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ATALOW: Reduced Dose Atazanavir/Ritonavir in HIV-1

NCT02473328Phase 2

Key facts

Status: Completed
Start: Jun 2015
Primary completion: Dec 2017
Countries: 1
Sponsor: Centre de Recherches et d'Études sur la Pathologie Tropicale et le Sida
Modality: Small Molecules

Drugs: atazanavir
Conditions: human immunodeficiency virus type 1 infection (HIV-1)

Overview

Phase 2, open-label, single-arm trial of atazanavir in human immunodeficiency virus type 1 infection (HIV-1), sponsored by Centre de Recherches et d'Études sur la Pathologie Tropicale et le Sida. Primary endpoints: Maintenance of undetectable plasma HIV viral load at 1 year, Adverse Events at 1 year and 6 more. Started Jun 2015; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Experimental Arm
Atazanavir 200 mg/ritonavir 100 mg + 2 NRTIs

Endpoints

Primary

Maintenance of undetectable plasma HIV viral load1 year
Adverse Events1 year
Number of patients interrupting treatment for virological failure1 year
Target trough plasma concentration of atazanavir1 year
HIV strains with mutations associated to treatment resistance1 year

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