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

NCT06749054 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: GS-US-200-6712
• Study Type: interventional
• Target: 12
• Locations: 2 countries
• Sites: 9

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

Outcome Measures

Primary Outcomes (3)

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

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

  Week 26

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

  First dose date up to Week 26

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

  First dose date up to Week 26

Secondary Outcomes (14)

• PK Parameter: Cmax, D1-W26 of LEN

  Day 1 up to Week 26

• PK Parameter: AUC D1-W26 of LEN

  Day 1 up to Week 26

• Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52

  First dose date up to Week 52

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

  First dose date up to Week 52

• 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

  Week 26

Study Arms (1)

LEN

EXPERIMENTAL

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.

Drug: Oral Lenacapavir; Drug: Subcutaneous Lenacapavir; Drug: Optimized Background Regimen (OBR)

Interventions

Oral Lenacapavir DRUG

Tablets administered without regard to food

Also known as: GS-6207, Sunlenca®

LEN

Subcutaneous Lenacapavir DRUG

Administered via subcutaneous injections

Also known as: GS-6207, Sunlenca®

LEN

Optimized Background Regimen (OBR) DRUG

Optimized background regimen as prescribed by the Investigator

LEN

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (9)

Grady Health System, Ponce De Leon Center

Atlanta, Georgia, 30308, United States

RECRUITING

FAMCRU

Cape Town, 7505, South Africa

RECRUITING

CRISMO Research Centre

Germiston, 1401, South Africa

RECRUITING

Wits RHI Shandukani Research Centre CRS

Johannesburg, 2038, South Africa

RECRUITING

Rahima Moosa Mother and Child Hospital

Johannesburg, 2112, South Africa

RECRUITING

Clinical Research Institute of South Africa (CRISA)

KwaDukuza, 4449, South Africa

RECRUITING

Durban International Clinical Research Site, Enhancing Care Foundation

KwaZulu - Natal, 4093, South Africa

RECRUITING

Be Part Research Pty (Ltd)

Paarl, 7626, South Africa

RECRUITING

Perinatal HIV Research Unit (PHRU)

Soweto, 2013, South Africa

WITHDRAWN

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Interventions

lenacapavir

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Central Study Contacts

Gilead Clinical Study Information Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: March 26, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (8); US (1)