Clinical trial for pre-exposure prophylaxis for HIV infection toward Tokyo Olympic

Mizushima Daisuke0 sites124 target enrollmentFebruary 19, 2019

ConditionsHIV

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: HIV
Sponsor: Mizushima Daisuke
Enrollment: 124
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The present study showed that the prophylactic effect against HIV infection and the retention and adherence rates of PrEP were high, although PrEP initiation increased the incidence of STI among Japanese MSM. The use of PrEP in Japan is feasible, and therefore, the implementation of PrEP is highly recommended, combined with safer sex promotion.

Registry

who.int

Start Date

February 19, 2019

End Date

March 31, 2021

Last Updated

2 years ago

Study Type

Interventional

Sex

Male

Investigators

Sponsor

Mizushima Daisuke

Eligibility Criteria

Inclusion Criteria

•1\. Non HIV\-infected MSM who have anal sexual intercouse.
•2\. Aged 20 years or over
•3\. At high 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 cohort for one year and understand importance and significance of

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 antiinflammatory 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