We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)
August 21, 2006
August 23, 2006
October 5, 2016
February 6, 2017
February 6, 2017
July 2006
December 2008   (Final data collection date for primary outcome measure)
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.
Limb fat and mitochondrial indices
Complete list of historical versions of study NCT00367744 on ClinicalTrials.gov Archive Site
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.
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infections
  • Drug: Rosiglitazone
    Rosiglitazone 4mg BID
    Other Name: Glitazones, avandia
  • Drug: Placebo
    Placebo for rosiglitazone
  • Active Comparator: Rosigitazone arm
    Rosiglitazone active 4 mg BID
    Intervention: Drug: Rosiglitazone
  • Placebo Comparator: Placebo arm
    Matching Placebo BID
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00367744
AI060484-02-C
AI060484-C ( Other Grant/Funding Number: NIAID )
No
Not Provided
Plan to Share IPD: No
National Institute of Allergy and Infectious Diseases (NIAID)
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