RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2025-03-26

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06749054

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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).	* 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.

Inclusion Criteria

Exclusion 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).

* 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.

Contacts and Locations

Study Contact

Gilead Clinical Study Information Center

CONTACT

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

GileadClinicalTrials@gilead.com

Principal Investigator

Gilead Study Director

STUDY_DIRECTOR

Gilead Sciences

Study Locations (Sites)

Grady Health System, Ponce De Leon Center

Atlanta, Georgia, 30308

United States

Collaborators and Investigators

Sponsor: Gilead Sciences

Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-26

Study Completion Date2026-12

Study Record Updates

Study Start Date2025-03-26

Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

HIV-1-infection