Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects

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 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.

Inclusion Criteria:

• fasting triglycerides >= 200 mg/dL but <1,200 mg/dL
• fasting LDL <= 160 mg/dL
• participation in a lipid-lowering diet and exercise program for at least 28 days
• treatment with stable HAART consisting of first or second RTV-boosted PI regimen plus optimized background ART for at least 3 months
• plasma HIV-1 RNA <50 copies/mL
• CD4+ cell count >50 cells/mm3
• male subjection testosterone replacement therapy with total testosterone level <= 1 x upper limit of normal
• female study volunteer must use a form of contraception
• ability and willing ness to give written informed consent

Exclusion Criteria:

• any Grade 4 laboratory abnormality
• currently taking amprenavir or fosamprenavir
• required a second RTV-boosted PI for reasons of virologic failure
• atherosclerotic disease risk
• congestive heart failure (NYHA Class III or IV)
• uncontrolled hypertension
• history of pancreatitis
• active bleeding disorder
• recent history of significant renal, pulmonary, biliary, hepatic or gastrointestinal disease
• current diabetes mellitus requiring pharmacological treatment
• use of systemic cancer chemotherapy; active cancer
• pregnancy or breast-feeding
• requirement for any lipid-lowering agent after baseline
• use of hormonal anabolic therapies, systemic steroids, immune modulators
• use of anticoagulants, investigational antiretroviral drugs
• allergy to study drugs
• active CDC clinical category C event