Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)

NCT ID: NCT06513312

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 268 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-07
• Study Completion Date: 2028-12-31

Brief Summary

The goals of this clinical study are to learn more about the study drug lenacapavir (LEN), by comparing the consistent and continuous use of LEN and emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®) (F/TDF), then by observing the safety of LEN and F/TDF, evaluating the acceptability of LEN injections and oral F/TDF, and observe how LEN moves throughout the body in people who would benefit from pre-exposure prophylaxis (PrEP).

The primary objective of this study is to compare LEN and F/TDF consistent and continuous use among people who would benefit from PrEP.

Conditions

Pre-Exposure Prophylaxis of HIV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Randomized Phase: Lenacapavir (LEN) Group

Participants will receive subcutaneous (SC) LEN 927 mg on Day 1 and 26 weeks and oral LEN 600 mg on Day 1 and 2.

Group Type: EXPERIMENTAL

Lenacapavir Injection

Intervention Type: DRUG

Administered subcutaneously

Lenacapavir Tablet

Intervention Type: DRUG

Administered orally

Randomized Phase: F/TDF

Participants will receive daily F/TDF (200/300 mg) fixed dose combination (FDC) tablets for up to 52 weeks.

Group Type: ACTIVE_COMPARATOR

Emtricitabine/tenofovir disoproxil fumarate (F/TDF)

Intervention Type: DRUG

Administered orally

LEN Open Label Extension (OLE) Phase

Participants in the F/TDF group will transition to get LEN and participants in the LEN group will continue to get LEN. All participants will get SC LEN on Day 1 and week 26 of the OLE phase.

Group Type: EXPERIMENTAL

Lenacapavir Injection

Intervention Type: DRUG

Administered subcutaneously

Lenacapavir Tablet

Intervention Type: DRUG

Administered orally

Pharmacokinetic (PK) Tail Phase: F/TDF

After completion of the LEN OLE Phase or upon discontinuation from the Randomized Phase for those receiving LEN, participants will be transitioned to receive F/TDF in the PK Tail Phase. Participants will receive once daily F/TDF for 78 weeks, beginning 26 weeks after the last LEN injection

Group Type: EXPERIMENTAL

Emtricitabine/tenofovir disoproxil fumarate (F/TDF)

Intervention Type: DRUG

Administered orally

Interventions

Lenacapavir Injection

Administered subcutaneously

Intervention Type: DRUG

Lenacapavir Tablet

Administered orally

Intervention Type: DRUG

Emtricitabine/tenofovir disoproxil fumarate (F/TDF)

Administered orally

Intervention Type: DRUG

Other Intervention Names

GS-6207; Yeztugo®; GS-6207; Truvada®

Eligibility Criteria

Inclusion Criteria

• Able to comprehend and provide a signed written informed consent, which must be obtained prior to initiation of study procedures.
• Cisgender men who have sex with men, transgender women, transgender men, cisgender women, and nonbinary people.
• Increased likelihood of HIV acquisition as indicated by at least one of the following:

1. Condomless sex with ≥ 2 partners in the past 6 months

2. Diagnosis of a bacterial sexually transmitted infection (STI) in the past 12 months

3. Engagement in sex work or transactional sex in the past 12 months

4. Use of ≥ 2 courses of nonoccupational HIV post-exposure prophylaxis (nPEP) in the past 12 months

5. Condomless sex with a partner living with HIV who has unknown or unsuppressed viral load (≥ 200 copies/mL) in the past 12 months

• Negative local rapid HIV-1/2 antibody (Ab)/antigen (Ag) test, central HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT) at screening.

1) If rapid HIV-1/2 Ab/Ag tests are unavailable due to extenuating circumstances, sites may run a laboratory-instrumented HIV-1/2 Ab/Ag test at their local laboratory, only if they confirm this is a fourth-generation assay and the time from blood draw to injection at any injection visit is < 48 hours.

• Estimated glomerular filtration rate (GFR) at least 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr):

• (140 - age in years) × (weight in kg) x (0.85 if female) = CLcr (mL/min) / 72 × (serum creatinine in mg/dL)

Exclusion Criteria

• Coenrollment in any other clinical study (including observational) without prior approval from the sponsor is prohibited while participating in this study.
• Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
• Current use of PrEP, defined as the use of PrEP in the preceding 4 weeks. PrEP should not be discontinued to facilitate study participation. For cabotegravir, this is defined as 4 weeks since the next injection was due (ie, 12 weeks since their most recent cabotegravir injection).
• Current use of nPEP, unless the prescribed course will be completed prior to randomization.
• Past or current participation in HIV vaccine or HIV broadly neutralizing Ab study unless participant provides documentation of receipt of placebo (ie, not active product).
• Acute viral hepatitis A, B, or C or evidence of chronic hepatitis B or C infection
• Severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding).
• Have a suspected or known active, serious infection(s) (eg, active tuberculosis, etc).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Hopital Avicenne

Bobigny, , France

Hopital Europeen Marseille

Marseille, , France

CHU Nice Archet

Nice, , France

Hopital Saint Louis - Assistance Publique des Hopitaux de Paris

Paris, , France

APHP Hopital Saint-Antoine

Paris, , France

APHP Bichat Claude-Bernard Hospital

Paris, , France

University Hospitals Birmingham NHS Foundation Trust, Birmingham Heartlands Hospital

Birmingham, , United Kingdom

Clinical Research Facility, University Hospitals Sussex NHS Foundation Trust

Brighton, , United Kingdom

Axess Sexual Health, Liverpool University Hospitals NHS Trust

Liverpool, , United Kingdom

Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital, Barts Health NHS Trust

London, , United Kingdom

Homerton Healthcare NHS Foundation Trust, Homerton University Hospital

London, , United Kingdom

Caldecot Centre, Kings College Hospital, Kings College Hospital NHS Foundation Trust

London, , United Kingdom

Chelsea and Westminster Hospital NHS Foundation Trust, Clinical Research Facility, Chelsea and Westminster Hospital

London, , United Kingdom

Manchester University NS Foundation Trust

Manchester, , United Kingdom

Countries

France; United Kingdom

Related Links

https://www.gileadclinicaltrials.com/study?nctid=NCT06513312

Gilead Clinical Trials Website

Other Identifiers

2023-507891-31

Identifier Type: OTHER

Identifier Source: secondary_id

GS-US-528-6727

Identifier Type: -

Identifier Source: org_study_id