-based antiretroviral therapy (ART) in the single-arm trials IMPAACT P1093 (P1093) and IMPAACT 2019. METHODS: We 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. BAZ changes were assessed using a mixed model for repeated measures. RESULTS: We 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 < 0.05) and non-significantly in IMPAACT 2019 (0.3; 95% CI, -0.03, 0.58; p = 0.074). 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. CONCLUSIONS: Small 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.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- Dolutegravir-based antiretroviral therapy
- Population
- Children and adolescents with HIV-1 initiating or switching to dolutegravir-based ART (238 total participants across two trials)
Key finding
Adjusted mean BMI-for-age z-score increased significantly by 0.3 in one trial (p<0.05) and non-significantly by 0.3 in the other (p=0.074).
McKenna et al. · OpenAlex · 12 Sept 2026