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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01010399
First Posted: November 10, 2009
Last Update Posted: April 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Felizarta, Franco, M.D.
Results First Submitted: March 26, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Hypertriglyceridemia
HIV Infection
Interventions: Dietary Supplement: Lovaza
Drug: fosamprenavir/ritonavir

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Boosted Lexiva With Lovaza No text entered.

Participant Flow:   Overall Study
    Boosted Lexiva With Lovaza
STARTED   36 
COMPLETED   31 
NOT COMPLETED   5 



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information