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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02039921
First Posted: January 20, 2014
Last Update Posted: June 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fundacion SEIMC-GESIDA
  Purpose
The study aims to describe the changes of combination antiretroviral therapy and the causes that motivated them.

Condition
HIV

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Fundacion SEIMC-GESIDA:

Primary Outcome Measures:
  • 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


Enrollment: 250
Study Start Date: October 2013
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV patients that have changed antirretroviral régimen between Jan 2011 and Jul 2012
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039921


Locations
Spain
Hospital de Santiago de Compostela
Santiago de Compostela, La Coruña, Spain
Hospital Príncipe de Asturias
Alcalá de Henares, Madrid, Spain
Hospital Santa Creu i Sant Pau
Barcelona, Spain
Hospital Vall D'Hebron
Barcelona, Spain
Hospital San Cecilio
Granada, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Gregorio Marañón
Madrid, Spain
Hospital La paz
Madrid, Spain
Hospital Virgen de la Victoria
Málaga, Spain
Hospital Virgen del Rocio
Sevilla, Spain
Hospital Miguel Servet
Zaragoza, Spain
Sponsors and Collaborators
Fundacion SEIMC-GESIDA
  More Information

Responsible Party: Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier: NCT02039921     History of Changes
Other Study ID Numbers: GESIDA-7913
First Submitted: January 15, 2014
First Posted: January 20, 2014
Last Update Posted: June 29, 2016
Last Verified: January 2014