Rosiglitazone Effect on Mitochondria and Lipoatrophy

NCT ID: NCT00367744

Last Updated: 2017-02-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rosigitazone arm

Rosiglitazone active 4 mg BID

Group Type ACTIVE_COMPARATOR

Rosiglitazone

Intervention Type DRUG

Rosiglitazone 4mg BID

Placebo arm

Matching Placebo BID

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for rosiglitazone

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rosiglitazone

Rosiglitazone 4mg BID

Intervention Type DRUG

Placebo

Placebo for rosiglitazone

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Glitazones, avandia

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Grace McComsey

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cleveland Clinc Foundation

Cleveland, Ohio, United States

Site Status

University Hospitals of Cleveland/Case Western Reserve University

Cleveland, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 20969457 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20453626 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://www.ncbi.nlm.nih.gov/pubmed/20453626

to find more about rosiglitazone effectiveness on Lipoatrophy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AI060484-C

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AI060484-02-C

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.