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)

NCT05996471 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 209639
• Study Type: interventional
• Target: 185
• Locations: 2 countries
• Sites: 45

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. The study will be conducted in 3 parts followed by a Long-Term Follow-up phase (LTFU).

Conditions

HIV Infections

Keywords

VH3810109; Cabotegravir; Standard of care; HIV; Long acting; Virologically Suppressed

Outcome Measures

Primary Outcomes (1)

• Part 1 and Part 2B and 2C: 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 Outcomes (18)

• Part 1, 2 and 3: Number of Participants with Serious Adverse Events (SAEs), Deaths, and Adverse Events (AEs) Leading to Discontinuation of Investigational Product (IP)

  Up to Month 24

• Part 1, 2 and 3: Number of Participants with Grade 3-4 AEs

  Up to Month 24

• Part 1, 2 and 3: Number of Participants with Grade 3-4 Laboratory Abnormalities

  Up to Month 24

• Part 1, 2 and 3: Number of Participants with Grade 1-4 Injection/infusion Site Reactions

  Up to Month 24

• Part 1, 2 and 3: Number of Participants Meeting Confirmed Virologic Failure (CVF) Criteria over time

  Up to Month 24

Study Arms (8)

Part 1A: Participants Receiving VH3810109 Formulation 1 plus Cabotegravir

EXPERIMENTAL

Participants will receive VH3810109 formulation 1 intravenously (IV) and Cabotegravir intramuscularly (IM) every month (QM). Participants from this arm will either transition to Part 2A or discontinue from the study and enter the LTFU period.

Biological: VH3810109; Drug: Cabotegravir

Part 1B: Participants Receiving VH3810109 plus rHuPH20 plus Cabotegravir

EXPERIMENTAL

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 Part 1A at the next dosing visit or withdraw from the Investigational Product (IP) and enter the LTFU.

Biological: VH3810109; Drug: Cabotegravir; Biological: rHuPH20

Part 1C: Participants Receiving SOC ART

ACTIVE COMPARATOR

Participants in this arm will either transition to Part 2B or Part 2C or discontinue from the study.

Drug: Standard of care (SOC)

Part 2A: Participants Receiving VH3810109 Formulation 2 plus Cabotegravir Q2M

EXPERIMENTAL

Participants will receive VH3810109 formulation 2 intravenously (IV) and Cabotegravir intramuscularly (IM) every 2 months (Q2M). Participants from this arm will either transition to Part 3A or discontinue from the study and enter the LTFU period.

Biological: VH3810109; Drug: Cabotegravir

Part 2B: Participants Receiving VH3810109 Formulation 2 plus Cabotegravir

EXPERIMENTAL

Participants will receive VH3810109 formulation 2 intravenously (IV) and Cabotegravir intramuscularly (IM) at Day 1, Month 1, Month 2 and then Q2M. Participants from this arm will either transition to Part 3A or discontinue from the study and enter the LTFU period.

Biological: VH3810109; Drug: Cabotegravir

Part 2C: Participants continuing SOC ART

ACTIVE COMPARATOR

Participants in this arm will either transition to Part 3B or discontinue from the study.

Drug: Standard of care (SOC)

Part 3A: Participants continuing VH3810109 Formulation 2 plus Cabotegravir Q2M

EXPERIMENTAL

Participants will continue to receive VH3810109 formulation 2 intravenously (IV) and Cabotegravir intramuscularly (IM) every 2 months (Q2M).

Biological: VH3810109; Drug: Cabotegravir

Part 3B: Participants receiving VH3810109 Formulation 2 plus Cabotegravir

EXPERIMENTAL

Participants will receive VH3810109 formulation 2 intravenously (IV) and Cabotegravir intramuscularly (IM) at Day 1, Month 1, Month 2 and then Q2M.

Biological: VH3810109; Drug: Cabotegravir

Interventions

VH3810109 BIOLOGICAL

VH3810109 will be administered.

Part 1A: Participants Receiving VH3810109 Formulation 1 plus Cabotegravir; Part 1B: Participants Receiving VH3810109 plus rHuPH20 plus Cabotegravir; Part 2A: Participants Receiving VH3810109 Formulation 2 plus Cabotegravir Q2M; Part 2B: Participants Receiving VH3810109 Formulation 2 plus Cabotegravir; Part 3A: Participants continuing VH3810109 Formulation 2 plus Cabotegravir Q2M; Part 3B: Participants receiving VH3810109 Formulation 2 plus Cabotegravir

Cabotegravir DRUG

Cabotegravir will be administered.

Part 1A: Participants Receiving VH3810109 Formulation 1 plus Cabotegravir; Part 1B: Participants Receiving VH3810109 plus rHuPH20 plus Cabotegravir; Part 2A: Participants Receiving VH3810109 Formulation 2 plus Cabotegravir Q2M; Part 2B: Participants Receiving VH3810109 Formulation 2 plus Cabotegravir; Part 3A: Participants continuing VH3810109 Formulation 2 plus Cabotegravir Q2M; Part 3B: Participants receiving VH3810109 Formulation 2 plus Cabotegravir

Standard of care (SOC) DRUG

Pre-baseline SOC antiretroviral therapy (ART) will be administered.

Part 1C: Participants Receiving SOC ART; Part 2C: Participants continuing SOC ART

rHuPH20 BIOLOGICAL

rHuPH20 will be administered.

