Dolutegravir/Rilpivirine, Antiretroviral Efficacy Study Using Real-world Data in Subjects With Human Immunodeficiency Virus (HIV)-1
JUNGLE
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
1 other identifier
observational
209
1 country
23
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2018
Longer than P75 for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2018
CompletedFirst Posted
Study publicly available on registry
May 8, 2018
CompletedStudy Start
First participant enrolled
June 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2023
CompletedResults Posted
Study results publicly available
October 16, 2024
CompletedOctober 16, 2024
October 1, 2024
4.9 years
April 26, 2018
May 13, 2024
October 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Sustained Virologic Suppression at Year 3
Virologic suppression (VS) was defined as HIV-RNA less than (\<) 50 copies (c)/mL for at least 6 months or, if between 50-200 c/mL with a subsequent next available measurement (within 120 days) \<50 c/mL at Year 3 follow-up. Any subsequent measurement was accepted as a consecutive measurement as long as measured no later than 120 days after the initial measurement. If no subsequent HIV-RNA measurement was performed within 120 days, this was scored as a confirmed HIV-RNA greater than or equal to (\>=)200 c/mL.
At Year 3
Secondary Outcomes (12)
Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2
At Year 1 and Year 2
Number of Participants With Low Level Viremia
At Year 1, Year 2 and Year 3
Number of Participants With Virologic Rebound
At Year 1, Year 2 and Year 3
Number of Participants With Treatment Switch
At Year 1, Year 2 and Year 3
Number of Monitoring Measures During the 3-year Follow-up
Up to Year 3
- +7 more secondary outcomes
Study Arms (1)
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.
Interventions
JULUCA is a combination of dolutegravir (INSTI) and rilpivirine (NNRTI).
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Any contraindication according to JULUCA SmPC.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ViiV Healthcarelead
- MUC Research GmbHcollaborator
Study Sites (23)
GSK Investigational Site
Aachen, 52062, Germany
GSK Investigational Site
Berlin, 10117, Germany
GSK Investigational Site
Berlin, 10243, Germany
GSK Investigational Site
Berlin, 10629, Germany
GSK Investigational Site
Berlin, 12163, Germany
GSK Investigational Site
Berlin, 14057, Germany
GSK Investigational Site
Berlin, 14059, Germany
GSK Investigational Site
Bochum, 44787, Germany
GSK Investigational Site
Chemnitz, 09111, Germany
GSK Investigational Site
Cologne, 50668, Germany
GSK Investigational Site
Cologne, 50674, Germany
GSK Investigational Site
Essen, 45122, Germany
GSK Investigational Site
Hamburg, 20146, Germany
GSK Investigational Site
Hamburg, 20246, Germany
GSK Investigational Site
München, 80331, Germany
GSK Investigational Site
München, 80335, Germany
GSK Investigational Site
München, 80336, Germany
GSK Investigational Site
München, 80801, Germany
GSK Investigational Site
München, 81675, Germany
GSK Investigational Site
Münster, 48143, Germany
GSK Investigational Site
Osnabrück, 49090, Germany
GSK Investigational Site
Tübingen, 72076, Germany
GSK Investigational Site
Weimar, 99427, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
ViiV Healthcare
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2018
First Posted
May 8, 2018
Study Start
June 25, 2018
Primary Completion
May 14, 2023
Study Completion
May 14, 2023
Last Updated
October 16, 2024
Results First Posted
October 16, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share