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

N/ACompletedNCT02076386

ViiV Healthcare411 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

411

Conditions

Infection, Human Immunodeficiency Virus

Interventions

DolutegravirDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (38)

GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Stuttgart, Baden-Wurttemberg, Germany

GSK Investigational Site

Tübingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Fürth, Bavaria, Germany

Outcomes

Primary Outcomes

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.

Time frame: up to 3 years

Secondary Outcomes

Type of the therapeutic monitoring measures

Time frame: 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.

Time frame: up to 3 years

Efficacy

Defined as viral load \< 50 copies/ml

Time frame: from start of dolutegravir up to 3 years

Resistance profile

To characterise resistance profile in case of virological failure

Time frame: 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

Time frame: Up to 3 years from baseline

Reasons for selecting dolutegravir-containing ART

Time frame: Baseline

Reasons for discontinuing dolutegravir-containing ART

Time frame: Up to 3 years after baseline