E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | 10020161 |
E.1.2 | Term | HIV infection |
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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 evaluate variation in soluble inflammatory immune mediators and in immune cells expressing adhesion and activation markers or Toll-like receptors (TLR) in HIV-positive naive patients treated with ATV/r compared to LPV/r in combination with a fixed NRTI backbone composed by tenofovir and emtricitabine. |
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E.2.2 | Secondary objectives of the trial |
1. To evaluate HIV-RNA suppression in plasma of HIV-positive naive patients treated with ATV/r compared to LPV/r in combination with a fixed NRTI backbone composed by tenofovir and emtricitabine. 2. To evaluate variations in plasmatic CD4+ T cells levels. 3. To evaluate the metabolic changes following treatment with ATV/r compared to LPV/r based regimens. 4. To determine variation in endothelium function measured by flow-mediated dilation (FMD) of the radial artery and aortic pulse-wave velocity (PWV) 5. To determine variation in endothelium structure measured by echodoppler evaluation of carotid and femoral intima-media thickness (IMT). 6. To record baseline cardiovascular risks (CV risk, Hypertension, diabetes smoking status: current and past, family history of CV risks, heart disease) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- HIV-1-infected males or famele > 18 years of age with positive serology (ELISA) confirmed by Western Blot - CD4 + cell count between 250-350 cells/microL - no previous antiretroviral treatment - negative pregnancy test at least 14 days before the beginning of treatment - Signed informed consent in accoradnce with GCP and local regulatory reqirements prior to trial participation - Study drugs susceptibility based on HIV-1 genotypic resistance test |
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E.4 | Principal exclusion criteria |
- Presence of opportunistic infections - Presence of cardiovascular diseases - Presence of thyroid disfunction - Known intolerance or allergies to the treatments - Previous or current treatment with immunomodulant substances, growth factors or cytokines - Ongoing systemic treatment with corticosteroid or hormone therapy or lipid-lowering drugs - Pregnant or in breast-feeding patients - Patients with the following laboratory parameters abnormalities: AST,ALT > 2,5 times up to the normal value Serum creatinine > 1,5 times up to the normal value PMN < 1000/&#956;L Hb < 10 g/dL PLTS < 75,000/ &#956;L Reticulocytes > 2% - Karnofsky index < 50 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Endpoint adhesion molecules, selectins, integrins and chemokines: - macrophage chemo-attractant protein 1 (MCP-1) and its receptor CCL2; - interleukin-1 &#61537;, interleukin-1 &#61538;&#61484; interferon-&#61537;, interferon-&#61538;, tumour necrosis factors &#61537;&#61484; tumour necrosis factors &#61538;, transforming growth factors (TGF-&#61538;2), - inter-cellular cell adhesion molecule 1 (ICAM-1), vascular cell adhesion molecule (VCAM) - CC chemokines, CCL3 (MIP-1&#61537;), CC chemokines, CCL4 (MIP-1&#61538;),CC chemokines, CCL5 (RANTES); immune cells expressing adhesion and activation markers or Toll-like receptors (TLR), measured by flow cytometry: - CD8+CD25+, CD4+CD25+, CD8+DRII+, CD4+DRII+, CD4+CD44+, CD8+CD44+, CD4+CD11a+, CD8+CD11a+, CD4/CD62L, - CD8+CD11highRA+, CD8+CD11lowRA+, CD8+CD11highRO+, CD14+CD36+, CD14/TLR4, CD14/CD80 |
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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 | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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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Ultima visita dell`ultimo soggetto inserito |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |