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
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Rosiglitazone Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Placebo Controlled Study of Rosiglitazone in HIV Lipoatrophy |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
Primary Outcome Measures:
- Limb fat and mitochondrial indices [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Carotid IMT and cardiovascular markers [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 70 |
| Study Start Date: | July 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Rosiglitazone
|
Drug: Rosiglitazone
Rosiglitazone 4mg BID
|
|
Placebo Comparator: 2
Placebo
|
Drug: Placebo
Placebo for rosiglitazone
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Lipoatrophy
- Thymidine sparing ARV for at least 24 weeks
- Prior thymidine NRTIs for at least 12 months
Exclusion Criteria:
- Diabetes
- Heart failure
- Liver disease
- Hormonal therapies
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00367744
Locations
| United States, Ohio | |
| University Hospitals of Cleveland/Case Western Reserve University | |
| Cleveland, Ohio, United States, 44141 | |
| Cleveland Clinc Foundation | |
| Cleveland, Ohio, United States, 44106 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Principal Investigator: | Grace McComsey | Case Western Reserve University |
More Information
No publications provided by National Institute of Allergy and Infectious Diseases (NIAID)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Grace McComsey, MD, case Western reserve University |
| ClinicalTrials.gov Identifier: | NCT00367744 History of Changes |
| Other Study ID Numbers: | AI060484-02-C, AI060484-C |
| Study First Received: | August 21, 2006 |
| Last Updated: | February 22, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
mitochondria HIV lipoatrophy |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lipodystrophy Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Slow Virus Diseases Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders Metabolic Diseases Rosiglitazone Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013