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

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

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 Overview

• Status: Completed
• Conditions: Infection, Human Immunodeficiency Virus
• Intervention / Treatment: Drug: Dolutegravir

• Study Type: Observational
• Enrollment (Actual): 411

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14057
    • GSK Investigational Site
  • Berlin, Germany, 10777
    • GSK Investigational Site
  • Berlin, Germany, 13347
    • GSK Investigational Site
  • Berlin, Germany, 10961
    • GSK Investigational Site
  • Berlin, Germany, 10439
    • GSK Investigational Site
  • Berlin, Germany, 10405
    • GSK Investigational Site
  • Berlin, Germany, 10243
    • GSK Investigational Site
  • Berlin, Germany, 10707
    • GSK Investigational Site
  • Chemnitz, Germany, 09111
    • GSK Investigational Site
  • Hamburg, Germany, 20246
    • GSK Investigational Site
  • Hamburg, Germany, 20099
    • GSK Investigational Site
  • Hamburg, Germany, 20146
    • GSK Investigational Site
  • Koeln, Germany, 50668
    • GSK Investigational Site
  • Koeln, Germany, 50679
    • GSK Investigational Site
  • Weimar, Germany, 99427
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • 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
  • Bayern
    • Fuerth, Bayern, Germany, 90762
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 81675
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80335
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80336
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80331
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80801
      • GSK Investigational Site
  • Hessen
    • Frankfurt, Hessen, Germany, 60311
      • GSK Investigational Site
    • Frankfurt am Main, Hessen, Germany, 60590
      • GSK Investigational Site
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30159
      • GSK Investigational Site
    • Osnabrueck, Niedersachsen, Germany, 49090
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • 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
  • Rheinland-Pfalz
    • Koblenz, Rheinland-Pfalz, Germany, 56073
      • GSK Investigational Site
    • Mainz, Rheinland-Pfalz, Germany, 55116
      • GSK Investigational Site
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39120
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: ViiV Healthcare
• Collaborators: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2014
• Primary Completion (Actual): July 5, 2017
• Study Completion (Actual): July 5, 2017

Study Registration Dates

• First Submitted: February 20, 2014
• First Submitted That Met QC Criteria: February 27, 2014
• First Posted (Estimate): March 3, 2014

Study Record Updates

• Last Update Posted (Actual): August 13, 2018
• Last Update Submitted That Met QC Criteria: August 10, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Integrase Inhibitors; Integrase Inhibitors; Dolutegravir
• Other Study ID Numbers: 201067

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No