Effect of Omacor on Triglycerides in HIV Infected Subjects
March 27, 2009 updated by: Solvay Pharmaceuticals
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
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bochum, Germany
- Site 2
-
Hannover, Germany
- Site 1
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-
-
-
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London, United Kingdom
- Site 3
-
London, United Kingdom
- Site 4
-
London, United Kingdom
- Site 5
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A
|
n-3 PUFA
|
|
Placebo Comparator: B
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percent change in serum triglycerides from baseline to treatment endpoint versus placebo
Time Frame: 12 weeks treatment
|
12 weeks treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Absolute change in serum triglycerides
Time Frame: 12 weeks
|
12 weeks
|
|
Absolute and percent change in cholesterol and cholesterol subfractions
Time Frame: 12 weeks
|
12 weeks
|
|
Absolute and percent change in apolipoprotein A and B
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
January 11, 2008
First Submitted That Met QC Criteria
January 11, 2008
First Posted (Estimate)
January 23, 2008
Study Record Updates
Last Update Posted (Estimate)
March 30, 2009
Last Update Submitted That Met QC Criteria
March 27, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S185.4.001
- 2007-001921-86
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.