NCT06786520

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Cabotegravir Ultra Long-acting (CAB ULA) Following Switch From Cabotegravir Long-acting (CAB LA) in Healthy Adults

A Phase 1 Single Arm, Repeat Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Switching to Cabotegravir Ultra Long-acting From Cabotegravir Long-acting in Healthy Adult Volunteers

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study will assess the pharmacokinetics (PK), safety, and tolerability of CAB ULA administered every 4 months (Q4M) following administration of CAB LA every 2 months (Q2M), in healthy adult volunteers.

Detailed description

The participants in the study will receive CAB LA in the CAB LA phase and CAB ULA in the CAB ULA phase.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	CAB LA	CAB LA injection will be administered
DRUG	CAB ULA	CAB ULA injection will be administered

Timeline

• Start date: 2025-01-17
• Primary completion: 2027-03-09
• Completion: 2027-11-08
• First posted: 2025-01-22
• Last updated: 2025-06-19

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study