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

No results posted yet for this study

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

  • Bristol-Myers Squibb

    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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02542852 on ClinicalTrials.gov