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
Results First Received: March 26, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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
No text entered.

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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Boosted Lexiva With Lovaza No text entered.

Baseline Measures
    Boosted Lexiva With Lovaza  
Number of Participants  
[units: participants]
  36  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     36  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  48.3  ± 6.9  
Gender  
[units: participants]
 
Female     1  
Male     35  
Region of Enrollment  
[units: participants]
 
United States     36  



  Outcome Measures
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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
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   1%  

Reporting Groups
  Description
Boosted Lexiva With Lovaza No text entered.

Other Adverse Events
    Boosted Lexiva With Lovaza  
Total, other (not including serious) adverse events    
# participants affected / at risk     6/36  
Gastrointestinal disorders    
diarrhea *  
# participants affected / at risk     1/36 (2.78%)  
# events     1  
Infections and infestations    
influenza *  
# participants affected / at risk     1/36 (2.78%)  
# events     1  
Metabolism and nutrition disorders    
hypercholesterolemia    
# participants affected / at risk     4/36 (11.11%)  
# events     4  
* Events were collected by non-systematic assessment



  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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