Omega-3 Fatty Acids for High Triglycerides in HIV-infected Patients

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Information provided by (Responsible Party):
Todd T. Brown, MD, PhD, Brown, Todd, M.D., Ph.D.
ClinicalTrials.gov Identifier:
NCT00346697
First received: June 29, 2006
Last updated: November 4, 2014
Last verified: November 2014
Results First Received: July 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infections
AIDS
Dyslipidemia
Hypertriglyceridemia
Interventions: Drug: Omega-3 fatty acid administration
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
Recruitment took plave between November 2006 and September 2010 at 3 sites (Johns Hopkins University, Baltimore, MD;Veteran’s Administration Greater Los Angeles Healthcare System (Los Angeles, CA), and the Georgetown University Hospital (Washington, DC). Participants were recruited from the HIV Clinics at these institutions.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None

Reporting Groups
  Description
LOVAZA 4 g/d of omega-3 fatty acid esters, plus dietary counseling
Placebo Corn oil placebo, plus dietary counselling

Participant Flow:   Overall Study
    LOVAZA     Placebo  
STARTED     24     24  
COMPLETED     24     23  
NOT COMPLETED     0     1  
Lost to Follow-up                 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 4 g/d of omega-3 fatty acid esters, plus dietary counseling
Placebo Corn oil placebo, plus dietary counselling
Total Total of all reporting groups

Baseline Measures
    LOVAZA     Placebo     Total  
Number of Participants  
[units: participants]
  24     24     48  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     24     24     48  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  50.3  (5.2)     48.2  (8.0)     49.2  (6.8)  
Age  
[units: years]
Median (Inter-Quartile Range)
  50    (47 to 52)     48    (41 to 52)     49.5    (45.5 to 52.5)  
Gender  
[units: participants]
     
Female     3     2     5  
Male     21     22     43  
Region of Enrollment  
[units: participants]
     
United States     24     24     48  



  Outcome Measures
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1.  Primary:   Change in Triglyceride Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.   [ Time Frame: 8 weeks ]

2.  Secondary:   Change in Total Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group   [ Time Frame: 8 weeks ]

3.  Secondary:   Change in Non-HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group   [ Time Frame: 8 weeks ]

4.  Secondary:   Change in HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group   [ Time Frame: 8 weeks ]

5.  Secondary:   Change in HOMA-IR From Baseline in the LOVAZA Group Compared to the Placebo Group   [ Time Frame: 8 weeks ]

6.  Secondary:   Change in CD4+ T-cell Counts From Baseline in the LOVAZA Group Compared to the Placebo Group   [ Time Frame: 8 weeks ]

7.  Secondary:   Change in hsCRP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.   [ Time Frame: 8 weeks ]

8.  Secondary:   Change in IL-6 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.   [ Time Frame: 8 weeks ]

9.  Secondary:   Change in TNF-a Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.   [ Time Frame: 8 weeks ]

10.  Secondary:   Change in sTNFR1 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.   [ Time Frame: 8 weeks ]

11.  Secondary:   Change in sTNFR2 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.   [ Time Frame: 8 weeks ]

12.  Secondary:   Change in CTX Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.   [ Time Frame: 8 weeks ]

13.  Secondary:   Change in P1NP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.   [ Time Frame: 8 weeks ]

14.  Secondary:   Change in Collagen ADP From Baseline in the LOVAZA Group Compared to the Placebo Group.   [ Time Frame: 8 weeks ]

15.  Secondary:   Change in Collagen Epinephrine From Baseline in the LOVAZA Group Compared to the Placebo Group.   [ Time Frame: 8 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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr Todd Brown, Associate Professor of Medicine and Epidemiology
Organization: Johns Hopkins University
phone: 410-502-2327
e-mail: tbrown27@jhmi.edu


Publications of Results:

Responsible Party: Todd T. Brown, MD, PhD, Brown, Todd, M.D., Ph.D.
ClinicalTrials.gov Identifier: NCT00346697     History of Changes
Other Study ID Numbers: K23 AT002862-01, K23AT002862-01
Study First Received: June 29, 2006
Results First Received: July 15, 2014
Last Updated: November 4, 2014
Health Authority: United States: Federal Government