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

August 21, 2006
February 22, 2010
July 2006
December 2008   (final data collection date for primary outcome measure)
Limb fat and mitochondrial indices [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Limb fat and mitochondrial indices
Complete list of historical versions of study NCT00367744 on ClinicalTrials.gov Archive Site
Carotid IMT and cardiovascular markers [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Carotid IMT and cardiovascular markers
Not Provided
Not Provided
 
Rosiglitazone Effect on Mitochondria and Lipoatrophy
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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infections
  • Drug: Rosiglitazone
    Rosiglitazone 4mg BID
  • Drug: Placebo
    Placebo for rosiglitazone
  • Active Comparator: 1
    Rosiglitazone
    Intervention: Drug: Rosiglitazone
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00367744
AI060484-02-C, AI060484-C
Not Provided
Grace McComsey, MD, case Western reserve University
National Institute of Allergy and Infectious Diseases (NIAID)
GlaxoSmithKline
Principal Investigator: Grace McComsey Case Western Reserve University
National Institute of Allergy and Infectious Diseases (NIAID)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP