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
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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
Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Solvay Pharmaceuticals

Additional 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
Study First Received: January 11, 2008
Last Updated: March 27, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Solvay Pharmaceuticals:
HIV infection

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

ClinicalTrials.gov processed this record on April 23, 2014