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 not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by ViiV Healthcare
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT02076386
First received: February 20, 2014
Last updated: February 27, 2014
Last verified: February 2014
  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 ]

Estimated Enrollment: 400
Study Start Date: March 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 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

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

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: February 27, 2014
Health Authority: Germany: BfArM

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

ClinicalTrials.gov processed this record on August 28, 2014