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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

November 9, 2009
March 26, 2012
September 2009
November 2010   (final data collection date for primary outcome measure)
Proportion of Subjects With Triglycerides <200 mg/dL [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01010399 on ClinicalTrials.gov Archive Site
Proportion of Subjects With HIV-1 RNA <50 Copies/mL [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects
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.
Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypertriglyceridemia
  • HIV Infection
  • 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
Experimental: Boosted Lexiva with Lovaza
Interventions:
  • Dietary Supplement: Lovaza
  • Drug: fosamprenavir/ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01010399
COL112948
No
Felizarta, Franco, M.D.
Felizarta, Franco, M.D.
GlaxoSmithKline
Principal Investigator: Franco Felizarta, MD Franco Felizarta, MD
Felizarta, Franco, M.D.
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP