REYAGEN study. Optimization of unboosted atazanavir dosing, when associated with tenofovir,guided by pharmacogenetics profile of HIV-patients - ND

Conditions: HIV infection
MedDRA version: 9.1Level: PTClassification code 10020161

Registration Number: EUCTR2009-014216-35-IT

Lead Sponsor: AZIENDA SANITARIA LOCALE 4 DI TORINO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-Age > 18 years.
-Informed consent given
-Being administered with a stable regimen including ATV 300 mg con RTV 100 mg + Truvada.
-Problems related to toxicity or tolerability that on basis of clinicians` judgement could lead the patient to
beneficiate of a switch to unboosted atazanavir
-Plasma HIV-RNA below 50 copies/ml from at least 6 months .
-No previous viriological failure in patients` history.
-No evidence of selection of any resistance mutations to NRTIs or PIs in previous genotypic tests.
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

-Opportunistic infections or neoplasms.
-Concomitant administration of drugs potentially interacting with atazanavir (e.g., proteon pump inhibitors,
rifampin, carbamazepine)
-Self reported adherence below 95% of prescribed doses.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Comparison of pharmacological exposure of atazanavir dosed without boosting of ritonavir between<br>subjects administered with standard dosing (400 mg qd) and patients with atazanavir dosing guided by<br>pharmacogenomics profile (400 mg qd or 200 mg bid);Secondary Objective: Differences of proportion of subjects with virological suppression at week 48, differences of lipids and bilirubin levels at week 48;Primary end point(s): Difference of proportion of patients with median atazanavir trough concentration below 150 ng/ml (minimum<br>effective concentration, MEC) at week 12 between the two arms.

Secondary Outcome Measures