Prospective Non-Interventional Observational Study of Use of TRIUMEQ and Corresponding Monitoring Measures in Clinical Practice in Germany
TRIUMPH
1 other identifier
observational
403
1 country
29
Brief Summary
TRIUMPH is a prospective, non-interventional observational study on the use of the fixdose combination TRIUMEQ (Dolutegravir/Abacavir/Lamivudine) and the respective monitoring measures in the practice of HIV care in Germany. The primary study objective is a descriptive report of the incidence of therapeutic monitoring measures in HIV-infected patients under TRIUMEQ therapy in everyday routine 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 TRIUMEQ, due to death, withdrawal of consent, lost to follow-up. TRIUMEQ is a registered trademark of the ViiV Healthcare group of companies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2015
Typical duration for all trials
29 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
January 15, 2015
CompletedFirst Posted
Study publicly available on registry
January 21, 2015
CompletedStudy Start
First participant enrolled
February 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2018
CompletedFebruary 11, 2019
February 1, 2019
3.7 years
January 15, 2015
February 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of therapeutic monitoring measures in HIV-infected patients
Descriptive documentation of the frequency of therapeutic monitoring measures in HIV-infected patients under TRIUMEQ in routine daily practice in Germany
up to 3 years
Secondary Outcomes (8)
Type of the therapeutic monitoring measures
up to 3 years
Details on conduct and logistics of HLA-B*5701 testing
Baseline
Number of participants with Serious Adverse Events and drug-related adverse events as a measure of safety and tolerability
up to 3 years
Efficacy
up to 3 years
Resistance profile
up to 3 years
- +3 more secondary outcomes
Study Arms (1)
Dolutegravir/Abacavir/Lamivudin
Prospective, non-interventional observational study on the use of TRIUMEQ and the respective monitoring measures in the practice of HIV care in Germany. No drug will be provided. No study visits or procedures are mandated per protocol.
Interventions
Prospective, non-interventional observational study on the use of TRIUMEQ and the respective monitoring measures in the practice of HIV care in Germany. No drug will be provided. No study visits or procedures are mandated per protocol.
Eligibility Criteria
Approx. 40 HIV treatment sites in Germany are planned to be involved in the documentation. The recruitment target is to include a total of 400 patients in the study across Germany. In order to allow for adequately answering in particular the problems regarding HLA-B\*5701 testing, at least half of the recruited population should not have received abacavir (ABC) in their prior therapy. Each site will be allowed to recruit a maximum of 5 patients per month and a maximum of 20 patients in total. If the monthly quota of 5 patients is not utilized, the difference may be transferred to the subsequent months.
You may qualify if:
- Documented HIV infection
- Age ≥ 18 years
- HLA-B\*5701-negative
You may not qualify if:
- Prior dolutegravir therapy (cf. also Capping ABC in section 3.3 Recruitment)
- Participation in a clinical trial during this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ViiV Healthcarelead
- GlaxoSmithKlinecollaborator
Study Sites (29)
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
Ulm, Baden-Wurttemberg, 89081, Germany
GSK Investigational Site
Munich, Bavaria, 80331, Germany
GSK Investigational Site
Munich, Bavaria, 80336, Germany
GSK Investigational Site
Munich, Bavaria, 80801, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60590, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60596, Germany
GSK Investigational Site
Osnabrück, Lower Saxony, 49090, Germany
GSK Investigational Site
Aachen, North Rhine-Westphalia, 52062, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, 50674, Germany
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, 40237, 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, 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
Dortmund, 44137, Germany
GSK Investigational Site
Hamburg, 20099, 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
January 15, 2015
First Posted
January 21, 2015
Study Start
February 19, 2015
Primary Completion
October 28, 2018
Study Completion
October 28, 2018
Last Updated
February 11, 2019
Record last verified: 2019-02