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Virus Therapy

Lenacapavir for HIV Prevention (PURPOSE 2 Trial)

Phase 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
CGM, TGW, TGM, and GNB who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV infection.
Condomless receptive anal sex with ≥ 2 partners in the last 12 weeks
Must not have
Prior recipient of an HIV vaccine or HIV broadly neutralizing antibody formulation
Acute viral hepatitis A, B or C or evidence of chronic hepatitis B or C infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

This trial is testing lenacapavir, a drug that may help prevent HIV. It targets people who are at risk of getting HIV. The drug works by stopping the virus from making more copies of itself. Lenacapavir was developed by Gilead Sciences Inc. and has been approved for use in combination with other treatments.

Who is the study for?
This trial is for individuals at risk of HIV infection who have had condomless receptive anal sex with male partners, used stimulants during sex recently, or had certain sexually transmitted infections. They must have a kidney function test result (eGFR) ≥ 60 mL/min and not previously taken long-acting PrEP or oral PrEP in the past 12 weeks.
What is being tested?
The study tests Lenacapavir's effectiveness in preventing HIV. Participants will receive either oral Lenacapavir, subcutaneous Lenacapavir, placebos, or other pre-exposure prophylaxis drugs like F/TDF (and F/TAF for US participants).
What are the potential side effects?
Potential side effects of Lenacapavir include injection site reactions for the subcutaneous form and gastrointestinal issues such as nausea or diarrhea. Other general side effects may include fatigue and headache.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at risk for HIV due to unprotected sex with male partners.
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I've had unprotected receptive anal sex with 2 or more partners in the last 3 months.
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My kidney function, measured by eGFR, is 60 mL/min or higher.
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I am at risk for HIV due to unprotected sex.
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I've had unprotected receptive anal sex with 2 or more partners in the last 3 months.
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I have had syphilis, rectal gonorrhea, or rectal chlamydia in the past 6 months.
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My kidney function, measured by eGFR, is 60 mL/min or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received an HIV vaccine or broadly neutralizing antibody.
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I have acute or chronic hepatitis A, B, or C.
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I have severe liver problems or cirrhosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Group I: PK Tail PhaseExperimental Treatment2 Interventions
At the completion of the LEN OLE phase, participants will transition into the PK Tail phase. Additionally, participants that prematurely discontinue the study drug during blinded phase and participants that were randomized to LEN who choose not to continue in the LEN OLE Phase are also eligible to transition to the PK Tail Phase. Participants will receive oral F/TDF (or Emtricitabine/Tenofovir Alafenamide (F/TAF) for US participants only) once daily for 78 weeks beginning 26 weeks after the last injection of LEN.
Group II: LEN Open-Label Extension (OLE) PhaseExperimental Treatment2 Interventions
After completion of the Blinded phase, participants will be offered entry into the LEN OLE Phase. Participants randomized to LEN will continue to receive SC LEN 927 mg every 26 weeks for a total of 2 doses. Participants randomized to F/TDF will receive SC LEN 927 mg on OLE Day 1, OLE Week 26, and will also receive oral LEN 600 mg on OLE Days 1 and 2.
Group III: Blinded Phase: Placebo LEN + F/TDFExperimental Treatment3 Interventions
Participants will receive the following for at least 52 weeks: * SC LEN placebo every 26 weeks * Oral F/TDF 200/300 mg once daily * PTM Oral LEN on Days 1 and 2 Participants will receive oral LEN placebo if SC injections are not available
Group IV: Blinded Phase: LEN + Placebo-to-match (PTM) F/TDFExperimental Treatment3 Interventions
Participants will receive the following for at least 52 weeks: * Subcutaneous (SC) lenacapavir (LEN) 927 mg every 26 weeks * Oral PTM Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) once daily * Oral LEN 600 mg on Days 1 and 2 Participants will receive oral LEN if SC injections are not available
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
F/TDF
2018
Completed Phase 3
~250

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Lenacapavir is an HIV capsid inhibitor that disrupts the viral capsid, a protein shell essential for HIV replication and assembly, thereby preventing the virus from establishing infection. Common PrEP treatments like Tenofovir and Emtricitabine work by inhibiting reverse transcriptase, an enzyme crucial for converting viral RNA into DNA, thus blocking HIV replication. Understanding these mechanisms is vital for PrEP patients as it informs them about how these medications prevent HIV infection, helping them adhere to treatment and manage expectations regarding efficacy and potential side effects.
[Structural analysis of the PKR-binding region of HCV 1b samples from patients with chronic hepatitis C and the correlation with IFN-sensitivity].Tailored treatment for hepatitis C.

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,129 Previous Clinical Trials
864,288 Total Patients Enrolled
1 Trials studying Pre-Exposure Prophylaxis
57 Patients Enrolled for Pre-Exposure Prophylaxis
Gilead Study DirectorStudy DirectorGilead Sciences
356 Previous Clinical Trials
188,327 Total Patients Enrolled

Media Library

Lenacapavir (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04925752 — Phase 3
Pre-Exposure Prophylaxis Research Study Groups: PK Tail Phase, LEN Open-Label Extension (OLE) Phase, Blinded Phase: LEN + Placebo-to-match (PTM) F/TDF, Blinded Phase: Placebo LEN + F/TDF
Pre-Exposure Prophylaxis Clinical Trial 2023: Lenacapavir Highlights & Side Effects. Trial Name: NCT04925752 — Phase 3
Lenacapavir (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04925752 — Phase 3
Pre-Exposure Prophylaxis Patient Testimony for trial: Trial Name: NCT04925752 — Phase 3
~80 spots leftby Dec 2024