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

History of Changes

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:

MedlinePlus related topics: HIV/AIDS Triglycerides

Drug Information available for: Omega-3-acid Ethyl Esters Lovaza

U.S. FDA Resources

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):

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. Epub 2011 Dec 31.

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 May 21, 2013

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