Overview

This trial is active, not recruiting.

Condition infection, human immunodeficiency virus
Treatment dolutegravir
Sponsor ViiV Healthcare
Collaborator GlaxoSmithKline
Start date March 2014
End date May 2017
Trial size 411 participants
Trial identifier NCT02076386, 201067

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
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.
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 Outcomes

Measure
Frequency of therapeutic monitoring measures in HIV-infected patients
time frame: up to 3 years

Secondary Outcomes

Measure
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
time frame: up to 3 years
Efficacy
time frame: from start of dolutegravir up to 3 years
Resistance profile
time frame: from start of dolutegravir up to 3 years
Patient satisfaction
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Prospective, Non-interventional Study of the Use of Dolutegravir as Part of Combination Antiretroviral Therapy in Routine Daily Practice in Germany (DOL-ART)
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by ViiV Healthcare.