HIV InfectionsMVC-BoneNCT01428986
Safety Study of Maraviroc's Effect on Human Osteoclasts
An observational study of HIV Infections and AIDS, run by National Center for Global Health and Medicine, Japan at 1 site in Japan.
Trial 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 more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, AIDS
- What is being tested?
- Maraviroc
- How many people
- 16 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2009to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Treatment group: primary care clinic, Non-treatment group: primary care clinic and community sample
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
Trial locations and contacts
1 site in 1 country.
Japan1 site
National Center for Global Health and Medicine
Shinjuku, Tokyo, 1628655
About this study
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.
- Conditions
- HIV Infections, AIDS
- Being tested
- Maraviroc
- Keywords
- maraviroc, osteoclasts, Receptors, CCR5, Chemokine CCL5
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, Diabetes Mellitus, Insulin-Dependent, 22
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaravirocDrug
Also called Selzentry, or Celsentri
Maraviroc, 300mg BID for 72 weeks, except for cases with Efavirenz or Etravirine, 600mg BID for 72 weeks
| Study group | Role | What they receive |
|---|---|---|
| Maraviroc | Those whose take maraviroc as a part of their HIV treatment Receives: Drug: Maraviroc | |
| No maraviroc | Those who do not take maraviroc |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startNov 2009
- Primary completionMar 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Global Health and Medicine, Japan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kenji Yamamoto, MD PhD, Principal investigator, Vice Director-General of Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428986
- Sponsor's protocol ID
- FWA00005823-MVCBone2009
- Other IDs
- UMIN000006266
- Acronym
- MVC-Bone
- Status last verified
- Sep 2014
- First submitted
- 2 Sep 2011
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of Maraviroc's Effect on Human Osteoclasts
- ClinicalTrials.gov ID
- NCT01428986
- Acronym / sponsor ID
- MVC-Bone / FWA00005823-MVCBone2009
- Conditions
- HIV Infections, AIDS
- Keywords
- maraviroc, osteoclasts, Receptors, CCR5, Chemokine CCL5
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National Center for Global Health and Medicine, JapanOther government
- Study start
- Nov 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 5 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maraviroc | – | Drug: MaravirocThose whose take maraviroc as a part of their HIV treatment |
| No maraviroc | – | –Those who do not take maraviroc |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Treatment group: primary care clinic, Non-treatment group: primary care clinic and community sample
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MaravirocAlso: Selzentry, or CelsentriMaraviroc, 300mg BID for 72 weeks, except for cases with Efavirenz or Etravirine, 600mg BID for 72 weeks | Drug | Maraviroc |
Primary outcome
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
1 secondary outcome
Duration of the treatment efficacy
Time frame: 72 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenji Yamamoto, MD PhD principal investigator
Vice Director-General of Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and AIDS, run by National Center for Global Health and Medicine, Japan at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of maraviroc's effect to bone metabolism and bone mineral density (time frame: 78 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014; AzTrials last refreshed its copy on 6 Nov 2026.