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

Study Overview
=================
Brief 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.

Official Title
-----------------
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

Conditions
-----------------
Hypertriglyceridemia, HIV Infection

Intervention / Treatment
-----------------
* Dietary Supplement: Lovaza
* Drug: fosamprenavir/ritonavir


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Boosted Lexiva with Lovaza<br> | Dietary Supplement: Lovaza<br>* 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<br>Drug: fosamprenavir/ritonavir<br>* Lexiva (fosamprenavir calcium) 1400 mg per day, Norvir (ritonavir) 100 mg per day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With Triglycerides <200 mg/dL |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With HIV-1 RNA <50 Copies/mL |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, triglycerides, fosamprenavir