drugset / Trial / NCT03760458
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
Phase 1/2
Completed
57 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabInternational Maternal Pediatric Adolescent AIDS Clinical Trials Group · collabNational Institute of Mental Health (NIMH) · collabViiV Healthcare · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study was to examine the pharmacokinetics, safety, and tolerability of abacavir/dolutegravir/lamivudine dispersible and immediate release tablets in children living with HIV less than 12 years of age.
Timeline
- Start
- 2020-09-09
- Primary completion
- 2021-12-14
- Completion
- 2022-05-31
Publications
- Brooks KM, Kiser JJ, Ziemba L, Ward S, Rani Y, Cressey TR, Masheto GR, Cassim H, Deville JG, Ponatshego PL, Patel F, Aurpibul L, Barnabas SL, Mustich I, Coletti A, Heckman B, Krotje C, Lojacono M, Yin DE, Townley E, Moye J, Majji S, Acosta EP, Ryan K, Chandasana H, Brothers CH, Buchanan AM, Rabie H, Flynn PM; IMPAACT 2019 Study Team. Pharmacokinetics, safety, and tolerability of dispersible and immediate-release abacavir, dolutegravir, and lamivudine tablets in children with HIV (IMPAACT 2019): week 24 results of an open-label, multicentre, phase 1-2 dose-confirmation study. Lancet HIV. 2023 Aug;10(8):e506-e517. doi: 10.1016/S2352-3018(23)00107-8.
- Singh RP, Adkison KK, Baker M, Parasrampuria R, Wolstenholme A, Davies M, Sewell N, Brothers C, Buchanan AM. Development of Dolutegravir Single-entity and Fixed-dose Combination Formulations for Children. Pediatr Infect Dis J. 2022 Mar 1;41(3):230-237. doi: 10.1097/INF.0000000000003366.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abacavir | Other / unclassified | 60 mg | Oral |
| Subject | Abacavir | Other / unclassified | 600 mg | Oral |
| Subject | Dolutegravir | Other / unclassified | 5 mg | Oral |
| Subject | Dolutegravir | Other / unclassified | 50 mg | Oral |
| Subject | Lamivudine | Other / unclassified | 30 mg | Oral |
| Subject | Lamivudine | Other / unclassified | 300 mg | Oral |