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Description of Real World Antiviral Effectiveness and Sustainability of the 2-Drug Regimen Dolutegravir + Lamivudine in Untreated and Pre-treated Patients in Routine Clinical Care in Germany (URBAN)

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ClinicalTrials.gov Identifier: NCT03754803
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : November 30, 2018
Sponsor:
Collaborator:
MUC Research GmbH
Information provided by (Responsible Party):
ViiV Healthcare

Brief Summary:
This is a prospective, non-interventional, multi-center study, in subjects with clinical indication of Human Immunodeficiency Virus (HIV)-1 infection. The aim of the study is to generate the real world evidence for the use of DTG+3TC in routine clinical care in Germany to supplement data obtained from controlled clinical trials. Approximately, 300 treatment naïve and pre-treated HIV-1 positive subjects will be enrolled in the study. The observation period for the study will be 3 years. Data will be collected from routine clinical care via electronic data capture (EDC) system.

Condition or disease Intervention/treatment
HIV Infections Other: HIV Symptom Distress Module Questionnaire Other: HIV treatment satisfaction questionnaire

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Description of Real World Antiviral Effectiveness and Sustainability of the 2-Drug Regimen Dolutegravir + Lamivudine in Untreated and Pre-treated Patients in Routine Clinical Care in Germany
Actual Study Start Date : November 13, 2018
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
Treatment naïve subjects with HIV infection
Treatment naïve HIV-1 positive subjects for whom DTG+3TC is indicated according to local label will be included
Other: HIV Symptom Distress Module Questionnaire
The Symptom Distress Module is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment.

Other: HIV treatment satisfaction questionnaire
The HIV TSQ is a 10-item-self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience and flexibility.

Pre-treated subjects with HIV infection
Pre-treated HIV-1 positive subjects for whom DTG+3TC is indicated according to local label will be included.
Other: HIV Symptom Distress Module Questionnaire
The Symptom Distress Module is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment.

Other: HIV treatment satisfaction questionnaire
The HIV TSQ is a 10-item-self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience and flexibility.




Primary Outcome Measures :
  1. Percentage of subjects with sustained virologic suppression, with Viral load (VL) < 50 Copies per Milliliter (c/mL) [ Time Frame: Up to 36 months ]
    Percentage of subjects with sustained virologic suppression, defined as VL <50 c/mL or if between 50-200 c/mL with a subsequent next available measurement <50 c/mL (within 120 days) will be evaluated.


Secondary Outcome Measures :
  1. Percentage of pre-treated subjects with low level viremia [ Time Frame: Up to 36 months ]
    Percentage of subjects with low level viremia, defined as a VL measurement between >50 to <200 c/mL for pre-treated subjects will be evaluated.

  2. Percentage of naïve subjects with low level viremia after initial suppression [ Time Frame: Up to 36 months ]
    Percentage of subjects with low level viremia, defined as a VL measurement between >50 to <200 c/mL after initial suppression of <50 c/mL for naïve subjects will be evaluated.

  3. Percentage of virologic non-responders for naïve subjects [ Time Frame: Up to 36 months ]
    Percentage of virologic non-responders, defined as two consecutive measurements >=200 c/mL after at least 24 weeks of treatment in naïve subjects will be evaluated.

  4. Percentage of naïve subjects with virologic rebound [ Time Frame: Up to 36 months ]
    Percentage of naïve subjects with virologic rebound, defined as two consecutive VL measurements >=200 c/mL after suppression (one VL <50 c/mL) will be evaluated.

  5. Percentage of subjects with VL < 50 c/mL [ Time Frame: Up to 36 months ]
    Percentage of subjects with VL <50 c/mL will be evaluated.

  6. Percentage of subjects with two consecutive VL measurements of >=200 c/mL [ Time Frame: Up to 36 months ]
    Percentage of subjects with two consecutive VL measurements of >=200 c/mL will be evaluated.

  7. Percentage of subjects with treatment switch [ Time Frame: Up to 36 months ]
    Percentage of subjects with treatment switch due to virologic failure (VF) or due to intolerability determined at the discretion of the physician will be evaluated.

  8. Percentage of subjects with VL > 50 c/mL with emergent resistance mutations [ Time Frame: Up to 36 months ]
    Percentage of subjects with VL >50 c/mL with emergent resistance mutations will be summarized. Resistance analysis will be performed at the physician's discretion.

  9. Number of monitoring measures [ Time Frame: Up to 36 months ]
    Number of monitoring measures (normalized to subject years) will be summarized.

  10. Number and frequency of serious adverse events (SAE) [ Time Frame: Up to 36 months ]
    An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.

  11. Number and frequency of adverse drug reactions (ADRs) [ Time Frame: Up to 36 months ]
    An ADR is defined as a noxious and unintended response to a medicinal investigational product related to any dose where at least a reasonable possibility, that is the relationship cannot be ruled out.

  12. Adherence to therapy [ Time Frame: Up to 36 months ]
    Adherence to therapy will be determined from the number of monthly doses missed.

  13. Change from Baseline for lipid laboratory parameter: lactate dehydrogenase (LDH) [ Time Frame: Baseline and up to 36 months ]
    Lipid laboratory parameter LDH data will be evaluated at indicated time points.

  14. Change from Baseline for lipid laboratory parameters: cholesterol and triglycerides [ Time Frame: Baseline and up to 36 months ]
    Lipid laboratory parameters cholesterol and triglycerides data will be evaluated at indicated time points.

