Infection, Human Immunodeficiency VirusDOL-ARTNCT02076386
A Prospective, Non-interventional Study of the Use of Dolutegravir as Part of Combination Antiretroviral Therapy in Routine Daily Practice in Germany
An observational study of Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 38 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Human Immunodeficiency Virus
- What is being tested?
- Dolutegravir
- How many people
- 411 participants
- Where
- 38 sitesGermany
- Study dates
- 4 Mar 2014to 5 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
Germany38 sites
GSK Investigational Site
Aachen, North Rhine-Westphalia, 52062
GSK Investigational Site
Berlin, 10243
GSK Investigational Site
Berlin, 10405
GSK Investigational Site
Berlin, 10439
GSK Investigational Site
Berlin, 10707
GSK Investigational Site
Berlin, 10777
GSK Investigational Site
Berlin, 10961
GSK Investigational Site
Berlin, 13347
GSK Investigational Site
Berlin, 14057
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44787
GSK Investigational Site
Chemnitz, 09111
GSK Investigational Site
Cologne, North Rhine-Westphalia, 50674
GSK Investigational Site
Cologne, 50668
GSK Investigational Site
Cologne, 50679
GSK Investigational Site
Dortmund, North Rhine-Westphalia, 44137
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, 40237
GSK Investigational Site
Frankfurt am Main, Hesse, 60311
GSK Investigational Site
Frankfurt am Main, Hesse, 60590
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
GSK Investigational Site
Fürth, Bavaria, 90762
GSK Investigational Site
Hamburg, 20099
GSK Investigational Site
Hamburg, 20146
GSK Investigational Site
Hamburg, 20246
GSK Investigational Site
Hanover, Lower Saxony, 30159
GSK Investigational Site
Koblenz, Rhineland-Palatinate, 56073
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39120
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55116
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68161
GSK Investigational Site
Munich, Bavaria, 80331
GSK Investigational Site
Munich, Bavaria, 80335
GSK Investigational Site
Munich, Bavaria, 80336
GSK Investigational Site
Munich, Bavaria, 80801
GSK Investigational Site
Munich, Bavaria, 81675
GSK Investigational Site
Münster, North Rhine-Westphalia, 48143
GSK Investigational Site
Osnabrück, Lower Saxony, 49090
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70197
GSK Investigational Site
Tübingen, Baden-Wurttemberg, 72076
GSK Investigational Site
Weimar, 99427
About this study
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)
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).
- Conditions
- Infection, Human Immunodeficiency Virus
- Being tested
- Dolutegravir
- Medical subject headings
- Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DolutegravirDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dolutegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of therapeutic monitoring measures in HIV-infected patients
Descriptive characterization of the frequency of therapeutic monitoring measures in HIV-infected patients under dolutegravir-containing ART in routine daily practice in Germany.
Measured: up to 3 years
Secondary outcomes (7)
Type of the therapeutic monitoring measures
Measured: up to 3 years
Number of participants with Serious Adverse Events and drug-related adverse events as a measure of safety and tolerability
To evaluate the frequency and type of serious adverse events and drug-related adverse events in patients treated with dolutegravir.
Measured: up to 3 years
Efficacy
Defined as viral load < 50 copies/ml
Measured: from start of dolutegravir up to 3 years
Resistance profile
To characterise resistance profile in case of virological failure
Measured: from start of dolutegravir up to 3 years
Patient satisfaction
To evaluate the change in patient satisfaction relative to baseline in patients treated with dolutegravir
Measured: Up to 3 years from baseline
Reasons for selecting dolutegravir-containing ART
Measured: Baseline
Reasons for discontinuing dolutegravir-containing ART
Measured: Up to 3 years after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study start4 Mar 2014
- Primary completion5 Jul 2017
- Study completion5 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076386
- Sponsor's protocol ID
- 201067
- Acronym
- DOL-ART
- Status last verified
- Aug 2018
- First submitted
- 20 Feb 2014
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02076386
- Acronym / sponsor ID
- DOL-ART / 201067
- Conditions
- Infection, Human Immunodeficiency Virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 4 Mar 2014 (actual)
- Primary completion
- 5 Jul 2017 (actual)
- Study completion
- 5 Jul 2017 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dolutegravir | – | Drug: DolutegravirProspective, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DolutegravirProspective, 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 |
Primary outcome
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.
7 secondary outcomes
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
Efficacy
Time frame: from start of dolutegravir up to 3 years
Resistance profile
Time frame: from start of dolutegravir up to 3 years
Patient satisfaction
Time frame: Up to 3 years from baseline
Reasons for selecting dolutegravir-containing ART
Time frame: Baseline
Reasons for discontinuing dolutegravir-containing ART
Time frame: Up to 3 years after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
ViiV Healthcare
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 38 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of therapeutic monitoring measures in HIV-infected patients (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.