HIV infection MedDRA version: 9.1 Level: PT Classification code 10020161
Conditions
Interventions
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Atazanavir
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Sponsors
AZIENDA SANITARIA LOCALE 4 DI TORINO
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of pharmacological exposure of atazanavir dosed without boosting of ritonavir between subjects administered with standard dosing (400 mg qd) and patients with atazanavir dosing guided by 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 effective concentration, MEC) at week 12 between the two arms. | — |
Countries
Italy
Outcome results
None listed