A Prospective, Non-interventional Study of the Use of Dolutegravir as Part of Combination Antiretroviral Therapy in Routine Daily Practice in Germany
DOL-ART
1 other identifier
observational
411
1 country
38
Brief Summary
DOL-ART is a multi-center, prospective, non-interventional study of the use of doluetegravir as part of an antiretroviral combination therapy in routine daily practice in Germany. The primary study objective is a descriptive characterization of the frequency of therapeutic monitoring measures in HIV-infected patients under dolutegravir-containing ART in routine daily practice in Germany. 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2014
Typical duration for all trials
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2014
CompletedFirst Posted
Study publicly available on registry
March 3, 2014
CompletedStudy Start
First participant enrolled
March 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2017
CompletedAugust 13, 2018
August 1, 2018
3.3 years
February 20, 2014
August 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of therapeutic monitoring measures in HIV-infected patients
Descriptive characterization of the frequency of therapeutic monitoring measures in HIV-infected patients under dolutegravir-containing ART in routine daily practice in Germany.
up to 3 years
Secondary Outcomes (7)
Type of the therapeutic monitoring measures
up to 3 years
Number of participants with Serious Adverse Events and drug-related adverse events as a measure of safety and tolerability
up to 3 years
Efficacy
from start of dolutegravir up to 3 years
Resistance profile
from start of dolutegravir up to 3 years
Patient satisfaction
Up to 3 years from baseline
- +2 more secondary outcomes
Study Arms (1)
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
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
Approximately 40 HIV treatment centers in Germany are planned to be involved in the documentation. The participating study site will document a maximum of 20 patients for this observation study. Overall, approximately 400 patients under dolutegravir-containing ART are to be documented. This selection process is intended to achieve the documentation of patients under dolutegravir-containing ART in routine daily practice representative for Germany.
You may qualify if:
- Documented HIV infection
- Age ≥ 18 years
- Prior to the start of this study, the patient must have been receiving a dolutegravir-containing ART for at least 4 weeks
You may not qualify if:
- Discontinuation of dolutegravir as part of an ART prior to the start of the study documentation
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ViiV Healthcarelead
- GlaxoSmithKlinecollaborator
Study Sites (38)
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68161, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70197, Germany
GSK Investigational Site
Tübingen, Baden-Wurttemberg, 72076, Germany
GSK Investigational Site
Fürth, Bavaria, 90762, Germany
GSK Investigational Site
Munich, Bavaria, 80331, Germany
GSK Investigational Site
Munich, Bavaria, 80335, Germany
GSK Investigational Site
Munich, Bavaria, 80336, Germany
GSK Investigational Site
Munich, Bavaria, 80801, Germany
GSK Investigational Site
Munich, Bavaria, 81675, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60311, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60590, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30159, Germany
GSK Investigational Site
Osnabrück, Lower Saxony, 49090, Germany
GSK Investigational Site
Aachen, North Rhine-Westphalia, 52062, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44787, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, 50674, Germany
GSK Investigational Site
Dortmund, North Rhine-Westphalia, 44137, Germany
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, 40237, Germany
GSK Investigational Site
Münster, North Rhine-Westphalia, 48143, Germany
GSK Investigational Site
Koblenz, Rhineland-Palatinate, 56073, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55116, Germany
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39120, Germany
GSK Investigational Site
Berlin, 10243, Germany
GSK Investigational Site
Berlin, 10405, Germany
GSK Investigational Site
Berlin, 10439, Germany
GSK Investigational Site
Berlin, 10707, Germany
GSK Investigational Site
Berlin, 10777, Germany
GSK Investigational Site
Berlin, 10961, Germany
GSK Investigational Site
Berlin, 13347, Germany
GSK Investigational Site
Berlin, 14057, Germany
GSK Investigational Site
Chemnitz, 09111, Germany
GSK Investigational Site
Cologne, 50668, Germany
GSK Investigational Site
Cologne, 50679, Germany
GSK Investigational Site
Hamburg, 20099, Germany
GSK Investigational Site
Hamburg, 20146, Germany
GSK Investigational Site
Hamburg, 20246, Germany
GSK Investigational Site
Weimar, 99427, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
ViiV Healthcare
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2014
First Posted
March 3, 2014
Study Start
March 4, 2014
Primary Completion
July 5, 2017
Study Completion
July 5, 2017
Last Updated
August 13, 2018
Record last verified: 2018-08