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Rosiglitazone Effect on Mitochondria and Lipoatrophy

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Rosiglitazone

Placebo

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring mitochondria, HIV, lipoatrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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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