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

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ClinicalTrials.gov Identifier: NCT01010399
Recruitment Status : Completed
First Posted : November 10, 2009
Results First Posted : April 18, 2012
Last Update Posted : April 18, 2012
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Felizarta, Franco, M.D.

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
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Boosted Lexiva With Lovaza
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 36
Completed 31
Not Completed 5
Arm/Group Title Boosted Lexiva With Lovaza
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
<=18 years
0
   0.0%
Between 18 and 65 years
36
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants
48.3  (6.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
1
   2.8%
Male
35
  97.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants
36
1.Primary Outcome
Title Proportion of Subjects With Triglycerides <200 mg/dL
Hide Description [Not Specified]
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Boosted Lexiva With Lovaza
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: participants
12
2.Secondary Outcome
Title Proportion of Subjects With HIV-1 RNA <50 Copies/mL
Hide Description [Not Specified]
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Boosted Lexiva With Lovaza
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: participants
28
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Boosted Lexiva With Lovaza
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Boosted Lexiva With Lovaza
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Boosted Lexiva With Lovaza
Affected / at Risk (%) # Events
Total   0/36 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Boosted Lexiva With Lovaza
Affected / at Risk (%) # Events
Total   6/36 (16.67%)    
Gastrointestinal disorders   
diarrhea *  1/36 (2.78%)  1
Infections and infestations   
influenza *  1/36 (2.78%)  1
Metabolism and nutrition disorders   
hypercholesterolemia  4/36 (11.11%)  4
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Franco Felizarta, MD
Organization: Franco Felizarta, MD
Phone: 661-324-3128
Responsible Party: Felizarta, Franco, M.D.
ClinicalTrials.gov Identifier: NCT01010399     History of Changes
Other Study ID Numbers: COL112948
First Submitted: November 9, 2009
First Posted: November 10, 2009
Results First Submitted: March 26, 2012
Results First Posted: April 18, 2012
Last Update Posted: April 18, 2012