E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
-Human Imunodeficiency Virus (HIV) infection
-Endothelial dysfunction in HIV-infected patients
-immune activation in HIV-infected patients
-cardiovascular complications in HIV-infecetd patients |
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E.1.1.1 | Medical condition in easily understood language |
HIV-infection
Cardiovascular complications
antiretorviral therapy
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007648 |
E.1.2 | Term | Cardiovascular disease, unspecified |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008919 |
E.1.2 | Term | Chronic HIV infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10048554 |
E.1.2 | Term | Endothelial dysfunction |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
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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 the switch of lopinavir-ritonavir to raltegravir on endothelial function. |
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E.2.2 | Secondary objectives of the trial |
-To assess the effect of switching lopinavir-ritonavir to raltegravir on markers of endothelialfunction, immune activation, chronic inflammation, plasma lipids and plasma glucose.
-To assess the effect of switching lopinavir-ritonavir to raltegravir on plasma HIV-RNA below the cut-off of 50 copies/ml.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Age ≥ 18 years
-HIV-1 infection
-Treatment with antiretroviral regimen containing lopinavir-ritonavir for at least the previous 3 months
-No other protease inhibitors besides lopinavir-ritonavir in antiretroviral regimen
-Subjects must have a minimum period of viral suppression (plasma HIV-RNA < 50 copies/ml) of 6 months
-Subjects will not have a history of virological failure on antiretroviral therapy
-Results of previous resistance testing allowing replacement of lopinavir-ritonavir by raltegravir
-CD4+ cell count > 200 cells/µL
-Signed informed consent
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E.4 | Principal exclusion criteria |
-Pregnancy
-Breastfeeding
-Raltegravir hypersensitivity
-Treatment of underlying malignancy
-Renal insufficiency requiring dialysis
-Acute or decompensated chronic hepatitis (Child-Pugh score C)
-Modification of antiretroviral regimen in the previous 3 months
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in flow-mediated dilatation (FMD) of the brachial artery after 8 weeks of raltegravir treatment as compared to the control group (treatment with lopinavir-ritonavir) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
The following secondary endpoints will be measured and compared between treatment and control groups:
-Change in markers of chronic inflammation
-Change in markers of immune activation
-Change in markers of endothelial function
-Changes in plasma HIV-RNA below 50 copies/ml
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
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
|
Last visit of last subject undergoing the trial
or
-if (unexpectedly) the registrations of the studymedications involved has been withdrawn
-if there (unexpected) is a safety concern for the participants of 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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |