Status:
ACTIVE_NOT_RECRUITING
The Cheeky Study: A Novel Delivery System for CAB-RPV LA
Lead Sponsor:
Public Health Foundation Enterprises, Inc.
Collaborating Sponsors:
ViiV Healthcare
San Francisco Department of Public Health
Conditions:
HIV Infections
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
This is a single-arm implementation study of a novel integrated delivery model of CAB-RPV LA for transwomen living with HIV.
Detailed Description
CAB-RPV LA as a monthly injectable could address disparities in viral suppression among trans women living with HIV. This study is designed to enroll a diverse population of trans women living with HI...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Male sex at birth and gender identity other than male
- Willing and able to provide written informed consent
- HIV-infected, confirmed by laboratory testing (can be via medical record)
- Eligible to receive CAB-RPV LA per FDA-approved label
- Virologically suppressed at the last visit within the last 6 months (HIV RNA \<50 copies/ml)
- Interested in initiating CAB-RPV LA for HIV treatment and willing to receive injections at Bridge HIV
- Currently receiving HIV care by a care provider at one of the collaborating primary care clinics.
- Has a cell phone and active service
- Able to understand, read, and speak English
Exclusion
- Unable to receive gluteal injections
- Plans to move away from the site area within the next 9 months.
- History of known or suspected drug resistance that would compromise the CAB-RPV regimen
- Rilpivirine: L100I; K101E; V106I and A; V108I; E138K and A, G, Q, R; V179F and I; Y181C and I; V189I; G190E; H221Y and H/L; F227C; and M230I and L; K103N+K238T, K103N+E138G+K238T; Y188L
- Cabotegravir: Q146L; S153Y; I162M; T124A; Q148H, K; C56S; V72I; L74M; V75A; T122N; E138K; G140S; G149A; M154I; and N155H
- Prior hypersensitivity to cabotegravir or rilpivirine
- Current or expected use of any of the following medications:
- Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin
- Antimycobacterials: rifabutin, rifampin, rifapentine
- Systemic glucocorticoids: more than a single dose of dexamethasone
- Herbal: St John's Wort
- Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Key Trial Info
Start Date :
May 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05979714
Start Date
May 31 2023
End Date
December 1 2024
Last Update
August 5 2024
Active Locations (1)
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1
Bridge HIV, San Francisco Department of Public Health
San Francisco, California, United States, 94134