Phase 3 Completed N=117 Randomized Treatment

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

HIV-1 Infection

Source: ClinicalTrials.gov NCT01511809 ↗

Enrolled (actual)

117

Serious AEs

1.9%

Results posted

Nov 2014

Primary outcomePrimary: Proportion of Patients With Treatment Failure (TF) — 27.5; 15.4; 7.9; 15.4 percentage of patients

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.

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	—	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.