Effect of Omacor on Triglycerides in HIV Infected Subjects

Hyper-Triglyceridemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00598910
• Other study ID #: S185.4.001
• Secondary ID: 2007-001921-86
• Status: Terminated
• Phase: Phase 4
• First received: January 11, 2008
• Last updated: March 27, 2009
• Start date: August 2007
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: March 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyper-Triglyceridemia
• Hypertriglyceridemia

Intervention

Drug:
• Omacor
n-3 PUFA
• Placebo
Placebo

Locations

Country	Name	City	State
Germany	Site 2	Bochum
Germany	Site 1	Hannover
United Kingdom	Site 3	London
United Kingdom	Site 4	London
United Kingdom	Site 5	London

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in serum triglycerides from baseline to treatment endpoint versus placebo		12 weeks treatment	No
Secondary	Absolute change in serum triglycerides		12 weeks	No
Secondary	Absolute and percent change in cholesterol and cholesterol subfractions		12 weeks	No
Secondary	Absolute and percent change in apolipoprotein A and B		12 weeks	No