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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: Recruiting Phase 2 study of HIV-1-infection, sponsored by Gilead Sciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Ctrough, W26 is defined as the plasma concentration at the end of the dosing interval at Week 26.
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 |
What NCT06749054 shows while recruiting
NCT06749054 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (97% lower).
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 lists 9 locations in 2 states (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.
Learn More About Clinical Trials
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Where NCT06749054's enrollment target sits among peer trials
12 68th of 71 higher than 3 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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