About this trial
This study compares the efficacy, safety and tolerability of CAB ULA and RPV ULA administered with CAB long acting (LA) and RPV LA administered in adults and adolescents with HIV who are virologically suppressed on anti-retroviral therapy (ART).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
CAB ULA
DrugCAB ULA will be administered.
RPV ULA
DrugRPV ULA will be administered.
CAB LA
DrugCAB LA will be administered.
RPV LA
DrugRPV LA will be administered.
Treatment groups
Trial outcomes
Primary outcomes
Percentage of participants with plasma HIV-RNA greater than or equal to (>=) 50 copies (c)/mL as per Food and Drug Administration (FDA) Snapshot algorithm
Secondary outcomes
Percentage of participants with plasma HIV-RNA >= 50 c/mL as per FDA Snapshot algorithm
Percentage of participants with plasma HIV-RNA less than (<) 50 c/mL as per FDA Snapshot algorithm
Percentage of participants with confirmed virologic failure (CVF)
CVF is defined as 2 consecutive HIV-1 RNA levels \>=200 c/mL.
Number of participants with drug-related adverse events (AEs) as per severity of Grade 2-5
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity is graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.
Sponsors and contacts
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