Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023
Pharmacokinetic Data of Dolutegravir in Second-line Treatment of Children With Human Immunodeficiency Virus: Results From the CHAPAS4 Trial.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.
- Genetic variation on dolutegravir pharmacokinetics and relation to safety and efficacy outcomes: a systematic review.Pharmacogenomics · 2024Pooled it
- Pharmacokinetics of once-daily darunavir/ritonavir in second-line treatment in African children with HIV.The Journal of antimicrobial chemotherapy · 2024Trial
- Population Pharmacokinetics of Dolutegravir in African Children: Results From the CHAPAS-4 Trial.Journal of the Pediatric Infectious Diseases Society · 2024Trial
- Use of Integrase Strand Transfer Inhibitors Among Children Living With HIV in Latin America and the Caribbean.The Pediatric infectious disease journal · 2026Article
- Pharmacokinetics of lopinavir/ritonavir in second-line treatment of children with HIV in the CHAPAS-4 trial.AIDS (London, England) · 2025Article
- Influence of age and co-medication on dolutegravir glucuronidation in paediatric patients.British journal of clinical pharmacology · 2024Article
Corrections and comments
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Authors and funding
13 authors at 5 institutions in 6 countries.
Funding
Abstract
backgroundDolutegravir (DTG), combined with a backbone of 2 nucleoside reverse transcriptase inhibitors, is currently the preferred first-line treatment for human immunodeficiency virus (HIV) in childhood. CHAPAS4 is an ongoing randomized controlled trial investigating second-line treatment options for children with HIV. We did a nested pharmacokinetic (PK) substudy within CHAPAS4 to evaluate the DTG exposure in children with HIV taking DTG with food as part of their second-line treatment.
methodsAdditional consent was required for children on DTG enrolled in the CHAPAS4 trial to participate in this PK substudy. Children weighing 14-19.9 kg took 25 mg DTG as dispersible tablets and children ≥20 kg took 50 mg film-coated tablets. Steady-state 24-hour DTG plasma concentration-time PK profiling was done at t = 0 and 1, 2, 4, 6, 8, 12, and 24 hours after observed DTG intake with food. Reference adult PK data and pediatric data from the ODYSSEY trial were used primarily for comparison. The individual target trough concentration (Ctrough) was defined as 0.32 mg/L.
resultsThirty-nine children on DTG were included in this PK substudy. The geometric mean (GM) area under the concentration-time curve over the dosing interval (AUC0-24h) was 57.1 hours × mg/L (coefficient of variation [CV%], 38.4%), which was approximately 8% below the average AUC0-24h in children in the ODYSSEY trial with comparable dosages, but above the adult reference. The GM (CV%) Ctrough was 0.82 mg/L (63.8%), which was comparable to ODYSSEY and adult reference values.
conclusionsThis nested PK substudy shows that the exposure of DTG taken with food in children on second-line treatment is comparable with that of children in the ODYSSEY trial and adult references. Clinical Trials Registration.ISRCTN22964075.
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