Safety Study of Maraviroc's Effect on Human Osteoclasts

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety Study of Maraviroc's Effect on Human Osteoclasts

Conditions
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HIV Infections, AIDS

Intervention / Treatment
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* Drug: Maraviroc


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Maraviroc<br>Those whose take maraviroc as a part of their HIV treatment | Drug: Maraviroc<br>* Maraviroc, 300mg BID for 72 weeks, except for cases with Efavirenz or Etravirine, 600mg BID for 72 weeks<br>* Other names: Selzentry, or Celsentri;|
| No maraviroc<br>Those who do not take maraviroc | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 78 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 72 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maraviroc, osteoclasts, Receptors, CCR5, Chemokine CCL5