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

• Status: Completed
• Trial end date: 2018-10-28
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ViiV Healthcare
• Collaborator: GlaxoSmithKline
• Treatments: Abacavir; Dolutegravir

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