Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection

Prior treatment

• Have received investigational agents for the treatment or prevention of HIV-1 infection in the 30 days prior to screening
• Participation in any other clinical study (including observational studies) without prior approval from the sponsor is prohibited while participating in this study
• Need for continued use of any contraindicated concomitant medications
• Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements

Other illness

• Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
• Have a suspected or known active, serious infection(s)
• Acute viral hepatitis A, B, or C or evidence of chronic hepatitis B infection. Participants found to be susceptible to hepatitis B virus (HBV) infection should be referred for HBV vaccination. Participants found to be positive for hepatitis C virus (HCV) at screening must not have active infection or must have completed treatment and achieved a sustained virologic response.
• Have a history of osteoporosis or bone fragility fractures

Other

• Have an implanted defibrillator or pacemaker
• Current alcohol or substance abuse judged by the investigator to be problematic such that it potentially interferes with participant study compliance
• Grade 3 or Grade 4 proteinuria or glycosuria that is unexplained or not clinically manageable.

• HIV-1–negative status
• MSM or TGW (male at birth) who have at least one of the following: a) condomless anal intercourse with at least 2 unique male partners in the past 12 weeks (partners must be either PWH or of unknown HIV status) b) documented history of syphilis in the past 24 weeks c) documented history of rectal gonorrhea or chlamydia in the past 24 weeks
• Age ≥ 18 years
• Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min according to the Cockcroft-Gault formula for creatinine clearance {Cockcroft 1976}: (140 ― age in years) × (wt in kg) / 72 × (serum creatinine in mg/dL) = CLcr(mL/min)
• Adequate liver and hematologic function: • AST and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN); and total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin • Absolute neutrophil count ≥ 1000/mm3, platelets ≥ 75,000/mm3, and hemoglobin ≥ 10 g/dL
• Willing and able to comply with study procedures