UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017975 |
|---|---|
| Receipt number | R000020777 |
| Scientific Title | antiretroviral therapy regimen intensified with maraviroc during early HIV-1 infection |
| Date of disclosure of the study information | 2015/06/19 |
| Last modified on | 2018/12/25 19:24:49 |
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Basic information
Public title
antiretroviral therapy regimen intensified with maraviroc during early HIV-1 infection
Acronym
ART intensified by MVC with early HIV-1 infection
Scientific Title
antiretroviral therapy regimen intensified with maraviroc during early HIV-1 infection
Scientific Title:Acronym
ART intensified by MVC with early HIV-1 infection
Region
| Japan |
Condition
Condition
HIV-1 infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess efficacy and safety of standard ART regimen intensified with maraviroc, compared with historical standard triple-drug ART regimen
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of patients achieving plasma viral load less than 50 copies/mL at week 48
Key secondary outcomes
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
intensification with maraviroc for 24 weeks on standard ART regimen during early HIV-1 infection
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) HIV-1 infection with detected HIV-1 RNA
2) Incomplete HIV-1 Western blot on entry, or negative HIV-1 antibody within previous 1 year of entry
3) Written informed consent in Japanese is obtained
4) R5 HIV-1 as determined using the genotypic assay
Key exclusion criteria
1) coronary diseases: unstable angina or history of acute myocardial infarction within 6 months before entry
2) Viral hepatitis (HBV,HCV)
3) Any verified Grade 4 laboratory abnormality (excluding abnormal lipid metabolism)
4)Alanine aminotransferase (ALT) greater than 5 times the upper limit of normal
5) Subject has creatinine clearance of less than 50 mL/min via Cockroft-Gault method
6)Any evidence of primary viral resistance based on the presence of any major resistance-associated mutation [IAS-USA, 2014] in the Screening result or, if known, any historical resistance test results
7) Women who are pregnant or sexually active without effective contraception
8) Subjects whom investigators consider to be inappropriate to enroll in the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuma Shirasaka |
Organization
National Hospital Organization Osaka National Hospital
Division name
AIDS Medical Center
Zip code
Address
2-1-14 Houenzaka, Chuo-ku, Osaka city, Osaka Pref., Japan
TEL
81-6-6942-1331
sirasaka@onh.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Nagasawa |
Organization
National Hospital Organization Osaka National Hospital
Division name
AIDS Medical Center
Zip code
Address
2-1-14 Houenzaka, Chuo-ku, Osaka city, Osaka Pref., Japan
TEL
81-6-6942-1331
Homepage URL
nagasawa@onh.go.jp
Sponsor or person
Institute
National Hospital Organization Osaka National Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
H26-NHO_AIDS-02
Org. issuing International ID_1
National Hospital Organization
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 19 | 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
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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 19 | Day |
Last modified on
| 2018 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020777
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
