HAART-induced hypertriglyeridemia in HIV infected subjects MedDRA version: 9.1 Level: LLT Classification code 10020869 Term: Hypertriglyceridaemia
Conditions
Interventions
Trade Name: Omacor
Pharmaceutical Form: Capsule, soft
CAS Number: 86227-47-6
Other descriptive name: EPA ethyl ester
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
Solvay Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects = 18 years of age 2. Documented HIV-infection 3. On HAART for the last 3 months 4. Written informed consent 5. Plasma triglycerides values between 200 mg/100 ml and 1000 mg/100 ml 6. Fibrate treatment that has been ongoing for at least 3 months prior to randomization is considered acceptable 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 below 18 years 2. Other malign disease 3. Subjects assessed to be not compliant with study 4. Females must be non-lactating and either be of non-childbearing potential (i.e. sterilized via hysterectomy or bilateral tubal-ligation or at least one year postmenopausal) or if of childbearing potential, agree to practice effective barrier contraceptive methods, use an intrauterine device (IUD) or use birth-control pills or equivalent injectable contraceptive. The subjects must have been practicing the selected method of birth control for at least 3 months prior to visit 1. 5. Subjects taking fish oil capsules 8 weeks prior to inclusion in this study 6. Known allergy to fish oil or soy 7. Treatment with statins which can not be stopped 8. Treatment with oral anti-coagulants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives: - Absolute change in triglycerides - Absolute and percent change in cholesterol and cholesterol subfractions - Absolute and percent change in apolipoprotein A and B versus placebo ;Primary end point(s): Efficacy: Primary efficacy parameters are based on the reduction of serum trigycerides as the percentage change in serum triglycerides from baseline to treatment endpoint. Safety: Safety assessment consists of pysical examinations, determination of blood pressure and heart rate, routine laboratory values and virus load.;Main Objective: The study objective is to explore the effect of Omacor on HAART-induced hypertriglyceridemia in HIV-infected subjects. The primary objective will be the percent change in serum triglyerides from baseline to treatment endpoint (12 weeks, or earlier in case of premature termination) versus placebo. | — |
Countries
Germany, United Kingdom
Outcome results
None listed