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 sitesDecember 22, 2008

Overview

No summary available.

Registry

who.int

Start Date

December 22, 2008

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

AZIENDA OSPEDALIERA SAN GERARDO DI MONZA

•\- 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/\&\#956;L Hb \< 10 g/dL PLTS \< 75,000/ \&\#956;L Reticulocytes \> 2% \- Karnofsky index \< 50