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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000006266 | Other Identifier | University hospital Medical Information Network (UMIN) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maraviroc | Those whose take maraviroc as a part of their HIV treatment |
| |
| No maraviroc | Those who do not take maraviroc |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maraviroc | Drug | Maraviroc, 300mg BID for 72 weeks, except for cases with Efavirenz or Etravirine, 600mg BID for 72 weeks |
|
| 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:
| 78 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of the treatment efficacy | Evaluate overall HIV management status over time with:
| 72 weeks |
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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:
Exclusion Criteria: Cases applicable to ANY condition of the following:
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Treatment group: primary care clinic, Non-treatment group: primary care clinic and community sample
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| Name | Affiliation | Role |
|---|---|---|
| Kenji Yamamoto, MD PhD | Vice Director-General of Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center for Global Health and Medicine | Shinjuku | Tokyo | 1628655 | Japan |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| C567284 | Diabetes Mellitus, Insulin-Dependent, 22 |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000077592 | Maraviroc |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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Blood serum, blood plasma, urine
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |