Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1 (NCT06532656)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's National Hospital — Washington D.C., District of Columbia
Age range: 2 Years to 17 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (21 Sites)
- Children's National Hospital — Washington D.C., District of Columbia
- University of South Florida — Tampa, Florida
- Grady Ponce de Leon Center — Atlanta, Georgia
- Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois
- Helios Salud S.A — Buenos Aires,
- ASST FBF Sacco Ospedale Sacco — Milan,
- IRCCS Ospedale Pediatrico Bambino Gesu, UOS Infezioni Complesse e Perinatali — Roma,
- FAMCRU Ukwanda School for Rural Health — Cape Town,
- Be Part Yoluntu — Cape Town,
- Durban International Clinical Research Site, Enhancing Care Foundation — Durban,
- Monti Clinical Research Centre — East London,
- Perinatal HIV Research Unit — Johannesburg,
- Wits RHI Shandukani Research Centre CRS — Johannesburg,
- Nkanyezi VIDA Research Unit — Johannesburg,
- Khomanani Health Research and Wellness Centre — Ka-Majosi,
- Clinical Research Institute of South Africa (CRISA) — KwaDukuza,
- The Aurum Institute: Pretoria Clinical Research Centre — Pretoria,
- Setshaba Research Centre — Soshanguve,
- Hospital General Universitario Gregorio Marano — Madrid,
- Hospital Universitario 12 De Octubre — Madrid,
- Hospital Universitario La Paz — Madrid,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in HIV-1-infection
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen — Berkeley, California
- Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1 — Birmingham, Alabama
- Impact of HIV-1 and Aging on Mucosal Vaccine Responses — Aurora, Colorado
- Study of Oral Weekly Lepetegravir (Formerly GS-1720) and Lenacapavir Pacfosacil (Formerly GS-4182) Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed — Birmingham, Alabama
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy — Phoenix, Arizona
Explore by condition: All HIV-1-infection clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.