Antiretrovirals and Rate of Progression in Carotid Artery Intima-medial Thickness in HIV
This study has been completed.
Sponsor:
University Hospitals Cleveland Medical Center
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
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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:
Further study details as provided by University Hospitals Cleveland 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 (Adult, Senior) |
| 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
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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
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 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
| 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 Hospitals Cleveland 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 |
ClinicalTrials.gov processed this record on September 23, 2016