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).

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

Approximately 40 HIV treatment centers in Germany are planned to be involved in the documentation. The participating study site will document a maximum of 20 patients for this observation study. Overall, approximately 400 patients under dolutegravir-containing ART are to be documented. This selection process is intended to achieve the documentation of patients under dolutegravir-containing ART in routine daily practice representative for Germany.