A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV)
- Conditions
- HIV Infections
- Interventions
- Registration Number
- NCT05996471
- Lead Sponsor
- ViiV Healthcare
- Brief Summary
The study aims at evaluating the efficacy of VH3810109, dosed in accordance with the dosing schedule as either intravenous (IV) infusion or subcutaneous (SC) infusion with recombinant hyaluronidase (rHuPH20), in combination with cabotegravir (CAB) intramuscular (IM) dosed in accordance with the dosing schedule in virologically suppressed, Antiretroviral therapy (ART)-experienced adult participants living with HIV.
VH3810109 plus rHuPH20 plus Cabotegravir arm of the study has been discontinued based on preliminary results.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 135
Not provided
Medical conditions:
• Participants who are pregnant, breastfeeding, plan to become pregnant or breastfeed during the study
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Participants having skin disease or disorder (i.e. infection, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria) or tattoo overlying potential injection sites which may interfere with interpretation of injection site reactions or administration of VH3810109 or CAB
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Participant has a gluteal implant/enhancement (including fillers) overlying the gluteus area or any other area which may significantly interfere with interpretation of injection site reactions
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Participants with known history of cirrhosis with or without viral hepatitis co-infection
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Participants with ongoing or clinically relevant pancreatitis
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Untreated syphilis infection (positive rapid plasma reagin (RPR) at screening) without documentation of treatment. Participants who are at least 7 days post completed treatment are eligible if recruitment is open
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Prior receipt of licensed or investigational HIV monoclonal antibody
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Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease except cutaneous Kaposi's sarcoma not requiring systemic therapy. Historical or current CD4 cell counts less than 200 cells/mm^3 are not exclusionary
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History of sensitivity to any of the study medications or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation
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Any condition which, in the opinion of the investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs, cART or render the participant unable to take oral medication
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Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
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Previous exposure to cabotegravir
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Participant enrolled in a prior or concurrent clinical study that includes a drug intervention within the last 30 days
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Participants with ongoing chronic hepatitis B virus infection
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Participants with hepatitis C co-infection
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Participants who in the investigator's judgment, pose a significant suicidality risk
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Contraindications, as per the current Prescribing Information for cabotegravir.
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Previous hypersensitivity reaction to cabotegravir or
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Contraindicated co-administered drugs:
- Anticonvulsants: Carbamazepine, oxcarbazepine, phenobarbital, phenytoin
- Antimycobacterials: Rifabutin, rifampin, rifapentine
- Glucocorticoid (systemic): Dexamethasone (more than a single-dose treatment)
- Herbal product: St John's wort (Hypericum perforatum)
Prior/Concomitant Therapy:
• Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
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Previous exposure to cabotegravir.
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Treatment with any of the following agents within 60 days of screening:
-radiation therapy;
-cytotoxic chemotherapeutic agents;
-any systemic immune suppressant.
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Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of study medication.
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Current or anticipated need for chronic anti-coagulants.
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Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication.
Prior/Concurrent Clinical Study Experience • Participant enrolled in a prior or concurrent clinical study that includes a drug intervention within the last 30 days.
Diagnostic Assessments
• Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participants inclusion in the study of an investigational compound.
• Any evidence of viral resistance based on the presence of any major cabotegravir resistance-associated mutation [IAS-USA, 2022] in any historic resistance test result.
• Any verified Grade 4 laboratory abnormality with the exception of Grade 4 triglycerides or lipid abnormalities. A single repeat test is allowed during the Screening period to verify a result.
• Alanine aminotransferase (ALT) >=3 times the upper limit of normal (ULN)
- Creatinine clearance of <50 mL/min/1.73 m^2 via using the refitted, race-neutral Chronic Kidney Disease Epidemiology Collaboration (CKD-EPIcr_R) method.
- PT >=Grade 2 (>=1.25 ULN). A single repeat test is allowed during the Screening period to verify a result.
