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)

A Phase IIIB, Long-Term Follow-Up of CAB LA for Participants in HPTN 083 and HPTN 084 CAB PrEP Studies at Risk of HIV Acquisition

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,508 (estimated)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	CAB LA	Participants will receive CAB LA 600 mg via gluteal IM injection, once every 8 weeks (Q8W).

Timeline

• Start date: 2024-05-14
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2023-11-18
• Last updated: 2025-12-22

Locations

34 sites across 11 countries: Argentina, Botswana, Brazil, Eswatini, Kenya, Malawi, Peru, South Africa, Thailand, Uganda, Zimbabwe

Regulatory

• FDA-regulated drug study