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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03518060




Registration number
NCT03518060
Ethics application status
Date submitted
26/04/2018
Date registered
8/05/2018
Date last updated
16/10/2024

Titles & IDs
Public title
Dolutegravir/Rilpivirine, Antiretroviral Efficacy Study Using Real-world Data in Subjects With Human Immunodeficiency Virus (HIV)-1
Scientific 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
Secondary ID [1] 0 0
208982
Universal Trial Number (UTN)
Trial acronym
JUNGLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - JULUCA

Participants who received JULUCA - Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \[DTG\] / Rilpivirine \[RPV\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.


Treatment: Drugs: JULUCA
JULUCA is a combination of dolutegravir (INSTI) and rilpivirine (NNRTI).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Sustained Virologic Suppression at Year 3
Timepoint [1] 0 0
At Year 3
Secondary outcome [1] 0 0
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
Timepoint [1] 0 0
At Year 1 and Year 2
Secondary outcome [2] 0 0
Number of Participants With Low Level Viremia
Timepoint [2] 0 0
At Year 1, Year 2 and Year 3
Secondary outcome [3] 0 0
Number of Participants With Virologic Rebound
Timepoint [3] 0 0
At Year 1, Year 2 and Year 3
Secondary outcome [4] 0 0
Number of Participants With Treatment Switch
Timepoint [4] 0 0
At Year 1, Year 2 and Year 3
Secondary outcome [5] 0 0
Number of Monitoring Measures During the 3-year Follow-up
Timepoint [5] 0 0
Up to Year 3
Secondary outcome [6] 0 0
Number of Participants With Serious Adverse Events (SAEs)
Timepoint [6] 0 0
Up to Year 3
Secondary outcome [7] 0 0
Number of Participants With Adverse Drug Reactions (ADRs)
Timepoint [7] 0 0
Up to Year 3
Secondary outcome [8] 0 0
Number of Participants With Adherence to Therapy
Timepoint [8] 0 0
At Year 1, Year 2 and Year 3
Secondary outcome [9] 0 0
Change From Baseline (BL) in Lipid Laboratory Values
Timepoint [9] 0 0
At Year 1, Year 2 and Year 3
Secondary outcome [10] 0 0
Change in Treatment Satisfaction
Timepoint [10] 0 0
At Year 1, Year 2 and Year 3
Secondary outcome [11] 0 0
Change in Symptom Distress
Timepoint [11] 0 0
At Year 1, Year 2 and Year 3
Secondary outcome [12] 0 0
Number of Participants by Reasons for Therapy Switch to JULUCA
Timepoint [12] 0 0
At Baseline (Day 1)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/05/2023
Sample size
Target
Accrual to date
Final
209
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Aachen
Country [2] 0 0
Germany
State/province [2] 0 0
Berlin
Country [3] 0 0
Germany
State/province [3] 0 0
Bochum
Country [4] 0 0
Germany
State/province [4] 0 0
Chemnitz
Country [5] 0 0
Germany
State/province [5] 0 0
Essen
Country [6] 0 0
Germany
State/province [6] 0 0
Hamburg
Country [7] 0 0
Germany
State/province [7] 0 0
Koeln
Country [8] 0 0
Germany
State/province [8] 0 0
Muenchen
Country [9] 0 0
Germany
State/province [9] 0 0
Muenster
Country [10] 0 0
Germany
State/province [10] 0 0
Osnabrueck
Country [11] 0 0
Germany
State/province [11] 0 0
Tuebingen
Country [12] 0 0
Germany
State/province [12] 0 0
Weimar

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ViiV Healthcare
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
MUC Research GmbH
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03518060
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
ViiV Healthcare
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03518060