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Effect of Omacor on Triglycerides in HIV Infected Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00598910
Recruitment Status : Terminated (The study was discontinued prematurely on December 18 2008 due to slow recruitment)
First Posted : January 23, 2008
Last Update Posted : March 30, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
Omacor is likely to decrease lipid parameters in HIV infected subjects. In these subjects the lipid are decrease due to HAART treatment

Condition or disease Intervention/treatment Phase
Hyper-Triglyceridemia Drug: Omacor Drug: Placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Investigate the Effect of Omacor (n-3 PUFA) on Lipid Parameters in HIV Infected Subjects Treated With HAART
Study Start Date : August 2007
Primary Completion Date : September 2008
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A Drug: Omacor
n-3 PUFA
Placebo Comparator: B Drug: Placebo
Placebo


Outcome Measures

Primary Outcome Measures :
  1. Percent change in serum triglycerides from baseline to treatment endpoint versus placebo [ Time Frame: 12 weeks treatment ]

Secondary Outcome Measures :
  1. Absolute change in serum triglycerides [ Time Frame: 12 weeks ]
  2. Absolute and percent change in cholesterol and cholesterol subfractions [ Time Frame: 12 weeks ]
  3. Absolute and percent change in apolipoprotein A and B [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Triglycerides between 200 and 800
  • diagnosed HIV infection
  • following HAART therapy

Exclusion Criteria:

  • other malignant disease
  • not compliant
  • allergy against fish oil
  • soy or olive oil
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00598910


Locations
Germany
Site 2
Bochum, Germany
Site 1
Hannover, Germany
United Kingdom
Site 3
London, United Kingdom
Site 4
London, United Kingdom
Site 5
London, United Kingdom
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joachim Luszick, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00598910     History of Changes
Other Study ID Numbers: S185.4.001
2007-001921-86
First Posted: January 23, 2008    Key Record Dates
Last Update Posted: March 30, 2009
Last Verified: March 2009

Keywords provided by Solvay Pharmaceuticals:
HIV infection

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases