HIV infection MedDRA version: 9.1 Level: LLT Classification code 10020161 Term: HIV infection
Conditions
Interventions
Trade Name: REYATAZ*FL 60CPS 150MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Atazanavir
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Trade Name: KAL
Sponsors
AZIENDA OSPEDALIERA SAN GERARDO DI MONZA
Eligibility
Sex/Gender
All
Inclusion criteria
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 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 2% - Karnofsky index < 50
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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);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 f | — |
Countries
Italy
Outcome results
None listed