HIV infected Patients MedDRA version: 9.1 Level: LLT Classification code 10008922
Conditions
Interventions
Trade Name: REYATAZ*60CPS 100MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Atazanavir
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name:
Sponsors
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: age > 18 years - HIV infected patients - First line ATV/r based HAART with ATV/r plus 2 NRTIs for at least 48 weeks - Virological suppression (HIV-RNA100 cells/ml - PPI and H2-receptor antagonists as follows: the proton-pump inhibitors should not be used; if H2-receptor antagonists are co-administered, a dose equivalent to famotidine 20 mg BID should not be exceeded. - No detected genotypic resistance mutations to ATV at baseline (as specified in the IAS classification: 10I/F/V/C, 16E, 20R/M/I/T/V, 24I, 32I, 33F/I/V, 34Q, 36I/L/V, 46I/L, 48V, 50L, 53L/Y, 54A/L/M/T/V, 60E, 62V, 64L/M/V, 71V/I/T/L, 73C/S/T/A, 82A/F/I/T, 84V, 85V, 88S, 90M, 93L/M) 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Pregnancy and breast feeding women -AIDS defining events -active HBV infection (HBsAg positive) -Previous virological failure -Use of contraindicated drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. To evaluate the virological efficacy at week 96 and the durability of the two antiretroviral regimens. 2. To evaluate the immunological changes from baseline. 3. To evaluate the resistance profile and PK in patients with virologic rebound. 4. To evaluate and compare the safety profile 5. To evaluate the body fat redistribution 6. To evaluate the vertebral and femoral bone mineral density 7. To detect potential risk factors related with the monotherapy regimen failure, including adherence and neurocognitive assessments.;Main Objective: • To assess the non-inferiority of virological efficacy at week 48 of a monotherapy strategy with atazanavir/ritonavir vs atazanavir/ritonavir-based HAART, in patients treated with an ATV/r-based HAART since at least 48 weeks, fully suppressed since at least 24 weeks and with no previous virologic failures.;Primary end point(s): • The proportion of patients with confirmed virological failure (% of patients with HIV-RNA>50c/ml) at week 48. | — |
Countries
Italy
Outcome results
None listed