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

National Center for Global Health and Medicine, Japan

Status: Completed

Conditions: AIDS; HIV Infections

Treatments: Drug: Maraviroc

Study type: Observational

Funder types: Other

Identifiers

NCT01428986

UMIN000006266 (Other Identifier)

FWA00005823-MVCBone2009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

16 participants in 2 patient groups

Maraviroc

Description:

Those whose take maraviroc as a part of their HIV treatment

Treatment:

Drug: Maraviroc

No maraviroc

Description:

Those who do not take maraviroc