E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Infección crónica por VIH Hipercolesterolemia
Chronic HIV infection hypercholesterolemia |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020603 |
E.1.2 | Term | Hypercholesterolaemia |
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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 |
To assess the effect of ezetimibe monotherapy on plasma lipid profile in HIV-infected subjects receiving boosted protease inhibitors |
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E.2.2 | Secondary objectives of the trial |
-To evaluate if plasma levels of phytosterols are predictors of the cholesterol lowering effect of ezetimibe in this population. - To assess the effect of ezetimibe monotherapy on cholesterol synthesis and absorption in this population. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age: 18 years and above. - Gender: both - Confirmed HIV infection - ART including a boosted PI (PI/r) - On stable ART for at least 1 month - Hypercholesterolemia defined as: LDL-cholesterol between 130 and 190 mg/dl without treatment, or any with statin therapy. - Willingness to participate in the study
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E.4 | Principal exclusion criteria |
- Hypersensitivity to ezetimibe - Consumption of functional foods enriched in phytosterols in the month prior to scheduled study entry - Prior history of cardiovascular disease (coronary disease, cerebrovascular disease, peripheral vascular disease) - Secondary hypercholesterolemia: Untreated or uncontrolled hypothyroidism, nephrotic syndrome corticosteroid therapy - Renal insufficiency - Increased transaminase levels (5 times upper level of normality) - Concomitant treatment for HCV coinfection (interferon plus ribavirine) - Diabetes Mellitus: previous clinical diagnosis or actual fasting glycaemia > 125 mg/dl - Current illicit drug or alcohol abuse - Active AIDS-defining opportunistic infection within 3 months prior to study entry - Any acute illness that would interfere with the study within 30 days prior to study entry - Pregnancy or breastfeeding - Decreased mental capacity or any other condition that may interfere with the study
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E.5 End points |
E.5.1 | Primary end point(s) |
·Changes in total, HDL and LDL cholesterol levels after 8 weeks of ezetimibe treatment ·Baseline plasma phytosterols and cholesterol precursors concentration.
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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) | Yes |
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 10 |