Status:
RECRUITING
Implementation and Deliver of Lenacapavir for PrEP in a Community Pharmacy Setting
Lead Sponsor:
Kelley-Ross & Associates, Inc.
Collaborating Sponsors:
Gilead Sciences
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is an open-label, single center study to evaluate implementation of a pharmacist-managed delivery of L4P in a community pharmacy setting and the impact of twice-yearly vs. quarterly PrEP visits o...
Detailed Description
This is a prospective observational study enrolling 75 subjects into the cohort to report on the feasibility and acceptability of a pharmacist-managed L4P in a community pharmacy setting. The study wi...
Eligibility Criteria
Inclusion
- 18 years of age or older at the time of screening
- weight greater than or equal to 35kg
- HIV-negative status
- Willing to provide informed consent and undergo all required study procedures
Exclusion
- Unknown or positive HIV status
- Coadministration of drugs that significantly decreases lenacapavir concentrations according to the FDA package insert
- Any participant that do not meet criteria for management under the CDTA
Key Trial Info
Start Date :
September 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT07210125
Start Date
September 16 2025
End Date
June 30 2027
Last Update
October 7 2025
Active Locations (1)
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1
Kelley-Ross Pharmacy
Seattle, Washington, United States, 98122