NCT00143624

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 9, 2009

Status Verified

December 1, 2009

Enrollment Period

6.5 years

First QC Date

August 31, 2005

Last Update Submit

December 8, 2009

Conditions

AtherosclerosisHIV Infections

Keywords

Treatment ExperiencedHIV Metabolic SyndromeAtherosclerosis in HIV

Outcome Measures

Primary Outcomes (1)

  • Carotid intima media thickness (IMT)

    1 year

Secondary Outcomes (4)

  • Changes in glucose metabolism

    1 year

  • Changes in concentrations of blood lipids

    1 year

  • Changes in C-reactive protein

    1 year

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

    1 year

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Rosiglitazone maleate

2

PLACEBO COMPARATOR

The second group will be given a placebo.

Drug: Placebo

Interventions

Rosiglitazone maleateDRUG

See Detailed Description.

1
PlaceboDRUG

See detailed description.

2

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Links

MeSH Terms

Conditions

AtherosclerosisHIV Infections

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Greg Bondy, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

June 1, 2003

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 9, 2009

Record last verified: 2009-12

Locations

CA(1)