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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:
Information provided by (Responsible Party):
Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier:
NCT02039921
First received: January 15, 2014
Last updated: January 16, 2014
Last verified: January 2014
  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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier: NCT02039921     History of Changes
Other Study ID Numbers: GESIDA-7913
Study First Received: January 15, 2014
Last Updated: January 16, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

ClinicalTrials.gov processed this record on November 20, 2014