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Integrase Inhibitor

Bictegravir + Lenacapavir for HIV

Phase 2 & 3

Recruiting

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age and body weight at screening: Cohort 1: ≥ 12 years to < 18 years weighing ≥ 35 kg, Cohort 2: ≥ 6 years to < 12 years weighing ≥ 25 kg to < 35 kg, Cohort 3: ≥ 2 years to < 6 years weighing ≥ 10 kg to < 25 kg

Documented plasma HIV-1 ribonucleic acid (RNA) levels must be < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is < 50 copies/mL) in the last 6 months prior to screening (at least 1 measure prior to screening)

Must not have

Positive hepatitis C virus (HCV) antibody with detectable HCV RNA (participants positive for HCV antibody will have an HCV RNA test performed)

A history of or current decompensated liver cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding), Current alcohol or substance use judged by the investigator to potentially interfere with the participant's study compliance

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 up to week 48, as appropriate

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to understand how safe and well-tolerated the combination drug bictegravir/lenacapavir (BIC/LEN) is in children and teenagers with HIV-1

Who is the study for?

This trial is for children and adolescents with HIV-1 who are virologically suppressed on a complex ARV regimen. It includes three age-based cohorts: 12-18 years weighing ≥35kg, 6-12 years weighing ≥25 to <35kg, and 2-6 years weighing ≥10 to <25kg. Participants must have no resistance to certain HIV medications and meet specific health criteria like adequate neutrophil count and hemoglobin levels.

What is being tested?

The study tests the safety, tolerability, and body interaction of a combined drug bictegravir/lenacapavir (BIC/LEN) in children and adolescents with stable but complex anti-HIV treatment regimens. The trial aims to confirm appropriate dosing of LEN as well as understand how BIC/LEN works over time within the body.

What are the potential side effects?

While not explicitly listed here, potential side effects may include reactions typical of antiretroviral drugs such as digestive issues, headaches, fatigue, skin rashes or allergic reactions. Specific side effects will be monitored throughout the study's duration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My HIV-1 RNA levels have been undetectable or very low in the last 6 months.

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My HIV does not have resistance to certain HIV medications.

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I take more than one pill a day for HIV treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have hepatitis C with detectable virus levels.

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I do not have severe liver problems or current issues with alcohol or substance use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 up to week 48, as appropriate

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 up to week 48, as appropriate

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to week 48, as appropriate for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PK Parameter: AUCtau of BIC and LEN at Steady State

PK Parameter: Cmax of BIC and LEN at Steady State

PK Parameter: Ctrough of BIC and LEN at Steady State

Secondary study objectives

Acceptability and Palatability Summary of LEN Oral Loading Dose at Day 1 Assessed by Questionnaire

Acceptability and Palatability Summary of LEN Oral Loading Dose at Day 2 Assessed by Questionnaire

Acceptability and Palatability Summary of Oral BIC/LEN FDC at Week 24 Assessed by Questionnaire

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3: Participants Aged ≥ 2 to < 6 years with Weight ≥ 10 kg to < 25 kgExperimental Treatment2 Interventions

All participants will receive a 2-day oral loading dose of LEN, and daily oral BIC and LEN dose starting on Day 1 through Week 48. Dose in cohort 3 to be defined. Following Week 48, participants will have an option to continue BIC/LEN in the extension period.

Group II: Cohort 2: Participants Aged ≥ 6 to < 12 years with Weight ≥ 25 kg to < 35 kgExperimental Treatment2 Interventions

All participants will receive a 2-day oral loading dose of LEN, and daily oral BIC and LEN dose starting on Day 1 through Week 48. Dose in cohort 2 to be defined. Following Week 48, participants will have an option to continue BIC/LEN in the extension period.

Group III: Cohort 1: Participants Aged ≥ 12 to < 18 years with Weight ≥ 35 kg: BIC/LEN 75/50 mg FDCExperimental Treatment2 Interventions

Participants will receive a 2-day oral loading dose of LEN (600 mg) on Days 1 and 2 and daily oral BIC/LEN 75/50 mg starting on Day 1 through Week 48. Following Week 48, participants will have an option to continue BIC/LEN in the extension period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenacapavir

2018

Completed Phase 1

~60

0 / 6Eligibility criteria met