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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
Assessment method [1] 0 0
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.
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
Assessment method [1] 0 0
VS was defined as HIV-RNA \<50 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. 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 \>=200 c/mL.
Timepoint [1] 0 0
At Year 1 and Year 2
Secondary outcome [2] 0 0
Number of Participants With Low Level Viremia
Assessment method [2] 0 0
Low level viremia was defined as a VL greater than (\>) 50 to \<200 c/mL.
Timepoint [2] 0 0
At Year 1, Year 2 and Year 3
Secondary outcome [3] 0 0
Number of Participants With Virologic Rebound
Assessment method [3] 0 0
Virologic rebound was defined as two consecutive VL measurements of \>=200 c/mL.
Timepoint [3] 0 0
At Year 1, Year 2 and Year 3
Secondary outcome [4] 0 0
Number of Participants With Treatment Switch
Assessment method [4] 0 0
The treatment switch could have been due to virologic failure (VF) or due to intolerability and last observation carried forward (LOCF) as determined at the discretion of the physician.
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
Assessment method [5] 0 0
The HIV monitoring measures included were defined as HIV-RNA measurements, normalized to participant years.
Timepoint [5] 0 0
Up to Year 3
Secondary outcome [6] 0 0
Number of Participants With Serious Adverse Events (SAEs)
Assessment method [6] 0 0
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal investigational product, whether or not related to the medicinal investigational product. A SAEs was defined as any adverse event meeting the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a congenital anomaly in the off-spring of a participant, was medically significant or could have required intervention to prevent the previously stated outcomes.
Timepoint [6] 0 0
Up to Year 3
Secondary outcome [7] 0 0
Number of Participants With Adverse Drug Reactions (ADRs)
Assessment method [7] 0 0
An ADR was 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.
Timepoint [7] 0 0
Up to Year 3
Secondary outcome [8] 0 0
Number of Participants With Adherence to Therapy
Assessment method [8] 0 0
Adherence to therapy refers to the missed monthly doses. At each follow-up visit, participants were asked to give an estimation of their level of adherence to their antiretroviral therapy (ART).
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
Assessment method [9] 0 0
To assess the impact on the lipid metabolism, changes in the following parameters were analyzed: total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides.
Timepoint [9] 0 0
At Year 1, Year 2 and Year 3
Secondary outcome [10] 0 0
Change in Treatment Satisfaction
Assessment method [10] 0 0
The change in HIV treatment satisfaction was assessed with the help of the HIV Treatment Satisfaction questionnaire (HIVTSQs), which is a 10-item-self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility, etc. HIV TSQs total score: unweighted sum of 10 items of the HIV TSQs (range: 0-60; with higher scores indicating greater treatment satisfaction).
Timepoint [10] 0 0
At Year 1, Year 2 and Year 3
Secondary outcome [11] 0 0
Change in Symptom Distress
Assessment method [11] 0 0
The change in HIV symptom distress was assessed with the help of the HIV Symptom Distress Module (SDM); which is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. SDM total score: unweighted sum of the 20 items (using a 5-point scale, ranging from 0-4), ranging from 0 to 80. Higher scores indicate higher degrees of 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
Assessment method [12] 0 0
The primary and secondary reasons for therapy switch were presented.
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
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
MUC Research GmbH
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

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

Data sharing statement


What supporting documents are/will be available?



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03518060