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Nucleoside Reverse Transcriptase Inhibitor

Lenacapavir + F/TDF for HIV Prevention (PURPOSE 3 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

Report at least 1 episode of condomless vaginal or anal sex with a cisgender man in the 12 months before enrollment.

Noninjection recreational drug use (ecstasy, cocaine, crack cocaine, methamphetamine, ketamine, 3,4-methylenedioxy-methamphetamine, or prescription drugs apart from those prescribed by a licensed provider)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how a drug combination can help prevent HIV in US cisgender women.

Who is the study for?

This trial is for US cisgender women at high risk of HIV, including those who've exchanged sex for commodities, had condomless sex with a man in the past year, used noninjection drugs recreationally, or have multiple male sexual partners. Women must test negative for HIV and hepatitis B to join.

What is being tested?

The study tests Lenacapavir (LEN) injections and tablets alongside Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) to prevent HIV. It aims to understand how LEN works in the body, its safety as pre-exposure prophylaxis (PrEP), and if women find these methods acceptable.

What are the potential side effects?

Potential side effects include reactions where LEN is injected or taken orally. Since it's an HIV prevention study, detailed side effects aren't listed but may involve typical drug-related issues like nausea or headaches.

Eligibility Criteria

Inclusion Criteria

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

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I have had unprotected sex with a man in the past year.

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I do not use recreational drugs like ecstasy, cocaine, or meth.

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I have had two or more male sexual partners.

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I have had STIs like gonorrhea, chlamydia, or syphilis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52

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

Treatment Details

Study Objectives

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

Primary study objectives

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

PK Parameter: Ctrough for LEN at the End of Week 52

Pharmacokinetic (PK) Parameter: Ctrough for Lenacapavir (LEN) at the End of Week 26

+2 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: Randomized Phase: Lenacapavir (LEN) GroupExperimental Treatment2 Interventions

Participants will receive subcutaneous (SC) lenacapavir (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 oral F/TDF (200/300 mg) daily for 52 weeks.

Group III: PK Tail Phase: F/TDFExperimental Treatment1 Intervention

After the completion of the Randomized Phase, participants in LEN group will be transitioned to receive F/TDF and participants in F/TDF group will continue to receive F/TDF in the PK Tail Phase. All participants will receive F/TDF, once daily for 78 weeks beginning 26 weeks after the last LEN injection.

0 / 4Eligibility criteria met