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Effect of Omacor on Triglycerides in HIV Infected Subjects

This study has been terminated.
(The study was discontinued prematurely on December 18 2008 due to slow recruitment)
Information provided by:
Solvay Pharmaceuticals Identifier:
First received: January 11, 2008
Last updated: March 27, 2009
Last verified: March 2009
Omacor is likely to decrease lipid parameters in HIV infected subjects. In these subjects the lipid are decrease due to HAART treatment

Condition Intervention Phase
Hyper-Triglyceridemia Drug: Omacor Drug: Placebo Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Solvay Pharmaceuticals:

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

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

Enrollment: 51
Study Start Date: August 2007
Study Completion Date: March 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Omacor
n-3 PUFA
Placebo Comparator: B Drug: Placebo


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00598910

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
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Joachim Luszick, Solvay Pharmaceuticals Identifier: NCT00598910     History of Changes
Other Study ID Numbers: S185.4.001
Study First Received: January 11, 2008
Last Updated: March 27, 2009

Keywords provided by Solvay Pharmaceuticals:
HIV infection

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases processed this record on September 20, 2017