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Clinical Trials

MainTitle

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

This study is ongoing, but not recruiting participants.
Sponsor
ViiV Healthcare

Collaborator
GlaxoSmithKline

Information provided by (Responsible Party)
ViiV Healthcare
ClinicalTrials.gov Identifier
NCT02342769

First received: January 15, 2015
Last updated: September 26, 2017
Last Verified: September 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention
Infection, Human Immunodeficiency Virus

Drug : Dolutegravir/Abacavir/Lamivudin

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Prospective Non-Interventional Observational Study of Use of Triumeq® and Corresponding Monitoring Measures in Clinical Practice in Germany

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures

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

Enrollment: 403
Study Start Date: February 19, 2015
Estimated Study Completion Date: October 15, 2018
Estimated Primary Completion Date: October 15, 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
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.

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02342769

Locations

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

Sponsors and Collaborators

ViiV Healthcare
GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials ViiV Healthcare
More Information

More Information


Responsible Party: ViiV Healthcare  
ClinicalTrials.gov Identifier: NCT02342769   History of Changes  
Other Study ID Numbers: 202033  
Study First Received: January 15, 2015  
Last Updated: September 26, 2017  

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Abacavir
Lamivudine
Dolutegravir

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.