Safety Study of Maraviroc's Effect on Human Osteoclasts (MVC-Bone)

This study has been completed.

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: September 24, 2014

Last verified: September 2014

History of Changes

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Maraviroc

U.S. FDA Resources

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


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


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 24, 2014
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:


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

ClinicalTrials.gov processed this record on February 25, 2015

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