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NCT Number: NCT06749054

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

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.

Recruiting

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Key information

Conditions

HIV-1-infection

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

FAMCRU, Cape Town, South Africa

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m^2 using Bedside Schwartz Formula.
  • Absolute neutrophil count > 0.50 GI/L (> 500 cells/mm^3).
  • Hemoglobin ≥ 85 g/L (> 8.5 g/dL).
  • Platelets ≥ 50 GI/L (≥ 50,000/mm^3).
  • Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase) ≤ 5 × upper limit of normal.
  • 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.

Treatment and study plan

Oral Lenacapavir

Drug

Tablets administered without regard to food

Other names: GS-6207, Sunlenca®

Subcutaneous Lenacapavir

Drug

Administered via subcutaneous injections

Other names: GS-6207, Sunlenca®

Optimized Background Regimen (OBR)

Drug

Optimized background regimen as prescribed by the Investigator

Primary outcomes

  1. Pharmacokinetic (PK) Parameter: Ctrough, W26 of Lenacapavir (LEN)

    Time frame: Week 26

    Ctrough, W26 is defined as the plasma concentration at the end of the dosing interval at Week 26.

  2. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 26

    Time frame: First dose date up to Week 26

  3. Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 26

    Time frame: First dose date up to Week 26

Secondary outcomes

  1. PK Parameter: Cmax, D1-W26 of LEN

    Time frame: Day 1 up to Week 26

    Cmax, D1-W26 is defined as the maximum observed concentration of drug from Day 1 to Week 26.

  2. PK Parameter: AUC D1-W26 of LEN

    Time frame: Day 1 up to Week 26

    AUC D1-W26 is defined as the partial area under the concentration versus time curve from Day 1 to Week 26.

  3. Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52

    Time frame: First dose date up to Week 52

  4. Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 52

    Time frame: First dose date up to Week 52

  5. Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 26 Based on the US Food and Drug Administration (FDA)-Defined Snapshot Algorithm

    Time frame: Week 26

  6. Percentage of Participants with Plasma HIV-1 RNA < 50 Copies/mL at Week 52 Based on the US FDA-Defined Snapshot Algorithm

    Time frame: Week 52

  7. Change From Baseline in Clusters of Differentiation (CD4)+ Cell Counts at Week 26

    Time frame: Baseline, Week 26

  8. Change From Baseline in CD4+ Cell Counts at Week 52

    Time frame: Baseline, Week 52

  9. Percent Change From Baseline in CD4+ at Week 26

    Time frame: Baseline, Week 26

  10. Percent Change From Baseline in CD4+ at Week 52

    Time frame: Baseline, Week 52

  11. General Acceptability of Oral LEN as Assessed by Percentage of Participants With Acceptability Questionnaire Responses on Day 1

    Time frame: Day 1

    To assess the acceptability of the study drug, the participants will complete questionnaire including a question on general acceptability of the assigned study drug on an ordinal 5-category scale.

  12. General Acceptability of Oral LEN as Assessed by Percentage of Participants With Acceptability Questionnaire Responses on Day 2

    Time frame: Day 2

    To assess the acceptability of the study drug, the participants will complete questionnaire including a question on general acceptability of the assigned study drug on an ordinal 5-category scale.

  13. General Palatability of Oral LEN as Assessed by Percentage of Participants With Palatability Questionnaire Responses on Day 1

    Time frame: Day 1

    To assess the palatability of the study drug, the participants will complete questionnaire including a question on general palatability of the assigned study drug on an ordinal 5-category scale.

  14. General Palatability of Oral LEN as Assessed by Percentage of Participants With Palatability Questionnaire Responses on Day 2

    Time frame: Day 2

    To assess the palatability of the study drug, the participants will complete questionnaire including a question on general palatability of the assigned study drug on an ordinal 5-category scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Gilead Clinical Study Information Center

CONTACT

[email protected]

1-833-445-3230 (GILEAD-0)

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 27, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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