Safety Study of Maraviroc's Effect on Human Osteoclasts (MVC-Bone)
This study has been completed.
Sponsor:
National Center for Global Health and Medicine, Japan
ClinicalTrials.gov Identifier:
NCT01428986
First Posted: September 5, 2011
Last Update Posted: September 25, 2014
Information provided by (Responsible Party):
National Center for Global Health and Medicine, Japan
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Purpose
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 | Intervention |
|---|---|
| HIV Infections AIDS | Drug: Maraviroc |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Safety Study of Maraviroc's Effect on Human Osteoclasts |
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 ]
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 ]
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
| Enrollment: | 16 |
| Study Start Date: | November 2009 |
| Study Completion Date: | March 2014 |
| 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
Other Name: Selzentry, or Celsentri
|
|
No maraviroc
Those who do not take 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.
Eligibility
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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 Submitted: | September 2, 2011 |
| First Posted: | September 5, 2011 |
| 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 |