Virus Therapy

Oral Lenacapavir (LEN) for Pre-Exposure Prophylaxis

UCSD Anti Viral Research Center, San Diego, CA

Oral Lenacapavir (LEN) +6 morePhase 3RecruitingResearch Sponsored by Gilead Sciences

Eligibility Criteria Checklist

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

Must have

Incidence Phase:

CGM, TGW, TGM, and GNB who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV infection.

Must not have

Timeline

Screening 3 weeks

Treatment Varies

Follow Upwhen all participants have completed a minimum of 52 weeks of follow-up in the study, or permanent discontinuation, whichever occurs first (maximum approximately 130 weeks)

Awards & highlights

Approved for 5 Other Conditions

Pivotal Trial

Study Summary

This trial will study the effectiveness of a new drug, lenacapavir, in preventing HIV infection in people who are at risk. The trial will have two parts: a cross-sectional study to estimate the background HIV infection rate, and a double-blind, randomized study to study the drug.

Eligible Conditions

Pre-Exposure Prophylaxis (PrEP)

Eligibility Criteria

Inclusion Criteria

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

Select...

It seems like you provided a partial criterion. Could you please provide more details or context so that I can accurately summarize it for you?

Select...

You are someone who engages in condomless receptive anal sex with partners assigned male at birth and are at risk for HIV infection.

Select...

You have had unprotected anal sex with more than two partners in the past three months.

Select...

You have used drugs that increase your energy and sex drive in the past 12 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at screening

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at screening

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

Treatment Details

Study Objectives

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

Primary outcome measures

HIV Vaccine

Randomized Phase: Background HIV Incidence Reported Per 100-PY of Follow-up

Secondary outcome measures

HIV Incidence Among Participants While Adherent to Study Drug

Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities

Percentage of Participants Experiencing Treatment-Emergent Adverse Events

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

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

0 / 4Eligibility criteria met

Find a site

Who is running the clinical trial?

Gilead SciencesLead Sponsor

1,044 Previous Clinical Trials

774,882 Total Patients Enrolled

1 Trials studying Pre-Exposure Prophylaxis

57 Patients Enrolled for Pre-Exposure Prophylaxis

Gilead Study DirectorStudy Director

Gilead Sciences

332 Previous Clinical Trials

182,421 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

Frequently Asked Questions

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

Are there any vacancies in this clinical research program?

"Yes, the clinicaltrials.gov website confirms that this trial is open and actively recruiting participants. The study was first posted on June 28th, 2021 and was last updated November 4th, 2022. 61 different centres are looking to enroll a total of 3000 patients."

Answered by AI

In how many different geographic areas is this trial taking place?

"There are 61 locations where this study is running, some of which include Centro San Vincente in El Paso, Texas, Henry Ford Hospital in Detroit, Michigan and KC CARE Health Center in Kansas City, Missouri."

Answered by AI

Is the data on Lenacapavir (LEN) limited to one clinical trial?

"As of right now, 102 clinical trials are underway that focus on Oral Lenacapavir (LEN). Out of those 102 live studies, 32 are in Phase 3. The majority of research surrounding Oral Lenacapavir (LEN) is conducted in Boylston, Massachusetts; however, there are 1,679 locations worldwide where clinical trials for this treatment are taking place."

Answered by AI

What infections does Oral Lenacapavir (LEN) help to fight?

"Oral Lenacapavir (LEN) is an effective treatment against human immunodeficiency virus type 1 (HIV-1), HIV infections, and the transmission of HIV."

Answered by AI

What is the official position of the FDA on LEN?

"There is pre-existing clinical data supporting the safety of LEN, so it was given a score of 3."

Answered by AI

How many people are taking part in this scientific research project?

"This study necessitates 3000 willing and eligible participants. If you meet the requirements, which are detailed on the clinicaltrials.gov website, then you can sign up to participate at various locations such as Centro San Vincente in El Paso, Texas or Henry Ford Hospital in Detroit, Michigan."

Answered by AI