study of lenacapavir taken twice a year for hiv pre-exposure prophylaxis (prep)

Conditions: Pre-Exposure Prophylaxis of HIV Infection

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.


Eligibility criteria:
key 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) key 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