IMPALA Study

EnrollingPhase 3b RCT

Efficacy, safety and effectiveness of injectable cabotegravir/rilpivirine in improving HIV-1 control in Sub-Saharan Africa: a pragmatic phase 3b open-label randomized controlled trial

Target Population: Virologically suppressed HIV-1 infected adults who have a history of, or are at high risk of, sub-optimal adherence to daily oral ART and/or engagement in HIV care

Study Design

Randomized, open-label, multicenter, interventional study of 160 virologically suppressed HIV-1 infected adults (18 years or older) who have a history of, or are at high risk of, sub-optimal adherence to daily oral ART and/or engagement in HIV care comparing the efficacy of switching to every 2 months (Q2M) intramuscular (IM) injection of cabotegravir (CAB) long-acting (LA) plus rilpivirine (RPV) LA compared with continuation of daily oral ART

Primary Endpoint

Proportion with HIV-1 RNA ≥50 copies/mL at Week 48

Injectable CAB/RPV LA

Every 2 months intramuscular injection

Cabotegravir 400mg + Rilpivirine 600mg IM Q2M

Continued Oral ART

Daily oral antiretroviral therapy

Current stable oral ART regimen

Study Information

Duration24 months
Participants160 adults ≥18 years

Study Sites

Kenyatta National Hospital, Kenya
Multiple African research sites
Partner institutions across Sub-Saharan Africa

Treatment Innovation

Long-acting injectable therapy
Every 2 months dosing
Improved adherence potential