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)

July 30, 2025 updated by: ViiV Healthcare
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
376

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Suppression
Time Frame: At Year 3
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Low Level Viremia
Time Frame: At Month 6 and years 1, 2 and 3
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
Time Frame: From Baseline until Year 3
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
Time Frame: From Baseline until Year 3
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
Time Frame: At years 1, 2 and 3
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)
Time Frame: From Baseline until Year 3

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
Time Frame: From Baseline until Year 3

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)
Time Frame: From Baseline until Year 3

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
Time Frame: From Baseline until Year 3

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
Time Frame: From Baseline until Year 3
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
Time Frame: From Baseline until Year 3

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
Time Frame: At years 1, 2 and 3 compared to Baseline

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
Time Frame: At Baseline

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
Time Frame: At Baseline

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
Time Frame: At years 1, 2 and 3 compared to Baseline

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
Time Frame: At years 1, 2 and 3 compared to Baseline

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
Time Frame: From Baseline until Year 3
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
Time Frame: From Baseline until Year 3
Baseline represents the last visit before the start of therapy with DTG+3TC.
From Baseline until Year 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ViiV Healthcare

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
MUC Research GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: GSK Clinical Trials, ViiV Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 6, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 6, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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