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Completed

NCT Number: NCT00143624

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

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Blood-Borne Infections Cardiovascular Diseases Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Vascular Diseases Virus Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rosiglitazone maleate

Drug

See Detailed Description.

Placebo

Drug

See detailed description.

Primary outcomes

  1. Carotid intima media thickness (IMT)

    Time frame: 1 year

Secondary outcomes

  1. Changes in glucose metabolism

    Time frame: 1 year

  2. Changes in concentrations of blood lipids

    Time frame: 1 year

  3. Changes in C-reactive protein

    Time frame: 1 year

  4. Changes in pre-inflammatory cytokines (MCP-1, IL-6) and adipocytokines (RBP-4, adiponectin)

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Sep 2, 2005
Registry last updated
Dec 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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