Effect of Omacor on Triglycerides in HIV Infected Subjects

Phase 4

Terminated

• Conditions: Hyper-Triglyceridemia
• Interventions: Drug: Omacor; Drug: Placebo

• Registration Number: NCT00598910
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-01-11
• Study First Submitted QC: 2008-01-11
• Study First Posted: 2008-01-23
• Primary Completion: 2008-09
• Status Verified: 2009-03
• Study Completion: 2009-03
• Last Update Submitted: 2009-03-27
• Last Update Posted: 2009-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 51

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Omacor	-
B	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percent change in serum triglycerides from baseline to treatment endpoint versus placebo	12 weeks treatment

Secondary Outcome Measures

Name	Time	Method
Absolute change in serum triglycerides	12 weeks
Absolute and percent change in cholesterol and cholesterol subfractions	12 weeks
Absolute and percent change in apolipoprotein A and B	12 weeks

Trial Locations

Locations (5)

Site 2; 🇩🇪 Bochum, Germany

Site 5; 🇬🇧 London, United Kingdom

Site 1; 🇩🇪 Hannover, Germany

Site 3; 🇬🇧 London, United Kingdom

Site 4; 🇬🇧 London, United Kingdom