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

• Conditions: HIV infection; MedDRA version: 9.1Level: LLTClassification code 10020161Term: HIV infection

• Registration Number: EUCTR2008-006644-19-IT
• Lead Sponsor: AZIENDA OSPEDALIERA SAN GERARDO DI MONZA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-22
• Last Update Posted: 3 November 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified