Status:
ACTIVE_NOT_RECRUITING
Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)
Lead Sponsor:
Gilead Sciences
Conditions:
Pre-Exposure Prophylaxis of HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 (coform...
Eligibility Criteria
Inclusion
- Key
- 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:
- Condomless sex with ≥ 2 partners in the past 6 months
- Diagnosis of a bacterial sexually transmitted infection (STI) in the past 12 months
- Engagement in sex work or transactional sex in the past 12 months
- Use of ≥ 2 courses of nonoccupational HIV post-exposure prophylaxis (nPEP) in the past 12 months
- 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)
- Key
Exclusion
- 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
Key Trial Info
Start Date :
October 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2028
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT06513312
Start Date
October 7 2024
End Date
December 1 2028
Last Update
September 2 2025
Active Locations (14)
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1
Hopital Avicenne
Bobigny, France, 93000
2
Hopital Europeen Marseille
Marseille, France, 13006
3
CHU Nice Archet
Nice, France, 6202
4
Hopital Saint Louis - Assistance Publique des Hopitaux de Paris
Paris, France, 75010