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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001921-86 |
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The study was discontinued prematurely on December 18 2008 due to slow recruitment
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Omacor is likely to decrease lipid parameters in HIV infected subjects. In these subjects the lipid are decrease due to HAART treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omacor | Drug | n-3 PUFA |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in serum triglycerides from baseline to treatment endpoint versus placebo | 12 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in serum triglycerides | 12 weeks | |
| Absolute and percent change in cholesterol and cholesterol subfractions | 12 weeks | |
| Absolute and percent change in apolipoprotein A and B |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Director Solvay | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 2 | Bochum | Germany | ||||
| Site 1 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22212377 | Derived | Peters BS, Wierzbicki AS, Moyle G, Nair D, Brockmeyer N. The effect of a 12-week course of omega-3 polyunsaturated fatty acids on lipid parameters in hypertriglyceridemic adult HIV-infected patients undergoing HAART: a randomized, placebo-controlled pilot trial. Clin Ther. 2012 Jan;34(1):67-76. doi: 10.1016/j.clinthera.2011.12.001. Epub 2011 Dec 31. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C405603 | Omacor |
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| Drug |
Placebo |
|
| 12 weeks |
| Hanover |
| Germany |
| Site 3 | London | United Kingdom |
| Site 4 | London | United Kingdom |
| Site 5 | London | United Kingdom |
| 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 |