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

Study Overview
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Brief Summary
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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).

Official Title
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A Prospective, Non-interventional Study of the Use of Dolutegravir as Part of Combination Antiretroviral Therapy in Routine Daily Practice in Germany (DOL-ART)

Conditions
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Infection, Human Immunodeficiency Virus

Intervention / Treatment
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* Drug: Dolutegravir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dolutegravir<br>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. | Drug: Dolutegravir<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of therapeutic monitoring measures in HIV-infected patients | Descriptive characterization of the frequency of therapeutic monitoring measures in HIV-infected patients under dolutegravir-containing ART in routine daily practice in Germany. | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | To evaluate the frequency and type of serious adverse events and drug-related adverse events in patients treated with dolutegravir. | up to 3 years | 
| Efficacy | Defined as viral load < 50 copies/ml | from start of dolutegravir up to 3 years | 
| Resistance profile | To characterise resistance profile in case of virological failure | from start of dolutegravir up to 3 years | 
| Patient satisfaction | To evaluate the change in patient satisfaction relative to baseline in patients treated with dolutegravir | Up to 3 years from baseline | 
| Reasons for selecting dolutegravir-containing ART |  | Baseline | 
| Reasons for discontinuing dolutegravir-containing ART |  | Up to 3 years after baseline |