Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1
Running, not enrolling · Phase 2/Phase 3
Conditions studied: HIV-1-infection
In brief
The goal of this clinical study is to learn about the safety and tolerability of bictegravir/lenacapavir (BIC/LEN) and to learn how the study drug interacts with the body in virologically suppressed (VS) children and adolescents with human immunodeficiency virus type 1 (HIV-1) on a stable and complex antiretroviral (ARV) regimen. The study will also assess the safe loading dose of LEN and pharmacokinetics (PK) of BIC/LEN. The primary objectives of this study are: * To evaluate the steady-state PK of BIC and LEN and confirm the dose of the LEN loading dose and BIC/LEN FDC in VS children and adolescents with HIV-1. * To evaluate the safety and tolerability of BIC/LEN through Week 24 in VS children and adolescents with HIV-1.
Key facts
- Study ID
- NCT06532656
- Run by
- Gilead Sciences
- People needed
- 75
- Starts
- 2024-11-20
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2026-06-04
Who can join
Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Children's National Hospital — Washington D.C., District of Columbia, United States
- University of South Florida — Tampa, Florida, United States
- Grady Ponce de Leon Center — Atlanta, Georgia, United States
- Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
- Helios Salud S.A — Buenos Aires, Argentina
- ASST FBF Sacco Ospedale Sacco — Milan, Italy
- IRCCS Ospedale Pediatrico Bambino Gesu, UOS Infezioni Complesse e Perinatali — Roma, Italy
- FAMCRU Ukwanda School for Rural Health — Cape Town, South Africa
- Be Part Yoluntu — Cape Town, South Africa
- Durban International Clinical Research Site, Enhancing Care Foundation — Durban, South Africa
- Monti Clinical Research Centre — East London, South Africa
- Perinatal HIV Research Unit — Johannesburg, South Africa
- Wits RHI Shandukani Research Centre CRS — Johannesburg, South Africa
- Nkanyezi VIDA Research Unit — Johannesburg, South Africa
- Khomanani Health Research and Wellness Centre — Ka-Majosi, South Africa
- Clinical Research Institute of South Africa (CRISA) — KwaDukuza, South Africa
- The Aurum Institute: Pretoria Clinical Research Centre — Pretoria, South Africa
- Setshaba Research Centre — Soshanguve, South Africa
- Hospital General Universitario Gregorio Marano — Madrid, Spain
- Hospital Universitario 12 De Octubre — Madrid, Spain
- Hospital Universitario La Paz — Madrid, Spain
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.