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

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

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 Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Dolutegravir/Abacavir/Lamivudin

• Study Type: Observational
• Enrollment (Actual): 403

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14057
    • GSK Investigational Site
  • Berlin, Germany, 10777
    • GSK Investigational Site
  • Berlin, Germany, 13347
    • GSK Investigational Site
  • Berlin, Germany, 10961
    • GSK Investigational Site
  • Berlin, Germany, 10405
    • GSK Investigational Site
  • Berlin, Germany, 10243
    • GSK Investigational Site
  • Berlin, Germany, 10707
    • GSK Investigational Site
  • Chemnitz, Germany, 09111
    • GSK Investigational Site
  • Dortmund, Germany, 44137
    • GSK Investigational Site
  • Hamburg, Germany, 20246
    • GSK Investigational Site
  • Hamburg, Germany, 20099
    • GSK Investigational Site
  • Koeln, Germany, 50668
    • GSK Investigational Site
  • Koeln, Germany, 50679
    • GSK Investigational Site
  • Weimar, Germany, 99427
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Freiburg, Baden-Wuerttemberg, Germany, 79106
      • GSK Investigational Site
    • Mannheim, Baden-Wuerttemberg, Germany, 68161
      • GSK Investigational Site
    • Stuttgart, Baden-Wuerttemberg, Germany, 70197
      • GSK Investigational Site
    • Ulm, Baden-Wuerttemberg, Germany, 89081
      • GSK Investigational Site
  • Bayern
    • Muenchen, Bayern, Germany, 80336
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80331
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80801
      • GSK Investigational Site
  • Hessen
    • Frankfurt, Hessen, Germany, 60596
      • GSK Investigational Site
    • Frankfurt am Main, Hessen, Germany, 60590
      • GSK Investigational Site
  • Niedersachsen
    • Osnabrueck, Niedersachsen, Germany, 49090
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Aachen, Nordrhein-Westfalen, Germany, 52062
      • GSK Investigational Site
    • Duesseldorf, Nordrhein-Westfalen, Germany, 40237
      • GSK Investigational Site
    • Koeln, Nordrhein-Westfalen, Germany, 50674
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55116
      • GSK Investigational Site
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39120
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Approx. 40 HIV treatment sites in Germany are planned to be involved in the documentation. The recruitment target is to include a total of 400 patients in the study across Germany. In order to allow for adequately answering in particular the problems regarding HLA-B*5701 testing, at least half of the recruited population should not have received abacavir (ABC) in their prior therapy. Each site will be allowed to recruit a maximum of 5 patients per month and a maximum of 20 patients in total. If the monthly quota of 5 patients is not utilized, the difference may be transferred to the subsequent months.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ViiV Healthcare
• Collaborators: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2015
• Primary Completion (Actual): October 28, 2018
• Study Completion (Actual): October 28, 2018

Study Registration Dates

• First Submitted: January 15, 2015
• First Submitted That Met QC Criteria: January 15, 2015
• First Posted (Estimate): January 21, 2015

Study Record Updates

• Last Update Posted (Actual): February 11, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Integrase Inhibitors; Integrase Inhibitors; Dolutegravir; Abacavir
• Other Study ID Numbers: 202033