  15. Change in treatment satisfaction based on HIV Treatment Satisfaction questionnaire (HIV TSQ) [ Time Frame: Up to 36 months ]
    The HIV TSQ is a 10-item-self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience and flexibility. In treatment satisfaction score will range from 0-60, higher the score, greater the satisfaction with treatment. Individual item scores which included All rate score ranging from 0 (very dissatisfied, inconvenient, inflexible) to 6 (very satisfied, convenient, flexible), in case of general satisfaction , there will be 10 items which will be summed to produce a score ranging from 0 to 30, with higher the score greater the satisfaction with subscale. For lifestyle scale with 8 items which will be summed to produce a score ranging from 0 to 30, with higher the score greater the satisfaction with subscale.

  16. Change in Symptom Distress based on HIV Symptom Distress Module questionnaire [ Time Frame: Up to 36 months ]
    The Symptom Distress Module is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. This included sub-scales change in treatment satisfaction, individual satisfaction with treatment change. Treatment satisfaction score summed all items to produce scores ranging from +30 to -30, higher the score, greater the improvement in satisfaction with treatment, lower score greater is the deterioration in satisfaction. Individual item scores which included All rate score ranging from +3 (much more satisfied, much more convenient, much more flexible) to -3 (much less satisfied, much less convenient, much less flexible). General satisfaction and life style scores all items summed to produce score range +15 to -15, where higher the score greater the improvement in satisfaction, lower score greater is the deterioration in satisfaction.

  17. Reasons for switching to/prescription of DTG plus 3TC [ Time Frame: Day 1 ]
    The reasons for switching to/prescription of DTG plus 3TC as selected by the investigator from a pre-specified list will be summarized



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Approximately 300 treatment naïve and pre-treated HIV-1 positive subjects from Germany will be included.
Criteria

Inclusion Criteria:

  • Subjects with >= 18 years of age.
  • Subjects with documented HIV-1 infection.
  • Prescription of DTG + 3TC was issued independently from entering this study.
  • Subjects with the ability to understand informed consent form and other relevant regulatory documents.

Exclusion Criteria:

  • Any contraindication according to Tivicay or Lamivudine summaries of product characteristics (SmPCs).
  • Subjects with VL > 500 c/mL.
  • Any antiretroviral therapy for the treatment of HIV-1 in addition to DTG and 3TC or the DTG/3TC fixed dose combination (FDC).
  • Subjects with hepatitis B virus (HBV)- coinfection.
  • Subjects with current participation in the ongoing non-interventional study TRIUMPH (study number: 202033, NCT number: NCT02342769) or in any interventional clinical trial irrespective of indication.
  • Subjects who had previously participated in clinical trials assessing DTG+ 3TC.

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): NCT03754803


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
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Germany
GSK Investigational Site Not yet recruiting
Mannheim, Baden-Wuerttemberg, Germany, 68161
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Not yet recruiting
Tuebingen, Baden-Wuerttemberg, Germany, 72076
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 80331
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ramona Pauli         
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 80335
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Hans Jaeger         
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 80336
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Nils Postel         
GSK Investigational Site Not yet recruiting
Muenchen, Bayern, Germany, 80801
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Not yet recruiting
Frankfurt am Main, Hessen, Germany, 60590
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Not yet recruiting
Osnabrueck, Niedersachsen, Germany, 49090
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Not yet recruiting
Aachen, Nordrhein-Westfalen, Germany, 52062
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Not yet recruiting
Bochum, Nordrhein-Westfalen, Germany, 44787
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Not yet recruiting
Essen, Nordrhein-Westfalen, Germany, 45122
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Not yet recruiting
Koeln, Nordrhein-Westfalen, Germany, 50674
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Not yet recruiting
Magdeburg, Sachsen-Anhalt, Germany, 39120
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Berlin, Germany, 10117
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Sven Schellberg         
GSK Investigational Site Recruiting
Berlin, Germany, 10243
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Christiane Cordes         
GSK Investigational Site Recruiting
Berlin, Germany, 10243
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Heribert Hillenbrand         
GSK Investigational Site Recruiting
Berlin, Germany, 10707
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Thomas Wuensche         
GSK Investigational Site Not yet recruiting
Berlin, Germany, 10777
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Berlin, Germany, 12163
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Gordon Weinberg         
GSK Investigational Site Recruiting
Berlin, Germany, 14057
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ulrich Bohr         
GSK Investigational Site Recruiting
Berlin, Germany, 14059
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Kevin Ummard-Berger         
GSK Investigational Site Withdrawn
Chemnitz, Germany, 09111
GSK Investigational Site Withdrawn
Dortmund, Germany, 44137
GSK Investigational Site Withdrawn
Hamburg, Germany, 20099
GSK Investigational Site Not yet recruiting
Hamburg, Germany, 20146
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Not yet recruiting
Hamburg, Germany, 20246
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Not yet recruiting
Koeln, Germany, 50668
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Not yet recruiting
Weimar, Germany, 99427
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
ViiV Healthcare
MUC Research GmbH
Investigators
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Study Director: GSK Clinical Trials ViiV Healthcare
Study Director: GSK Clinical Trials GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT03754803     History of Changes
Other Study ID Numbers: 208983
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ViiV Healthcare:
Dolutegravir
Two-drug regimen
Human Immunodeficiency Virus
HIV Symptom Distress Module
Lamivudine
HIV treatment satisfaction questionnaire

Additional relevant MeSH terms:
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HIV Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Anti-HIV Agents
HIV Integrase Inhibitors
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Immune System Diseases
Lamivudine
Dolutegravir
Antiviral Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-Infective Agents
Integrase Inhibitors