Recruiting
Phase 2

Lenacapavir with OBR

Sponsor:

Gilead Sciences

Code:

NCT06749054

Conditions

HIV-1-infection

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Oral Lenacapavir

Subcutaneous Lenacapavir

Optimized Background Regimen (OBR)

Study Details

Brief summary:

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.

Conditions

HIV-1-infection

Study ID

NCT06749054

Start date

Mar 26, 2025

Status verified date

Apr, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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

Primary outcome measure

  • Pharmacokinetic (PK) Parameter: Ctrough, W26 of Lenacapavir (LEN) [ Time Frame: Week 26 ]
  • Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 26 [ Time Frame: First dose date up to Week 26 ]
  • Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 26 [ Time Frame: First dose date up to Week 26 ]

Central Contacts and Locations

Central contacts

Gilead Clinical Study Information Center

1-833-445-3230 (GILEAD-0)GileadClinicalTrials@gilead.com

Locations

Grady Health System, Ponce De Leon Center

Recruiting

Atlanta, Georgia, United States, 30308

More Information

Sponsor

Gilead Sciences

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Gilead Sciences on 2026-04-24.