Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000105741
Ethics application status
Approved
Date submitted
24/12/2021
Date registered
24/01/2022
Date last updated
15/08/2023
Date data sharing statement initially provided
24/01/2022
Date results information initially provided
15/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Injectable antiretroviral therapy feasibility study: JABS
Scientific title
Feasibility and effectiveness of long acting cabotegravir and rilpivirine for treatment of HIV infection in patients with complex needs.
Secondary ID [1] 306095 0
Nil Known
Universal Trial Number (UTN)
U1111-1272-7146
Trial acronym
JABS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV infection. 324759 0
Condition category
Condition code
Infection 322212 322212 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Open label, single arm interventional clinical trial of long acting cabotegravir 600mg and long acting rilpivirine 900mg administered by intramuscular injections every two months for a total of 12 months in subjects on standard of care oral regimens, including those with complex medical and social vulnerability factors. Adherence with treatment will be monitored using records of clinic attendance and administration of injections.
Intervention code [1] 322507 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329975 0
Adherence to long acting therapy, as assessed by records of clinic attendance and administration of injections by study staff.
Timepoint [1] 329975 0
48 weeks after revision to long acting therapy
Secondary outcome [1] 404492 0
Tolerability and safety of long acting therapy. This will be assessed by staff grading of injection site reactions and recording any adverse events. All adverse events will be graded using Common Terminology Criteria version 5 (CTCAE V 5.0).
Timepoint [1] 404492 0
At months 1, 2, 4, 6, 8, 10 and 12 after revision to long acting therapy
Secondary outcome [2] 404493 0
Satisfaction with long acting therapy, as assessed by a study specific questionnaire
Timepoint [2] 404493 0
At month 6 and 12 after revision to long acting therapy

Eligibility
Key inclusion criteria
• Aged 18 years or older at the time of signing the informed consent.
• Have HIV infection treated with a standard combination antiretroviral regimen for at least 6 months prior to screening.
• Documented evidence of at least one plasma HIV-1 RNA measurement <40 cps/mL in the 24 weeks prior to screening and within 4 weeks of enrolment.
• A female participant with reproductive potential but using acceptable forms of contraception is eligible to participate

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the investigators, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
• Any condition which, in the opinion of the investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to receive study medication.
• History or presence of allergy or intolerance to the study drugs or their components or drugs of their class.
• Current or anticipated need for chronic anti-coagulation or hereditary coagulation and platelet disorders such as haemophilia or Von Willebrand Disease.
• Any past history of virological failure on NNRTI or Integrase inhibitor therapy with or without documentation of any major known Integrase inhibitor (and L74I) or NNRTI resistance-associated mutation including K103N by any historical resistance test result.
• ALT >=5 × Upper Limit Normal (ULN) or ALT >=3xULN and bilirubin >=1.5xULN (with >35% direct bilirubin) over the last 6 months.
• Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening phase to verify a result.
• Participant has estimated creatinine clearance <50 mL/min/1.73meter^2 via the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The study size reflects the most feasible size that will ensure an adequate number of patients reflecting the diversity of background medical and social needs, and a distribution of HIV complexity scales.

The measures of adherence over all visits for each of 60 patients will be the primary outcome measures. The precision of the estimate of non-adherence will be an indicator of power, depending on rate of non-adherence. For example,
Assuming 10% non-adherence then the 95%CI in a n=60 sample is: 3.76% to 20.51%
At 5% non-adherence rate, the 95% CI around the 5% would be 1.04% to 13.92%
At 0% non-adherence, then for the one sided CI (97.5% - upper limit only) – is 0 to 5.96%

Descriptive statistics of, safety parameters including ISRs, reasons for withdrawal, numbers of re-scheduled injections, numbers of treatment breaks requiring oral bridging, numbers of visits for non-study related care or social support, will be provided including 95% confidence intervals for primary and secondary endpoints, as appropriate.

Exploratory univariate and multivariate regression analyses will be undertaken to assess the association(s) between primary and secondary endpoints including responses to the satisfaction surveys (as outcomes) and potentially predictive factors such as patients’ composite complexity rating, individual complexity factors, demographic, social and other baseline characteristics.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/01/2022
Actual
10/02/2022
Date of last participant enrolment
Anticipated
29/04/2022
Actual
10/06/2022
Date of last data collection
Anticipated
28/04/2023
Actual
25/05/2023
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 21392 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 36282 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 310439 0
Commercial sector/Industry
Name [1] 310439 0
ViiV Healthcare
Country [1] 310439 0
United Kingdom
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Contact : A/Professor Mina John
Department of Immunology
Royal Perth Hospital
Level 2, North Block, Wellington Street
Perth, Western Australia 6000
Australia
Country
Australia
Secondary sponsor category [1] 311592 0
None
Name [1] 311592 0
Address [1] 311592 0
Country [1] 311592 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310078 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 310078 0
Royal Perth Hospital
197 Wellington street
Perth WA, 6000
Australia
Ethics committee country [1] 310078 0
Australia
Date submitted for ethics approval [1] 310078 0
29/10/2021
Approval date [1] 310078 0
02/11/2021
Ethics approval number [1] 310078 0
RGS0000004857

Summary
Brief summary
This is a single-arm, open-label study to evaluate the feasibility and effectiveness of long acting antiretroviral therapy in a "real world" setting, with inclusion of patients with complex social and medical needs and who have been under-represented in randomised clinical trials. Standard assessments of virological suppression and tolerability will be carried out however the study will primarily assess adherence to injections, qualitative aspects of the patient experience and satisfaction with injections as long-term therapy by both patients and providers, compared with patients' previously prescribed oral regimens. The study will also aim to describe the operational changes in clinical service required to deliver LA therapy and the patient and health-service characteristics associated with best outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116402 0
A/Prof Mina John
Address 116402 0
Department of Clinical Immunology
Level 2, North Block
Royal Perth Hospital
Wellington Street, Perth, WA 6000
Australia
Country 116402 0
Australia
Phone 116402 0
+61 08 9224 1154
Fax 116402 0
Email 116402 0
Mina.John@health.wa.gov.au
Contact person for public queries
Name 116403 0
A/Prof Mina John
Address 116403 0
Department of Clinical Immunology
Level 2, North Block
Royal Perth Hospital
Wellington Street, Perth, WA 6000
Australia
Country 116403 0
Australia
Phone 116403 0
+61 08 9224 1154
Fax 116403 0
Email 116403 0
Mina.John@health.wa.gov.au
Contact person for scientific queries
Name 116404 0
A/Prof Mina John
Address 116404 0
Department of Clinical Immunology
Level 2, North Block
Royal Perth Hospital
Wellington Street, Perth, WA 6000
Australia
Country 116404 0
Australia
Phone 116404 0
+61 08 9224 1154
Fax 116404 0
Email 116404 0
Mina.John@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD sharing not part of IRB approval


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Conference posterNo M. John , L. Williams , G. Nolan , M. Bonnet , A. ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIReal-world use of long-acting cabotegravir and rilpivirine: 12-month results of the inJectable Antiretroviral therapy feasiBility Study (JABS)2024https://doi.org/10.1111/hiv.13647
N.B. These documents automatically identified may not have been verified by the study sponsor.