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
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 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 August 01, 2014