Rosiglitazone Effect on Mitochondria and Lipoatrophy
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rosiglitazone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring mitochondria, HIV, lipoatrophy
Eligibility Criteria
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
Sites / Locations
- Cleveland Clinc Foundation
- University Hospitals of Cleveland/Case Western Reserve University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Rosigitazone arm
Placebo arm
Arm Description
Rosiglitazone active 4 mg BID
Matching Placebo BID
Outcomes
Primary Outcome Measures
Change in Limb Fat at 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
the Change in the Carotid IMT of the Common Carotid Artery
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.
Full Information
NCT ID
NCT00367744
First Posted
August 21, 2006
Last Updated
December 8, 2016
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00367744
Brief Title
Rosiglitazone Effect on Mitochondria and Lipoatrophy
Official Title
Placebo Controlled Study of Rosiglitazone in HIV Lipoatrophy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
mitochondria, HIV, lipoatrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rosigitazone arm
Arm Type
Active Comparator
Arm Description
Rosiglitazone active 4 mg BID
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Matching Placebo BID
Intervention Type
Drug
Intervention Name(s)
Rosiglitazone
Other Intervention Name(s)
Glitazones, avandia
Intervention Description
Rosiglitazone 4mg BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for rosiglitazone
Primary Outcome Measure Information:
Title
Change in Limb Fat at 48 Weeks
Description
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.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
the Change in the Carotid IMT of the Common Carotid Artery
Description
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.
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace McComsey
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinc Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University Hospitals of Cleveland/Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44141
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20969457
Citation
Tungsiripat M, El-Bejjani D, Rizk N, Dogra V, O'Riordan MA, Ross AC, Hileman C, Storer N, Harrill D, McComsey GA. Carotid intima media thickness, inflammatory markers, and endothelial activation markers in HIV Patients with lipoatrophy increased at 48 weeks regardless of use of rosiglitazone or placebo. AIDS Res Hum Retroviruses. 2011 Mar;27(3):295-302. doi: 10.1089/aid.2010.0187. Epub 2010 Oct 23.
Results Reference
derived
PubMed Identifier
20453626
Citation
Tungsiripat M, Bejjani DE, Rizk N, O'riordan MA, Ross AC, Hileman C, Storer N, Harrill D, McComsey GA. Rosiglitazone improves lipoatrophy in patients receiving thymidine-sparing regimens. AIDS. 2010 Jun 1;24(9):1291-8. doi: 10.1097/QAD.0b013e328339e274.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/20453626
Description
to find more about rosiglitazone effectiveness on Lipoatrophy
Learn more about this trial
Rosiglitazone Effect on Mitochondria and Lipoatrophy
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