Other Exclusion Criteria
• To assess any potential impact on participant eligibility with regard to safety, the investigator must refer to the IB and supplements, approved product labels, and/or local prescribing information for detailed information regarding warnings, precautions, contraindications, AEs, drug interactions, and other significant data pertaining to the study drugs.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Participants Receiving VH3810109 plus Cabotegravir VH3810109 Participants will receive VH3810109 intravenously (IV) and Cabotegravir intramuscularly (IM). Participants Receiving VH3810109 plus Cabotegravir Cabotegravir Participants will receive VH3810109 intravenously (IV) and Cabotegravir intramuscularly (IM). Participants Receiving VH3810109 plus rHuPH20 plus Cabotegravir VH3810109 Participants will receive VH3810109 plus rHuPH20 via subcutaneous (SC) infusion and Cabotegravir IM. This arm was discontinued following preliminary results. Participants from this arm will either transition to the VH3810109 Plus Cabotegravir arm at the next dosing visit or withdraw from the Investigational Product (IP) and enter the long-term follow up period. Participants Receiving VH3810109 plus rHuPH20 plus Cabotegravir Cabotegravir Participants will receive VH3810109 plus rHuPH20 via subcutaneous (SC) infusion and Cabotegravir IM. This arm was discontinued following preliminary results. Participants from this arm will either transition to the VH3810109 Plus Cabotegravir arm at the next dosing visit or withdraw from the Investigational Product (IP) and enter the long-term follow up period. Participants Receiving VH3810109 plus rHuPH20 plus Cabotegravir rHuPH20 Participants will receive VH3810109 plus rHuPH20 via subcutaneous (SC) infusion and Cabotegravir IM. This arm was discontinued following preliminary results. Participants from this arm will either transition to the VH3810109 Plus Cabotegravir arm at the next dosing visit or withdraw from the Investigational Product (IP) and enter the long-term follow up period. Participants Receiving Standard of Care (SOC) Antiretroviral Therapy (ART) Standard of care (SOC) -
- Primary Outcome Measures
Name Time Method Number of Participants with Plasma HIV-1 Ribonucleic acid (RNA) Greater Than or Equal to (≥)50 Copies per Millilitre (c/mL) per Snapshot Algorithm at Month 6 Month 6
- Secondary Outcome Measures
Name Time Method Number of Participants with Serious Adverse Events (SAEs), Deaths, and Adverse Events (AEs) Leading to Discontinuation of Investigational Product (IP) Up to Month 24 Number of Participants with Plasma HIV-1 RNA Less Than (<)50 c/mL per Snapshot Algorithm Over Time Up to Month 24 Number of Participants with Grade 3-4 AEs Up to Month 24 Number of Participants with Grade 3-4 Laboratory Abnormalities Up to Month 24 Number of Participants with Grade 1-4 Injection/infusion Site Reactions Up to Month 24 Number of Participants with HIV Disease Progression Up to Month 24 Absolute Value for Cluster of Differentiation 8 (CD8+) T-Cell Count Up to Month 24 Number of Participants with Treatment-emergent Genotypic Resistance Up to Month 24 Number of Participants with Treatment-emergent Phenotypic Resistance Up to Month 24 Number of Participants Meeting Confirmed Virologic Failure (CVF) Criteria Through Month 24 Up to Month 24 Number of Participants with Plasma HIV-1 RNA ≥50 c/mL per Snapshot Algorithm Over Time Up to Month 24 Change From Baseline in CD4+ T-Cell Count Baseline (Day 1) and up to Month 24 Change From Baseline in CD8+ T-Cell Count Baseline (Day 1) up to Month 24 Number of Participants with Neutralizing Antibodies Against VH3810109 Up to Month 24 Serum Concentrations of VH3810109 Up to Month 24 Plasma Concentrations of Cabotegravir Up to Month 24 Absolute Value for Cluster of Differentiation 4 (CD4+) T-Cell Count Up to Month 24 Number of Participants with Anti-VH3810109 Antibodies Up to Month 24
Trial Locations
- Locations (1)
GSK Investigational Site
🇵🇷San Juan, Puerto Rico