drugset / Trial / NCT05896748
Study to Assess the Effects of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injections Following Sub-cutaneous (SC) Administration Compared With Intramuscular (IM) Administration in Adult Participants Living With Human Immunodeficiency Virus (HIV-1) Infection in the FLAIR Study
Phase 3
Completed
94 enrolled
ViiV Healthcare
GlaxoSmithKline · collabJanssen Pharmaceuticals · collab
NaSingle-groupOpen-labelTreatment
Summary
This study will assess the pharmacokinetics, safety, tolerability, maintenance of virological suppression and patient reported outcomes for participants receiving CAB and RPV LA injections following SC administration in the anterior abdominal wall SC tissue compared with IM administration in the gluteus medius muscle in adult participants living with HIV-1 infection in the FLAIR study (NCT02938520).
Timeline
- Start
- 2022-11-08
- Primary completion
- 2023-09-14
- Completion
- 2023-09-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cabotegravir | Small molecule | 400 mg | Subcutaneous |
| Subject | Rilpivirine | Small molecule | 600 mg | Subcutaneous |