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NCT Number: NCT02342769

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Freiburg im Breisgau, Baden-Wurttemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dolutegravir/Abacavir/Lamivudin

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Acronym: TRIUMPH

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 21, 2015
Registry last updated
Feb 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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