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CAB ULA

Phase 3

HIV Infections | Small molecule | Infectious Disease |GSK plc|Last Updated: Aug 14, 2026

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment564

FDA Designations

No designations recorded

Clinical trial landscape

CAB ULA · 1 trial · 1 indication

Phase 3 1
NCT07650916A 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 SuppressedHIV Infections
RECRUITING564 Analytics
PHASE3RECRUITING
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
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CAB ULA+ RPV ULAEXPERIMENTALParticipants will receive CAB ULA+RPV ULA.
CAB LA+ RPV LAACTIVE_COMPARATORParticipants will receive CAB LA+RPV LA.

Interventions

NameTypeDescription
CAB ULADRUGCAB ULA will be administered.
RPV ULADRUGRPV ULA will be administered.
CAB LADRUGCAB LA will be administered.
RPV LADRUGRPV LA will be administered.
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites88

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 assess...

Countries:United StatesArgentinaAustraliaCanadaJapanMexicoPuerto RicoSpainUnited Kingdom
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Recent Changes (Last 90 Days)

LOWAug 14, 2026NCT07650916lastUpdatePostDate: changed
LOWAug 14, 2026NCT07650916lastUpdatePostDate: changed
LOWAug 3, 2026NCT07650916Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 3, 2026NCT07650916Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 23, 2026NCT07650916lastUpdatePostDate: changed
LOWJun 23, 2026NCT07650916lastUpdatePostDate: changed
LOWJun 16, 2026NCT07650916NEW_TRIAL: changed
LOWJun 16, 2026NCT07650916NEW_TRIAL: changed
LOWJun 16, 2026NCT07650916NEW_TRIAL: changed

Frequently asked questions about CAB ULA

What is CAB ULA used for?

CAB ULA, or cabotegravir ultra long-acting, is an investigational small molecule being studied for the treatment of HIV infections. It is being evaluated in combination with rilpivirine ultra long-acting (RPV ULA) in adults and adolescents with HIV who are virologically suppressed. The drug is currently in Phase 3 clinical development.

Who makes CAB ULA?

CAB ULA is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting a Phase 3 clinical trial to investigate the drug in combination with rilpivirine ultra long-acting for the treatment of HIV infections in virologically suppressed adults and adolescents.

What phase is CAB ULA in?

CAB ULA is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 3 trial is recruiting participants to evaluate the safety and efficacy of CAB ULA in combination with rilpivirine ultra long-acting for HIV treatment.

What clinical trials is CAB ULA in?

CAB ULA is being studied in a Phase 3 clinical trial with the identifier NCT07650916. This randomized, active-controlled study is investigating cabotegravir ultra long-acting plus rilpivirine ultra long-acting in adults and adolescents with HIV who are virologically suppressed. The trial is recruiting 564 participants across multiple countries including the United States, Argentina, Australia, Canada, Japan, Mexico, Puerto Rico, Spain, and the United Kingdom.

How does CAB ULA work?

CAB ULA is an integrase inhibitor, a class of antiretroviral drugs that block the HIV integrase enzyme, preventing the virus from integrating its genetic material into human DNA. This mechanism helps suppress viral replication. The drug is being studied as an ultra long-acting formulation for HIV treatment in combination with rilpivirine ultra long-acting.