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)

ViiV Healthcare

Status: Completed

Conditions: HIV Infections

Treatments: Other: HIV treatment satisfaction questionnaire (TSQ); Other: HIV symptom distress module (SDM) questionnaire

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03754803

208983

Details and patient eligibility

About

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.

Enrollment: 376 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

376 participants in 1 patient group

Total participants

Description:

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

Treatment:

Other: HIV symptom distress module (SDM) questionnaire

Other: HIV treatment satisfaction questionnaire (TSQ)