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| ID | Type | Description | Link |
|---|---|---|---|
| AI060484-C | Other Grant/Funding Number | NIAID |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is to examine the effect of rosiglitazone on limb fat and mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that does not contain stavudine (d4T) or zidovudine (AZT).
This is a phase II, randomized, double-blind, placebo-controlled study of rosiglitazone for the treatment of HIV-associated lipoatrophy. Subjects will receive blinded study treatment for 48 weeks. This study will examine the effect of rosiglitazone on limb fat and mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that does not contain d4T or AZT. The study also will assess the safety and tolerability of rosiglitazone in this population, and its effect on carotid IMT, prevalence of metabolic syndrome, lipid parameters and glucose metabolism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosigitazone arm | Active Comparator | Rosiglitazone active 4 mg BID |
|
| Placebo arm | Placebo Comparator | Matching Placebo BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosiglitazone | Drug | Rosiglitazone 4mg BID |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Limb Fat at 48 Weeks | Limb fat was measured at baseline and visit week 48 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| the Change in the Carotid IMT of the Common Carotid Artery | Carotid IMT of the Common carotid artery (CCA) was measured at baseline and week 48, and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups. | 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grace McComsey | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinc Foundation | Cleveland | Ohio | 44106 | United States | ||
| University Hospitals of Cleveland/Case Western Reserve University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20969457 | Derived | Tungsiripat M, El-Bejjani D, Rizk N, Dogra V, O'Riordan MA, Ross AC, Hileman C, Storer N, Harrill D, McComsey GA. Carotid intima media thickness, inflammatory markers, and endothelial activation markers in HIV Patients with lipoatrophy increased at 48 weeks regardless of use of rosiglitazone or placebo. AIDS Res Hum Retroviruses. 2011 Mar;27(3):295-302. doi: 10.1089/aid.2010.0187. Epub 2010 Oct 23. | |
| 20453626 |
| Label | URL |
|---|---|
| to find more about rosiglitazone effectiveness on Lipoatrophy | View source |
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A total of 71 subjects were randomized. Results are reported for 71 subjects.
Recruited at Case Western Reserve University and Cleveland Clinic. Recruitment occurred between from July 2006 (first subject was randomized) to December 2007 (last subject was randomized).
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| ID | Title | Description |
|---|---|---|
| FG000 | Rosiglitazone | Rosiglitazone 4 mg daily for 4 weeks then the dose was increased to 4mg twice daily for the remainder of the study (44 weeks) |
| FG001 | Placebo | Placebo arm for the whole duration of the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rosiglitazone | Rosiglitazone 4mg daily for 4 weeks then the dose increased to 4mg twice daily for the remainder of the study (44 weeks) |
| BG001 | Placebo | Placebo arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Limb Fat at 48 Weeks | Limb fat was measured at baseline and visit week 48 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups. | Intention to treat analysis with last observation carried forward if week 48 limb fat data was missing and post-baseline limb fat was availble. | Posted | Median | Inter-Quartile Range | grams | 48 weeks |
|
weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rosiglitazone | Rosiglitazone 4mg daily for 4 weeks then 4mg BID for 44 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated Cholesterol (Grade 2 or 3) | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low Fasting Glucose (Grade 1) | Metabolism and nutrition disorders | Systematic Assessment |
Limitations of the study include a relative small sample size as well as loss of follow up of 9 participants at the end of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Grace McComsey | Case Western Reserve University | 216 844 3607 | mccomsey.grace@clevelandactu.org |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D008060 | Lipodystrophy |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000077154 | Rosiglitazone |
| D045162 | Thiazolidinediones |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Placebo | Drug | Placebo for rosiglitazone |
|
| Cleveland |
| Ohio |
| 44141 |
| United States |
| Derived |
| Tungsiripat M, Bejjani DE, Rizk N, O'riordan MA, Ross AC, Hileman C, Storer N, Harrill D, McComsey GA. Rosiglitazone improves lipoatrophy in patients receiving thymidine-sparing regimens. AIDS. 2010 Jun 1;24(9):1291-8. doi: 10.1097/QAD.0b013e328339e274. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| CD4+ cell count | Median | Inter-Quartile Range | cells/mm3 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | the Change in the Carotid IMT of the Common Carotid Artery | Carotid IMT of the Common carotid artery (CCA) was measured at baseline and week 48, and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups. | Intention to treat analysis with last observation carried forward if week 48 carotid IMT data was missing and post-baseline IMT data was available | Posted | Median | Inter-Quartile Range | mm | 48 weeks |
|
|
|
| 15 |
| 34 |
| 6 |
| 34 |
| EG001 | Placebo | Placebo arm | 13 | 37 | 7 | 37 |
| Elevated Triglycerides (Grade 2) | Blood and lymphatic system disorders | Systematic Assessment |
|
| Elevated LDL Cholesterol (Grade 2 or 3) | Vascular disorders | Systematic Assessment |
|
| Elevated Blood Pressure (Grade 2 or 3) | Vascular disorders | Systematic Assessment |
|
| Low ANC (Grade 2) | Blood and lymphatic system disorders | Systematic Assessment |
|
| Low Phosphate (Grade 2 or 3) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Elevated Creatinine (Grade 2) | Blood and lymphatic system disorders | Systematic Assessment |
|
| Irregular Pulse | Cardiac disorders | Systematic Assessment |
|
| Elevated AST (Grade 2) | Hepatobiliary disorders | Systematic Assessment |
|
| Elevated ALT | Hepatobiliary disorders | Systematic Assessment |
|
| Angina | Cardiac disorders | Systematic Assessment |
|
| Elevated Glucose (Grade 2) | Blood and lymphatic system disorders | Systematic Assessment |
|
| Decreased Platelets (Grade 2 or 3) | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Depression (Grade 2) | Psychiatric disorders | Systematic Assessment |
|
| Suicidal Gesture (Grade 4) | Psychiatric disorders | Systematic Assessment |
|
| Low Phosphate (Grade 2) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Elevated Bilirubin (Grade 2 or 3) | Blood and lymphatic system disorders | Systematic Assessment |
|
| Elevated Creatine Kinase (Grade 2) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| 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 |
| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |