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

Phase 2RecruitingNCT06749054

Gilead Sciences12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV-1-infection

Interventions

Oral Lenacapavir

Eligibility

Sex: ALLMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (9)

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

Durban International Clinical Research Site, Enhancing Care Foundation

KwaZulu - Natal, South Africa

RECRUITING

Be Part Research Pty (Ltd)

Paarl, South Africa

RECRUITING

Perinatal HIV Research Unit (PHRU)

Soweto, South Africa

RECRUITING

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

PK Parameter: Cmax, D1-W26 of LEN

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

Time frame: Day 1 up to Week 26

PK Parameter: AUC D1-W26 of LEN

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

Time frame: Day 1 up to Week 26

Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52

Time frame: First dose date up to Week 52

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

Time frame: 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

Time frame: Week 26

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

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

Time frame: Baseline, Week 26

Change From Baseline in CD4+ Cell Counts at Week 52

Time frame: Baseline, Week 52

Percent Change From Baseline in CD4+ at Week 26

Time frame: Baseline, Week 26

Percent Change From Baseline in CD4+ at Week 52

Time frame: Baseline, Week 52

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

Time frame: Day 1

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

Time frame: Day 2

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

Time frame: Day 1

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

Time frame: Day 2

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

Overview

Conditions

Interventions

Eligibility

Locations (9)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts