Clinical trial NCT00143624: 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
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
HIV Infections
Keywords: Treatment Experienced
HIV Metabolic Syndrome
Atherosclerosis in HIV
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2005-09-02
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Carotid intima media thickness (IMT)
timeFrame: 1 year
Secondary outcomes:
measure: Changes in glucose metabolism
timeFrame: 1 year
measure: Changes in concentrations of blood lipids
timeFrame: 1 year
measure: Changes in C-reactive protein
timeFrame: 1 year
measure: Changes in pre-inflammatory cytokines (MCP-1, IL-6) and adipocytokines (RBP-4, adiponectin)
timeFrame: 1 year
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Greg Bondy, MD
role: PRINCIPAL_INVESTIGATOR
References: