Clinical trial NCT03518060: Dolutegravir/Rilpivirine, Antiretroviral Efficacy Study Using Real-world Data in Subjects With Human Immunodeficiency Virus (HIV)-1
Official title: Durability of Antiretroviral Suppression and the Real World Clinical Profile of the Novel 2-Drug Regimen Juluca, a Onepill-Regimen Consisting of Dolutegravir and Rilpivirine, in Routine Clinical Care in Germany
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: 2 drug regimen
Juluca
Rilpivirine
Dolutegravir
Antiretroviral
One pill regimen
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: MUC Research GmbH
First posted: 2018-05-08
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two hundred treatment experienced and virologically suppressed HIV positive participants were included in this study. The participants were included at the discretion of the treating physician based on the local summary of product characteristics (SmPC) of JULUCA.

Brief summary: This was a prospective, non-interventional, single-arm, multi-center study aimed at gathering real-world data on JULUCA use in routine clinical care in Germany, to supplement clinical trial data to further improve/optimize care in HIV positive participants in Germany. Approximately 250 virologically suppressed HIV positive participants on stable antiretroviral therapy (ART) were included in the study at the discretion of treating physician. Eligible participants were followed up for approximately 3 years and data was collected during routine clinical care.


Eligibility criteria: Inclusion Criteria:

* Greated than or equal to (\>=)18 years of age.
* Documented HIV-1 infection.
* Virologically suppressed (HIV-1 ribonucleic acid \[RNA\] less than \[\<\] 50 copies \[c\]/mL for at least 6 months)
* Prescription for JULUCA was issued independently from entering this study.
* Ability to understand informed consent form and other relevant study documents

Exclusion Criteria:

* Any contraindication according to JULUCA SmPC.
* Documented viral load greater than (\>) 50 c/mL at any time point within 6 months prior to inclusion into this study.
* History of treatment failure.
* Known or suspected substitutions associated with resistance to any non-nucleoside reverse-transcriptase inhibitors (NNRTI) or integrase strand transfer inhibitor (INSTI).
* Any ART for the treatment of HIV-1 in addition to JULUCA.
* Hepatitis B virus (HBV)-co-infection.
* Current participation in the ongoing non-interventional study TRIUMPH (study number: 202033) or any interventional clinical trial irrespective of indication.
* Previous participation in clinical trials involving JULUCA.

Primary outcomes:
measure: Number of Participants With Sustained Virologic Suppression at Year 3
timeFrame: At Year 3
Secondary outcomes:
measure: Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
timeFrame: At Year 1 and Year 2
measure: Number of Participants With Low Level Viremia
timeFrame: At Year 1, Year 2 and Year 3
measure: Number of Participants With Virologic Rebound
timeFrame: At Year 1, Year 2 and Year 3
measure: Number of Participants With Treatment Switch
timeFrame: At Year 1, Year 2 and Year 3
measure: Number of Monitoring Measures During the 3-year Follow-up
timeFrame: Up to Year 3
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to Year 3
measure: Number of Participants With Adverse Drug Reactions (ADRs)
timeFrame: Up to Year 3
measure: Number of Participants With Adherence to Therapy
timeFrame: At Year 1, Year 2 and Year 3
measure: Change From Baseline (BL) in Lipid Laboratory Values
timeFrame: At Year 1, Year 2 and Year 3
measure: Change in Treatment Satisfaction
timeFrame: At Year 1, Year 2 and Year 3
measure: Change in Symptom Distress
timeFrame: At Year 1, Year 2 and Year 3
measure: Number of Participants by Reasons for Therapy Switch to JULUCA
timeFrame: At Baseline (Day 1)
Other outcomes:
Locations:
city: Aachen
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: Berlin
country: Germany
facility: GSK Investigational Site
city: Bochum
country: Germany
facility: GSK Investigational Site
city: Chemnitz
country: Germany
facility: GSK Investigational Site
city: Essen
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: Koeln
country: Germany
facility: GSK Investigational Site
city: Muenchen
country: Germany
facility: GSK Investigational Site
city: Muenchen
country: Germany
facility: GSK Investigational Site
city: Muenchen
country: Germany
facility: GSK Investigational Site
city: Muenchen
country: Germany
facility: GSK Investigational Site
city: Muenchen
country: Germany
facility: GSK Investigational Site
city: Muenster
country: Germany
facility: GSK Investigational Site
city: Osnabrueck
country: Germany
facility: GSK Investigational Site
city: Tuebingen
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: