NCT07650916RecruitingPhase 3
A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Cabotegravir Ultra Long-acting Plus Rilpivirine Ultra Long-acting or Cabotegravir Long-acting Plus Rilpivirine Long-acting in Adults and Adolescents With HIV Who Are Virologically Suppressed on ART
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- ViiV Healthcare
- Enrollment
- 564
- Locations
- 88
- Primary Endpoint
- 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
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
This is an open-label study.
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Arms & Interventions
CAB LA+ RPV LA
Active Comparator
Participants will receive CAB LA+RPV LA.
Intervention: CAB LA (Drug)
CAB LA+ RPV LA
Active Comparator
Participants will receive CAB LA+RPV LA.
Intervention: RPV LA (Drug)
CAB ULA+ RPV ULA
Experimental
Participants will receive CAB ULA+RPV ULA.
Intervention: CAB ULA (Drug)
CAB ULA+ RPV ULA
Experimental
Participants will receive CAB ULA+RPV ULA.
Intervention: RPV ULA (Drug)
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
Time Frame: At Month 11
Secondary Outcomes
- Percentage of participants with plasma HIV-RNA >= 50 c/mL as per FDA Snapshot algorithm(At Month 23)
- Percentage of participants with plasma HIV-RNA less than (<) 50 c/mL as per FDA Snapshot algorithm(At Month 11 and Month 23)
- Percentage of participants with confirmed virologic failure (CVF)(Up to Month 23)
- Number of participants with drug-related adverse events (AEs) as per severity of Grade 2-5(Up to Month 23)
- Number of participants with drug-related serious adverse events (SAEs)(Up to Month 23)
- Number of participants who discontinue treatment due to AEs or injection intolerability(Up to Month 23)
- Number of participants with treatment emergent genotypic or phenotypic resistance to CAB and RPV(Up to Month 23)
- Ctrough of CAB and RPV(Up to Month 23)
- Maximum concentrations post dose (Cmax) of CAB and RPV(Up to Month 23)
- Area under the curve (AUC) of CAB and RPV(Up to Month 23)
- Absolute value of CD4+ cell counts in participants(Up to Month 23)
- Change from Baseline in CD4+ cell counts in participants(At Month 23 compared to baseline (Day 1))
Investigators
Study Sites (88)
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