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NCT02039921 Clinical Trial

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

HIV Clinical Trial

— SWITCHART  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02039921
Other study ID # GESIDA-7913
Secondary ID
Status Completed
Phase N/A
First received January 15, 2014
Last updated June 28, 2016
Start date October 2013
Est. completion date December 2013

Study information
Verified date January 2014
Source Fundacion SEIMC-GESIDA
Contact n/a
Is FDA regulated No
Health authority Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date December 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
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 de Santiago de Compostela Santiago de Compostela La Coruña
Spain Hospital Virgen del Rocio Sevilla
Spain Hospital Miguel Servet Zaragoza

Sponsors (1)
Lead Sponsor Collaborator
Fundacion SEIMC-GESIDA

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients that change the treatment and the reason for it 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 No
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