Clinical Trials


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

This study has been completed
Felizarta, Franco, M.D.


Information provided by (Responsible Party)
Felizarta, Franco, M.D. Identifier

First received: November 9, 2009
Last updated: March 26, 2012
Last Verified: March 2012
History of Changes


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
HIV Infection

Dietary Supplement : Lovaza
Drug : fosamprenavir/ritonavir
Phase 4

Study Type: Interventional
Study Design: 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

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

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



Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  


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

Contacts and Locations

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Please refer to this study by its identifier: NCT01010399


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

Sponsors and Collaborators

Felizarta, Franco, M.D.


Principal Investigator: Franco Felizarta, MD Franco Felizarta, MD
More Information

More Information

Responsible Party: Felizarta, Franco, M.D. Identifier: NCT01010399   History of Changes  
Other Study ID Numbers: COL112948  
Study First Received: November 9, 2009  
Last Updated: March 26, 2012  

Keywords provided by Felizarta, Franco, M.D.:


Additional relevant MeSH terms:
Fosamprenavir processed this data on December 13, 2019
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