Rosiglitazone Effect on Mitochondria and Lipoatrophy - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:	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:	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

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

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

National Institute of Allergy and Infectious Diseases (NIAID)

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):

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. 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.

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 February 09, 2012