Feasibility and effectiveness of long acting cabotegravir and rilpivirine for treatment of HIV infection in patients with complex needs.

Royal Perth Hospital0 个研究点目标入组 60 人开始时间: 2022年1月24日最近更新: 2023年8月21日

适应症

试验速览

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•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

•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.

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