A Prospective, Non-interventional Study of the Use of Dolutegravir as Part of Combination Antiretroviral Therapy in Routine Daily Practice in Germany
NCT ID: NCT02076386
Last Updated: 2018-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
411 participants
OBSERVATIONAL
2014-03-04
2017-07-05
Brief Summary
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The study is designed to enroll approximately 400 patients. There are no protocol-mandated visits or procedures associated with the study. Each patient is expected to participate for a maximum of 3 years or until premature discontinuation (i.e., discontinuation of dolutegravir, due to death, withdrawal of consent, lost to follow-up).
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Dolutegravir
Prospective, non-interventional study of the use of doluetegravir as part of an antiretroviral combination therapy in routine daily practice in Germany. No drug will be provided. No study visits or procedures are mandated per protocol.
Dolutegravir
Prospective, non-interventional study of the use of doluetegravir as part of an antiretroviral combination therapy in routine daily practice in Germany. No drug will be provided. No study visits or procedures are mandated per protocol.
Interventions
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Dolutegravir
Prospective, non-interventional study of the use of doluetegravir as part of an antiretroviral combination therapy in routine daily practice in Germany. No drug will be provided. No study visits or procedures are mandated per protocol.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Decision for the first initiation of dolutegravir as part of an ART by the attending physician irrespective of inclusion in this observational study
* Prior to the start of this study, the patient must have been receiving a dolutegravir-containing ART for at least 4 weeks
Exclusion Criteria
* Participation in a clinical trial during this study
* Participation in a clinical trial or compassionate use program with dolutegravir being or having been part of the investigational medication
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
ViiV Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
ViiV Healthcare
Locations
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GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, Germany
GSK Investigational Site
Tübingen, Baden-Wurttemberg, Germany
GSK Investigational Site
Fürth, Bavaria, Germany
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, Germany
GSK Investigational Site
Hanover, Lower Saxony, Germany
GSK Investigational Site
Osnabrück, Lower Saxony, Germany
GSK Investigational Site
Aachen, North Rhine-Westphalia, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, Germany
GSK Investigational Site
Dortmund, North Rhine-Westphalia, Germany
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, Germany
GSK Investigational Site
Münster, North Rhine-Westphalia, Germany
GSK Investigational Site
Koblenz, Rhineland-Palatinate, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, Germany
GSK Investigational Site
Magdeburg, Saxony-Anhalt, Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Chemnitz, , Germany
GSK Investigational Site
Cologne, , Germany
GSK Investigational Site
Cologne, , Germany
GSK Investigational Site
Hamburg, , Germany
GSK Investigational Site
Hamburg, , Germany
GSK Investigational Site
Hamburg, , Germany
GSK Investigational Site
Weimar, , Germany
Countries
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Other Identifiers
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201067
Identifier Type: -
Identifier Source: org_study_id
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