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Rosiglitazone (Avandia®) Treatment in HIV: Its Effect on Blood Vessels

Primary Purpose

Atherosclerosis, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Rosiglitazone maleate
Placebo
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis focused on measuring Treatment Experienced, HIV Metabolic Syndrome, Atherosclerosis in HIV

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Paul's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

The first group will receive 8 mg of the study drug (rosiglitazone).

The second group will be given a placebo.

Outcomes

Primary Outcome Measures

Carotid intima media thickness (IMT)

Secondary Outcome Measures

Changes in glucose metabolism
Changes in concentrations of blood lipids
Changes in C-reactive protein
Changes in pre-inflammatory cytokines (MCP-1, IL-6) and adipocytokines (RBP-4, adiponectin)

Full Information

First Posted
August 31, 2005
Last Updated
December 8, 2009
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT00143624
Brief Title
Rosiglitazone (Avandia®) Treatment in HIV: Its Effect on Blood Vessels
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, HIV Infections
Keywords
Treatment Experienced, HIV Metabolic Syndrome, Atherosclerosis in HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
The first group will receive 8 mg of the study drug (rosiglitazone).
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
The second group will be given a placebo.
Intervention Type
Drug
Intervention Name(s)
Rosiglitazone maleate
Intervention Description
See Detailed Description.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
See detailed description.
Primary Outcome Measure Information:
Title
Carotid intima media thickness (IMT)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Changes in glucose metabolism
Time Frame
1 year
Title
Changes in concentrations of blood lipids
Time Frame
1 year
Title
Changes in C-reactive protein
Time Frame
1 year
Title
Changes in pre-inflammatory cytokines (MCP-1, IL-6) and adipocytokines (RBP-4, adiponectin)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Bondy, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.hivnet.ubc.ca
Description
Related Info

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Rosiglitazone (Avandia®) Treatment in HIV: Its Effect on Blood Vessels

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