Prospective Non-Interventional Observational Study of Use of TRIUMEQ and Corresponding Monitoring Measures in Clinical Practice in Germany

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Non-Interventional Observational Study of Use of Triumeq® and Corresponding Monitoring Measures in Clinical Practice in Germany

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Dolutegravir/Abacavir/Lamivudin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented HIV infection Age ≥ 18 years HLA-B*5701-negative Decision for first initiation of TRIUMEQ therapy made by the attending physician independent of the inclusion in this observational study Exclusion Criteria: Prior dolutegravir therapy (cf. also Capping ABC in section 3.3 Recruitment) Participation in a clinical trial during this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dolutegravir/Abacavir/Lamivudin<br>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. | Drug: Dolutegravir/Abacavir/Lamivudin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of the therapeutic monitoring measures | Descriptive characterization of therapeutic monitoring measures in HIV-infected patients under TRIUMEQ in routine daily practice in Germany | 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 | 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 | up to 3 years | 
| Efficacy | Defined as viral load < 50 copies/ml | up to 3 years | 
| Resistance profile | To characterise resistance profile in case of virological failure | up to 3 years | 
| Patient satisfaction | To evaluate the change in patient satisfaction relative to baseline in patients treated with TRIUMEQ | up to 3 years | 
| Reasons for selecting TRIUMEQ |  | Baseline | 
| Reasons for discontinuing TRIUMEQ |  | up to 3 years |