NCT02881320

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1

A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 177 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 1 Month – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	B/F/TAF (Adult Strength)	50/200/25 mg FDC tablets administered orally once daily without regard to food.
DRUG	B/F/TAF (Low Dose)	30/120/15 mg FDC tablets administered orally once daily without regard to food.
DRUG	B/F/TAF (TOS)	2 x B/F/TAF 15/60/7.5 mg (total daily dose 30/120/15 mg) FDC tablets administered orally as TOS, once daily.
DRUG	B/F/TAF (TOS)	2 x B/F/TAF 3.75/15/1.88 mg (total daily dose 15/60/7.52 mg) FDC tablets administered orally as TOS, twice daily.
DRUG	B/F/TAF (TOS)	1 x B/F/TAF 3.75/15/1.88 mg (total daily dose 7.5/30/3.76 mg) FDC tablets administered orally as TOS, twice daily.
DRUG	B/F/TAF (TOS)	1 x B/F/TAF 1.88/7.5/0.94 mg (total daily dose 3.76/15/1.88 mg) FDC tablets administered orally as TOS, twice daily

Timeline

• Start date: 2016-09-21
• Primary completion: 2025-03-24
• Completion: 2026-11-01
• First posted: 2016-08-26
• Last updated: 2026-03-24

Locations

25 sites across 4 countries: United States, South Africa, Thailand, Uganda

Regulatory

• FDA-regulated drug study