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Antiretrovirals and Rate of Progression in Carotid Artery Intima-medial Thickness in HIV

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Grace McComsey, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT00575939
First received: December 14, 2007
Last updated: January 14, 2014
Last verified: June 2013

December 14, 2007
January 14, 2014
November 2007
July 2013   (final data collection date for primary outcome measure)
Changes in Carotid IMT [ Time Frame: Annualy for 4 years ] [ Designated as safety issue: Yes ]
Changes in Carotid IMT [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00575939 on ClinicalTrials.gov Archive Site
  • Increase or decrease in Inflammatory markers [ Time Frame: Annually for 4 years ] [ Designated as safety issue: No ]
  • Changes in Fasting lipids [ Time Frame: Annually for 4 years ] [ Designated as safety issue: Yes ]
  • Change in Insulin resistance by HOMA score [ Time Frame: Annually for 4 years ] [ Designated as safety issue: Yes ]
  • Inflammatory markers [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Fasting lipids [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Insulin resistance [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Antiretrovirals and Rate of Progression in Carotid Artery Intima-medial Thickness in HIV
Assessment of the Use of a Metabolically-friendly Antiretroviral Regimen to Slow Down the Rate of Progression in Carotid Artery Intima-medial Thickness in Adults With HIV

It is well known that HIV-infected subjects frequently experience hyperlipidemias, insulin resistance, and visceral adiposity, which are known to increase the risk of atherosclerosis. Several cohorts have shown an increased risk of heart disease in people with HIV. The effect of HIV treatment versus HIV itself on the incidence of heart disease is unclear. In this study the investigators will assess the effect on carotid IMT of the initiation of antiretroviral combinations that are known to have a minimal effect on lipids and insulin resistance. We will also assess the changes in several inflammation and cardiovascular markers,as well as endothelial activation markers,and how these changes relate to therapy-induced changes in immunologic, virologic and metabolic markers.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Stored plasma and serum

Probability Sample

80 HIV-infected adults older than 18 years of age, ART-naïve with CD4 count of at least 400 cells/mm3

The control group will be adults, healthy controls with no active infection or inflammatory condition, who are matched by gender and age to the HIV positive group

  • HIV Infections
  • Atherosclerosis
Not Provided
  • HIV positive
    HIV infected treatment naive with CD4 cell count of at least 400
  • Healthy controls
    Healthy controls
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
November 2014
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria for HIV positive group:

  • HIV-1 infection
  • Age at least 18 years
  • Naïve to antiretroviral therapy
  • CD4 cell count > 400 cells/mm3

For controls: Age at least 18 years, no known HIV infection, and no known medical condition requiring chronic use of prescription medications.

Exclusion Criteria (both groups):

  • Diabetes
  • Pregnant or breastfeeding
  • Women of child bearing age who refuse or are unable to use appropriate methods of contraception during the entire study period.
  • Active infectious or inflammatory condition
  • In jail or involuntarily incarcerated
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00575939
AIDS 070711, BMS
No
Grace McComsey, University Hospitals of Cleveland
University Hospital Case Medical Center
Bristol-Myers Squibb
Principal Investigator: Grace A McComsey, MD Case Western Reserve University and University Hospitals of Cleveland
University Hospital Case Medical Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP