Improving HIV-1 Control in Africa with Long Acting Antiretrovirals (NCT05546242) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Improving HIV-1 Control in Africa with Long Acting Antiretrovirals
Kenya, South Africa, Uganda540 participantsStarted 2022-12-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 18 years of age and above
✓. HIV-1 infection confirmed in clinic records or by study team.
✓. Two consecutive HIV-1 VL \<200 copies/mL ≥3 months apart prior to randomization.
✓. On an oral regimen of 2NRTI + DTG as part of first line ART
✓. Is identified as a participant with a history of, sub-optimal ART adherence or engagement in care based on one or more of the following criteria:
✓. Documented detectable HIV-1 VL (\>1000 c/mL) on all-oral ART (EFV/NVP or DTG-based) in the prior 2 years despite being ART-experienced for
✓. History of being lost to follow-up from care (\>4 weeks elapsed since a missed scheduled clinic appointment or refill in the prior 2 years).
✓. Failed to link to HIV care despite ≥3 months elapsed since HIV diagnosis.
Exclusion criteria
✕. Not virologically suppressed (VL\<200 c/mL) for ≥3 months at the end of the screening process.
✕. Previous use, or intention to use, protease inhibitor-based ART at any time.
✕. Evidence of prior HIV-1 resistance test with NNRTI drug resistance mutations (other than K103N) and/or INSTI drug resistance mutations.
✕. Unwillingness to receive 2 injections on a 2 monthly basis.