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

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

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:

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

Primary Outcome Measures:
  • Changes in Carotid IMT [ Time Frame: Annualy for 4 years ]

Secondary Outcome Measures:
  • 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 ]

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)
HIV positive
HIV infected treatment naive with CD4 cell count of at least 400
Healthy controls
Healthy controls


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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


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 identifier: NCT00575939

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

Responsible Party: Grace McComsey, Professor of Pediatrics and Medicine, University Hospital Case Medical Center Identifier: NCT00575939     History of Changes
Other Study ID Numbers: AIDS 070711
Study First Received: December 14, 2007
Last Updated: December 18, 2014

Keywords provided by Grace McComsey, University Hospital Case Medical Center:
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on September 21, 2017