NCT00367744

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for phase_2 hiv-infections

Timeline
Completed

Started Jul 2006

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
8.2 years until next milestone

Results Posted

Study results publicly available

February 6, 2017

Completed
Last Updated

February 6, 2017

Status Verified

August 1, 2006

Enrollment Period

2.4 years

First QC Date

August 21, 2006

Results QC Date

October 5, 2016

Last Update Submit

December 8, 2016

Conditions

HIV Infections

Keywords

mitochondriaHIVlipoatrophy

Outcome Measures

Primary Outcomes (1)

  • 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.

    48 weeks

Secondary Outcomes (1)

  • the Change in the Carotid IMT of the Common Carotid Artery

    48 weeks

Study Arms (2)

Rosigitazone arm

ACTIVE COMPARATOR

Rosiglitazone active 4 mg BID

Drug: Rosiglitazone

Placebo arm

PLACEBO COMPARATOR

Matching Placebo BID

Drug: Placebo

Interventions

RosiglitazoneDRUG

Rosiglitazone 4mg BID

Also known as: Glitazones, avandia
Rosigitazone arm
PlaceboDRUG

Placebo for rosiglitazone

Placebo arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Lipoatrophy
  • Thymidine sparing ARV for at least 24 weeks
  • Prior thymidine NRTIs for at least 12 months

You may not qualify if:

  • Diabetes
  • Heart failure
  • Liver disease
  • Hormonal therapies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cleveland Clinc Foundation

Cleveland, Ohio, 44106, United States

Location

University Hospitals of Cleveland/Case Western Reserve University

Cleveland, Ohio, 44141, United States

Location

Related Publications (2)

  • 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.

    PMID: 20969457DERIVED

  • 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.

    PMID: 20453626DERIVED

Related Links

MeSH Terms

Conditions

HIV InfectionsLipodystrophy

Interventions

RosiglitazoneThiazolidinediones

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSkin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

Limitations of the study include a relative small sample size as well as loss of follow up of 9 participants at the end of the study.

Results Point of Contact

Title
Dr. Grace McComsey
Organization
Case Western Reserve University
mccomsey.grace@clevelandactu.org
216 844 3607

Study Officials

  • Grace McComsey

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2006

First Posted

August 23, 2006

Study Start

July 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

February 6, 2017

Results First Posted

February 6, 2017

Record last verified: 2006-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)