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

February 7, 2019 updated by: ViiV Healthcare

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
403

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
up to 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
up to 3 years
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
Baseline
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
up to 3 years
Efficacy
Time Frame: up to 3 years
Defined as viral load < 50 copies/ml
up to 3 years
Resistance profile
Time Frame: up to 3 years
To characterise resistance profile in case of virological failure
up to 3 years
Patient satisfaction
Time Frame: up to 3 years
To evaluate the change in patient satisfaction relative to baseline in patients treated with TRIUMEQ
up to 3 years
Reasons for selecting TRIUMEQ
Time Frame: Baseline
Baseline
Reasons for discontinuing TRIUMEQ
Time Frame: up to 3 years
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ViiV Healthcare

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 19, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 28, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 28, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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