Effect of Omacor on Triglycerides in HIV Infected Subjects

Solvay

Status and phase: Terminated; Phase 4

Conditions: Hyper-Triglyceridemia

Treatments: Drug: Placebo; Drug: Omacor

Study type: Interventional

Funder types: Industry

Identifiers

NCT00598910

2007-001921-86

S185.4.001

Details and patient eligibility

About

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

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: Omacor

B

Placebo Comparator group

Treatment:

Drug: Placebo