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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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208982
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Universal Trial Number (UTN)
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Trial acronym
JUNGLE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV Infections
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Condition category
Condition code
Infection
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Acquired immune deficiency syndrome (AIDS / HIV)
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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).
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of subjects with sustained virologic suppression
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Assessment method [1]
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Sustained virological suppression is defined as viral load (VL) <50 copies/milliliter (c/mL) or if between 50 to 200 c/mL with a subsequent next available measurement (within 120 days) <50 c/mL at year 1, 2 and 3.
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Timepoint [1]
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Up to 3 years
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Secondary outcome [1]
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Number of subjects with low level viremia
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Assessment method [1]
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Low level viremia is defined as a VL measurement >50 to <200 c/mL. Number of subjects with low level viremia will be presented.
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Timepoint [1]
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Up to 3 years
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Secondary outcome [2]
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Number of subjects with VL >50 c/mL with emergent resistance mutations
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Assessment method [2]
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Number of subjects with VL >50 c/mL with emergent resistance mutations will be presented.
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Timepoint [2]
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Up to 3 years
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Secondary outcome [3]
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Number of subjects with virologic rebound
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Assessment method [3]
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Virologic rebound is defined as two consecutive VL measurements of >=200 c/mL. Number of subjects with virologic rebound will be presented.
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Timepoint [3]
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Up to 3 years
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Secondary outcome [4]
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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
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Assessment method [4]
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Number of subjects with two consecutive measurements of >=200 c/mL, or treatment switch due to VF or due to intolerability as determined at the discretion of the physician will be presented.
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Timepoint [4]
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Up to 3 years
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Secondary outcome [5]
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Number of subjects with VL <50 c/mL
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Assessment method [5]
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Number of subjects with VL <50 c/mL will be presented.
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Timepoint [5]
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Up to 3 years
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Secondary outcome [6]
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Number of monitoring measures
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Assessment method [6]
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Number of therapeutic monitoring measures in HIV-infected subjects will be recorded.
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Timepoint [6]
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Up to 3 years
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Secondary outcome [7]
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Number and frequency of serious adverse events (SAEs)
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Assessment method [7]
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An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.
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Timepoint [7]
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Up to 3 years
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Secondary outcome [8]
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Number and frequency of adverse drug reactions (ADRs)
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Assessment method [8]
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An ADR is defined as a noxious and unintended response to a medicinal investigational product related to any dose where at least a reasonable possibility, i.e. the relationship cannot be ruled out.
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Timepoint [8]
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Up to 3 years
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Secondary outcome [9]
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Adherence to therapy
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Assessment method [9]
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Adherence refers to missed monthly doses. At Baseline and at each Follow-up visit, subjects will be asked to give an estimation of their level of adherence to their ART.
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Timepoint [9]
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Up to 3 years
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Secondary outcome [10]
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Change in lipid laboratory values
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Assessment method [10]
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Impact on lipid metabolism will be assessed by changes in lipid laboratory values. Changes in lipid laboratory values will be recorded.
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Timepoint [10]
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Up to 3 years
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Secondary outcome [11]
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Change in treatment satisfaction based on HIV Treatment Satisfaction questionnaire (TSQ)
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Assessment method [11]
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The HIV TSQ is a 10-item-self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility, etc.
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Timepoint [11]
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Up to 3 years
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Secondary outcome [12]
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Change in symptom distress based on HIV Symptom Distress Module questionnaire
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Assessment method [12]
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HIV Symptom Distress Module (also called the HIV Symptom Index or Symptoms Impact Questionnaire) is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment.
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Timepoint [12]
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Up to 3 years
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Secondary outcome [13]
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Reason for switch to Juluca
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Assessment method [13]
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The reasons for switch to Juluca will be recorded.
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Timepoint [13]
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Baseline
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/06/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
14/05/2023
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Sample size
Target
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Accrual to date
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Final
200
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Germany
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State/province [1]
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Baden-Wuerttemberg
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Country [2]
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Germany
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State/province [2]
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Bayern
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Country [3]
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Germany
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State/province [3]
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Niedersachsen
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Country [4]
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Germany
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State/province [4]
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Nordrhein-Westfalen
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Country [5]
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Germany
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State/province [5]
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Berlin
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Country [6]
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Germany
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State/province [6]
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Chemnitz
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Country [7]
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Germany
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State/province [7]
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Hamburg
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Country [8]
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Germany
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State/province [8]
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Koeln
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Country [9]
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Germany
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State/province [9]
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Weimar
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
ViiV Healthcare
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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MUC Research GmbH
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is 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 subjects in Germany.
Approximately 250 virologically suppressed HIV positive subjects on stable antiretroviral
therapy (ART) will be included in the study at the discretion of treating physician. Eligible
subjects will be followed up for approximately 3 years and data will be collected during
routine clinical care.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03518060
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Trial related presentations / publications
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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
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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ViiV Healthcare
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03518060
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