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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Grace McComsey, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT00575939
First received: December 14, 2007
Last updated: December 18, 2014
Last verified: December 2014
History of Changes
  Purpose

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.


Condition
HIV Infections
Atherosclerosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • Changes in Carotid IMT [ Time Frame: Annualy for 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

Stored plasma and serum
Enrollment: 120
Study Start Date: November 2007
Study Completion Date: November 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV positive
HIV infected treatment naive with CD4 cell count of at least 400
Healthy controls
Healthy controls

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575939

Locations
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospital Case Medical Center
Bristol-Myers Squibb
Investigators
Principal Investigator: Grace A McComsey, MD Case Western Reserve University and University Hospitals of Cleveland
  More Information

No publications provided

Responsible Party: Grace McComsey, Professor of Pediatrics and Medicine, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT00575939     History of Changes
Other Study ID Numbers: AIDS 070711, BMS
Study First Received: December 14, 2007
Last Updated: December 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospital Case Medical Center:
HIV
IMT
coronary
Treatment Naive

ClinicalTrials.gov processed this record on February 27, 2015