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
  Purpose

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.


Condition Intervention
HIV Infections
AIDS
Drug: Maraviroc

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by National Center for Global Health and Medicine, Japan:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples Without DNA

Blood serum, blood plasma, urine


Estimated Enrollment: 20
Study Start Date: November 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
No maraviroc
Those who do not take maraviroc

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: National Center for Global Health and Medicine, Japan
ClinicalTrials.gov Identifier: NCT01428986     History of Changes
Other Study ID Numbers: FWA00005823-MVCBone2009, UMIN000006266
Study First Received: September 2, 2011
Last Updated: September 2, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 21, 2014