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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
564 patients around the world
Available in Argentina, Puerto Rico, United States
ViiV Healthcare
564Patients around the world
This study is for people with
Hiv
Requirements for the patient
From 12 Years
All Gender
Medical requirements
- Patient Study Participant (PSP) Inclusion criteria.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).
- Patient Study Participant (PSP) Exclusion criteria.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.
SponsorViiV Healthcare
Study typeInterventional
Conditions
Hiv
Requirements
From 12 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07650916
