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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014