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| ID | Type | Description | Link |
|---|---|---|---|
| K23AT002862-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of omega-3-fatty acids in HIV-infected patients with hypertriglyceridemia. In addition, we, the researchers, will evaluate the effect of omega-3 fatty acid administration of markers of bone turnover and inflammation.
Hypertriglyceridemia is common among HIV-infected patients receiving Highly Active Antiretroviral Therapy (HAART). Although fibrates, statins, and niacin have all been used in the management of hypertriglyceridemia in HIV-infected patients, optimal control is difficult to achieve and other agents are needed. Omega-3 fatty acids are effective for lowering triglycerides in patients without HIV infection, but experience in HIV-infected patients is limited. In addition, omega-3 fatty acids may also have secondary benefits in decreasing bone resorption and decreasing markers of systemic inflammation. The purpose of this study is to evaluate the efficacy and safety of omega-3-fatty acids in HIV-infected patients with hypertriglyceridemia. In addition, we will evaluate the effect of omega-3 fatty acid administration of markers of bone turnover and inflammation. It is 8- week randomized, double-blind trial of omega-3 fatty acids (LOVAZA, GSK, Inc) compared to placebo in 48 HAART-treated HIV-infected patients with triglycerides between 250 and 1000 mg/dl receiving dietary counseling. Subjects will be recruited from three centers (Johns Hopkins, Georgetown, and Los Angeles VAMC). The primary endpoint will be the change in triglyceride concentrations from baseline in the LOVAZA group compared to the placebo group. Secondary endpoints include the effect of LOVAZA on other lipid targets (total cholesterol, LDL cholesterol, HDL-cholesterol), markers of systemic inflammation, markers of bone turnover, markers of insulin resistance, HIV-disease control (CD4+ counts, HIV viral loads), measures of hepatotoxicity (ALT), platelet function, and patient reports of adverse events. Omega-3 fatty acids may be a useful adjunct in the treatment of hypertriglyceridemia in HIV-infected patients, but additional controlled studies are needed to assess its safety and efficacy using a purified, standardized preparation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LOVAZA | Experimental | 4 g/d of omega-3 fatty acid esters, plus dietary counseling |
|
| Placebo | Placebo Comparator | Corn oil placebo, plus dietary counselling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 fatty acid administration | Drug | LOVAZA 1 gram capsules, 4 capsules daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Triglyceride Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group | 8 weeks | |
| Change in Non-HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Todd T. Brown, MD | Johns Hopkins University | Principal Investigator |
| David Leaf, MD | Veterans Adminstration of Greater Los Angeles Health System | Principal Investigator |
| Mattew Goetz, MD | Veterans Adminstration of Greater Los Angeles Health System | Principal Investigator |
| Adrian S Dobs, MD | Johns Hopkins University | Principal Investigator |
| Joseph Timpone, MD | Georgetown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Administration of Greater Los Angeles Health System | Los Angeles | California | 90073 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23683266 | Result | Metkus TS, Timpone J, Leaf D, Bidwell Goetz M, Harris WS, Brown TT. Omega-3 fatty acid therapy reduces triglycerides and interleukin-6 in hypertriglyeridemic HIV patients. HIV Med. 2013 Oct;14(9):530-9. doi: 10.1111/hiv.12046. Epub 2013 May 19. |
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Recruitment took plave between November 2006 and September 2010 at 3 sites (Johns Hopkins University, Baltimore, MD;Veteran's Administration Greater Los Angeles Healthcare System (Los Angeles, CA), and the Georgetown University Hospital (Washington, DC). Participants were recruited from the HIV Clinics at these institutions.
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| ID | Title | Description |
|---|---|---|
| FG000 | LOVAZA | 4 g/d of omega-3 fatty acid esters, plus dietary counseling |
| FG001 | Placebo | Corn oil placebo, plus dietary counselling |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LOVAZA | 4 g/d of omega-3 fatty acid esters, plus dietary counseling |
| BG001 | Placebo | Corn oil placebo, plus dietary counselling |
| 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 Triglyceride Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group. | Posted | Median | Inter-Quartile Range | mg/dl | 8 weeks |
|
|
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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 | 4 g/d of omega-3 fatty acid esters, plus dietary counseling Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointesitnal Side effects (dyspepsia, bloating, fishy taste) | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Todd Brown, Associate Professor of Medicine and Epidemiology | Johns Hopkins University | 410-502-2327 | tbrown27@jhmi.edu |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| D050171 | Dyslipidemias |
| D015228 | Hypertriglyceridemia |
| D007249 | Inflammation |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Placebo |
| Drug |
Corn-oil placebo |
|
| Change in HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group | 8 weeks |
| Change in HOMA-IR From Baseline in the LOVAZA Group Compared to the Placebo Group | 8 weeks |
| Change in CD4+ T-cell Counts From Baseline in the LOVAZA Group Compared to the Placebo Group | 8 weeks |
| Change in hsCRP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group. | 8 weeks |
| Change in IL-6 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group. | 8 weeks |
| Change in TNF-a Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group. | 8 weeks |
| Change in sTNFR1 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group. | 8 weeks |
| Change in sTNFR2 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group. | 8 weeks |
| Change in CTX Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group. | 8 weeks |
| Change in P1NP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group. | 8 weeks |
| Change in Collagen ADP From Baseline in the LOVAZA Group Compared to the Placebo Group. | 8 weeks |
| Change in Collagen Epinephrine From Baseline in the LOVAZA Group Compared to the Placebo Group. | 8 weeks |
| Georgetown University |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in Total Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group | Posted | Median | Inter-Quartile Range | mg/dl | 8 weeks |
|
|
|
|
| Secondary | Change in Non-HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group | Posted | Median | Inter-Quartile Range | mg/dl | 8 weeks |
|
|
|
|
| Secondary | Change in HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group | Posted | Median | Inter-Quartile Range | mg/dl | 8 weeks |
|
|
|
|
| Secondary | Change in HOMA-IR From Baseline in the LOVAZA Group Compared to the Placebo Group | Analysis done on all participants with available data | Posted | Median | Inter-Quartile Range | units on a scale | 8 weeks |
|
|
|
|
| Secondary | Change in CD4+ T-cell Counts From Baseline in the LOVAZA Group Compared to the Placebo Group | Analysis done on all participants with available data | Posted | Median | Inter-Quartile Range | cells/cc | 8 weeks |
|
|
|
|
| Secondary | Change in hsCRP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group. | Analysis done on all participants with available data | Posted | Median | Inter-Quartile Range | ng/ml | 8 weeks |
|
|
|
|
| Secondary | Change in IL-6 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group. | Analysis done on all participants with available data | Posted | Median | Inter-Quartile Range | pg/mL | 8 weeks |
|
|
|
|
| Secondary | Change in TNF-a Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group. | Analysis done on all participants with available data | Posted | Median | Inter-Quartile Range | pg/mL | 8 weeks |
|
|
|
|
| Secondary | Change in sTNFR1 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group. | Analysis done on all participants with available data | Posted | Median | Inter-Quartile Range | pg/mL | 8 weeks |
|
|
|
|
| Secondary | Change in sTNFR2 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group. | Analysis done on all participants with available data | Posted | Median | Inter-Quartile Range | pg/mL | 8 weeks |
|
|
|
|
| Secondary | Change in CTX Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group. | Analysis done on all participants with available data | Posted | Median | Inter-Quartile Range | ng/mL | 8 weeks |
|
|
|
|
| Secondary | Change in P1NP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group. | Analysis done on all participants with available data | Posted | Median | Inter-Quartile Range | mcg/L | 8 weeks |
|
|
|
|
| Secondary | Change in Collagen ADP From Baseline in the LOVAZA Group Compared to the Placebo Group. | Analysis done on all participants with available data | Posted | Median | Inter-Quartile Range | seconds | 8 weeks |
|
|
|
|
| Secondary | Change in Collagen Epinephrine From Baseline in the LOVAZA Group Compared to the Placebo Group. | Analysis done on all participants with available data | Posted | Median | Inter-Quartile Range | seconds | 8 weeks |
|
|
|
|
| 0 |
| 24 |
| 4 |
| 24 |
| EG001 | Placebo | Corn oil placebo, plus dietary counselling Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily | 0 | 24 | 8 | 24 |
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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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 |
| D012897 | Slow Virus Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006949 | Hyperlipidemias |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |