Consider Gilead’s new US-based PrEP trial

[+ SirBillybob]

There may still be room in the N=300 Phase 3 single enrolment arm once yearly long-acting Lenacapavir intramuscular injection pharmacokinetics/ safety/ tolerability study. PURPOSE365 that follows the five twice-yearly subQ injection completed or ongoing trials where effectiveness is already established.

It is anticipated that there will likely be no breakthrough infection due to the very low incidence among vastly larger cohorts for the semi-annual formulation.  No oral PrEP comparator arm this time. Emphasis on blood levels and assessing adequate protective drug concentration during tail phases (the time period nearing 365-day finish lines). Everybody will receive the product and in extension phase I think it’s coverage for this extremely expensive PrEP product for up to 3 years, though the details of eligibility for extension seem ambiguous. Status is “recruiting” unless there has been a delay in closure status delineation.

A few dozen research subjects have received a single dose without problematic issues in a small dose-level trial.

You can be taking PrEP currently but there would be a washout period. You cannot have taken LEN oral or subcutaneous. You can (or should if that’s your perspective) use condoms as is encouraged in all of these trials. Such a measure does not undermine the study goals because sample power requirements for efficacy computations are not relevant. 

I have set up the appended brief video to scroll through the locations.

 

Edited yesterday at 07:58 PM by SirBillybob

[+ nycman]

Another link to the study:

https://www.gileadclinicaltrials.com/study?nctid=NCT07047716