Lenacapavir + F/TDF for HIV Prevention (PURPOSE 4 Trial)

Phase 2

Recruiting

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

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

Must have

Estimated glomerular filtration rate (GFR) at least 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr).

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 52

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study how lenacapavir (LEN) moves through the body and assess the safety of LEN and emtricitabine/tenofovir disoproxil f

Who is the study for?

This trial is for people in the US who inject drugs and have shared needles within the last month. They must not have HIV or hepatitis B, should have a kidney function with GFR of at least 60 mL/min, and show recent signs of injection use. A positive drug screen for substances like opioids or stimulants is also required.

What is being tested?

The study tests how lenacapavir (LEN), given as tablets and injections, moves through the body and its safety when combined with Truvada® (F/TDF) as a preventive treatment against HIV in those who inject drugs.

What are the potential side effects?

While specific side effects are not listed here, typically antiretroviral drugs like LEN and F/TDF can cause symptoms such as nausea, diarrhea, headaches, fatigue, and sometimes more serious effects on liver or kidney health.

Eligibility Criteria

Inclusion Criteria

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

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My kidney function, measured by GFR, is 60 mL/min or higher.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 52 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

General Acceptability of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Acceptability Questionnaire Responses

Satisfaction With Use of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Satisfaction Questionnaire Responses

Willingness to Use LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Willingness to Use Questionnaire Responses

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Randomized Phase: Lenacapavir (LEN) GroupExperimental Treatment2 Interventions

Participants will receive subcutaneous (SC) LEN 927 mg on Day 1 and Week 26 and oral LEN 600 mg on Days 1 and 2.

Group II: Randomized Phase: Emtricitabine/ Tenofovir Disoproxil Fumarate (F/TDF) GroupExperimental Treatment1 Intervention

Participants will receive daily F/TDF (200/300 mg) fixed dose combination (FDC) tablets for up to 52 weeks.

Group III: Pharmacokinetic (PK) Tail Phase: F/TDFExperimental Treatment1 Intervention

Participants eligible for the PK Tail Phase will receive open-label oral F/TDF once daily for up to 78 weeks and complete study visits every 13 weeks (± 7 days). PK Tail Day 1 visit will occur 26 weeks (± 7 days) after the last SC LEN injection.

Group IV: Open-label Extension Phase: LENExperimental Treatment2 Interventions

Participants randomized to LEN in the Randomized Phase who choose to participate in the LEN Open-Label Extension (OLE) Phase will receive SC LEN every 26 weeks (± 7 days) and have study visits every 13 weeks (± 7 days). Participants randomized to F/TDF in the Randomized Phase who choose to participate in LEN OLE Phase will switch to SC LEN and have study visits at LEN OLE Day 1, Week 4 (± 2 days), Week 13 (± 7 days), and every 13 weeks (± 7 days) thereafter. SC LEN will be administered at the LEN OLE Day 1 visit and every 26 weeks thereafter. These participants will also receive loading doses of oral LEN on OLE Days 1 and 2. Upon completion of the LEN OLE Phase, participants will transition to local HIV prevention services and return for a 30-day follow-up visit. At that time, participation in the study will end.

0 / 1Eligibility criteria met