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

Purpose

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).

Condition	Intervention
Infection, Human Immunodeficiency Virus	Drug: Dolutegravir


Study Type:	Observational
Study Design:	Observational Model: Other Time Perspective: Prospective
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)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Dolutegravir Dolutegravir sodium

U.S. FDA Resources

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:

Frequency of therapeutic monitoring measures in HIV-infected patients [ Time Frame: 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:

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


Enrollment:	411
Actual Study Start Date:	March 4, 2014
Estimated Study Completion Date:	May 31, 2017
Estimated Primary Completion Date:	May 31, 2017 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.	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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Approximately 40 HIV treatment centers in Germany are planned to be involved in the documentation. The participating study site will document a maximum of 20 patients for this observation study. Overall, approximately 400 patients under dolutegravir-containing ART are to be documented. This selection process is intended to achieve the documentation of patients under dolutegravir-containing ART in routine daily practice representative for Germany.

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02076386

Locations


Germany
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68161
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70197
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72076
GSK Investigational Site
Fuerth, Bayern, Germany, 90762
GSK Investigational Site
Muenchen, Bayern, Germany, 80331
GSK Investigational Site
Muenchen, Bayern, Germany, 80335
GSK Investigational Site
Muenchen, Bayern, Germany, 80336
GSK Investigational Site
Muenchen, Bayern, Germany, 80801
GSK Investigational Site
Muenchen, Bayern, Germany, 81675
GSK Investigational Site
Frankfurt am Main, Hessen, Germany, 60590
GSK Investigational Site
Frankfurt, Hessen, Germany, 60311
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30159
GSK Investigational Site
Osnabrueck, Niedersachsen, Germany, 49090
GSK Investigational Site
Aachen, Nordrhein-Westfalen, Germany, 52062
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44787
GSK Investigational Site
Dortmund, Nordrhein-Westfalen, Germany, 44137
GSK Investigational Site
Duesseldorf, Nordrhein-Westfalen, Germany, 40237
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50674
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48143
GSK Investigational Site
Koblenz, Rheinland-Pfalz, Germany, 56073
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39120
GSK Investigational Site
Berlin, Germany, 10243
GSK Investigational Site
Berlin, Germany, 10405
GSK Investigational Site
Berlin, Germany, 10439
GSK Investigational Site
Berlin, Germany, 10707
GSK Investigational Site
Berlin, Germany, 10777
GSK Investigational Site
Berlin, Germany, 10961
GSK Investigational Site
Berlin, Germany, 13347
GSK Investigational Site
Berlin, Germany, 14057
GSK Investigational Site
Chemnitz, Germany, 09111
GSK Investigational Site
Hamburg, Germany, 20099
GSK Investigational Site
Hamburg, Germany, 20146
GSK Investigational Site
Hamburg, Germany, 20246
GSK Investigational Site
Koeln, Germany, 50668
GSK Investigational Site
Koeln, Germany, 50679
GSK Investigational Site
Weimar, Germany, 99427

Sponsors and Collaborators

ViiV Healthcare

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	ViiV Healthcare

More Information


Responsible Party:	ViiV Healthcare
ClinicalTrials.gov Identifier:	NCT02076386 History of Changes
Other Study ID Numbers:	201067
Study First Received:	February 20, 2014
Last Updated:	May 24, 2017

Additional relevant MeSH terms:


Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases	Slow Virus Diseases Dolutegravir HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on June 22, 2017

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