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:
ViiV Healthcare
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT02076386
First received: February 20, 2014
Last updated: August 16, 2016
Last verified: August 2016
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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: | May 2017 |
| Estimated Primary Completion Date: | May 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 (Adult, Senior) |
| 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
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, 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 |
More Information
| Responsible Party: | ViiV Healthcare |
| ClinicalTrials.gov Identifier: | NCT02076386 History of Changes |
| Other Study ID Numbers: | 201067 |
| Study First Received: | February 20, 2014 |
| Last Updated: | August 16, 2016 |
| Health Authority: | Germany: BfArM |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on September 29, 2016