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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
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

NCT03754803

CompletedN/A

Sponsor: ViiV Healthcare

Conditions: HIV Infections

Interventions: HIV symptom distress module (SDM) questionnaire, HIV treatment satisfaction questionnaire (TSQ)

Countries: Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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.
Locations (18)
  • Aachen, Germany
  • Berlin, Germany
  • Berlin, Germany
  • Berlin, Germany
  • Berlin, Germany
  • Berlin, Germany
  • Berlin, Germany
  • Bochum, Germany
  • Cologne, Germany
  • Cologne, Germany
  • Hamburg, Germany
  • Hamburg, Germany
  • Mannheim, Germany
  • München, Germany
  • München, Germany
  • München, Germany
  • Osnabrück, Germany
  • Weimar, Germany