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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Gilead Clinical Study Information Center
• Email: GileadClinicalTrials@gilead.com
• Phone: 1-833-445-3230 (GILEAD-0)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.