Phase 3b RCTEnrolling

IMPALA Study

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.

Duration

24 months

Participants

160 adults

Dosing

Q2M inj.

Study Design

Randomized, open-label, multicenter, interventional study of 160 virologically suppressed HIV-1 infected adults (≥18 years) who have a history of, or are at high risk of, sub-optimal adherence to daily oral ART and/or engagement in HIV care. The study compares every 2-month intramuscular injection of cabotegravir long-acting plus rilpivirine LA against continuation of daily oral ART.

Primary Endpoint

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

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 — a population often excluded from traditional clinical trials.

Treatment Arms

Injectable CAB/RPV LA

Every 2 months intramuscular injection

CAB 400 mg + RPV 600 mg IM Q2M

Continued Oral ART

Daily oral antiretroviral therapy

Current stable oral ART regimen