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| ID | Type | Description | Link |
|---|---|---|---|
| BMS |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV positive | HIV infected treatment naive with CD4 cell count of at least 400 | ||
| Healthy controls | Healthy controls |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in Carotid IMT | Annualy for 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Increase or decrease in Inflammatory markers | Annually for 4 years | |
| Changes in Fasting lipids | Annually for 4 years | |
| Change in Insulin resistance by HOMA score |
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Inclusion Criteria for HIV positive group:
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):
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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
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| Name | Affiliation | Role |
|---|---|---|
| Grace A McComsey, MD | Case Western Reserve University and University Hospitals of Cleveland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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Stored plasma and serum
| Annually for 4 years |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |