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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 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.

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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.

Conditions Studied

HIV-1-infection

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

FieldValue
Enrollment Target 75 participants
Start Date 2024-11-20
Est. Completion 2028-08
Phase Phase 2

Sponsor

Gilead Sciences

504 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06532656

The ClinicalTrials.gov registry entry for NCT06532656 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (79% lower). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.