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.
Study Type
OBSERVATIONAL
Enrollment
403
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.
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
Ulm, Baden-Wurttemberg, 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
Osnabrück, Lower Saxony, Germany
...and 19 more locations
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
Time frame: up to 3 years
Type of the therapeutic monitoring measures
Descriptive characterization of therapeutic monitoring measures in HIV-infected patients under TRIUMEQ in routine daily practice in Germany
Time frame: up to 3 years
Details on conduct and logistics of HLA-B*5701 testing
Descriptive characterization of conduct and logistics of HLA-B\*5701 testing in HIV-infected patients under TRIUMEQ in routine daily practice in Germany
Time frame: Baseline
Number of participants with Serious Adverse Events and drug-related adverse events as a measure of safety and tolerability
To evaluate the frequency and type of serious adverse events and drug-related adverse events in patients treated with dolutegravir
Time frame: up to 3 years
Efficacy
Defined as viral load \< 50 copies/ml
Time frame: up to 3 years
Resistance profile
To characterise resistance profile in case of virological failure
Time frame: up to 3 years
Patient satisfaction
To evaluate the change in patient satisfaction relative to baseline in patients treated with TRIUMEQ
Time frame: up to 3 years
Reasons for selecting TRIUMEQ
Time frame: Baseline
Reasons for discontinuing TRIUMEQ
Time frame: up to 3 years
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