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
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
2 other identifiers
interventional
564
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hiv-infections
Started Jun 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2026
CompletedFirst Posted
Study publicly available on registry
June 16, 2026
CompletedStudy Start
First participant enrolled
June 29, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 4, 2029
June 23, 2026
June 1, 2026
3.2 years
June 10, 2026
June 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
At Month 11
Secondary Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (2)
CAB ULA+ RPV ULA
EXPERIMENTALParticipants will receive CAB ULA+RPV ULA.
CAB LA+ RPV LA
ACTIVE COMPARATORParticipants will receive CAB LA+RPV LA.
Interventions
Eligibility Criteria
You may qualify if:
- 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 qualify 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ViiV Healthcarelead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This is an open-label study.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2026
First Posted
June 16, 2026
Study Start
June 29, 2026
Primary Completion (Estimated)
September 4, 2029
Study Completion (Estimated)
September 4, 2029
Last Updated
June 23, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
- Access Criteria
- Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer tohttps://www.viiv-studyregister.com/documents/About\_ViiV\_Patient\_Level\_Data\_Sharing\_Final\_25Sep2023.pdf.