E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HAART-induced hypertriglyeridemia in HIV infected subjects |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020869 |
E.1.2 | Term | Hypertriglyceridaemia |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |