Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ViiV Healthcare
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
You may not be if
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.
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.
