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Clinical Trials

MainTitle

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

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

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

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: 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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

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

More Information


Responsible Party: Felizarta, Franco, M.D.  
ClinicalTrials.gov 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.:

HIV
triglycerides
fosamprenavir

Additional relevant MeSH terms:
HIV Infections
Hypertriglyceridemia
Ritonavir
Fosamprenavir

ClinicalTrials.gov processed this data on October 18, 2017
This information is provided by ClinicalTrials.gov.