Status:
COMPLETED
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
Lead Sponsor:
ViiV Healthcare
Collaborating Sponsors:
MUC Research GmbH
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 8 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 6 2024
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT03754803
Start Date
November 8 2018
End Date
May 6 2024
Last Update
August 17 2025
Active Locations (18)
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1
GSK Investigational Site
Aachen, Germany, 52062
2
GSK Investigational Site
Berlin, Germany, 10243
3
GSK Investigational Site
Berlin, Germany, 10629
4
GSK Investigational Site
Berlin, Germany, 10777