At a glance
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A Pilot, Open-Label Study of Adjunctive Therapy With Lovaza® in Hypertriglyceridemic, HIV-Infected Subjects Who Switched Protease Inhibitor to Once-Daily Lexiva® 1400mg Plus Norvir® 100mg Plus Optimized Background
In Brief
A Phase 4 clinical trial evaluating Lovaza and fosamprenavir/ritonavir for Hypertriglyceridemia and HIV Infection. Completed, enrolled 36 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
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
Lexiva (fosamprenavir calcium) 1400 mg per day, Norvir (ritonavir) 100 mg per day