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Switch to Darunavir/r + Maraviroc Quaque Die in Patients With R5 Tropism by Viral DNA Genotyping (GUSTA)

NCT01367210 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2016-02-08

No results posted yet for this study

Summary

Objectives of the study:

1. To verify the safety and the efficacy of the study treatment, defined as the persistent control of the virus' replication at 48 weeks after the simplification to maraviroc + darunavir with ritonavir in patients with R5 tropism by viral DNA genotyping.
2. To collect relevant information about the safety, the immunologic and the economic impact of this strategy.

Conditions

  • HIV Infection

Interventions

DRUG

Maraviroc, Darunavir/r

Maraviroc 300 mg Darunavir 800 mg Ritonavir 100 mg

DRUG

current antiretroviral therapy with 3 drugs

To continue the assumption of previous HAART

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Andrea De Luca, Prof · Catholic University of the Sacred Heart

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Italy

Study Locations

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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 NCT01367210 on ClinicalTrials.gov