Status:
NOT_YET_RECRUITING
Chemsex Health Evaluation With Extended Release System for HIV Treatment
Lead Sponsor:
Clinique Médicale L'Actuel
Collaborating Sponsors:
ViiV Healthcare
Conditions:
HIV
Eligibility:
MALE
18-99 years
Brief Summary
CHEERS is an observational cohort for people living with HIV who are actively practicing chemsex and who are switching to CAB + RPV LA after being virologically suppressed on a stable oral ART regimen...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Man, trans-woman or gender diverse person who was assigned male at birth and is over 18 y.o.
- Actively practices chemsex, as assessed by self-reported use of substances (methamphetamine, GHB/GBL, ketamine and mephedrone) as a mean of prolonging sexual relations, intensifying sexual pleasure and/or exploring one's sexual subjectivity at least once in the last month prior to screening\*.
- Living with HIV-1 and virologically suppressed (plasma HIV RNA \< 50 c/ml) on stable oral ART regimen for at least one month prior to screening.
- Not currently receiving psychosocial support, either on site or outside of the clinic, as evaluated by an absence of self- reported psychosocial consultation in the last 3 months prior to screening.
- Participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
- Participant is able to locally source Cabenuva, as this product is not provided in the context of this study.
- If a patient only tried it once and it occurred in the last month prior to screening, we will consider that they meet the inclusion criteria, although we will focus on enrolling patients with a documented history of regular substance use, as pre-identified by chart review.
- Exclusion Criteria
- History or presence of allergy, resistance or intolerance to Cabotegravir or Rilpivirine, or drugs of their class.
- Exposure to an experimental drug or experimental vaccine within 30 days prior to first dose of study treatment.
- Alanine aminotransferase (ALT) 5 times the upper limit of normal (ULN); or ALT 3xULN and bilirubin 1.5xULN (with \>35% direct bilirubin).
- Participant has estimated creatine clearance \<30mL/min per 1.73 m2
- Any concomitant condition or medication prohibited by local prescribing information.
- Any condition judged by the investigator that may interfere with the study or the patient's well being if they were being enrolled.
Exclusion
Key Trial Info
Start Date :
August 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06565013
Start Date
August 1 2024
End Date
February 1 2026
Last Update
August 21 2024
Active Locations (1)
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1
Clinique Médicale l'Actuel
Montreal, Quebec, Canada, H2L4P9