Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
71 participants
INTERVENTIONAL
2006-07-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rosigitazone arm
Rosiglitazone active 4 mg BID
Rosiglitazone
Rosiglitazone 4mg BID
Placebo arm
Matching Placebo BID
Placebo
Placebo for rosiglitazone
Interventions
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Rosiglitazone
Rosiglitazone 4mg BID
Placebo
Placebo for rosiglitazone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Thymidine sparing ARV for at least 24 weeks
* Prior thymidine NRTIs for at least 12 months
Exclusion Criteria
* Heart failure
* Liver disease
* Hormonal therapies
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Grace McComsey
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University
Locations
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Cleveland Clinc Foundation
Cleveland, Ohio, United States
University Hospitals of Cleveland/Case Western Reserve University
Cleveland, Ohio, United States
Countries
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References
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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.
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.
Related Links
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to find more about rosiglitazone effectiveness on Lipoatrophy
Other Identifiers
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AI060484-C
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
AI060484-02-C
Identifier Type: -
Identifier Source: org_study_id
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