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

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ClinicalTrials.gov Identifier: NCT01010399
Recruitment Status : Completed
First Posted : November 10, 2009
Results First Posted : April 18, 2012
Last Update Posted : April 18, 2012
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Felizarta, Franco, M.D.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia HIV Infection Dietary Supplement: Lovaza Drug: fosamprenavir/ritonavir Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

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U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Subjects With Triglycerides <200 mg/dL [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Proportion of Subjects With HIV-1 RNA <50 Copies/mL [ Time Frame: 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010399


Locations
United States, California
Franco Felizarta, MD
Bakersfield, California, United States, 93301
Sponsors and Collaborators
Felizarta, Franco, M.D.
GlaxoSmithKline
Investigators
Principal Investigator: Franco Felizarta, MD Franco Felizarta, MD
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Felizarta, Franco, M.D.
ClinicalTrials.gov Identifier: NCT01010399     History of Changes
Other Study ID Numbers: COL112948
First Posted: November 10, 2009    Key Record Dates
Results First Posted: April 18, 2012
Last Update Posted: April 18, 2012
Last Verified: March 2012

Keywords provided by Felizarta, Franco, M.D.:
HIV
triglycerides
fosamprenavir

Additional relevant MeSH terms:
HIV Infections
Hypertriglyceridemia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
 Metabolic Diseases
Ritonavir
Fosamprenavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors