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

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ClinicalTrials.gov Identifier: NCT00575939
Recruitment Status : Completed
First Posted : December 18, 2007
Last Update Posted : December 19, 2014
Information provided by (Responsible Party):

December 14, 2007
December 18, 2007
December 19, 2014
November 2007
July 2013   (Final data collection date for primary outcome measure)
Changes in Carotid IMT [ Time Frame: Annualy for 4 years ]
Changes in Carotid IMT [ Time Frame: 4 years ]
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 ]
  • Changes in Fasting lipids [ Time Frame: Annually for 4 years ]
  • Change in Insulin resistance by HOMA score [ Time Frame: Annually for 4 years ]
  • Inflammatory markers [ Time Frame: 4 years ]
  • Fasting lipids [ Time Frame: 4 years ]
  • Insulin resistance [ Time Frame: 4 years ]
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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.
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Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
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
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  • 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.
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
AIDS 070711
Not Provided
Not Provided
Grace McComsey, University Hospital Case Medical Center
University Hospitals Cleveland Medical Center
Bristol-Myers Squibb
Principal Investigator: Grace A McComsey, MD Case Western Reserve University and University Hospitals of Cleveland
University Hospitals Cleveland Medical Center
December 2014