Safety Study of Maraviroc's Effect on Human Osteoclasts

National Center for Global Health and Medicine, Japan16 enrolled

Overview

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.

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

Enrollment

Conditions

HIV Infections AIDS

Interventions

MaravirocDRUG

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

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

National Center for Global Health and Medicine

Shinjuku, Tokyo, Japan

Outcomes

Primary Outcomes

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

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

Time frame: 78 weeks

Secondary Outcomes

Duration of the treatment efficacy

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

Time frame: 72 weeks

Data from ClinicalTrials.gov

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