HIV MedDRA version: 14.1 Level: LLT Classification code 10008922 Term: Chronic infection with HIV System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: REYATAZ*1FL 30CPS 300MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ATAZANAVIR SULFATE
CAS Number: 229975-97-7
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
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 (VL200 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of patients with viral load 50 copies/mL) at survival intention-to-treat with switch = failure analysis at 48 and 96 weeks • Proportion of patients with viral load < 50 copies/mL and time to loss of virological response at week 48 and 96 at the “as treated” analysis • Proportion of patients with viral load < 50 copies/mL and time to loss of virological response at week 48 and 96 at the “per protocol” analysis • Median increase of CD4 cell count during follow-up time • Median changes in atazanavir through concentrations during follow-up time • Median change in lipid (total cholesterol, HDL, LDL, TC/HDL ratio, triglycerides) and glucose and insulin levels during follow-up time • Median change in renal function (creatinine, MDRD) during follow-up time • Median change in bone density (hip and lumbar) at DEXA-scan and in markers of bone metabolism at weeks 24, 48, 72 and 96 • Median changes in upper and lower limb fat at DEXA-scan at 24, 48, 72 and 96 weeks • Median changes in IMT and FMD at 24, 48 and 96 weeks • Changes in the results of Neuropsychological tests at 48 and 96 weeks • Changes in adherence and quality of life measured by validated questionnaires at 24, 48, 72 and 96 weeks;Timepoint(s) of evaluation of this end point: 48 and 96 weeks | — |
Countries
Italy
Contacts
Public ContactSegreteria Istituto Mal. Infettive
Istituto Malattie Infettive Policlinico Gemelli
Outcome results
None listed