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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2008

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

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

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

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

Overall Clinical Trial Officials and Contacts

Grace McComsey Principal Investigator Case Western Reserve University  

Overall Contact: Grace McComsey, MD 2168443645 mccomsey.grace@clevelandactu.org

Information obtained from ClinicalTrials.gov on September 05, 2008

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