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

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Felizarta, Franco, M.D.
• Collaborator: GlaxoSmithKline
• Treatments: Fosamprenavir; Ritonavir

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