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NCT06532656 · ClinicalTrials.gov registry record · Phase 2
Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1
A Phase 2 study of HIV-1-infection, sponsored by Gilead Sciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
- 20
- Study locations
NCT06532656: Recruiting Phase 2 study of HIV-1-infection, sponsored by Gilead Sciences.
NCT06532656 is a Phase 2 study of HIV-1-infection that is actively recruiting participants, run by Gilead Sciences. The registered enrollment target is 75 participants, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06532656, a Phase 2 study of HIV-1-infection, is actively recruiting participants, sponsored by Gilead Sciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Cmax is defined as the maximum observed concentration of drug at steady state.
Conditions Studied
Interventions
- DRUG Lenacapavir
- DRUG BIC/LEN FDC
Study Locations (20)
Other
- 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
District of Columbia
- Children's National Hospital - Washington D.C.
Florida
- University of South Florida - Tampa
Georgia
- Grady Ponce de Leon Center - Atlanta
Illinois
- Ann and Robert H. Lurie Children's Hospital of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2024-11-20 |
| Est. Completion | 2028-08 |
| Phase | Phase 2 |
What NCT06532656 shows while recruiting
NCT06532656 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (79% lower).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 2 interventions - of which Lenacapavir is the first listed.
NCT06532656 names 20 study sites across 5 states, led by Other, District of Columbia, Florida.
Frequently Asked Questions
What is clinical trial NCT06532656 about?
NCT06532656 is a clinical study titled "Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1". 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 comple...
What is the current status of trial NCT06532656?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2024-11-20. Estimated completion is 2028-08.
What conditions does trial NCT06532656 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT06532656?
The interventions under investigation include: Lenacapavir (DRUG), BIC/LEN FDC (DRUG).
Who is sponsoring clinical trial NCT06532656?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06532656 being conducted?
This trial has 20 study locations across District of Columbia, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06532656's enrollment target sits among peer trials
75 39th of 71 higher than 32 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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