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Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1
Sponsor: Gilead Sciences
Summary
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.
Official title: A Phase 2/3, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2024-11-20
Completion Date
2028-08
Last Updated
2026-01-12
Healthy Volunteers
No
Conditions
Interventions
Lenacapavir
Tablets administered orally without regard to food
BIC/LEN FDC
Tablets administered orally without regard to food
Locations (21)
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