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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Gilead Sciences
Study ID
NCT06749054
Phase
PHASE2
Status
Recruiting
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Conditions

  • HIV-1-infection

Eligibility Criteria

Sex
ALL
Age
N/A - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Oral Lenacapavir — DRUG
    Tablets administered without regard to food
  • Subcutaneous Lenacapavir — DRUG
    Administered via subcutaneous injections
  • Optimized Background Regimen (OBR) — DRUG
    Optimized background regimen as prescribed by the Investigator

Study Details

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.

Key Dates

Start date
Mar 26, 2025
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LEN
    Participants will receive oral LEN 600 mg on Days 1 and 2. Participants will also receive 2 doses of LEN 927 mg as subcutaneous (SC) injection on Day 1 and Week 26 along with their OBR per clinical practice. At the Week 52, participants will be given the option to receive SC LEN every 6 months while continuing their OBR for at least another 2 SC LEN doses in the extension phase.

Primary Outcome Measure

Pharmacokinetic (PK) Parameter: Ctrough, W26 of Lenacapavir (LEN) [ Time Frame: Week 26 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Grady Health System, Ponce De Leon CenterAtlantaGeorgia30308-

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Grady Health System, Ponce De Leon Center· Atlanta, GA

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