NCT03754803: URBAN

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

Completed Results posted Last updated 17 August 2025

What this trial tests

trial testing HIV symptom distress module (SDM) questionnaire in HIV Infections in 376 participants. Completed in 6 May 2024.

Timeline

8 November 2018

Primary endpoint
6 May 2024

6 May 2024

Quick facts

Lead sponsor	ViiV Healthcare
Status	Completed
Study type	OBSERVATIONAL
Enrollment	376
Start date	8 November 2018
Primary completion	6 May 2024
Estimated completion	6 May 2024
Sites	18 locations across Germany

Drugs / interventions tested

• HIV symptom distress module (SDM) questionnaire
• HIV treatment satisfaction questionnaire (TSQ)

Conditions studied

• HIV Infections — all drugs for HIV Infections →

Sponsor

ViiV Healthcare — full company profile →

Who can join

18 and older, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Low Level Viremia Secondary · 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.

Month 6

Group	Value	95% CI
ART-naive Participants	3.2
Pre-treated Participants	1.8

Year 1

Group	Value	95% CI
ART-naive Participants	3.2
Pre-treated Participants	1.5

Year 2

Group	Value	95% CI
ART-naive Participants	6.5
Pre-treated Participants	0.9

Year 3

Group	Value	95% CI
ART-naive Participants	3.2
Pre-treated Participants	1.8

Percentage of Participants With Virologic Rebound Secondary · 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.

Group	Value	95% CI
ART-naive Participants	3.4
Pre-treated Participants	0.3

Percentage of Participants With Treatment Switch Due to Virologic Reasons or Due to Intolerability Secondary · 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.

Virologic reasons

Group	Value	95% CI
ART-naive Participants	3.2
Pre-treated Participants	1.5

Intolerability

Group	Value	95% CI
ART-naive Participants	9.7
Pre-treated Participants	3.6

Percentage of Participants With Missed Monthly Doses Secondary · 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 Year 1 - 0-2 missed doses

Group	Value	95% CI
Total Participants	93

At Year 1 - 3-4 Missed doses

Group	Value	95% CI
Total Participants	14

At Year 1 - 5-6 Missed doses

Group	Value	95% CI
Total Participants	1

At Year 1 - >6 Missed doses

Group	Value	95% CI
Total Participants	1

At Year 2 - 0-2 missed doses

Group	Value	95% CI
Total Participants	98

At Year 2 - 3-4 Missed doses

Group	Value	95% CI
Total Participants	1

At Year 2 - 5-6 Missed doses

Group	Value	95% CI
Total Participants	1

At Year 2 - >6 Missed doses

Group	Value	95% CI
Total Participants	1

Number of Serious Adverse Events (SAEs) Secondary · 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.

Group	Value	95% CI
ART-naive Participants	1
Pre-treated Participants	78

Frequency of Serious Adverse Events Secondary · 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.

Group	Value	95% CI
ART-naive Participants	0.01
Pre-treated Participants	0.09

Number of Serious and Non-serious Adverse Drug Reactions (ADRs) Secondary · 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.

Serious ADRs

Group	Value	95% CI
ART-naive Participants	5
Pre-treated Participants	27

Non-serious ADRs

Group	Value	95% CI
ART-naive Participants	5
Pre-treated Participants	22

Frequency of Any Adverse Drug Reactions Secondary · 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.

Group	Value	95% CI
ART-naive Participants	0.06
Pre-treated Participants	0.03

Discontinuation Rates Due to Adverse Drug Reactions Secondary · From Baseline until Year 3

Baseline represents the last visit before the start of therapy with DTG+3TC.

Group	Value	95% CI
Total Participants	3.9

Percentage of Participants With VL > 50 c/mL With Emergent Resistance Mutations Secondary · 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.

