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

Mazonson & Santas

Status and phase: Completed; Phase 4

Conditions: Hypertriglyceridemia; HIV Infection

Treatments: Dietary Supplement: Lovaza; Drug: fosamprenavir/ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01010399

COL112948

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Boosted Lexiva with Lovaza

Experimental group

Treatment:

Dietary Supplement: Lovaza

Drug: fosamprenavir/ritonavir