Prevention for HIV infection
Conditions
Interventions
oral administration of one pill daily of co-formulated FTC 200mg/TDF 300mg Duration:from the enrollment to March 2021
Sponsors
National Center for Global Health and Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. non HIV-infected MSM who have anal sexual intercouse. 2. aged 20 years or over 3. at high risk risk for acquiring HIV infection as below had STI within one year had anal sexual intercouse without condome use within 6 months have sex partners with HIV infection had use of stimulants within 6 months 4. live in Japan and understand Japanese 5. Participate in a MSM cohort study "Sexual Health Clinic" and continue to attend the cohortfor for one year and understand importance and significance of HIV prevention by PrEP. 6. Willing and able to provide informed consent
Exclusion criteria
Exclusion criteria: 1. suspected acute HIV infected 2. having severe hepatic disorder or renal dysfunction (eGFR<60ml/min/1.73m2) 3. Concurrently taking a nephrotoxic agent (e.g., high-dose non-stroidal anti-inflammatory drugs/NSAIDs) 4. allergic to TDF and/or FTC 5. concurrently taking prescribed products containing TDF or FTC 6. possiblity to be unable to continue taking truvada during the study period 7. considered to be inadequate for PrEP due to other factors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of HIV infection among MSM on PrEP (/100 person-year), (time frame: 24 months of follow-up) | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Incidence of STI among MSM on PrEP (2)Incidence of adverse event related to use of Truvada(TDF/FTC) (3)Frecuency of high-risk sexual activity (4)rate of lost to follow-up and adherence for medication (time frame: 24 months of follow-up) | — |
Countries
Japan
Contacts
Public ContactDaisuke Mizushima
National Center for Global Health and Medicine AIDS Clinical Center
Outcome results
None listed