Infection, Human Immunodeficiency Virus
Conditions
Brief 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).
Interventions
DRUGDolutegravir
Prospective, non-interventional study of the use of doluetegravir as part of an antiretroviral combination therapy in routine daily practice in Germany. No drug will be provided. No study visits or procedures are mandated per protocol.
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of therapeutic monitoring measures in HIV-infected patients | up to 3 years | Descriptive characterization of the frequency of therapeutic monitoring measures in HIV-infected patients under dolutegravir-containing ART in routine daily practice in Germany. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Type of the therapeutic monitoring measures | up to 3 years | — |
| Number of participants with Serious Adverse Events and drug-related adverse events as a measure of safety and tolerability | up to 3 years | To evaluate the frequency and type of serious adverse events and drug-related adverse events in patients treated with dolutegravir. |
| Efficacy | from start of dolutegravir up to 3 years | Defined as viral load \< 50 copies/ml |
| Resistance profile | from start of dolutegravir up to 3 years | To characterise resistance profile in case of virological failure |
| Patient satisfaction | Up to 3 years from baseline | To evaluate the change in patient satisfaction relative to baseline in patients treated with dolutegravir |
| Reasons for selecting dolutegravir-containing ART | Baseline | — |
| Reasons for discontinuing dolutegravir-containing ART | Up to 3 years after baseline | — |
Countries
Germany
Outcome results
None listed