UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trial for pre-exposure prophylaxis for HIV infection toward Tokyo Olympic
Acronym	PrEP feasibility study in Tokyo
Scientific Title	Clinical trial for pre-exposure prophylaxis for HIV infection toward Tokyo Olympic
Scientific Title:Acronym	PrEP feasibility study in Tokyo
Region	Japan

Condition
Condition	Prevention for HIV infection
Classification by specialty	Infectious disease Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of PrEP among MSM who use PrEP and assess feasiblity of PrEP in Japan by survey on influence of PrEP on their high-risk sexual behavior.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of HIV infection among MSM on PrEP (/100 person-year), (time frame: 24 months of follow-up)
Key secondary outcomes	(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)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	oral administration of one pill daily of co-formulated FTC 200mg/TDF 300mg Duration:from the enrollment to March 2021
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key 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
Key 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
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Mizushima
Organization	National Center for Global Health and Medicine
Division name	AIDS Clinical Center
Zip code	162-8655
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan
TEL	03-3202-7181
Email	dmizushi@acc.ncgm.go.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Mizushima
Organization	National Center for Global Health and Medicine
Division name	AIDS Clinical Center
Zip code	162-8655
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan
TEL	03-3202-7181
Homepage URL
Email	dmizushi@acc.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)	Torii Pharmaceutical Co., Ltd. JAPAN TOBACCO INC. Gilead Sciences, Inc.

IRB Contact (For public release)
Organization	Division of Medical Research Management, Management and Planning Bureau National Center for Global Health and Medicine
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
Tel	03-3202-7181
Email	rinrijm@hosp.ncgm.go.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	jRCTs031180134
Org. issuing International ID_1	Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立研究開発法人国立国際医療研究センター（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 29 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	124
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 12 Month 08 Day
Date of IRB	2017 Year 09 Month 27 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 01 Month 29 Day
Last modified on	2022 Year 08 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035271