Status:
COMPLETED
Incidence of Human Immunodeficiency Virus-1 (HIV-1) Infection in HIV-1 Uninfected High Risk Men Who Have Sex With Men
Lead Sponsor:
ViiV Healthcare
Conditions:
Infection, Human Immunodeficiency Virus
HIV Infections
Eligibility:
All Genders
18+ years
Brief Summary
Studies to assess the effectiveness of interventions to prevent HIV infection depend upon robust estimates of Baseline HIV incidence rates. The changing landscape of high-risk populations, as well as ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 31 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
578 Patients enrolled
Trial Details
Trial ID
NCT03310515
Start Date
August 31 2017
End Date
December 31 2018
Last Update
March 12 2020
Active Locations (9)
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1
GSK Investigational Site
Guangzhou, Guangdong, China, 510060
2
GSK Investigational Site
Shenyang, Liaoning, China, 110001
3
GSK Investigational Site
Chengdu, Sichuan, China, 610066
4
GSK Investigational Site
Hangzhou, Zhejiang, China, 310000