A Study to Investigate Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA) in Adults and Adolescents With HIV Who Are Virologically Suppressed
Adults and adolescents with HIV-1 infection aged 12 years or older with a weight \>35 kg.
Documented HIV-1 RNA measurements \<50 copies/mL in the 12 months prior to Screening.
HIV-1 RNA \<50 copies/mL at screening assessment.
Must be on current daily oral antiretroviral regimen for at least 6 months uninterrupted prior to Screening.
Any prior switch in therapy must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for virologic treatment failure (HIV-1 RNA ≥200 copies/mL).
You may not be if
Any evidence of primary resistance based on the presence of any major known INSTI (including CAB) or NNRTI (including RPV) resistance-associated mutation.
Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening.
Any history of receiving long-acting therapy for HIV.
Previous exposure to CAB and/or RPV for treatment or prevention of HIV-1 infection.
Significant uncontrolled or clinically relevant comorbidities (e.g., cardiovascular, hepatic, renal, neurological, psychiatric) that may impact safety or study participation.
Clareo Health | A Study to Investigate Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA) in Adults and Adolescents With HIV Who Are Virologically Suppressed
