Trial intelligence / Profile preview

OREY: Atazanavir/Ritonavir Maintenance in HIV

NCT00337467Phase 3

Key facts

Status: Completed
Start: Jun 2006
Primary completion: May 2008
Countries: 1
Sponsor: Bristol Myers Squibb
Modality: Small Molecules

Drugs: atazanavir
Conditions: human immunodeficiency virus infection (HIV)

Overview

Phase 3, open-label, single-arm trial of atazanavir in human immunodeficiency virus infection (HIV), sponsored by Bristol Myers Squibb. Primary endpoint: Percentage of Participants With Treatment Failure at 48 weeks. Started Jun 2006; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Atazanavir + Ritonavir
Atazanavir 300mg + Ritonavir 100mg once daily

Who it enrols

HIV-infected patients on continued ARV treatment with no discontinuation for 6 months, HIV RNA < 50 copies/mL, on ATV/RTV + 2 NRTIs for at least 8 weeks. Excludes patients with chronic hepatitis B receiving lamivudine, tenofovir, or emtricitabine.

Endpoints

Primary

Percentage of Participants With Treatment Failure48 weeks

Secondary

Percentage of Participants With Treatment Failure96 weeks
Percentage of Participants With Virological Rebound96 weeks
Mean Change From Baseline in CD4 Cell Count96 weeks
Mean Percent Changes From Baseline in Lipids96 weeks
Number of Participants With Genotype Substitutions for Virologic Rebounds96 weeks
Percentage of Participants With Adverse Events96 weeks

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