What side effects are associated with this type of intervention?

Common treatments for Pre-Exposure Prophylaxis (PrEP) include medications like tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). Known side effects of these treatments can include gastrointestinal issues such as nausea and diarrhea, headaches, and potential renal and bone density effects with long-term use. For newer treatments like Lenacapavir, specific side effects are still being studied, but they may include injection site reactions, potential hypersensitivity reactions, and other mild to moderate adverse effects similar to those observed with other antiretroviral therapies.

What prior FDA approvals exist?

The FDA has approved several drugs for Pre-Exposure Prophylaxis (PrEP) to prevent HIV infection. The most notable approvals include Truvada (emtricitabine/tenofovir disoproxil fumarate) and Descovy (emtricitabine/tenofovir alafenamide), both of which are nucleoside reverse transcriptase inhibitors (NRTIs). These drugs work by inhibiting the reverse transcriptase enzyme, preventing HIV from replicating in the body. Lenacapavir, currently under study, is an HIV Capsid Inhibitor, which represents a different mechanism of action by targeting the HIV capsid protein, potentially offering a new option for PrEP.

What other types of research exist?

Promising novel alternatives to Lenacapavir for HIV PrEP in 2024 include: 1) Cabotegravir, a long-acting injectable integrase inhibitor, which has shown high efficacy in preventing HIV infection in clinical trials. 2) PRO 140 (Leronlimab), a CCR5-directed monoclonal antibody, which has demonstrated potency against CCR5-tropic virus and is being studied for its use in PrEP. 3) Islatravir, a nucleoside reverse transcriptase translocation inhibitor (NRTTI), which is in advanced stages of clinical development and has shown promise in both treatment and prevention of HIV.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

0 / 10Eligibility criteria met

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.