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NCT06749054 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children
A Phase 2 study of HIV-1-infection, sponsored by Gilead Sciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 9
- Study locations
NCT06749054 is a Phase 2 study of HIV-1-infection that is actively recruiting participants, run by Gilead Sciences. The registered enrollment target is 12 participants, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (97% lower). The trial reports 9 study locations across 2 states.
The verdict
NCT06749054, a Phase 2 study of HIV-1-infection, is actively recruiting participants, sponsored by Gilead Sciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 9
- Study locations
Study Summary
The goal of this clinical study is to learn more about the study drug, lenacapavir (LEN). The study will assess the safety, tolerability, and efficacy of long-acting LEN when combined with other medicines in adolescents and children living with HIV-1 who weigh at least 35 kg and have been treated before for HIV-1. The study will also see how easy it is for participants to take LEN as injection or an oral pill. The primary objectives are to evaluate the pharmacokinetics and safety of LEN in combination with optimized background regimen (OBR) in TE pediatric participants with HIV-1.
Conditions Studied
Interventions
- DRUG Oral Lenacapavir
- DRUG Subcutaneous Lenacapavir
- DRUG Optimized Background Regimen (OBR)
Study Locations (9)
Other
- FAMCRU - Cape Town
- CRISMO Research Centre - Germiston
- Wits RHI Shandukani Research Centre CRS - Johannesburg
- Rahima Moosa Mother and Child Hospital - Johannesburg
- Clinical Research Institute of South Africa (CRISA) - KwaDukuza
- Durban International Clinical Research Site, Enhancing Care Foundation - KwaZulu - Natal
- Be Part Research Pty (Ltd) - Paarl
- Perinatal HIV Research Unit (PHRU) - Soweto
Georgia
- Grady Health System, Ponce De Leon Center - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-03-26 |
| Est. Completion | 2027-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06749054
The ClinicalTrials.gov registry entry for NCT06749054 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (97% 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 3 interventions - of which Oral Lenacapavir is the first listed.
NCT06749054 reports 9 study locations spanning 2 distinct geographic areas - top geographies include Other, Georgia.
Frequently Asked Questions
What is clinical trial NCT06749054 about?
NCT06749054 is a clinical study titled "Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children". The goal of this clinical study is to learn more about the study drug, lenacapavir (LEN). The study will assess the safety, tolerability, and efficacy of long-acting LEN when combined with other medicines in adolescents and children living with HIV-1 who weigh at least 35 kg and have been treated be...
What is the current status of trial NCT06749054?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2025-03-26. Estimated completion is 2027-04.
What conditions does trial NCT06749054 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT06749054?
The interventions under investigation include: Oral Lenacapavir (DRUG), Subcutaneous Lenacapavir (DRUG), Optimized Background Regimen (OBR) (DRUG).
Who is sponsoring clinical trial NCT06749054?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06749054 being conducted?
This trial has 9 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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