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Effect of Omacor on Triglycerides in HIV Infected Subjects

Primary Purpose

Hyper-Triglyceridemia

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Omacor
Placebo
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyper-Triglyceridemia focused on measuring HIV infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site 2
  • Site 1
  • Site 3
  • Site 4
  • Site 5

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Percent change in serum triglycerides from baseline to treatment endpoint versus placebo

Secondary Outcome Measures

Absolute change in serum triglycerides
Absolute and percent change in cholesterol and cholesterol subfractions
Absolute and percent change in apolipoprotein A and B

Full Information

First Posted
January 11, 2008
Last Updated
March 27, 2009
Sponsor
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00598910
Brief Title
Effect of Omacor on Triglycerides in HIV Infected Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Terminated
Why Stopped
The study was discontinued prematurely on December 18 2008 due to slow recruitment
Study Start Date
August 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyper-Triglyceridemia
Keywords
HIV infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Omacor
Intervention Description
n-3 PUFA
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Percent change in serum triglycerides from baseline to treatment endpoint versus placebo
Time Frame
12 weeks treatment
Secondary Outcome Measure Information:
Title
Absolute change in serum triglycerides
Time Frame
12 weeks
Title
Absolute and percent change in cholesterol and cholesterol subfractions
Time Frame
12 weeks
Title
Absolute and percent change in apolipoprotein A and B
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 2
City
Bochum
Country
Germany
Facility Name
Site 1
City
Hannover
Country
Germany
Facility Name
Site 3
City
London
Country
United Kingdom
Facility Name
Site 4
City
London
Country
United Kingdom
Facility Name
Site 5
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22212377
Citation
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.
Results Reference
derived

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Effect of Omacor on Triglycerides in HIV Infected Subjects

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