Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children
NCT ID: NCT06749054
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
12 participants
INTERVENTIONAL
2025-03-26
2027-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Oral Lenacapavir
Tablets administered without regard to food
Subcutaneous Lenacapavir
Administered via subcutaneous injections
Optimized Background Regimen (OBR)
Optimized background regimen as prescribed by the Investigator
Interventions
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Oral Lenacapavir
Tablets administered without regard to food
Subcutaneous Lenacapavir
Administered via subcutaneous injections
Optimized Background Regimen (OBR)
Optimized background regimen as prescribed by the Investigator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* On a stable failing antiretroviral (ARV) regimen for \> 8 weeks before screening and willing to continue the regimen until Day 1.
* Plasma HIV-1 RNA ≥ 400 copies/mL on at least 2 consecutive occasions spanning at least 6 months, including at screening.
* Have previously changed their ARV regimen due to treatment failure.
* ARV treatment options limited due to resistance, tolerability, contraindications, safety, drug access.
* Able and willing to commit to taking LEN in combination with their OBR.
* The following laboratory parameters at screening:
1. Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m\^2 using Bedside Schwartz Formula.
2. Absolute neutrophil count \> 0.50 GI/L (\> 500 cells/mm\^3).
3. Hemoglobin ≥ 85 g/L (\> 8.5 g/dL).
4. Platelets ≥ 50 GI/L (≥ 50,000/mm\^3).
5. Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase) ≤ 5 × upper limit of normal.
6. Total bilirubin ≤ 23 μmol/L (≤ 1.5 mg/dL) and direct bilirubin ≤ 7 μmol/L (≤ 0.4 mg/dL).
Exclusion Criteria
* An opportunistic illness requiring treatment within the 30 days prior to screening.
* Evidence of active pulmonary or extra-pulmonary tuberculosis within 3 months prior to screening.
* Hepatitis C virus (HCV) antibody positive with detectable HCV RNA at screening.
* Hepatitis B virus (HBV) surface antigen (HBsAg) positive or HBV core antibody (antibody against hepatitis B core antigen (anti-HBc)) positive; if individual is HBsAg negative and anti-HBc positive but HBV DNA undetectable, individual may be enrolled.
17 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Grady Health System, Ponce De Leon Center
Atlanta, Georgia, United States
FAMCRU
Cape Town, , South Africa
CRISMO Research Centre
Germiston, , South Africa
Wits RHI Shandukani Research Centre CRS
Johannesburg, , South Africa
Rahima Moosa Mother and Child Hospital
Johannesburg, , South Africa
Clinical Research Institute of South Africa (CRISA)
KwaDukuza, , South Africa
Durban International Clinical Research Site, Enhancing Care Foundation
KwaZulu - Natal, , South Africa
Be Part Research Pty (Ltd)
Paarl, , South Africa
Perinatal HIV Research Unit (PHRU)
Soweto, , South Africa
Countries
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Central Contacts
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Related Links
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Gilead Clinical Trials Website
Other Identifiers
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GS-US-200-6712
Identifier Type: -
Identifier Source: org_study_id
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