Effect of Omacor on Triglycerides in HIV Infected Subjects

Phase 4TerminatedNCT00598910

Solvay Pharmaceuticals51 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hyper-Triglyceridemia

Interventions

OmacorDRUG

n-3 PUFA

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Site 2

Bochum, Germany

Site 1

Hanover, Germany

Site 3

London, United Kingdom

Site 4

London, United Kingdom

Site 5

London, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 12 weeks treatment

Secondary Outcomes

Absolute change in serum triglycerides

Time frame: 12 weeks

Absolute and percent change in cholesterol and cholesterol subfractions

Time frame: 12 weeks

Absolute and percent change in apolipoprotein A and B

Time frame: 12 weeks

Data from ClinicalTrials.gov

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