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
  Hide Participant Flow

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
No text entered.

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
  Hide Baseline Characteristics

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.
No text entered.

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
  Hide All Outcome Measures

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

Measure Type Primary
Measure Title Proportion of Subjects With Triglycerides <200 mg/dL
Measure Description No text entered.
Time Frame 24 weeks  
Safety Issue No  

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.
No text entered.

Reporting Groups
  Description
Boosted Lexiva With Lovaza No text entered.

Measured Values
    Boosted Lexiva With Lovaza  
Number of Participants Analyzed  
[units: participants]
  36  
Proportion of Subjects With Triglycerides <200 mg/dL  
[units: participants]
  12  

No statistical analysis provided for Proportion of Subjects With Triglycerides <200 mg/dL



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

Measure Type Secondary
Measure Title Proportion of Subjects With HIV-1 RNA <50 Copies/mL
Measure Description No text entered.
Time Frame 24 weeks  
Safety Issue No  

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.
No text entered.

Reporting Groups
  Description
Boosted Lexiva With Lovaza No text entered.

Measured Values
    Boosted Lexiva With Lovaza  
Number of Participants Analyzed  
[units: participants]
  36  
Proportion of Subjects With HIV-1 RNA <50 Copies/mL  
[units: participants]
  28  

No statistical analysis provided for Proportion of Subjects With HIV-1 RNA <50 Copies/mL




  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Franco Felizarta, MD
Organization: Franco Felizarta, MD
phone: 661-324-3128
e-mail: felizarta@pol.net


No publications provided


Responsible Party: Felizarta, Franco, M.D.
ClinicalTrials.gov Identifier: NCT01010399     History of Changes
Other Study ID Numbers: COL112948
Study First Received: November 9, 2009
Results First Received: March 26, 2012
Last Updated: March 26, 2012
Health Authority: United States: Institutional Review Board