A Prospective, Non-interventional Study of the Use of Dolutegravir as Part of Combination Antiretroviral Therapy in Routine Daily Practice in Germany (DOL-ART)
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| ClinicalTrials.gov Identifier: NCT02076386 |
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Recruitment Status
:
Completed
First Posted
: March 3, 2014
Last Update Posted
: October 25, 2017
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Sponsor:
ViiV Healthcare
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
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Brief Summary:
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 or disease | Intervention/treatment |
|---|---|
| Infection, Human Immunodeficiency Virus | Drug: Dolutegravir |
| Study Type : | Observational |
| Actual Enrollment : | 411 participants |
| 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) |
| Actual Study Start Date : | March 4, 2014 |
| Actual Primary Completion Date : | June 20, 2017 |
| Actual Study Completion Date : | June 20, 2017 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
|
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 ]
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| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| Responsible Party: | ViiV Healthcare |
| ClinicalTrials.gov Identifier: | NCT02076386 History of Changes |
| Other Study ID Numbers: |
201067 |
| First Posted: | March 3, 2014 Key Record Dates |
| Last Update Posted: | October 25, 2017 |
| Last Verified: | October 2017 |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
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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 |