Rosiglitazone Effect on Mitochondria and Lipoatrophy

Phase 2

Completed

• Conditions: HIV Infections
• Interventions: Drug: Placebo; Drug: Rosiglitazone

• Registration Number: NCT00367744
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

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).

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.

Study Timeline

• Study Start: 2006-07
• Status Verified: 2006-08
• Study First Submitted: 2006-08-21
• Study First Submitted QC: 2006-08-21
• Study First Posted: 2006-08-23
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2016-10-05
• Results First Submitted QC: 2016-12-08
• Last Update Submitted: 2016-12-08
• Results First Posted: 2017-02-06
• Last Update Posted: 2017-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo arm	Placebo	Matching Placebo BID
Rosigitazone arm	Rosiglitazone	Rosiglitazone active 4 mg BID

Primary Outcome Measures

Name	Time	Method
Change in Limb Fat at 48 Weeks	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

Name	Time	Method
the Change in the Carotid IMT of the Common Carotid Artery	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.

Trial Locations

Locations (2)

Cleveland Clinc Foundation; 🇺🇸 Cleveland, Ohio, United States

University Hospitals of Cleveland/Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States