Trial reportJournal of the Pediatric Infectious Diseases Society2025
Longitudinal Evaluation of Bone Safety in Children and Adolescents With HIV-1 Starting Tenofovir Alafenamide-Containing Antiretroviral Therapy.
Trial report in Journal of the Pediatric Infectious Diseases Society, 2025. 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. Cited by 2 papers.
What it found
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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.
A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children
A Phase 2/3, Open-Label, Multi-Cohort Switch Study to Evaluate Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected Children and Adolescents Virologically Suppressed on a 2-NRTI-Containing Regimen
Who cites it
2 citing papers in PubMed.
- A novel all-in-one injectable composed of tenofovir alafenamide-dolutegravir-lamivudine exhibits long-acting plasma and cell drug persistence for 8 weeks.AIDS (London, England) · 2026Article
- Simulation-Based Predictions to Support the Development of a Pediatric Fixed-Dose Combination of Dolutegravir/Emtricitabine/Tenofovir Alafenamide Fumarate.Clinical pharmacokinetics · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
backgroundAdult participants taking tenofovir alafenamide (TAF) in clinical trials had a better bone safety profile than those taking tenofovir disoproxil fumarate. Herein, we report medium- to long-term effects of TAF-containing regimens on bone health in children and adolescents with human immunodeficiency virus (HIV).
methodsThis post hoc pooled analysis of data from 2 phase 2/3 clinical studies (NCT01854775 and NCT02285114) evaluated the pharmacokinetics, safety, and efficacy of TAF-based regimens in children and adolescents with HIV-1. Participants were categorized into group 1 (aged 12 to < 18 years, weighing ≥ 35 kg), group 2 (aged 6 to < 12 years, weighing ≥ 25 kg), and group 3 (aged ≥ 2 years, weighing 14 to < 25 kg). Evaluations included virologic suppression, height Z-score, Tanner stage, bone mineral density (BMD) of the spine and total body less head (TBLH; absolute and height-for-age Z-score adjusted [HAZ-adjusted] for both), bone serum markers, bone-related adverse events, and pharmacokinetic assessments.
resultsOverall, 169 participants were enrolled and treated (78, 61, and 30 in groups 1, 2, and 3, respectively). Median (range) exposure to study drug was 320.3 (8.3-492.3), 290.1 (24.0-393.9), and 168.3 (9.0-193.0) weeks in groups 1, 2, and 3, respectively. Virologic suppression (HIV-1 RNA < 50 copies/mL) rates were high across all groups. Spine and TBLH absolute BMD increased over time in all groups, and spine and TBLH HAZ-adjusted BMD Z-scores increased or remained stable in all groups. There were no significant changes in bone serum markers, and no treatment-related fractures or bone-related adverse events.
conclusionsTAF-based regimens demonstrated acceptable medium- to long-term bone safety in children and adolescents with HIV.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.