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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)

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ClinicalTrials.gov Identifier: NCT02039921
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
Fundacion SEIMC-GESIDA

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

Condition or disease
HIV

Study Type : Observational
Actual Enrollment : 250 participants
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
Study Start Date : October 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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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

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

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