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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT02076386
First received: February 20, 2014
Last updated: January 29, 2015
Last verified: January 2015
  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: 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:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Defined as viral load < 50 copies/ml

  • Resistance profile [ Time Frame: from start of dolutegravir up to 3 years ] [ Designated as safety issue: No ]
    To characterise resistance profile in case of virological failure

  • Patient satisfaction [ Time Frame: Up to 3 years from baseline ] [ Designated as safety issue: No ]
    To evaluate the change in patient satisfaction relative to baseline in patients treated with dolutegravir

  • Reasons for selecting dolutegravir-containing ART [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Reasons for discontinuing dolutegravir-containing ART [ Time Frame: Up to 3 years after baseline ] [ Designated as safety issue: No ]

Enrollment: 411
Study Start Date: March 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 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
Genders Eligible for Study:   Both
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, 80801
GSK Investigational Site
Muenchen, Bayern, Germany, 80331
GSK Investigational Site
Muenchen, Bayern, Germany, 80336
GSK Investigational Site
Muenchen, Bayern, Germany, 80335
GSK Investigational Site
Muenchen, Bayern, Germany, 81675
GSK Investigational Site
Frankfurt, Hessen, Germany, 60311
GSK Investigational Site
Frankfurt am Main, Hessen, Germany, 60590
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, 44791
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, 10707
GSK Investigational Site
Berlin, Germany, 10405
GSK Investigational Site
Berlin, Germany, 10243
GSK Investigational Site
Berlin, Germany, 13353
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, 20246
GSK Investigational Site
Hamburg, Germany, 20146
GSK Investigational Site
Hamburg, Germany, 20099
GSK Investigational Site
Koeln, Germany, 50679
GSK Investigational Site
Koeln, Germany, 50668
GSK Investigational Site
Weimar, Germany, 99427
Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
  More Information

No publications provided

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT02076386     History of Changes
Other Study ID Numbers: 201067
Study First Received: February 20, 2014
Last Updated: January 29, 2015
Health Authority: Germany: BfArM

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Dolutegravir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Integrase Inhibitors
Integrase Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015