Efficacy of atazanavir/ritonavir monotherapy as maintenance in patients with viral suppression. Randomized, open label non inferiority trial. (MODAt STUDY) - ND

• Conditions: HIV infected Patients; MedDRA version: 9.1Level: LLTClassification code 10008922

• Registration Number: EUCTR2010-020442-10-IT
• Lead Sponsor: FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-13
• Last Update Posted: 22 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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-RNA<50 c/ml) by at least 24 weeks with ATV/r plus 2 NRTIs
- CD4 cells nadir >100 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

-Pregnancy and breast feeding women
-AIDS defining events
-active HBV infection (HBsAg positive)
-Previous virological failure
-Use of contraindicated drugs

Study & Design

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