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Virus Therapy

Lenacapavir + OBR for Drug-Resistant HIV (CAPELLA Trial)

Phase 2 & 3

Waitlist Available

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

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

Must have

Able and willing to receive an OBR together with lenacapavir

Adult aged ≥ 18 years (at all sites) or adolescent aged ≥ 12 and weighing ≥ 35 kg (at sites in North America and Dominican Republic)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 26 (26 weeks after first dose of subcutaneous lenacapavir)

Summary

This trial will test lenacapavir as an addition to existing HIV treatments for people with drug resistance. The goal is to see if lenacapavir can help people with failing HIV treatment regimens.

Who is the study for?

This trial is for adults and adolescents living with HIV who have developed resistance to multiple drugs, specifically at least two agents from three or more of the main classes of antiretroviral (ARV) medications. Participants must be on a failing ARV regimen, have an HIV-1 RNA level ≥ 400 copies/mL, and not have an ongoing Hepatitis C infection.

What is being tested?

The study tests Lenacapavir's effectiveness when added to a failing drug regimen in patients with multi-drug resistant HIV. It involves comparing placebo treatments against subcutaneous and oral forms of Lenacapavir alongside an Optimized Background Regimen (OBR).

What are the potential side effects?

While specific side effects are not listed here, participants may experience adverse reactions related to Lenacapavir or their individual OBRs. These could include typical ARV-related side effects such as gastrointestinal issues, fatigue, potential liver toxicity, and possible injection site reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am willing to take lenacapavir with an optimized background regimen.

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I am an adult over 18 or a teenager over 12 and weigh more than 35 kg in North America or the Dominican Republic.

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My HIV treatment is not working against multiple drugs.

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I have only 2 effective HIV drugs left that can be combined.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 26 (26 weeks after first dose of subcutaneous lenacapavir)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 26 (26 weeks after first dose of subcutaneous lenacapavir)

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 26 (26 weeks after first dose of subcutaneous lenacapavir) for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Plasma Exchange

Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 50 Copies/mL at Week 26 Based on the US FDA-defined Snapshot Algorithm

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 2: LenacapavirExperimental Treatment3 Interventions

Participants with a ≥ 0.5 log10 copies/mL HIV-1 RNA decline at the Cohort Selection Visit compared with the screening visit or with HIV-1 RNA \< 400 copies/mL or if Cohort 1 is fully enrolled will receive oral LEN 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, and will initiate an OBR on Day 1 in Oral Lead-in Period (Baseline to Day 14); followed by Maintenance Period where participants will receive SC LEN 927 mg at Day 1 SC Visit (14 days after the first dose of oral LEN) while continuing their OBR. Participants will receive their subsequent SC LEN injection at Week 26 Visit (relative to Day 1 SC). Participants will be given an option to receive SC LEN injection at Weeks 52 and 156, while continuing their OBR, until the product becomes accessible to participants through an access program or until Gilead elects to discontinue the study in the country.

Group II: Cohort 1A: LenacapavirExperimental Treatment4 Interventions

Participants with HIV-1 ribonucleic acid (RNA) ≥ 400 copies/mL and with a \<0.5 log10 HIV-1 RNA decline at Cohort Selection visit compared with screening visit will receive oral lenacapavir (LEN) 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, while continuing their failing regimen in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants will receive subcutaneous (SC) LEN 927 mg and will initiate an optimized background regimen (OBR) at Day 1 SC Visit (14 days after the first dose of oral LEN). Participants will receive their subsequent SC LEN injection at Week 26 Visit (relative to Day 1 SC). Participants will be given an option to receive SC LEN injection at Weeks 52 and 156, while continuing their OBR, until product becomes accessible to participants through an access program or until Gilead elects to discontinue the study in the country.

Group III: Cohort 1B: Placebo to LenacapavirPlacebo Group5 Interventions

Participants with HIV-1 RNA ≥ 400 copies/mL and with a \<0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit will receive oral LEN placebo on Days 1, 2, and 8 while continuing their failing regimen in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants will receive oral LEN 600 mg on Days 15 and 16 and 300 mg on Day 22, and will initiate an OBR on Day 15. At Day 1 SC (14 days after the first dose of oral LEN), participants will receive SC LEN 927 mg while continuing OBR. Participants will receive their subsequent SC LEN injection at Week 26 Visit (relative to Day 1 SC). Participants will be given an option to receive SC LEN injection at Weeks 52 and 156, while continuing their OBR, until the product becomes accessible to participants through an access program or until Gilead elects to discontinue study in the country.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Subcutaneous Lenacapavir

2019

Completed Phase 2

~220

Oral Lenacapavir

2019

Completed Phase 2

~220