drugset / Trial / NCT05546242

Improving HIV-1 Control in Africa With Long Acting Antiretrovirals

NCT05546242 ↗

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
2025-04-14
Completion
2026-03-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Cabotegravir Small molecule 600 mg Intramuscular
Comparator Dolutegravir Other / unclassified 50 mg Oral
Comparator Lamivudine Other / unclassified 300 mg Oral
Subject Rilpivirine Small molecule 900 mg Intramuscular
Comparator Tenofovir disoproxil fumarate Small molecule 300 mg Oral
Comparator emtricitabine Other / unclassified 200 mg Oral