Efficacy of Atazanavir/Ritonavir Monotherapy as Maintenance in Patients With Viral Suppression

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ospedale San Raffaele
• Collaborator: Bristol-Myers Squibb
• Treatments: Atazanavir Sulfate; Ritonavir

Criteria

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