Clinical trial NCT03310515: Incidence of Human Immunodeficiency Virus-1 (HIV-1) Infection in HIV-1 Uninfected High Risk Men Who Have Sex With Men
Official title: A Cohort Study to Determine the Incidence of HIV-1 Infection in HIV-1 Uninfected High Risk Participants Who Are Male Sex at Birth and Have Sex With Men
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection, Human Immunodeficiency Virus
HIV Infections
Keywords: PrEP
MSM
seroincidence
HIV-1
TGW
STIs
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
First posted: 2017-10-16
Enrollment: 578
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This prospective cohort study will involve population of HIV-1 uninfected Chinese MSM and TGW who are at high-risk of HIV infection.

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 the evolution of biomedical pre-exposure prophylaxis (PrEP) interventions, requires a contemporary evaluation of HIV incidence as well as demographic, behavioral and other subject factors which may impact HIV incidence. This is a prospective cohort study to measure HIV-1 seroincidence in a study population of HIV-1 uninfected Chinese men who have sex with men (MSM) and transgender women (TGW) who are at high-risk of HIV infection. Approximately 550 subjects who are male sex at birth and have sex with men shall enter the study, which will allow for a 10% drop out rate to maintain 500 subjects at the conclusion of the cohort. This is a single arm cohort study to determine HIV-1 seroincidence rates in high risk MSM and TGW when combined with a comprehensive prevention package including HIV and safe sex counseling, provision of condoms and water-based lubricant, and sexually transmitted infection (STI) screening and referral for treatment. It will be determined what proportion of high-risk MSM and TGW who are given a comprehensive HIV-1 prevention package will acquire HIV-1 infection.


Eligibility criteria: 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.

Primary outcomes:
measure: HIV-1 seroincidence rate in a cohort of high-risk MSM and TGW
timeFrame: Baseline, Day 1, Weeks 5, 9, and every 8 week intervals thereafter until study completion, an average of 12 months
measure: HIV-1 seroincidence rate in a cohort of high-risk TGW
timeFrame: Baseline, Day 1, Weeks 5, 9, and every 8 week intervals thereafter until study completion, an average of 12 months
Secondary outcomes:
measure: Number of subjects diagnosed with gonorrhea, chlamydia, and syphilis post screening
timeFrame: Day 1, Week 9, and every 16 weeks interval thereafter until study completion, an average of 12 months
measure: Number of subjects with demographic factors
timeFrame: Day 1, Week 9, and every 8 weeks interval thereafter until study completion, an average of 12 months
measure: Number of subjects enrolled and retained in to the study
timeFrame: Day 1, Weeks 5, 9, and every 8 or 16 weeks interval thereafter until study completion, an average of 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: GSK Investigational Site
state: Guangdong
city: Shenyang
country: China
facility: GSK Investigational Site
state: Liaoning
city: Chengdu
country: China
facility: GSK Investigational Site
state: Sichuan
city: Hangzhou
country: China
facility: GSK Investigational Site
state: Zhejiang
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Changsha
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shenzhen
country: China
facility: GSK Investigational Site
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: