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

ViiV Healthcare

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Dolutegravir/Abacavir/Lamivudin

Study type: Observational

Funder types: Industry

Identifiers

NCT02342769

202033

Details and patient eligibility

About

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.

Enrollment: 403 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

403 participants in 1 patient group

Dolutegravir/Abacavir/Lamivudin

Description:

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.

Treatment:

Drug: Dolutegravir/Abacavir/Lamivudin