Screening HIV in health volunteers for phase 1/2 trials

[Alexander]

I have a question about HIV testing in Phase 1/2 clinical trials. The guidance states that a negative HIV test result at screening is valid for 56 days. Why is a single test sufficient for this period, rather than repeating the test to confirm HIV status throughout the trial? Any specific concerns you have about the 56-day validity period? Thanks.

[Mike Dawe]

Hi

Please pose your question to:

https://forums.mhra.gov.uk/forumdisp...Practice-(GCP)

Kind regards

Mike