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

Completed

• Conditions: HIV Infections
• Interventions: Drug: Dolutegravir/Abacavir/Lamivudin

• Registration Number: NCT02342769
• Lead Sponsor: ViiV Healthcare

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-15
• Study First Submitted QC: 2015-01-15
• Study First Posted: 2015-01-21
• Study Start: 2015-02-19
• Primary Completion: 2018-10-28
• Study Completion: 2018-10-28
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 403

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dolutegravir/Abacavir/Lamivudin	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.

Primary Outcome Measures

Name	Time	Method
Frequency of therapeutic monitoring measures in HIV-infected patients	up to 3 years	Descriptive documentation of the frequency of therapeutic monitoring measures in HIV-infected patients under TRIUMEQ in routine daily practice in Germany

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Weimar, Germany