None listed
Conditions
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.
Interventions
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.
Sponsors
Royal Perth Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed