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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02076386
First Posted: March 3, 2014
Last Update Posted: October 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
February 20, 2014
March 3, 2014
October 25, 2017
March 4, 2014
June 20, 2017   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02076386 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Prospective, Non-interventional Study of the Use of Dolutegravir as Part of Combination Antiretroviral Therapy in Routine Daily Practice in Germany
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).

Not Provided
Observational
Observational Model: Other
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Infection, Human Immunodeficiency Virus
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.
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.
Intervention: Drug: Dolutegravir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
411
June 20, 2017
June 20, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT02076386
201067
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
ViiV Healthcare
ViiV Healthcare
GlaxoSmithKline
Study Director: GSK Clinical Trials ViiV Healthcare
ViiV Healthcare
October 2017