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

NCT ID: NCT02342769

Last Updated: 2019-02-11

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

403 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-19

Study Completion Date

2018-10-28

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.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Dolutegravir/Abacavir/Lamivudin

Intervention Type DRUG

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

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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.

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

ViiV Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Stuttgart, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Ulm, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Munich, Bavaria, Germany

Site Status

GSK Investigational Site

Munich, Bavaria, Germany

Site Status

GSK Investigational Site

Munich, Bavaria, Germany

Site Status

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

Site Status

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

Site Status

GSK Investigational Site

Osnabrück, Lower Saxony, Germany

Site Status

GSK Investigational Site

Aachen, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Cologne, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Magdeburg, Saxony-Anhalt, Germany

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GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Chemnitz, , Germany

Site Status

GSK Investigational Site

Cologne, , Germany

Site Status

GSK Investigational Site

Cologne, , Germany

Site Status

GSK Investigational Site

Dortmund, , Germany

Site Status

GSK Investigational Site

Hamburg, , Germany

Site Status

GSK Investigational Site

Hamburg, , Germany

Site Status

GSK Investigational Site

Weimar, , Germany

Site Status

Countries

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Germany

Other Identifiers

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202033

Identifier Type: -

Identifier Source: org_study_id

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