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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infection; Hypertriglyceridemia
• Intervention / Treatment: Dietary supplement: Lovaza; Drug: fosamprenavir/ritonavir

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Bakersfield, California, United States, 93301
      • Franco Felizarta, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Boosted Lexiva with Lovaza	Dietary supplement: Lovaza; 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; Drug: fosamprenavir/ritonavir; Lexiva (fosamprenavir calcium) 1400 mg per day, Norvir (ritonavir) 100 mg per day

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Felizarta, Franco, M.D.
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Franco Felizarta, MD, Franco Felizarta, MD

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ACTUAL): November 1, 2010
• Study Completion (ACTUAL): November 1, 2010

Study Registration Dates

• First Submitted: November 9, 2009
• First Submitted That Met QC Criteria: November 9, 2009
• First Posted (ESTIMATE): November 10, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): April 18, 2012
• Last Update Submitted That Met QC Criteria: March 26, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: HIV; triglycerides; fosamprenavir
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypertriglyceridemia; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir; Fosamprenavir
• Other Study ID Numbers: COL112948