Phase 3
N=117
Efficacy of Atazanavir/Ritonavir Monotherapy as Maintenance in Patients With Viral Suppression
HIV-1 Infection
Bottom Line
View on ClinicalTrials.gov: NCT01511809 ↗Enrolled (actual)
117
Serious AEs
1.9%
Results posted
Nov 2014
Primary outcome: Primary: Proportion of Patients With Treatment Failure (TF) — 27.5; 15.4; 7.9; 15.4 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Atazanavir/ritonavir monotherapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- IRCCS San Raffaele
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Treatment Failure (TF) |
27.5; 15.4; 7.9; 15.4 | — |
| SECONDARY Efficacy and Safety |
— | — |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01511809). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.