Clinical trial NCT03754803: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Dolutegravir
Two-drug regimen
Human Immunodeficiency Virus
HIV Symptom Distress Module
Lamivudine
HIV treatment satisfaction questionnaire
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: MUC Research GmbH
First posted: 2018-11-27
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 300 treatment naïve and pre-treated HIV-1 positive subjects from Germany will be included.

Brief summary: This is a prospective, non-interventional, multi-center study, in subjects with clinical indication of Human Immunodeficiency Virus (HIV)-1 infection. The aim of the study is 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. Approximately, 300 treatment naïve and pre-treated HIV-1 positive subjects will be enrolled in the study. The observation period for the study will be 3 years. Data will be collected from routine clinical care via electronic data capture (EDC) system.


Eligibility criteria: Inclusion Criteria:

* Subjects with \>= 18 years of age.
* Subjects with documented HIV-1 infection.
* Prescription of DTG + 3TC was issued independently from entering this study.
* Subjects 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).
* Subjects 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).
* Subjects with hepatitis B virus (HBV)- coinfection.
* Subjects 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.
* Subjects who had previously participated in clinical trials assessing DTG+ 3TC.

Primary outcomes:
measure: Percentage of subjects with sustained virologic suppression, with Viral load (VL) < 50 Copies per Milliliter (c/mL)
timeFrame: Up to 36 months
Secondary outcomes:
measure: Percentage of pre-treated subjects with low level viremia
timeFrame: Up to 36 months
measure: Percentage of naïve subjects with low level viremia after initial suppression
timeFrame: Up to 36 months
measure: Percentage of virologic non-responders for naïve subjects
timeFrame: Up to 36 months
measure: Percentage of naïve subjects with virologic rebound
timeFrame: Up to 36 months
measure: Percentage of subjects with VL < 50 c/mL
timeFrame: Up to 36 months
measure: Percentage of subjects with two consecutive VL measurements of >=200 c/mL
timeFrame: Up to 36 months
measure: Percentage of subjects with treatment switch
timeFrame: Up to 36 months
measure: Percentage of subjects with VL > 50 c/mL with emergent resistance mutations
timeFrame: Up to 36 months
measure: Number of monitoring measures
timeFrame: Up to 36 months
measure: Number and frequency of serious adverse events (SAE)
timeFrame: Up to 36 months
measure: Number and frequency of adverse drug reactions (ADRs)
timeFrame: Up to 36 months
measure: Adherence to therapy
timeFrame: Up to 36 months
measure: Change from Baseline for lipid laboratory parameter: lactate dehydrogenase (LDH)
timeFrame: Baseline and up to 36 months
measure: Change from Baseline for lipid laboratory parameters: cholesterol and triglycerides
timeFrame: Baseline and up to 36 months
measure: Change in treatment satisfaction based on HIV Treatment Satisfaction questionnaire (HIV TSQ)
timeFrame: Up to 36 months
measure: Change in Symptom Distress based on HIV Symptom Distress Module questionnaire
timeFrame: Up to 36 months
measure: Reasons for switching to/prescription of DTG plus 3TC
timeFrame: Day 1
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Osnabrueck
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Aachen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Koeln
country: Germany
facility: GSK Investigational Site
city: Weimar
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: