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| Name | Class |
|---|---|
| The Campbell Foundation | OTHER |
| Case Western Reserve University | OTHER |
| GlaxoSmithKline | INDUSTRY |
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Several studies have shown that there is an increased risk of heart disease in people with HIV. In this study the investigators are looking at the effect of Lovaza (Omega-3 fatty acid) on improving endothelial function and decreasing inflammation which may contribute to this increased risk. The investigators will also be doing studies to analyze coagulation and inflammation markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lovaza | Active Comparator | Lovaza 1 gram by mouth twice a day for 24 weeks. |
|
| Placebo | Placebo Comparator | Placebo capsule by mouth twice a day x 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lovaza | Drug | Lovaza one gram twice a day for 24 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Flow Mediated Dilation (FMD) of the Brachial Artery | Flow mediated dilation (FMD) of the brachial artery measured by ultrasound is a measure of endothelium dependent endothelial cell function. FMD is expressed as a percent change from baseline brachial artery diameter to brachial artery diameter after reactive hyperemia. | baseline and week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grace McComsey, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Cleveland Case Medical Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21870979 | Result | Hileman CO, Carman TL, Storer NJ, Labbato DE, White CA, McComsey GA. Omega-3 fatty acids do not improve endothelial function in virologically suppressed HIV-infected men: a randomized placebo-controlled trial. AIDS Res Hum Retroviruses. 2012 Jul;28(7):649-55. doi: 10.1089/aid.2011.0088. Epub 2011 Oct 17. |
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No wash out, run-in or transition period required for this study.
From April 22, 2009 to September 1, 2009 35 individuals were enrolled and randomized. Participants were recruited from the Special Immunology Unit at University Hospitals Case Medical Center and from other HIV clinics in Cleveland, Ohio.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lovaza | Lovaza 1 gram by mouth twice a day x 24 weeks |
| FG001 | Placebo | Placebo capsule by mouth twice a day x 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lovaza | Lovaza 1 gram by mouth twice a day x 24 weeks |
| BG001 | Placebo | Placebo capsule by mouth twice a day x 24 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Flow Mediated Dilation (FMD) of the Brachial Artery | Flow mediated dilation (FMD) of the brachial artery measured by ultrasound is a measure of endothelium dependent endothelial cell function. FMD is expressed as a percent change from baseline brachial artery diameter to brachial artery diameter after reactive hyperemia. | Randomized to have equal number in both groups | Posted | Mean | Standard Deviation | percent change | baseline and week 24 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lovaza | Lovaza 1 gram by mouth twice a day x 24 weeks |
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Small sample size may have precluded our ability to detect a small effect. Pill counts were used to monitor adherence. All participants were male.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grace McComsey, MC | University Hospitals Case Medical Center | 216-844-3607 | mccomsey.grace@clevelandactu.org |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C405603 | Omacor |
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Placebo | Drug | Placebo |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Placebo | Placebo capsule by mouth twice a day x 24 weeks | 0 | 17 | 0 | 17 |
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| 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 |
| D002318 | Cardiovascular Diseases |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |