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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 first dose date up to 30 days post last dose at week 78

Awards & highlights

PURPOSE 3 Trial 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.Check my eligibility

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.See study design

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.

PURPOSE 3 Trial 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.

PURPOSE 3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose date up to 30 days post last dose at week 78

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose date up to 30 days post last dose at week 78

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose date up to 30 days post last dose at week 78 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

+4 more

Secondary outcome measures

Number of Participants with Adherence to F/TDF, as Assessed by Adherence Levels Based on Tenofovir diphosphate (TFV-DP) Concentrations in Dried Blood Spot (DBS)

Number of Participants with Adherence to LEN, as Assessed by on-time LEN Injections Received

PURPOSE 3 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

Find a Location

Who is running the clinical trial?

HIV Prevention Trials NetworkNETWORK

30 Previous Clinical Trials

568,454 Total Patients Enrolled

Gilead SciencesLead Sponsor

1,084 Previous Clinical Trials

848,229 Total Patients Enrolled

1 Trials studying Pre-Exposure Prophylaxis

57 Patients Enrolled for Pre-Exposure Prophylaxis

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

186,443 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment currently in need of research participants?

"Sadly, clinicaltrials.gov indicates that this medical study is no longer open to recruitment. The trial was posted on the 12th of December 2023 and last updated on the 9th November 2023, but there are 461 alternatives currently recruiting patients."

Answered by AI

Has the FDA issued a stamp of approval for Randomized Phase: Lenacapavir (LEN) Group?

"The safety of Lenacapavir (LEN) Group is estimated to be a 2 on the 1-3 scale because this Phase 2 trial has data supporting its safety, though no evidence demonstrating efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN-102)

2023. "Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN-102)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06101329.

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