Safety and efficacy of switching a stable combined antiretroviral therapeutic regimen to atazanavir with ritonavir plus lamivudine in treatment experienced HIV positive patients with full and stable virological suppressio

• Conditions: HIV; MedDRA version: 14.1Level: LLTClassification code 10008922Term: Chronic infection with HIVSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-001060-21-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-06
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•HIV positive patients 18 years of age or older who signed an informed consent form
•On cART since no more than 3 years, without any treatment interruption.
•Treated with a cART regimen containing atazanavir boosted with ritonavir since at least 3 months
•With full virological suppression (VL<50 copies/mL) for a minimum of six months and in at least in two consecutive determination 3 months ?2 weeks apart from each other
•With CD4 cell count >200 since at least 6 months and without opportunistic infections or other AIDS-related events since at least one year before screening
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 66

Exclusion Criteria

•Previous virological failure on a lamivudine- or PI-containing regimen or previous exposure to lamivudine-containing suboptimal antiretroviral regimens
•Patients with at least a single viral load blip over 200 copies/mL
•Patients with M184V or major atazanavir resistance mutation at previous genotypic resistance test (historical genotype)
•Pregnancy or lactation, planned pregnancy in the short-term
•Patients with HBsAg positive chronic HBV infection
•Patients who experienced major toxicities related to any of the study drugs in the past
•Patients with grade 4 laboratory abnormalities at baseline (excluding lipid profile).
•Patients with non-AIDS related illnesses which could, in the Clinician’s judgement, jeopardize the patient’s compliance to the study procedures (i.e. Child-Pugh B or higher liver cirrhosis, active cancers on treatment…).
•Patients treated with proton-pump inhibitors or other concomitant medication with potential for interactions reducing exposure to atazanavir

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Primary end point(s): •Proportion of patients with viral load < 50 copies/mL at week 48 at the intention-to-treat with switch = failure analysis;Timepoint(s) of evaluation of this end point: week 48;Main Objective: To evaluate the virological efficacy of maintainance therapy with atazanavir with ritonavir combined with lamivudine in treatment experienced HIV positive patients with full and stable virological suppression;Secondary Objective: To evaluate the efficacy and the safety of atazanavir with ritonavir combined with lamivudine in treatment experienced HIV positive patients with full and stable virological suppression