Overview

A Prospective, Non-interventional Study of the Use of Dolutegravir as Part of Combination Antiretroviral Therapy in Routine Daily Practice in Germany

Status:
Completed
Trial end date:
2017-07-05
Target enrollment:
0
Participant gender:
All
Summary
DOL-ART is a multi-center, prospective, non-interventional study of the use of doluetegravir as part of an antiretroviral combination therapy in routine daily practice in Germany. The primary study objective is a descriptive characterization of the frequency of therapeutic monitoring measures in HIV-infected patients under dolutegravir-containing ART in routine daily 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 dolutegravir, due to death, withdrawal of consent, lost to follow-up).
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ViiV Healthcare
Collaborator:
GlaxoSmithKline
Treatments:
Dolutegravir
Criteria
Inclusion Criteria:

- Documented HIV infection

- Age ≥ 18 years

- Decision for the first initiation of dolutegravir as part of an ART by the attending
physician irrespective of inclusion in this observational study

- Prior to the start of this study, the patient must have been receiving a
dolutegravir-containing ART for at least 4 weeks

Exclusion Criteria:

- Discontinuation of dolutegravir as part of an ART prior to the start of the study
documentation

- Participation in a clinical trial during this study

- Participation in a clinical trial or compassionate use program with dolutegravir being
or having been part of the investigational medication