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RECRUITING
NCT06532656
PHASE2/PHASE3

Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1

Sponsor: Gilead Sciences

View on ClinicalTrials.gov

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

DRUG

Lenacapavir

Tablets administered orally without regard to food

DRUG

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