Status:
COMPLETED
Efficacy of Atazanavir/Ritonavir Monotherapy as Maintenance in Patients With Viral Suppression
Lead Sponsor:
IRCCS San Raffaele
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
HIV-1 Infection
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief 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 a...
Detailed Description
This is a randomised (1:1), multicentre, comparative, parallel-group, prospective, open label, non-inferiority controlled clinical trial. Enrolled patients, taking an ATV/r based HAART and with stabl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT01511809
Start Date
September 1 2010
End Date
May 1 2015
Last Update
February 9 2024
Active Locations (1)
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1
Infectious Diseases Department Fondazione Centro San Raffaele
Milan, Lombardy, Italy, 20127