Evaluation of inflammatory immune parameters predicting cardiovascular risk in HIV-1-infected antiretroviral therapy naive patients treated with atazanavir/ritonavir versus lopinavir/ritonavir based regimens. - CRISTA

AZIENDA OSPEDALIERA SAN GERARDO DI MONZA0 个研究点开始时间: 2008年12月22日最近更新: 2014年11月3日

适应症

试验速览

暂无简介。

•- 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

•- 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/μL Hb < 10 g/dL PLTS < 75,000/ μL Reticulocytes > 2% - Karnofsky index < 50

发起方

AZIENDA OSPEDALIERA SAN GERARDO DI MONZA