Study Details

OVERVIEW

A Phase 2, Open-label, Multicenter, Randomized Study to Evaluate the Persistence, Safety, Acceptability, and Pharmacokinetics of Twice Yearly Long-acting Subcutaneous Lenacapavir for HIV Pre-Exposure Prophylaxis (PrEP) in People Who Would Benefit From PrEP (PURPOSE 5)

PROTOCOL 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.

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

true

Medical Condition

Pre-Exposure Prophylaxis of HIV Infection

Gender

Cisgender male, Cisgender female, Transgender male, Transgender female, and Gender non-binary

Date

October 2024 - January 2027

Study Type

INTERVENTIONAL

Study Phase

PHASE2

Product

Lenacapavir Injection, Lenacapavir Tablet, Emtricitabine/tenofovir disoproxil fumarate (F/TDF)

Eligibility Information

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).
Note: Other protocol defined Inclusion/Exclusion criteria may apply

Locations

Locations (14)

Hopital Avicenne

Bobigny, France, 93000

Hopital Europeen Marseille

Marseille, France, 13006

CHU Nice Archet

Nice, France, 6202

Hopital Saint Louis - Assistance Publique des Hopitaux de Paris

Paris, France, 75010

APHP Hopital Saint-Antoine

Paris, France, 75012

APHP Bichat Claude-Bernard Hospital

Paris, France, 75018

University Hospitals Birmingham NHS Foundation Trust, Birmingham Heartlands Hospital

Birmingham, United Kingdom, B9 5SS

Clinical Research Facility, University Hospitals Sussex NHS Foundation Trust

Brighton, United Kingdom, BN2 3EW

Axess Sexual Health, Liverpool University Hospitals NHS Trust

Liverpool, United Kingdom, L7 8YE

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

London, United Kingdom, E11BB

Homerton Healthcare NHS Foundation Trust, Homerton University Hospital

London, United Kingdom, E9 6SR

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

London, United Kingdom, SE5 9RS

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

London, United Kingdom, SW10 9NH

Manchester University NS Foundation Trust

Manchester, United Kingdom, M13 0FH

Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP) (PURPOSE 5)