Rosiglitazone Effect on Mitochondria and Lipoatrophy
This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00367744
First received: August 21, 2006
Last updated: February 22, 2010
Last verified: August 2006
| Tracking Information | |||||
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| First Received Date ICMJE | August 21, 2006 | ||||
| Last Updated Date | February 22, 2010 | ||||
| Start Date ICMJE | July 2006 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Limb fat and mitochondrial indices [ Time Frame: 48 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Limb fat and mitochondrial indices | ||||
| Change History | Complete list of historical versions of study NCT00367744 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Carotid IMT and cardiovascular markers [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE |
Carotid IMT and cardiovascular markers | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Rosiglitazone Effect on Mitochondria and Lipoatrophy | ||||
| Official Title ICMJE | Placebo Controlled Study of Rosiglitazone in HIV Lipoatrophy | ||||
| Brief Summary | 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). |
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| Detailed Description | 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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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | HIV Infections | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 70 | ||||
| Completion Date | December 2008 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00367744 | ||||
| Other Study ID Numbers ICMJE | AI060484-02-C, AI060484-C | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Grace McComsey, MD, case Western reserve University | ||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
| Collaborators ICMJE | GlaxoSmithKline | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
| Verification Date | August 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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