Group	Value	95% CI
ART-naive Participants	0
Pre-treated Participants	0.3

Change in Lipid Laboratory Values Secondary · 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 Year 1 - Total cholesterol

Group	Value	95% CI
ART-naive Participants	13.0	-2.0 – 24.0
Pre-treated Participants	-4.0	-21.0 – 15.0

At Year 2 - Total cholesterol

Group	Value	95% CI
ART-naive Participants	-1.0	-12.0 – 43.0
Pre-treated Participants	-1.0	-22.0 – 14.0

At Year 3 - Total cholesterol

Group	Value	95% CI
ART-naive Participants	8.5	-9.0 – 14.0
Pre-treated Participants	-6.0	-39.0 – 14.0

At Year 1 - LDL cholesterol

Group	Value	95% CI
ART-naive Participants	3.5	-10.0 – 17.0
Pre-treated Participants	0.0	-16.0 – 16.0

At Year 2 - LDL cholesterol

Group	Value	95% CI
ART-naive Participants	2.0	-7.0 – 27.0
Pre-treated Participants	2.0	-18.0 – 20.0

At Year 3 - LDL cholesterol

Group	Value	95% CI
ART-naive Participants	8.5	-16.5 – 19.5
Pre-treated Participants	0.0	-28.0 – 17.4

At Year 1 - HDL cholesterol

Group	Value	95% CI
ART-naive Participants	1.0	-3.0 – 5.0
Pre-treated Participants	0.0	-5.0 – 4.0

At Year 2 - HDL cholesterol

Group	Value	95% CI
ART-naive Participants	3.0	-2.0 – 5.0
Pre-treated Participants	0.0	-4.0 – 5.0

Percentage of Participants With Reasons for Therapy Switch to DTG+3TC Secondary · 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.

Side effects of previous ART

Group	Value	95% CI
Pre-treated Participants	39

Low potential for interaction

Group	Value	95% CI
Pre-treated Participants	14

Preference of a 2-drug regime

Group	Value	95% CI
Pre-treated Participants	62

Tolerability profile of DTG+/3TC

Group	Value	95% CI
Pre-treated Participants	26

Pill size

Group	Value	95% CI
Pre-treated Participants	1

Easy to take (once daily, independent of meals)

Group	Value	95% CI
Pre-treated Participants	21

Patient's preference

Group	Value	95% CI
Pre-treated Participants	21

Other

Group	Value	95% CI
Pre-treated Participants	15

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ART-naive Participants

Serious: 1/31 (3%)

Deaths: 0/31

Pre-treated Participants

Serious: 78/337 (23%)

Deaths: 2/337

Serious adverse events (66 terms)

Reaction	System	ART-naive Participants	Pre-treated Participants
Fall	Injury, poisoning and procedural complications	—	—
Pneumonia	Infections and infestations	—	—
Acute myocardial infarction	Cardiac disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Death	General disorders	—	—
Pneumococcal sepsis	Infections and infestations	—	—
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Depression	Psychiatric disorders	—	—
Acute coronary syndrome	Cardiac disorders	—	—
Cardiac failure	Cardiac disorders	—	—
Coronary artery disease	Cardiac disorders	—	—
Ischaemic cardiomyopathy	Cardiac disorders	—	—
Fanconi syndrome	Congenital, familial and genetic disorders	—	—
Hyperthyroidism	Endocrine disorders	—	—
Macular degeneration	Eye disorders	—	—
Macular hole	Eye disorders	—	—
Obstructive pancreatitis	Gastrointestinal disorders	—	—
Chest pain	General disorders	—	—
Bile duct stone	Hepatobiliary disorders	—	—
Anal abscess	Infections and infestations	—	—
Herpes zoster	Infections and infestations	—	—
Medical device site infection	Infections and infestations	—	—
Postoperative wound infection	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Pneumonia bacterial	Infections and infestations	—	—

Most-reported serious reactions: Fall, Pneumonia, Acute myocardial infarction, Atrial fibrillation, Death, Pneumococcal sepsis, Basal cell carcinoma, Depression.

Data from ClinicalTrials.gov NCT03754803 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.