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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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In subjects on boosted protease inhibitor (PI)-regimens who have elevated triglycerides, a switch to fosamprenavir/ritonavir once daily followed by the addition of Lovaza will result in 30% of patients achieving a reduction in fasting triglycerides < 200 mg /dL while maintaining virologic suppression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Boosted Lexiva with Lovaza | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lovaza | Dietary Supplement | Lovaza at a dose of 4g per day with each 1g capsule containing 465 mg of eicosapentaenoic acid (EPA) and 375 mg of docosahexaenoic acid (DHA) for 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Triglycerides <200 mg/dL | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With HIV-1 RNA <50 Copies/mL | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franco Felizarta, MD | Franco Felizarta, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franco Felizarta, MD | Bakersfield | California | 93301 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Boosted Lexiva With Lovaza |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Boosted Lexiva With Lovaza |
| 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 | Proportion of Subjects With Triglycerides <200 mg/dL | Posted | Number | participants | 24 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 | Boosted Lexiva With Lovaza |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypercholesterolemia | Metabolism and nutrition disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Franco Felizarta, MD | Franco Felizarta, MD | 661-324-3128 | felizarta@pol.net |
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C405603 | Omacor |
| C426859 | fosamprenavir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| fosamprenavir/ritonavir | Drug | Lexiva (fosamprenavir calcium) 1400 mg per day, Norvir (ritonavir) 100 mg per day |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Proportion of Subjects With HIV-1 RNA <50 Copies/mL | Posted | Number | participants | 24 weeks |
|
|
|
| 0 |
| 36 |
| 6 |
| 36 |
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| influenza | Infections and infestations | Non-systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| 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 |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |