HIV InfectionsTRIUMPHNCT02342769
Prospective Non-Interventional Observational Study of Use of TRIUMEQ and Corresponding Monitoring Measures in Clinical Practice in Germany
An observational study of HIV Infections, run by ViiV Healthcare at 29 sites in Germany.
Trial summary
TRIUMPH is a prospective, non-interventional observational study on the use of the fixdose combination TRIUMEQ (Dolutegravir/Abacavir/Lamivudine) and the respective monitoring measures in the practice of HIV care in Germany. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Dolutegravir/Abacavir/Lamivudin
- How many people
- 403 participants
- Where
- 29 sitesGermany
- Study dates
- 19 Feb 2015to 28 Oct 2018
- 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: Approx. 40 HIV treatment sites in Germany are planned to be involved in the documentation. The recruitment target is to include a total of 400 patients in the study across Germany. In order to allow for adequately answering in particular the problems regarding HLA-B*5701 testing, at least half of the recruited population should not have received abacavir (ABC) in their prior therapy. Each site will be allowed to recruit a maximum of 5 patients per month and a maximum of 20 patients in total. If the monthly quota of 5 patients is not utilized, the difference may be transferred to the subsequent months.
Who may be able to join
- Documented HIV infection
- Age ≥ 18 years
- HLA-B*5701-negative
- Decision for first initiation of TRIUMEQ therapy made by the attending physician independent of the inclusion in this observational study
Who cannot join
- Prior dolutegravir therapy (cf. also Capping ABC in section 3.3 Recruitment)
- Participation in a clinical trial during this study
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Germany29 sites
GSK Investigational Site
Aachen, North Rhine-Westphalia, 52062
GSK Investigational Site
Berlin, 10243
GSK Investigational Site
Berlin, 10405
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
Chemnitz, 09111
GSK Investigational Site
Cologne, North Rhine-Westphalia, 50674
GSK Investigational Site
Cologne, 50668
GSK Investigational Site
Cologne, 50679
GSK Investigational Site
Dortmund, 44137
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, 40237
GSK Investigational Site
Frankfurt am Main, Hesse, 60590
GSK Investigational Site
Frankfurt am Main, Hesse, 60596
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
GSK Investigational Site
Hamburg, 20099
GSK Investigational Site
Hamburg, 20246
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, 80336
GSK Investigational Site
Munich, Bavaria, 80801
GSK Investigational Site
Osnabrück, Lower Saxony, 49090
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70197
GSK Investigational Site
Ulm, Baden-Wurttemberg, 89081
GSK Investigational Site
Weimar, 99427
About this study
Official title: Prospective Non-Interventional Observational Study of Use of Triumeq® and Corresponding Monitoring Measures in Clinical Practice in Germany
TRIUMPH is a prospective, non-interventional observational study on the use of the fixdose combination TRIUMEQ (Dolutegravir/Abacavir/Lamivudine) and the respective monitoring measures in the practice of HIV care in Germany. The primary study objective is a descriptive report of the incidence of therapeutic monitoring measures in HIV-infected patients under TRIUMEQ therapy in everyday routine 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 TRIUMEQ, due to death, withdrawal of consent, lost to follow-up. TRIUMEQ is a registered trademark of the ViiV Healthcare group of companies.
- Conditions
- HIV Infections
- Being tested
- Dolutegravir/Abacavir/Lamivudin
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolutegravir/Abacavir/LamivudinDrug
Prospective, non-interventional observational study on the use of TRIUMEQ and the respective monitoring measures in the practice of HIV care in Germany. No drug will be provided. No study visits or procedures are mandated per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Dolutegravir/Abacavir/Lamivudin | Prospective, non-interventional observational study on the use of TRIUMEQ and the respective monitoring measures in the practice of HIV care in Germany. No drug will be provided. No study visits or procedures are mandated per protocol. Receives: Drug: Dolutegravir/Abacavir/Lamivudin |
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 documentation of the frequency of therapeutic monitoring measures in HIV-infected patients under TRIUMEQ in routine daily practice in Germany
Measured: up to 3 years
Secondary outcomes (8)
Type of the therapeutic monitoring measures
Descriptive characterization of therapeutic monitoring measures in HIV-infected patients under TRIUMEQ in routine daily practice in Germany
Measured: up to 3 years
Details on conduct and logistics of HLA-B*5701 testing
Descriptive characterization of conduct and logistics of HLA-B*5701 testing in HIV-infected patients under TRIUMEQ in routine daily practice in Germany
Measured: Baseline
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: up to 3 years
Resistance profile
To characterise resistance profile in case of virological failure
Measured: up to 3 years
Patient satisfaction
To evaluate the change in patient satisfaction relative to baseline in patients treated with TRIUMEQ
Measured: up to 3 years
Reasons for selecting TRIUMEQ
Measured: Baseline
Reasons for discontinuing TRIUMEQ
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study start19 Feb 2015
- Primary completion28 Oct 2018
- Study completion28 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- 403 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
- NCT02342769
- Sponsor's protocol ID
- 202033
- Acronym
- TRIUMPH
- Status last verified
- Feb 2019
- First submitted
- 15 Jan 2015
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Non-Interventional Observational Study of Use of Triumeq® and Corresponding Monitoring Measures in Clinical Practice in Germany
- ClinicalTrials.gov ID
- NCT02342769
- Acronym / sponsor ID
- TRIUMPH / 202033
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 19 Feb 2015 (actual)
- Primary completion
- 28 Oct 2018 (actual)
- Study completion
- 28 Oct 2018 (actual)
- First posted
- 21 Jan 2015 (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.
TRIUMPH is a prospective, non-interventional observational study on the use of the fixdose combination TRIUMEQ (Dolutegravir/Abacavir/Lamivudine) and the respective monitoring measures in the practice of HIV care in Germany. The primary study objective is a descriptive report of the incidence of therapeutic monitoring measures in HIV-infected patients under TRIUMEQ therapy in everyday routine 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 TRIUMEQ, due to death, withdrawal of consent, lost to follow-up. TRIUMEQ is a registered trademark of the ViiV Healthcare group of companies.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dolutegravir/Abacavir/Lamivudin | – | Drug: Dolutegravir/Abacavir/LamivudinProspective, non-interventional observational study on the use of TRIUMEQ and the respective monitoring measures in the practice of HIV care 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
- Approx. 40 HIV treatment sites in Germany are planned to be involved in the documentation. The recruitment target is to include a total of 400 patients in the study across Germany. In order to allow for adequately answering in particular the problems regarding HLA-B*5701 testing, at least half of the recruited population should not have received abacavir (ABC) in their prior therapy. Each site will be allowed to recruit a maximum of 5 patients per month and a maximum of 20 patients in total. If the monthly quota of 5 patients is not utilized, the difference may be transferred to the subsequent months.
Key inclusion criteria (4 listed)
- Documented HIV infection
- Age ≥ 18 years
- HLA-B*5701-negative
- Decision for first initiation of TRIUMEQ therapy made by the attending physician independent of the inclusion in this observational study
Key exclusion criteria (2 listed)
- Prior dolutegravir therapy (cf. also Capping ABC in section 3.3 Recruitment)
- Participation in a clinical trial during this study
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 |
|---|---|---|
| Dolutegravir/Abacavir/LamivudinProspective, non-interventional observational study on the use of TRIUMEQ and the respective monitoring measures in the practice of HIV care in Germany. No drug will be provided. No study visits or procedures are mandated per protocol. | Drug | Dolutegravir/Abacavir/Lamivudin |
Primary outcome
Frequency of therapeutic monitoring measures in HIV-infected patients
Time frame: up to 3 years
Descriptive documentation of the frequency of therapeutic monitoring measures in HIV-infected patients under TRIUMEQ in routine daily practice in Germany
8 secondary outcomes
Type of the therapeutic monitoring measures
Time frame: up to 3 years
Details on conduct and logistics of HLA-B*5701 testing
Time frame: Baseline
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: up to 3 years
Resistance profile
Time frame: up to 3 years
Patient satisfaction
Time frame: up to 3 years
Reasons for selecting TRIUMEQ
Time frame: Baseline
Reasons for discontinuing TRIUMEQ
Time frame: up to 3 years
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 11 Feb 2019.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by ViiV Healthcare at 29 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 2 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 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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 11 Feb 2019.