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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

Tracking Information
First Submitted Date January 15, 2015
First Posted Date January 21, 2015
Last Update Posted Date February 11, 2019
Actual Study Start Date February 19, 2015
Actual Primary Completion Date October 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 15, 2015)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 15, 2015)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Non-Interventional Observational Study of Use of TRIUMEQ and Corresponding Monitoring Measures in Clinical Practice in Germany
Official Title Prospective Non-Interventional Observational Study of Use of Triumeq® and Corresponding Monitoring Measures in Clinical Practice in Germany
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 Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition HIV Infections
Intervention 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.
Study Groups/Cohorts 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.
Intervention: Drug: Dolutegravir/Abacavir/Lamivudin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 26, 2017)
403
Original Estimated Enrollment
 (submitted: January 15, 2015)
400
Actual Study Completion Date October 28, 2018
Actual Primary Completion Date October 28, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02342769
Other Study ID Numbers 202033
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party ViiV Healthcare
Study Sponsor ViiV Healthcare
Collaborators GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
PRS Account ViiV Healthcare
Verification Date February 2019