NCT02039921

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Shorter than P25 for all trials

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
Last Updated

June 29, 2016

Status Verified

January 1, 2014

Enrollment Period

1 month

First QC Date

January 15, 2014

Last Update Submit

June 28, 2016

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV patients that have changed antirretroviral régimen between Jan 2011 and Jul 2012

You may qualify if:

  • Patients older than 18 years
  • Patients with HIV
  • Patients in antiretroviral regimen, that have changed the antirretroviral treatment.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Hospital Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Location

Hospital Vall D'Hebron

Barcelona, Barcelona, Spain

Location

Hospital San Cecilio

Granada, Granada, Spain

Location

Hospital de Santiago de Compostela

Santiago de Compostela, La Coruña, Spain

Location

Hospital Príncipe de Asturias

Alcalá de Henares, Madrid, Spain

Location

Hospital 12 de Octubre

Madrid, Madrid, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Location

Hospital Gregorio Marañón

Madrid, Madrid, Spain

Location

Hospital La paz

Madrid, Madrid, Spain

Location

Hospital Virgen de la Victoria

Málaga, Málaga, Spain

Location

Hospital Virgen del Rocio

Seville, Sevilla, Spain

Location

Hospital Miguel Servet

Zaragoza, Zaragoza, Spain

Location

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2014

First Posted

January 20, 2014

Study Start

October 1, 2013

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

June 29, 2016

Record last verified: 2014-01

Locations

ES(12)