drugset / Trial / NCT05546242
Improving HIV-1 Control in Africa with Long Acting Antiretrovirals
Phase 3
Active not recruiting
540 enrolled
MRC/UVRI and LSHTM Uganda Research Unit
Janssen Pharmaceuticals · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
IMPALA is a randomized, open-label, multicenter, interventional study of 540 virologically suppressed HIV-1 infected adults who have a history of sub-optimal adherence to daily oral ART and/or engagement in HIV care. The study will seek to demonstrate non-inferior antiviral effectiveness of the 2-monthly long-acting injectable combination of cabotegravir/rilpivirine as compared to continuation of first line oral antiretroviral therapy.
Timeline
- Start
- 2022-12-08
- Primary completion
- 2025-04
- Completion
- 2026-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cabotegravir | Small molecule | 600 mg | Intramuscular |
| Comparator | Dolutegravir | Other / unclassified | 50 mg | Oral |
| Subject | Rilpivirine | Small molecule | 900 mg | Intramuscular |