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 participants with clinical indication of Human Immunodeficiency Virus (HIV)-1 infection. The aim of the study was 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. Treatment naïve and pre-treated HIV-1 positive participants were enrolled in the study. The observation period for the study was 3 years. Data was collected from routine clinical care via electronic data capture (EDC) system.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Other: HIV symptom distress module (SDM) questionnaire; Other: HIV treatment satisfaction questionnaire (TSQ)

• Study Type: Observational
• Enrollment (Actual): 376

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52062
    • GSK Investigational Site
  • 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
  • Bochum, Germany, 44787
    • GSK Investigational Site
  • Hamburg, Germany, 20246
    • GSK Investigational Site
  • Hamburg, Germany, 20146
    • GSK Investigational Site
  • Koeln, Germany, 50668
    • GSK Investigational Site
  • Koeln, Germany, 50674
    • GSK Investigational Site
  • Mannheim, Germany, 68161
    • GSK Investigational Site
  • Muenchen, Germany, 80336
    • GSK Investigational Site
  • Muenchen, Germany, 80331
    • GSK Investigational Site
  • Muenchen, Germany, 80335
    • GSK Investigational Site
  • Osnabruck, Germany, 49090
    • GSK Investigational Site
  • Weimar, Germany, 99427
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Treatment naïve and pre-treated HIV-1 positive participants from Germany were included in this study.

Description

Inclusion Criteria:

• Participants >= 18 years of age.
• Participants with documented HIV-1 infection.
• Prescription of DTG + 3TC was issued independently from entering this study.
• Participants 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).
• Participants 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).
• Participants with hepatitis B virus (HBV)- coinfection.
• Participants 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.
• Participants 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

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Total participants; Antiretroviral treatment (ART) naïve and pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.

Other: HIV symptom distress module (SDM) questionnaire; The SDM 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 (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Sustained Virologic Suppression	Virologic suppression is defined as a viral load (VL) less than (<) 50 copies (c)/mL or, if between 50-200 c/mL, with a subsequent next available measurement <50 c/mL (within 120 days).	At Year 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Low Level Viremia	Low level viremia is defined as a VL measurement greater than (>) 50 - <200 c/mL for pre-treated participants. For naive participants, a VL measurement between >50 to <200 c/mL after initial suppression of <50 c/mL was evaluated.	At Month 6 and years 1, 2 and 3
Percentage of Participants With Virologic Rebound	Virologic rebound is defined as 2 consecutive VL measurements >=200 c/mL after suppression. Baseline represents the last visit before the start of therapy with DTG+3TC.	From Baseline until Year 3
Percentage of Participants With Treatment Switch Due to Virologic Reasons or Due to Intolerability	The intolerability was determined at the discretion of the physician. Baseline represents the last visit before the start of therapy with DTG+3TC.	From Baseline until Year 3
Percentage of Participants With Missed Monthly Doses	Participants were prompted to give an estimate of their level of adherence in a single-item question part of their self-assessment questionnaires. 0-2 missed doses, 3-4 missed doses, 5-6 missed doses, and >6 missed doses were reported.	At years 1, 2 and 3
Number of Serious Adverse Events (SAEs)	An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. A 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. Baseline represents the last visit before the start of therapy with DTG+3TC.	From Baseline until Year 3
Frequency of Serious Adverse Events	An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. A 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. Baseline represents the last visit before the start of therapy with DTG+3TC.	From Baseline until Year 3
Number of Serious and Non-serious 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, i.e. the relationship cannot be ruled out. A serious ADR 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. Baseline represents the last visit before the start of therapy with DTG+3TC.	From Baseline until Year 3
Frequency of Any Adverse Drug Reactions	Any = serious and non-serious 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, i.e. the relationship cannot be ruled out. A serious ADR 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. Baseline represents the last visit before the start of therapy with DTG+3TC.	From Baseline until Year 3
Discontinuation Rates Due to Adverse Drug Reactions	Baseline represents the last visit before the start of therapy with DTG+3TC.	From Baseline until Year 3
Percentage of Participants With VL > 50 c/mL With Emergent Resistance Mutations	Newly identified resistance-associated mutations, including those detected before initiating treatment with DTG+3TC and most recent HIV-RNA levels. Baseline represents the last visit before the start of therapy with DTG+3TC.	From Baseline until Year 3
Change in Lipid Laboratory Values	The following lipid parameters are presented: total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides. Baseline represents the last visit before the start of therapy with DTG+3TC.	At years 1, 2 and 3 compared to Baseline
Percentage of Participants With Reasons for Therapy Switch to DTG+3TC	The primary reasons for therapy switch are side effects of previous ART, low potential for interaction, preference of a 2-drug regime, tolerability profile of DTG+3TC, pill size, easy to take (once daily, independent of meals), patient's preference, and other. Baseline represents the last visit before the start of therapy with DTG+3TC.	At Baseline
Percentage of Participants With Reasons for DTG+3TC Therapy Initiation	The primary reasons for therapy switch are low potential for interaction, preference of a 2-drug regime, prevention of potential long-term toxicities of other therapies, tolerability profile of DTG+3TC, easy to take (once daily, independent of meals), and other. Baseline represents the last visit before the start of therapy with DTG+3TC.	At Baseline
Change in Treatment Satisfaction	The change in treatment satisfaction is based on the 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 ranges from 0-60, where 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. Baseline represents the last visit before the start of therapy with DTG+3TC.	At years 1, 2 and 3 compared to Baseline
Change in Symptom Distress	The change in symptom distress is based on the HIV Symptom Distress Module (SDM) questionnaire. The SDM is a 20-item self-reported tool that assesses the presence and distress of symptoms related to HIV or its treatment. It includes sub-scales for treatment satisfaction and individual satisfaction with treatment changes. The treatment satisfaction score sums all items, ranging from +30 (greater improvement) to -30 (greater deterioration). Individual item scores range from +3 (much more satisfied, convenient, flexible) to -3 (much less satisfied, convenient, flexible). General satisfaction and lifestyle scores sum all items, ranging from +15 (greater improvement) to -15 (greater deterioration). Baseline represents the last visit before the start of therapy with DTG+3TC.	At years 1, 2 and 3 compared to Baseline
Number of HIV-RNA Monitoring Measures	Baseline represents the last visit before the start of therapy with DTG+3TC.	From Baseline until Year 3
Percentage of Participants Referred to Another Medical Specialist	Baseline represents the last visit before the start of therapy with DTG+3TC.	From Baseline until Year 3

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): May 6, 2024
• Study Completion (Actual): May 6, 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): August 17, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

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: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: 208983

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.ViiV-studyregister.com/documents/About_ViiV_Patient_Level_Data_Sharing_Final_25Sep2023.pdf.
• 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