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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Felizarta, Franco, M.D.
ClinicalTrials.gov Identifier:
NCT01010399
First received: November 9, 2009
Last updated: March 26, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Hypertriglyceridemia
HIV Infection
 Dietary Supplement: Lovaza
Drug: fosamprenavir/ritonavir
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Felizarta, Franco, M.D.:

Primary Outcome Measures:
  • Proportion of Subjects With Triglycerides <200 mg/dL [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of Subjects With HIV-1 RNA <50 Copies/mL [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: September 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Felizarta, Franco, M.D.
ClinicalTrials.gov Identifier: NCT01010399     History of Changes
Other Study ID Numbers: COL112948
Study First Received: November 9, 2009
Results First Received: March 26, 2012
Last Updated: March 26, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Hypertriglyceridemia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Hyperlipidemias
Dyslipidemias
 Lipid Metabolism Disorders
Metabolic Diseases
Protease Inhibitors
Ritonavir
Fosamprenavir
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
HIV Protease Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2013