Several investigations show that HIV infected patients have a higher risk for development of heart disease if treated with HAART. The investigation will evaluate the effect of fish oil on blood lipids and on the function of blood vessels in HIV infected patients on antiretroviral therapy (HAART).
Conditions
Interventions
Trade Name: Omacor
Product Name: Omacor
Pharmaceutical Form: Capsule, soft
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use
Sponsors
Jeppe Hagstrup Christensen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male/female age > 18 years 2) Documented HIV infection 3) Active HAART treatment in a periode of 3 month 4) Signed informed consent 5) Understands and read english or danish Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Age < 18 years 2) Cancers except from skin basalcell carcinom 3) Patients assessed as in cooperative in the protocol 4) Pregnant or wish to get pregnant within the next 3 month 5) Allergic to fish
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if N-3 PUFA’s significant will reduce plasma triglycerides in HIV-patients on HAART treatment. ;Secondary Objective: Secondary efficacy parameters: PWV and FMD. Tertiary efficacy parameters: non-HDL-C, LDL-C, HDL-C, ICAM, VCAM, Sens. CRP, Apo A, Apo B, Lp(a), fibrinogen, PAI-1 ag, vw-faktor, Trombomodulin, oxideret LDL, small dense LDL, Granulocytlipid, LTB4. ;Primary end point(s): Plasma triglycerides | — |
Countries
Denmark
Outcome results
None listed