Clinical Trial

Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)

Study acronym: PALISADE
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The purpose of this study is long-term evaluation of long-acting injectable cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in eligible participants who have completed DAIDS (Division of AIDS) sponsored studies HPTN 083 and HPTN 084 and associated sub-studies. Participants will continue receiving CAB LA and be followed for new HIV diagnosis, SAEs (serious adverse events), Grade 3 and Grade 4 ISRs (injection site reactions), and AEs (adverse events) leading to withdrawal.
Protocol Amendment History 4 changes
critical Enrollment closed, study ongoing 2026-07-31
notable Enrollment reduced: 3508 -> 2996 participants 2026-07-31
notable Primary completion pushed: 2029-01-01 -> 2029-03-14 2026-07-31
minor Completion pushed: 2029-01-01 -> 2029-03-14 2026-07-31
Trial Details
NCT Number NCT06134362
Lead Sponsor ViiV Healthcare
Collaborators: GlaxoSmithKline, PPD Development, LP
Conditions HIV Infections
Enrollment 2,996 participants
Start Date 2024-05-14
Primary Completion 2029-03-14 (estimated)
Study Completion 2029-03-14 (estimated)
Updated on ClinicalTrials.gov 2026-07-30