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Study details
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Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children

Gilead Sciences
NCT IDNCT06749054ClinicalTrials.gov data as of Apr 2026
Phase

Phase 2

Target enrollment

12

Study length

about 2.1 years

Ages

≤17

Locations

1 site in GA

About this study

Researchers are testing a new treatment, lenacapavir (LEN), to see if it's safe and effective in children and adolescents who have already been treated for HIV. The trial will evaluate how well LEN works when combined with other medicines, either as an injection or an oral pill.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Receive Subcutaneous Lenacapavir
  • 2.Take Optimized Background Regimen (OBR)
  • 3.Take Oral Lenacapavir
PhasePhase 2
DrugOral Lenacapavir
Routeinjection
Primary goalPercentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 26

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low11%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

lenacapavir

Drug routes

injection, subcutaneous, oral

Endpoints

Primary: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 26, Pharmacokinetic (PK) Parameter: Ctrough, W26 of Lenacapavir (LEN)

Secondary: Change From Baseline in CD4+ Cell Counts at Week 52, Change From Baseline in Clusters of Differentiation (CD4)+ Cell Counts at Week 26, PK Parameter: AUC D1-W26 of LEN, PK Parameter: Cmax, D1-W26 of LEN, Percent Change From Baseline in CD4+ at Week 26, Percent Change From Baseline in CD4+ at Week 52, Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52

Body systems

Immune, Infectious