Prospective Non-Interventional Observational Study of Use of Triumeq® and Corresponding Monitoring Measures in Clinical Practice in Germany
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- ViiV Healthcare
- Enrollment
- 403
- Locations
- 1
- Primary Endpoint
- Frequency of therapeutic monitoring measures in HIV-infected patients
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & 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.
Intervention: Dolutegravir/Abacavir/Lamivudin (Drug)
Outcomes
Primary Outcomes
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
- Number of participants with Serious Adverse Events and drug-related adverse events as a measure of safety and tolerability(up to 3 years)
- Reasons for selecting TRIUMEQ(Baseline)
- Details on conduct and logistics of HLA-B*5701 testing(Baseline)
- Resistance profile(up to 3 years)
- Reasons for discontinuing TRIUMEQ(up to 3 years)
- Type of the therapeutic monitoring measures(up to 3 years)
- Efficacy(up to 3 years)
- Patient satisfaction(up to 3 years)