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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
25/08/2023

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

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

Subjects receiving Juluca - Approximately 250 virologically suppressed HIV positive subjects on a stable antiretroviral regimen as indicated in local SmPC of Juluca will be included in the study. The subjects will be followed 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 subjects with sustained virologic suppression
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [1] 0 0
Number of subjects with low level viremia
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Number of subjects with VL >50 c/mL with emergent resistance mutations
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
Number of subjects with virologic rebound
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
Number of subjects with two consecutive measurements of >=200 c/mL, or treatment switch due to virological failure (VF) or due to intolerability as determined at the discretion of the physician
Timepoint [4] 0 0
Up to 3 years
Secondary outcome [5] 0 0
Number of subjects with VL <50 c/mL
Timepoint [5] 0 0
Up to 3 years
Secondary outcome [6] 0 0
Number of monitoring measures
Timepoint [6] 0 0
Up to 3 years
Secondary outcome [7] 0 0
Number and frequency of serious adverse events (SAEs)
Timepoint [7] 0 0
Up to 3 years
Secondary outcome [8] 0 0
Number and frequency of adverse drug reactions (ADRs)
Timepoint [8] 0 0
Up to 3 years
Secondary outcome [9] 0 0
Adherence to therapy
Timepoint [9] 0 0
Up to 3 years

Eligibility
Key inclusion criteria
* >=18 years of age.
* Documented HIV-1 infection.
* Virologically suppressed (HIV-1 ribonucleic acid [RNA] <50 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 >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
27/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/05/2023
Sample size
Target
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ViiV Healthcare
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03518060