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| Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) GlaxoSmithKline |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00367744 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Placebo Controlled Study of Rosiglitazone in HIV Lipoatrophy |
| Estimated Enrollment: | 70 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | April 2009 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Rosiglitazone
|
Drug: Rosiglitazone
Rosiglitazone 4mg BID
|
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2: Placebo Comparator
Placebo
|
Drug: Placebo
Placebo for rosiglitazone
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Grace McComsey, MD | 2168443645 | mccomsey.grace@clevelandactu.org |
| United States, Ohio | |
| University Hospitals of Cleveland/Case Western Reserve University | Recruiting |
| Cleveland, Ohio, United States, 44141 | |
| Contact: Grace McComsey, MD 216-844-3645 mccomsey.grace@clevelandactu.org | |
| Contact: Norma Storer, RN 2168442752 storer.norma@clevelandactu.org | |
| Principal Investigator: Grace McComsey, MD | |
| Cleveland Clinc Foundation | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Marisa Tungsiripat, MD 216-444-2037 TUNGSIM@ccf.org | |
| Contact: Marisa Tungsiripat, MD 2164442037 TUNGSIM@ccf.org | |
| Principal Investigator: | Grace McComsey | Case Western Reserve University |
More Information
| Responsible Party: | case Western reserve University ( Grace McComsey, MD ) |
| Study ID Numbers: | AI060484-02-C, AI060484-C |
| Study First Received: | August 21, 2006 |
| Last Updated: | May 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00367744 |
| Health Authority: | United States: Federal Government |
|
mitochondria HIV lipoatrophy |
|
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Rosiglitazone Retroviridae Infections Immunologic Deficiency Syndromes |
|
RNA Virus Infections Hypoglycemic Agents Slow Virus Diseases Immune System Diseases |
Physiological Effects of Drugs Lentivirus Infections Infection Pharmacologic Actions |
