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

Sponsor
ViiV Healthcare (Industry)
Overall Status
Completed
CT.gov ID
NCT02076386
Collaborator
GlaxoSmithKline (Industry)
411
Enrollment
38
Locations
40
Actual Duration (Months)
10.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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 Phase

Study Design

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 :
Mar 4, 2014
Actual Primary Completion Date :
Jul 5, 2017
Actual Study Completion Date :
Jul 5, 2017

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Frequency of therapeutic monitoring measures in HIV-infected patients [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

  1. Type of the therapeutic monitoring measures [up to 3 years]

  2. Number of participants with Serious Adverse Events and drug-related adverse events as a measure of safety and tolerability [up to 3 years]

    To evaluate the frequency and type of serious adverse events and drug-related adverse events in patients treated with dolutegravir.

  3. Efficacy [from start of dolutegravir up to 3 years]

    Defined as viral load < 50 copies/ml

  4. Resistance profile [from start of dolutegravir up to 3 years]

    To characterise resistance profile in case of virological failure

  5. Patient satisfaction [Up to 3 years from baseline]

    To evaluate the change in patient satisfaction relative to baseline in patients treated with dolutegravir

  6. Reasons for selecting dolutegravir-containing ART [Baseline]

  7. Reasons for discontinuing dolutegravir-containing ART [Up to 3 years after baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 GSK Investigational Site Freiburg Baden-Wuerttemberg Germany 79106
2 GSK Investigational Site Mannheim Baden-Wuerttemberg Germany 68161
3 GSK Investigational Site Stuttgart Baden-Wuerttemberg Germany 70197
4 GSK Investigational Site Tuebingen Baden-Wuerttemberg Germany 72076
5 GSK Investigational Site Fuerth Bayern Germany 90762
6 GSK Investigational Site Muenchen Bayern Germany 80331
7 GSK Investigational Site Muenchen Bayern Germany 80335
8 GSK Investigational Site Muenchen Bayern Germany 80336
9 GSK Investigational Site Muenchen Bayern Germany 80801
10 GSK Investigational Site Muenchen Bayern Germany 81675
11 GSK Investigational Site Frankfurt am Main Hessen Germany 60590
12 GSK Investigational Site Frankfurt Hessen Germany 60311
13 GSK Investigational Site Hannover Niedersachsen Germany 30159
14 GSK Investigational Site Osnabrueck Niedersachsen Germany 49090
15 GSK Investigational Site Aachen Nordrhein-Westfalen Germany 52062
16 GSK Investigational Site Bochum Nordrhein-Westfalen Germany 44787
17 GSK Investigational Site Dortmund Nordrhein-Westfalen Germany 44137
18 GSK Investigational Site Duesseldorf Nordrhein-Westfalen Germany 40237
19 GSK Investigational Site Koeln Nordrhein-Westfalen Germany 50674
20 GSK Investigational Site Muenster Nordrhein-Westfalen Germany 48143
21 GSK Investigational Site Koblenz Rheinland-Pfalz Germany 56073
22 GSK Investigational Site Mainz Rheinland-Pfalz Germany 55116
23 GSK Investigational Site Magdeburg Sachsen-Anhalt Germany 39120
24 GSK Investigational Site Berlin Germany 10243
25 GSK Investigational Site Berlin Germany 10405
26 GSK Investigational Site Berlin Germany 10439
27 GSK Investigational Site Berlin Germany 10707
28 GSK Investigational Site Berlin Germany 10777
29 GSK Investigational Site Berlin Germany 10961
30 GSK Investigational Site Berlin Germany 13347
31 GSK Investigational Site Berlin Germany 14057
32 GSK Investigational Site Chemnitz Germany 09111
33 GSK Investigational Site Hamburg Germany 20099
34 GSK Investigational Site Hamburg Germany 20146
35 GSK Investigational Site Hamburg Germany 20246
36 GSK Investigational Site Koeln Germany 50668
37 GSK Investigational Site Koeln Germany 50679
38 GSK Investigational Site Weimar Germany 99427

Sponsors and Collaborators

  • ViiV Healthcare
  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, ViiV Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT02076386
Other Study ID Numbers:
  • 201067
First Posted:
Mar 3, 2014
Last Update Posted:
Aug 13, 2018
Last Verified:
Aug 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Dolutegravir

Study Results

No Results Posted as of Aug 13, 2018