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:
National Center for Global Health and Medicine, Japan
Information provided by (Responsible Party):
National Center for Global Health and Medicine, Japan
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 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 |
| Actual Primary Completion Date : | March 2013 |
| Actual 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
| 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
|
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
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| 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
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 |
| 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 |