NCT03754803Completed
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
Source: ClinicalTrials.gov · Last updated 17 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 376 (actual)
- First submitted
- 11 Oct 2018
- Start date
- 8 Nov 2018
- Primary completion date
- 6 May 2024
- Lead sponsor
- ViiV Healthcare
- Diseases
- HIV
- NCT number
- NCT03754803
What you commit to
- Study type: Observational
- Participants enrolled: 376
- From 8 Nov 2018 to the primary completion date, 6 May 2024
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who had previously participated in clinical trials assessing DTG+ 3TC.
Other illness
- 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.
Other
- Any contraindication according to Tivicay or Lamivudine summaries of product characteristics (SmPCs).
- Participants with VL \> 500 c/mL.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GSK Investigational Site Coordinator of this site? Confirm its status | Aachen | Germany | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Bochum | Germany | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Mannheim | Germany | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Osnabrück | Germany | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Weimar | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.