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CompletedNCT01428986MVC-BoneUpdated Sep 25, 2014

Safety Study of Maraviroc's Effect on Human Osteoclasts

An observational study in HIV Infections and AIDS, sponsored by National Center for Global Health and Medicine, Japan. Completed at 1 site in Japan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-25.

Sponsored by National Center for Global Health and Medicine, Japan · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
16
Ages
20 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • HIV Infections
  • AIDS

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Keywords

  • maraviroc
  • osteoclasts
  • Receptors, CCR5
  • Chemokine CCL5
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In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 16 is below the median of 200 across 713 observational studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

National Center for Global Health and Medicine, Japan is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
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

Eligibility 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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
16 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • Maraviroc

    Those whose take maraviroc as a part of their HIV treatment

    Drug: Maraviroc

  • No maraviroc

    Those who do not take maraviroc

Interventions

  • DrugMaraviroc

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

    Also known as: Selzentry, or Celsentri

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What researchers measure

Primary outcomes

  1. Evaluation of maraviroc's effect to bone metabolism and bone mineral density

    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

    Time frame: 78 weeks

Secondary outcomes

  1. Duration of the treatment efficacy

    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

    Time frame: 72 weeks

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Study locations

1 site
  • National Center for Global Health and Medicine
    Shinjuku, Tokyo 1628655, Japan
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01428986
Lead sponsor
National Center for Global Health and Medicine, Japan
Responsible party
Sponsor
First posted
Sep 5, 2011
Start date
Nov 2009
Primary completion
Mar 2013
Completion
Mar 2014
Last update
Sep 25, 2014

Study contacts

Kenji Yamamoto, MD PhD
principal investigator · Vice Director-General of Research Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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