Incidence of Human Immunodeficiency Virus-1 (HIV-1) Infection in HIV-1 Uninfected High Risk Men Who Have Sex With Men

Inclusion Criteria:

• Subjects are Chinese MSM and/or TGW and must be 18 years or older at the time of screening.

• Subjects of male sex at birth and who have sex with men, who in the 6 months prior to screening report one or more of the following risk criteria:

  • Unprotected (condomless) receptive anal intercourse with one or more partners.
  • More than five partners in the 6 months prior to enrolment (regardless of condom use and HIV serostatus, as reported by the enrolee).
  • Reported STI with syphilis, gonorrhea, chlamydia, chancroid, or lymphogranuloma venereum.

Subjects in a monogamous relationship with an HIV-1 seronegative partner or a virologically-suppressed HIV-1 + partner for >1 year are not eligible for participation.

• Males, agree to appropriate use of contraceptive measures during heterosexual intercourse.
• Subjects who have non reactive fourth generation HIV test and undetectable HIV-1 RNA at screening.
• Capable of giving signed informed consent.

Exclusion Criteria:

• Subjects with known moderate to severe hepatic impairment as per liver function test criteria outlined below.
• Subject who, in the investigator's judgment, poses a significant suicide risk.
• The Subject has a tattoo or other dermatological condition overlying the gluteus region.
• Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease.
• Use of PrEP or post exposure prophylaxis (PEP) within the last 30 days prior to screening.
• Current use or anticipated need for use high dose aspirin or other anticoagulants including antiplatelet medications that would interfere with the ability to receive intramuscular (IM) injections.
• Exposure to an experimental drug and/or experimental vaccine within 28 days or 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the screening.
• Anti-tuberculosis therapy.
• Alcohol use that in the judgment of the investigator would interfere with the subject's ability to complete study procedures.
• Active injection drug use that in the judgment of the investigator would interfere with the subject's ability to complete study procedures.
• Any medical condition, including psychiatric conditions, that in the judgment of the investigator would interfere with the subject's ability to complete study procedures.
• A reactive HIV test at screening.
• A positive Hepatitis B surface antigen.
• A positive Hepatitis C antibody with an HCV viral ribose nucleic acid (RNA) above the lower limit of detection.

• Any of the following laboratory values at screening:

  • Hemoglobin (Hgb) <11 gram per deciliter (g/dL).
  • Absolute neutrophil count <750 cells per cubic millimeter (cells/mm^3).
  • Platelet count <100,000 cells/mm^3.
  • Presence of a coagulopathy defined by an international normalized ratio (INR)>1.5 or a partial thromboplastin time (PTT)>45 seconds.
  • Creatinine clearance <60 milliliter per minute (mL/min) using the Cockroft-Gault equation.
  • Aspartate aminotransferase (AST) >1.5 times upper limit of normal (ULN).
  • Direct Bilirubin >2.0 milligram per deciliter (mg/dL).
• Co-enrolment in any other HIV interventional studies.