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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
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Grace McComsey, University Hospital Case Medical Center

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease
HIV Infections Atherosclerosis

Study Design
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Study Type : Observational
Actual Enrollment : 120 participants
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
Study Start Date : November 2007
Actual Primary Completion Date : July 2013
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
HIV positive
HIV infected treatment naive with CD4 cell count of at least 400
Healthy controls
Healthy controls


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Secondary Outcome Measures :
  1. Increase or decrease in Inflammatory markers [ Time Frame: Annually for 4 years ]
  2. Changes in Fasting lipids [ Time Frame: Annually for 4 years ]
  3. Change in Insulin resistance by HOMA score [ Time Frame: Annually for 4 years ]

Biospecimen Retention:   Samples Without DNA
Stored plasma and serum

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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

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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575939


Locations
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Bristol-Myers Squibb
Investigators
Principal Investigator: Grace A McComsey, MD Case Western Reserve University and University Hospitals of Cleveland
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: December 18, 2007    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: December 2014

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

Additional relevant MeSH terms:
HIV Infections
Atherosclerosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
 Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases