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

HIV Infections Clinical Trial

— TRIUMPH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02342769
• Other study ID #: 202033
• Status: Completed
• Start date: February 19, 2015
• Est. completion date: October 28, 2018

Study information

• Verified date: February 2019
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: October 28, 2018
• Est. primary completion date: October 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Aachen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Chemnitz
Germany	GSK Investigational Site	Dortmund
Germany	GSK Investigational Site	Duesseldorf	Nordrhein-Westfalen
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Frankfurt am Main	Hessen
Germany	GSK Investigational Site	Freiburg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Koeln
Germany	GSK Investigational Site	Koeln
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Magdeburg	Sachsen-Anhalt
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Osnabrueck	Niedersachsen
Germany	GSK Investigational Site	Stuttgart	Baden-Wuerttemberg
Germany	GSK Investigational Site	Ulm	Baden-Wuerttemberg
Germany	GSK Investigational Site	Weimar

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Efficacy	Defined as viral load < 50 copies/ml	up to 3 years
Secondary	Resistance profile	To characterise resistance profile in case of virological failure	up to 3 years
Secondary	Patient satisfaction	To evaluate the change in patient satisfaction relative to baseline in patients treated with TRIUMEQ	up to 3 years
Secondary	Reasons for selecting TRIUMEQ		Baseline
Secondary	Reasons for discontinuing TRIUMEQ		up to 3 years