drugset / Trial / NCT06134362
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)
Phase 3
Recruiting
3508 enrolled
ViiV Healthcare
GlaxoSmithKline · collabPPD Development, LP · collab
NaSingle-groupOpen-labelPrevention
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.
Timeline
- Start
- 2024-05-14
- Primary completion
- 2029-01-01
- Completion
- 2029-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cabotegravir | Small molecule | 600 mg | Intramuscular |