Rosiglitazone (Avandia®) Treatment in HIV: Its Effect on Blood Vessels - Full Text View

Sponsor:	University of British Columbia
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00143624

Purpose

This trial will study the effect of rosiglitazone on the progression of atherosclerosis (hardening of blood vessels) through improvements of the sugar and fat metabolism (body buildup, breakdown and excretion of sugar and fat).

Participants will be randomly assigned to one of two groups: the first group will receive 8 mg of the study drug and the second group will be given a placebo, though neither group will know which formulation they are receiving. The study will follow both groups for one year, during which it will measure changes in blood vessel composition and activity, sugar metabolism, concentration of blood fat, and body fat distribution. This single-site study aims to enroll 50 participants.

Condition	Intervention
Atherosclerosis HIV Infections	Drug: Rosiglitazone maleate Drug: Placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title:	Effect of Rosiglitazone Maleate (Avandia®) on Carotid Intima Media Thickness, Brachial Artery Reactivity, Glucose Metabolism, Blood Lipid Concentrations, Body Fat Distribution, and Biochemical Markers of Cardiovascular Risk in Patients With the HIV Metabolic Syndrome

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

Carotid intima media thickness (IMT) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in glucose metabolism [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Changes in concentrations of blood lipids [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Changes in C-reactive protein [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Changes in pre-inflammatory cytokines (MCP-1, IL-6) and adipocytokines (RBP-4, adiponectin) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	June 2003
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental The first group will receive 8 mg of the study drug (rosiglitazone).	Drug: Rosiglitazone maleate See Detailed Description.
2: Placebo Comparator The second group will be given a placebo.	Drug: Placebo See detailed description.

Eligibility

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV-positive
Between 30 and 70 years of age
Elevated blood levels of fat
On two or more anti-HIV drugs for at least12 months in a row and unlikely to change anti-HIV therapy during the study
On stable regimen for at least 6 months for women taking oral contraceptive agents or hormone replacement
On a stable regimen for at least 6 months for men on testosterone replacement
If taking nevirapine, on therapy for at least 3 months with stable liver function tests

Exclusion Criteria:

Pregnancy and breastfeeding
Poorly controlled diabetes
Uncontrolled hypertension or clinical evidence of heart failure
Any serious medical conditions, including an active AIDS-defining condition, pancreatitis, or hepatitis within 6 months prior to the study
Laboratory abnormalities (see investigator)
On lipid lowering agents, insulin, anabolic steroids (except for testosterone at replacement doses), oral corticosteroids at greater than replacement doses, or growth hormones
History of liver reaction or severe edema associated with current thiazolidinedione
History of hypersensitivity to thiazolidinedione

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143624

Locations

Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:

Greg Bondy, MD

University of British Columbia

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of British Columbia ( Dr. Greg Bondy )
Study ID Numbers:	P02-0086, CTN 178
Study First Received:	August 31, 2005
Last Updated:	December 8, 2009
ClinicalTrials.gov Identifier:	NCT00143624 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Treatment Experienced
HIV Metabolic Syndrome
Atherosclerosis in HIV

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Atherosclerosis
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Physiological Effects of Drugs
Acquired Immunodeficiency Syndrome
Vascular Diseases
Arteriosclerosis
Infection

Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
Hypoglycemic Agents
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Cardiovascular Diseases
Rosiglitazone
Retroviridae Infections

ClinicalTrials.gov processed this record on February 08, 2010