Safety Study of Maraviroc's Effect on Human Osteoclasts (MVC-Bone)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
National Center for Global Health and Medicine, Japan
ClinicalTrials.gov Identifier:
NCT01428986
First received: September 2, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted

September 2, 2011
September 2, 2011
November 2009
March 2013   (final data collection date for primary outcome measure)
Evaluation of maraviroc's effect to bone metabolism and bone mineral density [ Time Frame: 78 weeks ] [ Designated as safety issue: Yes ]

Follow up HIV infected patients who take maraviroc for their bone mineral density by DEXA and for following blood/urine markers of bone metabolism and chemokine for 72 weeks:

  • Bone and chemokine markers (DPD, NTX, CTX, TRACP, BAP, osteocalcin, MIP-1alpha, MIP-1beta and RANTES)
  • Dual-energy X-ray absorptiometry
Same as current
No Changes Posted
Duration of the treatment efficacy [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]

Evaluate overall HIV management status over time with:

  • 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
Same as current
Not Provided
Not Provided
 
Safety Study of Maraviroc's Effect on Human Osteoclasts
Not Provided

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, measuring bone mineral density and markers for bone formation, desorption and chemokine.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood serum, blood plasma, urine

Non-Probability Sample

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

  • HIV Infections
  • AIDS
Drug: Maraviroc
Maraviroc, 300mg BID for 72 weeks, except for cases with Efavirenz or Etravirine, 600mg BID for 72 weeks
  • Maraviroc
    Those whose take maraviroc as a part of their HIV treatment
    Intervention: Drug: Maraviroc
  • No maraviroc
    Those who do not take maraviroc
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
20
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
20 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01428986
FWA00005823-MVCBone2009, UMIN000006266
Yes
National Center for Global Health and Medicine, Japan
National Center for Global Health and Medicine, Japan
Not Provided
Principal Investigator: Kenji Yamamoto, MD PhD Vice Director-General of Research Institute
National Center for Global Health and Medicine, Japan
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP