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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name