drugset / Trial / NCT02881320
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1
Non-randomizedSequentialOpen-labelTreatment
Summary
The goals of this clinical study are to learn how Bictegravir/Emtricitabine/Tenofovir Alafenamide fixed dose combination (FDC) interacts with the body, confirm the dose, and also to learn more about the safety and tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide FDC in adolescents and children with HIV-1.
Timeline
- Start
- 2016-09-21
- Primary completion
- 2025-03-24
- Completion
- 2026-11
Publications
- Rodriguez CA, Natukunda E, Strehlau R, Venter EL, Rungmaitree S, Cunningham CK, Lalloo U, Kosalaraksa P, HellstrOm E, Liberty A, McGrath EJ, Kaur M, Leisegang R, Hindman JT, Vieira VA, Kersey K, Cotton MF, Rakhmanina N, Gaur AH. Pharmacokinetics and safety of coformulated bictegravir, emtricitabine, and tenofovir alafenamide in children aged 2 years and older with virologically suppressed HIV: a phase 2/3, open-label, single-arm study. Lancet HIV. 2024 May;11(5):e300-e308. doi: 10.1016/S2352-3018(23)00327-2. Epub 2024 Apr 12.
- Gaur AH, Cotton MF, Rodriguez CA, McGrath EJ, Helstrom E, Liberty A, Natukunda E, Kosalaraksa P, Chokephaibulkit K, Maxwell H, Wong P, Porter D, Majeed S, Yue MS, Graham H, Martin H, Brainard DM, Pikora C. Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide in adolescents and children with HIV: week 48 results of a single-arm, open-label, multicentre, phase 2/3 trial. Lancet Child Adolesc Health. 2021 Sep;5(9):642-651. doi: 10.1016/S2352-4642(21)00165-6. Epub 2021 Jul 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | bictegravir | Small molecule | 1.88 mg | Oral |
| Subject | bictegravir | Small molecule | 3.75 mg | Oral |
| Subject | bictegravir | Small molecule | 7.5 mg | Oral |
| Subject | bictegravir | Small molecule | 15 mg | Oral |
| Subject | bictegravir | Small molecule | 30 mg | Oral |
| Subject | bictegravir | Small molecule | 50 mg | Oral |
| Subject | emtricitabine | Other / unclassified | 7.5 mg | Oral |
| Subject | emtricitabine | Other / unclassified | 15 mg | Oral |
| Subject | emtricitabine | Other / unclassified | 30 mg | Oral |
| Subject | emtricitabine | Other / unclassified | 60 mg | Oral |
| Subject | emtricitabine | Other / unclassified | 120 mg | Oral |
| Subject | emtricitabine | Other / unclassified | 200 mg | Oral |
| Subject | tenofovir alafenamide | Small molecule | 0.94 mg | Oral |
| Subject | tenofovir alafenamide | Small molecule | 1.88 mg | Oral |
| Subject | tenofovir alafenamide | Small molecule | 3.76 mg | Oral |
| Subject | tenofovir alafenamide | Small molecule | 7.52 mg | Oral |
| Subject | tenofovir alafenamide | Small molecule | 15 mg | Oral |
| Subject | tenofovir alafenamide | Small molecule | 25 mg | Oral |