Efficacy of Atazanavir / Ritonavir Monotherapy as Maintenance in Patients With Viral Suppression. Randomized, Open Label Non Inferiority Trial. A Phase 3 Study.

MODAt

The study will assess whether Atazanavir/ritonavir monotherapy provides a non-inferior proportion of virological efficacy with respect to ATV/RTV + 2 NRTIs in patients with stable suppressed viremia and no prior virologic failures.

2010-09-01

2013-07-01

2015-05-01

Completed

Early phase I

117

Inclusion Criteria: * HIV infected patients * age \> 18 years * On treatment 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 * No virologic failure after the initiation of the first antiretroviral therapy. Previous treatment changes due to toxicity or treatment simplifications will be permitted only if occurred with documented virological suppression. * CD4 cells nadir \>100 cells/µL * 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. Exclusion Criteria: * Pregnancy and breast feeding women * AIDS defining events * Evidence of active HBV infection (HBsAg positive) * Previous virological failure * History of resistance to ATV * Use of contraindicated medications

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 117, 'type': 'ACTUAL'}}

2024-02-09