Effect of Omacor on Triglycerides in HIV Infected Subjects

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00598910

Enrollment

Registered

2008-01-23

Start date

2007-08-31

Completion date

2009-03-31

Last updated

2009-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyper-Triglyceridemia

Keywords

HIV infection

Brief summary

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

Interventions

DRUGOmacor

n-3 PUFA

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Percent change in serum triglycerides from baseline to treatment endpoint versus placebo	12 weeks treatment

Secondary

Measure	Time frame
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

Countries

Germany, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026