Rosiglitazone Effect on Mitochondria and Lipoatrophy

Verified by: National Institute of Allergy and Infectious Diseases (NIAID), August 2006
First Received: August 21, 2006 | Last Updated: February 22, 2010 | Phase: Phase 2 | Start Date: July 2006
Overall Status: Completed | Estimated Enrollment: 70
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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)...

Brief Summary

Official Title: “Placebo Controlled Study of Rosiglitazone in HIV Lipoatrophy”

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).

  • 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
  • Study Primary Completion Date: December 2008

Detailed Clinical Trial 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.

Intervention(s) in this Clinical Trial

  • Drug: Rosiglitazone
    • Rosiglitazone 4mg BID
  • Drug: Placebo
    • Placebo for rosiglitazone

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
    • Rosiglitazone
  • Placebo Comparator: 2
    • Placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Limb fat and mitochondrial indices
    • Time Frame: 48 weeks
      Safety Issue?: No

Secondary Measures

  • Carotid IMT and cardiovascular markers
    • Time Frame: 48 weeks
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: National Institute of Allergy and Infectious Diseases (NIAID) NIH

Overall Clinical Trial Officials and Contacts

Grace McComsey Principal Investigator Case Western Reserve University  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00367744

Study ID Number: AI060484-02-C

ClinicalTrials.gov Identifier: NCT00367744

Health Authority: United States: Federal Government

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00367744