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

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ClinicalTrials.gov Identifier: NCT02342769
Recruitment Status : Completed
First Posted : January 21, 2015
Last Update Posted : February 11, 2019
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
HIV Infections Drug: Dolutegravir/Abacavir/Lamivudin

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Study Type : Observational
Actual Enrollment : 403 participants
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
Actual Study Start Date : February 19, 2015
Actual Primary Completion Date : October 28, 2018
Actual Study Completion Date : October 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. 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

  4. Efficacy [ Time Frame: up to 3 years ]
    Defined as viral load < 50 copies/ml

  5. Resistance profile [ Time Frame: up to 3 years ]
    To characterise resistance profile in case of virological failure

  6. Patient satisfaction [ Time Frame: up to 3 years ]
    To evaluate the change in patient satisfaction relative to baseline in patients treated with TRIUMEQ

  7. Reasons for selecting TRIUMEQ [ Time Frame: Baseline ]
  8. Reasons for discontinuing TRIUMEQ [ Time Frame: up to 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342769


Locations
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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
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Study Director: GSK Clinical Trials ViiV Healthcare

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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT02342769     History of Changes
Other Study ID Numbers: 202033
First Posted: January 21, 2015    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Dolutegravir
Abacavir
Lamivudine
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors