Long-acting Lenacapavir for treating HIV-1 in adolescents and children

A Phase 2, Open-label, Single-Arm Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Long-Acting Lenacapavir in Combination With an Optimized Background Regimen in Treatment-experienced Adolescents and Children With HIV-1

This study is testing a new long-acting HIV treatment called lenacapavir to see if it works better for adolescents and children who have had problems with their current medications.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: N/A to 17 Years
• Sex: All
• Sponsor: Gilead Sciences (Industry-sponsored)
• Locations: 9 sites (Atlanta, Georgia and 8 other locations)
• Trial ID: NCT06749054 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the safety, tolerability, and efficacy of long-acting lenacapavir (LEN) in combination with other medications for adolescents and children living with HIV-1 who have previously been treated. Participants must weigh at least 35 kg and have a history of treatment failure with their current antiretroviral regimen. The study will assess how well participants can take LEN either as an injection or an oral pill, while also monitoring pharmacokinetics and safety. The goal is to provide a more effective treatment option for this population.

Who should consider this trial

Good fit: Ideal candidates are adolescents and children weighing at least 35 kg who have experienced treatment failure with their current HIV-1 therapy.

Not a fit: Patients who have not previously failed an antiretroviral regimen or those who do not meet the weight requirement may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective and manageable option for adolescents and children living with HIV-1 who have limited treatment options.

How similar studies have performed: Other studies have shown promise with long-acting antiretroviral therapies, indicating potential for success with this approach.

Eligibility criteria

Key Inclusion Criteria:

* Body weight at screening ≥ 35 kg.
* 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).

Key Exclusion Criteria:

* Life expectancy ≤ 1 year.
* 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Atlanta, Georgia and 8 other locations

• Grady Health System, Ponce De Leon Center — Atlanta, Georgia, United States (Recruiting)
• Famcru — Cape Town, South Africa (Recruiting)
• CRISMO Research Centre — Germiston, South Africa (Recruiting)
• Wits RHI Shandukani Research Centre CRS — Johannesburg, South Africa (Recruiting)
• Rahima Moosa Mother and Child Hospital — Johannesburg, South Africa (Recruiting)
• Clinical Research Institute of South Africa (CRISA) — KwaDukuza, South Africa (Recruiting)
• Durban International Clinical Research Site, Enhancing Care Foundation — KwaZulu - Natal, South Africa (Recruiting)
• Be Part Research Pty (Ltd) — Paarl, South Africa (Recruiting)
• Perinatal HIV Research Unit (PHRU) — Soweto, South Africa (Withdrawn)

Study contacts

• Study coordinator: Gilead Clinical Study Information Center

Conditions HIV-1-infection