A Study of a Nucleoside Sparing Regimen in HIV-1 Infected Patients With Detectable Viremia
NCT02542852 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2024-02-13
Summary
Research ipotesis is to assess the efficacy and safety of a nucleos(t)ide sparing regimen of atazanavir/ritonavir 300 mg /100 mg QD + Dolutegravir 50 mg QD for the management of virological failure in HIV-1 infected patients.
The Primary Objective is to explore the 24-week efficacy of a nucleos(t)ide sparing regimen of atazanavir 300 mg QD/ ritonavir 100 mg QD + Dolutegravir 50 mg QD for the management of virologic failure in HIV-1 infected, integrase inhibitor-naïve subjects.
Conditions
- HIV-1 Infection
Interventions
- DRUG
-
atazanavir 300 mg + ritonavir 100 mg + dolutegravir 50 mg
Switch to single arm treatment atazanavir-ritonavir 300-100 mg + dolutegravir 50 mg therapy for 24 weeks
Sponsors & Collaborators
- collaborator INDUSTRY
-
ViiV Healthcare
collaborator INDUSTRY -
Castagna Antonella
lead OTHER
Principal Investigators
-
Adriano Lazzarin, Prof · Ospedale San Raffaele
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-09-30
- Primary Completion
- 2016-06-30
- Completion
- 2017-12-31
Countries
- Italy
Study Locations
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