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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01428986
Recruitment Status : Completed
First Posted : September 5, 2011
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
HIV Infections AIDS Drug: Maraviroc

Detailed Description:
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 Design

Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Safety Study of Maraviroc's Effect on Human Osteoclasts
Study Start Date : November 2009
Primary Completion Date : March 2013
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Maraviroc
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Maraviroc
Those whose take maraviroc as a part of their HIV treatment
Drug: Maraviroc
Maraviroc, 300mg BID for 72 weeks, except for cases with Efavirenz or Etravirine, 600mg BID for 72 weeks
Other Name: Selzentry, or Celsentri
No maraviroc
Those who do not take maraviroc


Outcome Measures

Primary Outcome Measures :
  1. Evaluation of maraviroc's effect to bone metabolism and bone mineral density [ Time Frame: 78 weeks ]

    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


Secondary Outcome Measures :
  1. Duration of the treatment efficacy [ Time Frame: 72 weeks ]

    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


Biospecimen Retention:   Samples Without DNA
Blood serum, blood plasma, urine

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428986


Locations
Japan
National Center for Global Health and Medicine
Shinjuku, Tokyo, Japan, 1628655
Sponsors and Collaborators
National Center for Global Health and Medicine, Japan
Investigators
Principal Investigator: Kenji Yamamoto, MD PhD Vice Director-General of Research Institute
More Information

Responsible Party: National Center for Global Health and Medicine, Japan
ClinicalTrials.gov Identifier: NCT01428986     History of Changes
Other Study ID Numbers: FWA00005823-MVCBone2009
UMIN000006266 ( Other Identifier: University hospital Medical Information Network (UMIN) )
First Posted: September 5, 2011    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014

Keywords provided by National Center for Global Health and Medicine, Japan:
maraviroc
osteoclasts
Receptors, CCR5
Chemokine CCL5

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Maraviroc
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents