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

Completed

• Conditions: Infection, Human Immunodeficiency Virus
• Interventions: Drug: Dolutegravir

• Registration Number: NCT02076386
• Lead Sponsor: ViiV Healthcare

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-20
• Study First Submitted QC: 2014-02-27
• Study First Posted: 2014-03-03
• Study Start: 2014-03-04
• Primary Completion: 2017-07-05
• Study Completion: 2017-07-05
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-10
• Last Update Posted: 2018-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 411

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dolutegravir	Dolutegravir	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Resistance profile	from start of dolutegravir up to 3 years	To characterise resistance profile in case of virological failure
Efficacy	from start of dolutegravir up to 3 years	Defined as viral load \< 50 copies/ml
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.
Reasons for selecting dolutegravir-containing ART	Baseline
Reasons for discontinuing dolutegravir-containing ART	Up to 3 years after baseline
Patient satisfaction	Up to 3 years from baseline	To evaluate the change in patient satisfaction relative to baseline in patients treated with dolutegravir

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Weimar, Germany