Observational, Retrospective, Multicenter Study to Describe the Reasons for the Change of the Regimen of Antiretroviral Therapy in HIV Patients (SWITCHART)

June 28, 2016 updated by: Fundacion SEIMC-GESIDA

Observational, Retrospective, Multicenter Study to Describe the Reasons for the Change of Antiretroviral Treatment Regimen in HIV-positive Patients Between January 2011 and July 2012 in Spanish Hospitals

The study aims to describe the changes of combination antiretroviral therapy and the causes that motivated them.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital Vall d'Hebron
      • Barcelona, Spain
        • Hospital Santa Creu i Sant Pau
      • Granada, Spain
        • Hospital San Cecilio
      • Madrid, Spain
        • Hospital 12 de Octubre
      • Madrid, Spain
        • Hospital Gregorio Marañón
      • Madrid, Spain
        • Hospital la Paz
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Málaga, Spain
        • Hospital Virgen de la Victoria
      • Sevilla, Spain
        • Hospital Virgen del Rocío
      • Zaragoza, Spain
        • Hospital Miguel Servet
    • La Coruña
      • Santiago de Compostela, La Coruña, Spain
        • Hospital de Santiago de Compostela
    • Madrid
      • Alcalá de Henares, Madrid, Spain
        • Hospital Principe de Asturias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HIV patients that have changed antirretroviral régimen between Jan 2011 and Jul 2012

Description

Inclusion Criteria:

  • Patients older than 18 years
  • Patients with HIV
  • Patients in antiretroviral regimen, that have changed the antirretroviral treatment.

Exclusion Criteria:

  • Patients unable to sign the consent form
  • patients that changing their treatment are going to take the same components in co-formulated
  • patients that changing their treatment are going to take the same components separately
  • Total or selective interrupts not indicated by the specialist
  • Patients that after changing antiretroviral therapy between January 2011 and July 2012, and during the next year, again suffered another change of treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients that change the treatment and the reason for it
Time Frame: 18 months
Describe the changes in combination antiretroviral therapy and the causes that led, in patients with HIV infection, between January 2011 and July 2012 in routine clinical practice
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion SEIMC-GESIDA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 15, 2014

First Submitted That Met QC Criteria

January 16, 2014

First Posted (Estimate)

January 20, 2014

Study Record Updates

Last Update Posted (Estimate)

June 29, 2016

Last Update Submitted That Met QC Criteria

June 28, 2016

Last Verified

January 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • GESIDA-7913

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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