UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031040 |
|---|---|
| Receipt number | R000035271 |
| Scientific Title | Clinical trial for pre-exposure prophylaxis for HIV infection toward Tokyo Olympic |
| Date of disclosure of the study information | 2018/01/29 |
| Last modified on | 2022/08/24 14:19:06 |
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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
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
dmizushi@acc.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035271