Part 1B: Participants Receiving VH3810109 plus rHuPH20 plus Cabotegravir

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age
• Participant must be 18 to 70 years of age inclusive, at the time of signing the informed consent.
• Type of Participant and Disease Characteristics
• Must be on uninterrupted current regimen for at least 6 months prior to Screening. Any prior switch, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for treatment failure (HIV-1 RNA ≥200 c/mL).
• Acceptable stable - ARV regimens prior to Screening include at least one NRTI plus:
• INSTI
• NNRTI
• Boosted PI (or atazanavir \[ATV\] unboosted)
• Excludes current use of cabotegravir or fostemsavir
• The addition, removal, or switch of a drug(s) that has been used to treat HIV based on antiretroviral properties of the drug constitutes a change in ART with the following limited exceptions:
• Historical changes in formulations of ART drugs or booster drugs will not constitute a change in ART regimen if the data support similar exposures and efficacy, and the change must have been at least 3 months prior to Screening.
• Historical maternal perinatal use of an NRTI when given in addition to an ongoing HAART will not be considered a change in ART regimen.
• A change in dosing scheme of the same drug from twice daily to once daily will not be considered a change in ART regimen if data support similar exposures and efficacy.
• For Part 2
• Any participant who has received or is currently receiving an INSTI at the time of screening must be on their first INSTI-containing regimen and must not have used any other INSTIs previously

You may not qualify if:

• Medical conditions:
• Participants who are pregnant, breastfeeding, plan to become pregnant or breastfeed during the study
• 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
• 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
• Participants with known history of cirrhosis with or without viral hepatitis co-infection
• Participants with ongoing or clinically relevant pancreatitis
• 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
• Prior receipt of licensed or investigational HIV monoclonal antibody
• 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
• 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
• Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
• Previous exposure to cabotegravir
• Participant enrolled in a prior or concurrent clinical study that includes a drug intervention within the last 30 days
• Participants with chronic hepatitis B (HBsAg positive) infection
• Individuals who are co-infected with HIV and Hepatitis B virus (HBV) will be excluded.

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (45)

GSK Investigational Site

Birmingham, Alabama, 35222, United States

Location

GSK Investigational Site

Bakersfield, California, 93301, United States

Location

GSK Investigational Site

Los Angeles, California, 90027, United States

Location

GSK Investigational Site

Los Angeles, California, 90069, United States

Location

GSK Investigational Site

Palm Springs, California, 92262, United States

Location

GSK Investigational Site

Sacramento, California, 95825, United States

Location

GSK Investigational Site

San Francisco, California, 94110, United States

Location

GSK Investigational Site

New Haven, Connecticut, 06510, United States

Location

GSK Investigational Site

Washington D.C., District of Columbia, 20007, United States

Location

GSK Investigational Site

Washington D.C., District of Columbia, 20037, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33308, United States

Location

GSK Investigational Site

Ft. Pierce, Florida, 34982, United States

Location

GSK Investigational Site

Miami, Florida, 33133, United States

Location

GSK Investigational Site

Orlando, Florida, 32803, United States

Location

GSK Investigational Site

Pensacola, Florida, 32503, United States

Location

GSK Investigational Site

Sarasota, Florida, 34237, United States

Location

GSK Investigational Site

Vero Beach, Florida, 32960, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33409, United States

Location

GSK Investigational Site

Decatur, Georgia, 30033, United States

Location

GSK Investigational Site

Chicago, Illinois, 60611, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02115, United States

Location

GSK Investigational Site

Springfield, Massachusetts, 01105, United States

Location

GSK Investigational Site

Southfield, Michigan, 48075, United States

Location

GSK Investigational Site

Columbia, Missouri, 65212, United States

Location

GSK Investigational Site

Newark, New Jersey, 07102, United States

Location

GSK Investigational Site

Albuquerque, New Mexico, 87109, United States

Location

GSK Investigational Site

Santa Fe, New Mexico, 87505, United States

Location

GSK Investigational Site

Manhasset, New York, 11030, United States

Location

GSK Investigational Site

New York, New York, 10029, United States

Location

GSK Investigational Site

New York, New York, 10032, United States

Location

GSK Investigational Site

New York, New York, 10461, United States

Location

GSK Investigational Site

The Bronx, New York, 10467, United States

Location

GSK Investigational Site

Greensboro, North Carolina, 27401-1209, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45267, United States

Location

GSK Investigational Site

Portland, Oregon, 97239, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

GSK Investigational Site

Nashville, Tennessee, 37208, United States

Location

GSK Investigational Site

Austin, Texas, 78705, United States

Location

GSK Investigational Site

Dallas, Texas, 75246, United States

Location

GSK Investigational Site

El Paso, Texas, 79902, United States

Location

GSK Investigational Site

Houston, Texas, 77030, United States

Location

GSK Investigational Site

Houston, Texas, 77098, United States

Location

GSK Investigational Site

Watertown, Wisconsin, 53226, United States

Location

GSK Investigational Site

San Juan, 00909, Puerto Rico

Location

GSK Investigational Site

San Juan, 909, Puerto Rico

Location

MeSH Terms

Conditions

HIV Infections

Interventions

cabotegravir; Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 18, 2023
• Study Start: August 17, 2023
• Primary Completion (Estimated): May 22, 2026
• Study Completion (Estimated): November 9, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

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 terminated asset(s) 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.

Locations

PR (2); US (43)