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
|
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Condition or disease |
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HIV Infections Atherosclerosis |
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 |

Group/Cohort |
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HIV positive
HIV infected treatment naive with CD4 cell count of at least 400
|
Healthy controls
Healthy controls
|
- Changes in Carotid IMT [ Time Frame: Annualy for 4 years ]
- 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

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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 |
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

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
United States, Ohio | |
University Hospitals Case Medical Center | |
Cleveland, Ohio, United States, 44106 |
Principal Investigator: | Grace A McComsey, MD | Case Western Reserve University and University Hospitals of Cleveland |
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 |