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

Infection, Human Immunodeficiency Virus Clinical Trial

— DOL-ART  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02076386
• Other study ID #: 201067
• Status: Completed
• Start date: March 4, 2014
• Est. completion date: July 5, 2017

Study information

• Verified date: August 2018
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 411
• Est. completion date: July 5, 2017
• Est. primary completion date: July 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection, Human Immunodeficiency Virus

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Aachen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Chemnitz
Germany	GSK Investigational Site	Dortmund	Nordrhein-Westfalen
Germany	GSK Investigational Site	Duesseldorf	Nordrhein-Westfalen
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Frankfurt am Main	Hessen
Germany	GSK Investigational Site	Freiburg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Fuerth	Bayern
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Koblenz	Rheinland-Pfalz
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Koeln
Germany	GSK Investigational Site	Koeln
Germany	GSK Investigational Site	Magdeburg	Sachsen-Anhalt
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenster	Nordrhein-Westfalen
Germany	GSK Investigational Site	Osnabrueck	Niedersachsen
Germany	GSK Investigational Site	Stuttgart	Baden-Wuerttemberg
Germany	GSK Investigational Site	Tuebingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Weimar

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Type of the therapeutic monitoring measures		up to 3 years
Secondary	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
Secondary	Efficacy	Defined as viral load < 50 copies/ml	from start of dolutegravir up to 3 years
Secondary	Resistance profile	To characterise resistance profile in case of virological failure	from start of dolutegravir up to 3 years
Secondary	Patient satisfaction	To evaluate the change in patient satisfaction relative to baseline in patients treated with dolutegravir	Up to 3 years from baseline
Secondary	Reasons for selecting dolutegravir-containing ART		Baseline
Secondary	Reasons for discontinuing dolutegravir-containing ART		Up to 3 years after baseline