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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)
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00598910
First received: January 11, 2008
Last updated: March 27, 2009
Last verified: March 2009

January 11, 2008
March 27, 2009
August 2007
September 2008   (final data collection date for primary outcome measure)
Percent change in serum triglycerides from baseline to treatment endpoint versus placebo [ Time Frame: 12 weeks treatment ] [ Designated as safety issue: No ]
Percent change in serum triglycerides from baseline to treatment endpoint [ Time Frame: 12 weeks treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00598910 on ClinicalTrials.gov Archive Site
  • Absolute change in serum triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Absolute and percent change in cholesterol and cholesterol subfractions [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Absolute and percent change in apolipoprotein A and B [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Absolute change in serum triglycerides, absolute and percent change in cholesterol, cholesterol subfractions and in apolipoprotein A and B [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect of Omacor on Triglycerides in HIV Infected Subjects
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

Omacor is likely to decrease lipid parameters in HIV infected subjects. In these subjects the lipid are decrease due to HAART treatment

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hyper-Triglyceridemia
  • Drug: Omacor
    n-3 PUFA
  • Drug: Placebo
    Placebo
  • Experimental: A
    Intervention: Drug: Omacor
  • Placebo Comparator: B
    Intervention: Drug: Placebo
Peters BS, Wierzbicki AS, Moyle G, Nair D, Brockmeyer N. The effect of a 12-week course of omega-3 polyunsaturated fatty acids on lipid parameters in hypertriglyceridemic adult HIV-infected patients undergoing HAART: a randomized, placebo-controlled pilot trial. Clin Ther. 2012 Jan;34(1):67-76. doi: 10.1016/j.clinthera.2011.12.001. Epub 2011 Dec 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
51
March 2009
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United Kingdom
 
NCT00598910
S185.4.001, 2007-001921-86
No
Joachim Luszick, Solvay Pharmaceuticals
Solvay Pharmaceuticals
Not Provided
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
Solvay Pharmaceuticals
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP