Overview

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