HIVSWITCHARTNCT02039921
Observational, Retrospective, Multicenter Study to Describe the Reasons for the Change of the Regimen of Antiretroviral Therapy in HIV Patients
An observational study of HIV, run by Fundacion SEIMC-GESIDA at 12 sites in Spain.
Trial summary
The study aims to describe the changes of combination antiretroviral therapy and the causes that motivated them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- How many people
- 250 participants
- Where
- 12 sitesSpain
- Study dates
- Oct 2013to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV patients that have changed antirretroviral régimen between Jan 2011 and Jul 2012
Who may be able to join
- Patients older than 18 years
- Patients with HIV
- Patients in antiretroviral regimen, that have changed the antirretroviral treatment.
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
Hospital Príncipe de Asturias
Alcalá de Henares, Madrid
Hospital Santa Creu i Sant Pau
Barcelona, Barcelona
Hospital Vall D'Hebron
Barcelona, Barcelona
Hospital San Cecilio
Granada, Granada
Hospital 12 de Octubre
Madrid, Madrid
Hospital Clínico San Carlos
Madrid, Madrid
Hospital Gregorio Marañón
Madrid, Madrid
Hospital La paz
Madrid, Madrid
Hospital Virgen de la Victoria
Málaga, Málaga
Hospital de Santiago de Compostela
Santiago de Compostela, La Coruña
Hospital Virgen del Rocio
Seville, Sevilla
Hospital Miguel Servet
Zaragoza, Zaragoza
About this study
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
The study aims to describe the changes of combination antiretroviral therapy and the causes that motivated them.
- Conditions
- HIV
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion SEIMC-GESIDA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039921
- Sponsor's protocol ID
- GESIDA-7913
- Acronym
- SWITCHART
- Status last verified
- Jan 2014
- First submitted
- 15 Jan 2014
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02039921
- Acronym / sponsor ID
- SWITCHART / GESIDA-7913
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Fundacion SEIMC-GESIDAUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to describe the changes of combination antiretroviral therapy and the causes that motivated them.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV patients that have changed antirretroviral régimen between Jan 2011 and Jul 2012
Key inclusion criteria (3 listed)
- Patients older than 18 years
- Patients with HIV
- Patients in antiretroviral regimen, that have changed the antirretroviral treatment.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Fundacion SEIMC-GESIDA at 12 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients that change the treatment and the reason for it (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2016.