Safety Study of Maraviroc's Effect on Human Osteoclasts

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.

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Key information

Conditions

HIV Infections AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Diabetes Mellitus, Insulin-Dependent, 22 Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Center for Global Health and Medicine

Shinjuku, Tokyo, 1628655, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maraviroc

Drug

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

Other names: Selzentry, or Celsentri

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

National Center for Global Health and Medicine, Japan

Other Gov

Registry information

Acronym: MVC-Bone

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2014
First posted: Sep 5, 2011
Registry last updated: Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed