Safety Study of Maraviroc's Effect on Human Osteoclasts

Completed

• Conditions: AIDS; HIV Infections
• Interventions: Drug: Maraviroc

• Registration Number: NCT01428986
• Lead Sponsor: National Center for Global Health and Medicine, Japan

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.

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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2011-09-02
• Study First Submitted QC: 2011-09-02
• Study First Posted: 2011-09-05
• Primary Completion: 2013-03
• Study Completion: 2014-03
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-24
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Maraviroc	Maraviroc	Those whose take maraviroc as a part of their HIV treatment

Primary Outcome Measures

Name	Time	Method
Evaluation of maraviroc's effect to bone metabolism and bone mineral density	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

Name	Time	Method
Duration of the treatment efficacy	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

Trial Locations

Locations (1)

National Center for Global Health and Medicine; 🇯🇵 Shinjuku, Tokyo, Japan