drugset / Trial / NCT02016924
Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV
Non-randomizedSequentialOpen-labelTreatment
Summary
The goal of this clinical study is to learn more about the safety and dosing of study drugs, cobicistat-boosted Atazanavir (ATV/co), cobicistat-boosted darunavir (DRV/co) and emtricitabine/tenofovir alafenamide (F/TAF), in children (age ≥ 4 weeks to \< 18 years) with HIV.
Timeline
- Start
- 2014-01-16
- Primary completion
- 2025-06-13
- Completion
- 2027-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atazanavir | Other / unclassified | — | Oral |
| Subject | Cobicistat | Small molecule | 30 mg | Oral |
| Subject | Cobicistat | Small molecule | 90 mg | Oral |
| Subject | Cobicistat | Small molecule | 150 mg | Oral |
| Subject | Darunavir | Small molecule | — | 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 | 1.88 mg | Oral |
| Subject | tenofovir alafenamide | Small molecule | 3.75 mg | Oral |
| Subject | tenofovir alafenamide | Small molecule | 7.5 mg | Oral |
| Subject | tenofovir alafenamide | Small molecule | 15 mg | Oral |
| Subject | tenofovir alafenamide | Small molecule | 25 mg | Oral |
| Background | Abacavir | Other / unclassified | — | — |
| Background | Didanosine | Small molecule | — | — |
| Background | Lamivudine | Other / unclassified | — | — |
| Background | Lopinavir | Other / unclassified | — | Oral |
| Background | Stavudine | Other / unclassified | — | — |
| Background | Tenofovir disoproxil fumarate | Small molecule | — | — |
| Background | Zidovudine | Small molecule | — | — |