Trial | NCT01428986  Report issue

Official Title

Safety Study of Maraviroc's Effect on Human Osteoclasts

  • Phase

    N/A

  • Study Type

    Observational

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    maraviroc ...

  • Study Participants

    16
This study is to investigate the safety of maraviroc by examining whether there is bone metabolism dysfunction in actual use of maraviroc in human body, or not, measuring bone mineral density and markers for bone formation, desorption and chemokine.
An observational study to investigate the safety of maraviroc by examining whether there is bone metabolism dysfunction in actual use of maraviroc in human body, or not, measuring bone mineral density and markers for bone formation, desorption and chemokine.
Study Started
Nov 30
2009
Primary Completion
Mar 31
2013
Study Completion
Mar 31
2014
Last Update
Sep 25
2014
Estimate

Drug Maraviroc

Maraviroc, 300mg BID for 72 weeks, except for cases with Efavirenz or Etravirine, 600mg BID for 72 weeks

  • Other names: Selzentry, or Celsentri

Maraviroc None

Those whose take maraviroc as a part of their HIV treatment

No maraviroc None

Those who do not take maraviroc

Population

Treatment group: primary care clinic, Non-treatment group: primary care clinic and community sample

Criteria 

Inclusion Criteria: Outpatients or inpatients that are treated for HIV infection at AIDS Clinical Center of National Center for Global Health and Medicine who meet all criteria following:

Those whose primary care physician acknowledged the necessity of maraviroc treatment due to multi-resistance HIV strain that is confirmed to have CCR5 tropism.
Those who are willing and able to consent to this study
20 years old or older

Exclusion Criteria: Cases applicable to ANY condition of the following:

Those who are not suited for maraviroc (whose HIV strain to be CXCR4 tropism)
Others who the principle investigator physician considered to be excluded
No Results Posted