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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Other: HIV Symptom Distress Module Questionnaire; Other: HIV treatment satisfaction questionnaire

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14059
    • GSK Investigational Site
  • Berlin, Germany, 14057
    • GSK Investigational Site
  • Berlin, Germany, 10777
    • GSK Investigational Site
  • Berlin, Germany, 10629
    • GSK Investigational Site
  • Berlin, Germany, 12163
    • GSK Investigational Site
  • Berlin, Germany, 10243
    • GSK Investigational Site
  • Hamburg, Germany, 20246
    • GSK Investigational Site
  • Hamburg, Germany, 20146
    • GSK Investigational Site
  • Koeln, Germany, 50668
    • GSK Investigational Site
  • Weimar, Germany, 99427
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Mannheim, Baden-Wuerttemberg, Germany, 68161
      • GSK Investigational Site
  • Bayern
    • Muenchen, Bayern, Germany, 80335
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80336
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80331
      • GSK Investigational Site
  • Niedersachsen
    • Osnabrueck, Niedersachsen, Germany, 49090
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Aachen, Nordrhein-Westfalen, Germany, 52062
      • GSK Investigational Site
    • Bochum, Nordrhein-Westfalen, Germany, 44787
      • GSK Investigational Site
    • Koeln, Nordrhein-Westfalen, Germany, 50674
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Approximately 300 treatment naïve and pre-treated HIV-1 positive subjects from Germany will be included.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects with sustained virologic suppression, with Viral load (VL) < 50 Copies per Milliliter (c/mL)	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.	Up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of pre-treated subjects with low level viremia	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.	Up to 36 months
Percentage of naïve subjects with low level viremia after initial suppression	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.	Up to 36 months
Percentage of virologic non-responders for naïve subjects	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.	Up to 36 months
Percentage of naïve subjects with virologic rebound	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.	Up to 36 months
Percentage of subjects with VL < 50 c/mL	Percentage of subjects with VL <50 c/mL will be evaluated.	Up to 36 months
Percentage of subjects with two consecutive VL measurements of >=200 c/mL	Percentage of subjects with two consecutive VL measurements of >=200 c/mL will be evaluated.	Up to 36 months
Percentage of subjects with treatment switch	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.	Up to 36 months
Percentage of subjects with VL > 50 c/mL with emergent resistance mutations	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.	Up to 36 months
Number of monitoring measures	Number of monitoring measures (normalized to subject years) will be summarized.	Up to 36 months
Number and frequency of serious adverse events (SAE)	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.	Up to 36 months
Number and frequency of adverse drug reactions (ADRs)	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.	Up to 36 months
Adherence to therapy	Adherence to therapy will be determined from the number of monthly doses missed.	Up to 36 months
Change from Baseline for lipid laboratory parameter: lactate dehydrogenase (LDH)	Lipid laboratory parameter LDH data will be evaluated at indicated time points.	Baseline and up to 36 months
Change from Baseline for lipid laboratory parameters: cholesterol and triglycerides	Lipid laboratory parameters cholesterol and triglycerides data will be evaluated at indicated time points.	Baseline and up to 36 months
Change in treatment satisfaction based on HIV Treatment Satisfaction questionnaire (HIV TSQ)	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.	Up to 36 months
Change in Symptom Distress based on 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. 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.	Up to 36 months
Reasons for switching to/prescription of DTG plus 3TC	The reasons for switching to/prescription of DTG plus 3TC as selected by the investigator from a pre-specified list will be summarized	Day 1

Collaborators and Investigators

• Sponsor: ViiV Healthcare
• Collaborators: MUC Research GmbH
• Investigators: Study Director: GSK Clinical Trials, ViiV Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2018
• Primary Completion (Actual): July 28, 2023
• Study Completion (Estimated): February 19, 2024

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: November 26, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Lamivudine; Human Immunodeficiency Virus; Dolutegravir; Two-drug regimen; HIV Symptom Distress Module; HIV treatment satisfaction questionnaire
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections
• Other Study ID Numbers: 208983

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No