Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Todd Conley, Tufts University
ClinicalTrials.gov Identifier:
NCT00795717
First received: November 19, 2008
Last updated: December 2, 2014
Last verified: December 2014
Results First Received: May 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Cardiovascular Disease
HIV Infection
Interventions: Drug: Lovaza
Drug: Placebo

  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
Phone contact n=109 Screening n=51 Eligible n=42 Screen failed n=9 Declined participation n=1 Randomized to treatment first n=20 Randomized to placebo first n=21

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
Lovaza Then Placebo

Lovaza, dietary counseling

Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks vs. placebo 2 capsules given twice daily.

Placebo Then Lovaza

Placebo, dietary counseling

Placebo : 2 capsules given twice daily vs. Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks


Participant Flow for 2 periods

Period 1:   Phase I Followed by Wash Out x 4 Weeks
    Lovaza Then Placebo     Placebo Then Lovaza  
STARTED     20 [1]   21 [2]
COMPLETED     18     19  
NOT COMPLETED     2     2  
alcohol treatment                 1                 0  
Adverse Event                 1                 1  
Lost to Follow-up                 0                 1  
[1] Randomized to treatment first
[2] Randomized to placebo first

Period 2:   Phase II
    Lovaza Then Placebo     Placebo Then Lovaza  
STARTED     18     19  
COMPLETED     18     18  
NOT COMPLETED     0     1  
too busy                 0                 1  



  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.
No text entered.

Reporting Groups
  Description
Lovaza Then Placebo

Lovaza, dietary counseling

Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks.

Placebo Then Lovaza

Placebo or Corn oil pill, dietary counseling

Corn oil pill : 2 capsules given twice daily for 12 weeks

Total Total of all reporting groups

Baseline Measures
    Lovaza Then Placebo     Placebo Then Lovaza     Total  
Number of Participants  
[units: participants]
  20     21     41  
Age  
[units: years]
Median ( Inter-Quartile Range )
  51.5  
  ( 46.5 to 55.0 )  
  55.0  
  ( 44.0 to 58.0 )  
  52.0  
  ( 45.0 to 58.0 )  
Gender  
[units: participants]
     
Female     3     3     6  
Male     17     18     35  
Region of Enrollment  
[units: participants]
     
United States     20     21     41  



  Outcome Measures
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1.  Primary:   Change in Baseline Mean Serum Triglyceride Level at Study End   [ Time Frame: Baseline and 12 weeks ]

2.  Secondary:   Serum HDL Level   [ Time Frame: 12 weeks ]

3.  Secondary:   Brachial Artery Reactivity   [ Time Frame: 12 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
We had low numbers that may not represent the overall population. There was not an HIV negative control arm. The 4 week wash out was too short and therefore difficult to compare the post-treatment vs true post placebo effects.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Christine A. Wanke, MD
Organization: Tufts University School of Medicine
phone: 617-636-3811
e-mail: christine.wanke@tufts.edu


No publications provided by Tufts University

Publications automatically indexed to this study:

Responsible Party: Todd Conley, Tufts University
ClinicalTrials.gov Identifier: NCT00795717     History of Changes
Other Study ID Numbers: LVZ111888, 011293-GSK Contract Reference#
Study First Received: November 19, 2008
Results First Received: May 7, 2013
Last Updated: December 2, 2014
Health Authority: United States: Food and Drug Administration