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Rosiglitazone Effect on Mitochondria and Lipoatrophy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00367744
First Posted: August 23, 2006
Last Update Posted: February 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:
  • Change in Limb Fat at 48 Weeks [ Time Frame: 48 weeks ]
    Limb fat was measured at baseline and visit week 48 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.


Secondary Outcome Measures:
  • the Change in the Carotid IMT of the Common Carotid Artery [ Time Frame: 48 weeks ]
    Carotid IMT of the Common carotid artery (CCA) was measured at baseline and week 48, and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.


Enrollment: 71
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: Rosigitazone arm
Rosiglitazone active 4 mg BID
Drug: Rosiglitazone
Rosiglitazone 4mg BID
Other Name: Glitazones, avandia
Placebo Comparator: Placebo arm
Matching Placebo BID
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00367744


Locations
United States, Ohio
Cleveland Clinc Foundation
Cleveland, Ohio, United States, 44106
University Hospitals of Cleveland/Case Western Reserve University
Cleveland, Ohio, United States, 44141
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
GlaxoSmithKline
Investigators
Principal Investigator: Grace McComsey Case Western Reserve University
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00367744     History of Changes
Other Study ID Numbers: AI060484-02-C
AI060484-C ( Other Grant/Funding Number: NIAID )
First Submitted: August 21, 2006
First Posted: August 23, 2006
Results First Submitted: October 5, 2016
Results First Posted: February 6, 2017
Last Update Posted: February 6, 2017
Last Verified: August 2006
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
mitochondria
HIV
lipoatrophy

Additional relevant MeSH terms:
HIV Infections
Lipodystrophy
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs


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