UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006266 |
|---|---|
| Receipt number | R000007416 |
| Scientific Title | CCR5 antagonist maraviroc's effect to osteoclasts in human |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2014/02/21 11:04:52 |
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Basic information
Public title
CCR5 antagonist maraviroc's effect to osteoclasts in human
Acronym
MVC Bone Study
Scientific Title
CCR5 antagonist maraviroc's effect to osteoclasts in human
Scientific Title:Acronym
MVC Bone Study
Region
| Japan |
Condition
Condition
HIV-1 infection, AIDS
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
CCR5 knockout mice exhibited a phenotype of osteopenia and osteoporosis. In a in vitro monocyte phagocytic system in vitro system where monocytes, osteoclastic development was inhibited under the presence of maraviroc. Maraviroc was originally introduced as a second-line regimen choice after HAART failure(s), thus the benefit may overcome minor side effects. But if the side effects had a potential to become more serious ones, that should be the time to consider changes of the regimen. This study is to investigate the safety of maraviroc by examining whether there is bone metabolism disfunction in actual use of maraviroc in human body, or not.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone metabolism and density evaluation by
- Bone and chemokine markers (DPD, NTX, CTX, TRACP, BAP, osteocalcin, MIP-1alpha, MIP-1beta and RANTES)
and
- DEXA
Key secondary outcomes
- Other infections: HBV, HCV, RPR, TPHA
- HIV treatment markers: CD4, CD8, CD4/CD8, HIV-RNA
- HAART regimens and start dates
- Other medications: antibiotics, anticoagulants, antiplatelets, NSAID, steroids
- Past medical history
- HIV risk behaviors, age, sex
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 and Female
Key inclusion criteria
Those who met all folowing criteria:
- Those whose primary care physician acknowledged the necessity of maraviroc treatment (had multi-resistance HIV strain confirmed to be CCR5 tropic).
- Those who are willing and able to consent to this study
- 20 years old or older
Key exclusion criteria
- Those who are not suited for maraviroc (whose HIV strain to be CXCR4 tropism)
- Others who the principle investigator physician considered to be excluded
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Oka |
Organization
National Center for Global Health and Medicine
Division name
AIDS Clinical Center
Zip code
Address
1-21-1 Toyama, Shinjuku, Tokyo, JAPAN
TEL
03-5273-5193
oka@acc.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumihide Kanaya |
Organization
National Center for Global Health and Medicine
Division name
AIDS Clinical Center
Zip code
Address
1-21-1 Toyama, Shinjuku, Tokyo, JAPAN
TEL
03-5273-5277
Homepage URL
fkanaya@yahoo.com
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
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study to examine side effects of a government approved standard treatment. As a control arm, the protocol was approved by IRB with a non-treatment group, those who are not taking maraviroc, of the similar size for comparison purposes.
Management information
Registered date
| 2011 | Year | 09 | Month | 01 | Day |
Last modified on
| 2014 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007416
