Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)
- Conditions
- Pre-Exposure Prophylaxis of HIV Infection
- Registration Number
- NCT06513312
- Lead Sponsor
- Gilead Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Key Inclusion Criteria:<br><br> - Able to comprehend and provide a signed written informed consent, which must be<br> obtained prior to initiation of study procedures.<br><br> - Cisgender men who have sex with men, transgender women, transgender men, cisgender<br> women, and nonbinary people<br><br> - Increased likelihood of HIV acquisition as indicated by at least one of the<br> following:<br><br> - Condomless sex with = 2 partners in the past 6 months<br><br> - Diagnosis of a bacterial sexually transmitted infection (STI) in the past 12<br> months<br><br> - Engagement in sex work or transactional sex in the past 12 months<br><br> - Use of = 2 courses of nonoccupational HIV post-exposure prophylaxis (nPEP) in<br> the past 12 months<br><br> - Condomless sex with a partner living with HIV who has unknown or unsuppressed<br> viral load (= 200 copies/mL) in the past 12 months<br><br> - Negative local rapid HIV-1/2 antibody (Ab)/antigen (Ag) test, central HIV-1/2 Ab/Ag,<br> and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT) at screening<br><br> - Estimated glomerular filtration rate (GFR) at least 60 mL/min at screening according<br> to the Cockcroft-Gault formula for creatinine clearance (CLcr):<br><br> - (140 - age in years) × (weight in kg) x [0.85 if female] = CLcr (mL/min) / 72 ×<br> (serum creatinine in mg/dL)<br><br>Key Exclusion Criteria:<br><br> - Coenrollment in any other clinical study (including observational) without prior<br> approval from the sponsor is prohibited while participating in this study.<br><br> - Known to the study drug, the metabolites, or formulation excipient.<br><br> - Current use of PrEP, defined as the use of PrEP in the preceding 4 weeks. PrEP<br> should not be discontinued to facilitate study participation.<br><br> - Current use of nPEP, unless the prescribed course will be completed prior to<br> randomization.<br><br> - Past or current participation in HIV vaccine or HIV broadly neutralizing Ab study<br> unless participant provides documentation of receipt of placebo (ie, not active<br> product).<br><br> - Acute viral hepatitis A, B, or C or evidence of chronic hepatitis B or C infection<br><br> - Severe hepatic impairment or a history of or current clinical decompensated liver<br> cirrhosis (eg, ascites, encephalopathy, variceal bleeding).<br><br> - Have a suspected or known active, serious infection(s) (eg, active tuberculosis,<br> etc).<br><br>Note: Other protocol defined Inclusion/Exclusion criteria may apply
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants with LEN and F/TDF Persistence through 52 Weeks
- Secondary Outcome Measures
Name Time Method Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs);Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities;Overall acceptability of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with responses to Question on Acceptability;Pharmacokinetic (PK) Parameter: Ctrough for LEN at Week 26;PK Parameter: Ctrough for LEN at Week 52