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AzTrials

HIV InfectionsPhase 2EMBRACENCT05996471

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)

A Phase 2 study testing VH3810109, Cabotegravir and rHuPH20 in people with HIV Infections, run by ViiV Healthcare at 45 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
HIV Infections
What is being tested?
VH3810109, Cabotegravir and rHuPH20
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
185 participants
Where
45 sitesin 2 countries
Study dates
17 Aug 2023to 9 Nov 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 33Show fewer
  • 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
  • Documented evidence of at least two plasma HIV-1 RNA measurements <50 c/mL in the 12 months prior to Screening: one within the 6 to 12-month window, and one within 6 months prior to Screening;
  • Plasma HIV-1 RNA <50 c/mL at Screening;
  • Screening CD4+ T-cell count ≥350 cells/mm3:
  • Weight
  • Body weight >=50 kg to <=115 kg.
  • Sex
  • Male and/or female Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies, assuring minimal contraception requirements noted below.
  • All participants participating in the study should be counselled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g. male condom) and on the risk of HIV transmission to an uninfected partner.
  • Participants who are female at birth are eligible to participate if at least one of the following conditions applies:
  • Not pregnant or breastfeeding and at least one of the following conditions applies:
  • Is not a participant of childbearing potential (POCBP). OR
  • Is a POCBP and using an acceptable contraceptive method during the intervention period (at a minimum until after the last dose of study intervention). The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
  • A POCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) on Day 1, prior to the first dose of study intervention.
  • If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
  • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.
  • QTc 8. QTc Interval <450 msec.
  • Phenotypic Sensitivity 9. Viral phenotypic sensitivity to VH3810109 based on IC90 of <=2 ug/mL and a Maximum Percent Inhibition >98% using the Monogram PhenoSense mAb Assay on sample obtained at a screening visit.
  • Informed Consent 10. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Who cannot join

  • 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
Show all 45Show fewer
  • 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
  • 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
  • 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.
  • Participants with hepatitis C co-infection
  • Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
  • Participants who in the investigator's judgment, pose a significant suicidality risk
  • Contraindications, as per the current Prescribing Information for cabotegravir.
  • Previous hypersensitivity reaction to cabotegravir or
  • 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.
  • Previous exposure to cabotegravir.
  • Treatment with any of the following agents within 60 days of screening:
  • -radiation therapy;
  • cytotoxic chemotherapeutic agents;
  • any systemic immune suppressant.
  • 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.
  • Current or anticipated need for chronic anti-coagulants.
  • 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.

Trial locations and contacts

45 sites in 2 countries.

45 sites in 2 countries

United States43 sites

  • GSK Investigational Site

    Albuquerque, New Mexico, 87109

  • GSK Investigational Site

    Austin, Texas, 78705-3326

  • GSK Investigational Site

    Bakersfield, California, 93309

  • GSK Investigational Site

    Birmingham, Alabama, 35222

  • GSK Investigational Site

    Boston, Massachusetts, 02115

  • GSK Investigational Site

    Chicago, Illinois, 60611-2826

  • GSK Investigational Site

    Cincinnati, Ohio, 45267

  • GSK Investigational Site

    Columbia, Missouri, 65212

  • GSK Investigational Site

    Dallas, Texas, 75246-2004

  • GSK Investigational Site

    Decatur, Georgia, 30033

  • GSK Investigational Site

    El Paso, Texas, 79902

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33308

  • GSK Investigational Site

    Ft. Pierce, Florida, 34982-7148

  • GSK Investigational Site

    Greensboro, North Carolina, 27401-1209

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Houston, Texas, 77098

  • GSK Investigational Site

    Los Angeles, California, 90027

  • GSK Investigational Site

    Los Angeles, California, 90069

  • GSK Investigational Site

    Manhasset, New York, 11030

  • GSK Investigational Site

    Miami, Florida, 33133

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53226-3548

  • GSK Investigational Site

    Nashville, Tennessee, 37208

  • GSK Investigational Site

    New Haven, Connecticut, 06510

  • GSK Investigational Site

    New York, New York, 10029

  • GSK Investigational Site

    New York, New York, 10032

  • GSK Investigational Site

    Newark, New Jersey, 07102

  • GSK Investigational Site

    Orlando, Florida, 32803-1851

  • GSK Investigational Site

    Palm Springs, California, 92262

  • GSK Investigational Site

    Pensacola, Florida, 32503

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104

  • GSK Investigational Site

    Portland, Oregon, 97239-3011

  • GSK Investigational Site

    Sacramento, California, 95825-2115

  • GSK Investigational Site

    San Francisco, California, 94110

  • GSK Investigational Site

    Santa Fe, New Mexico, 87505-4753

  • GSK Investigational Site

    Sarasota, Florida, 34237-3116

  • GSK Investigational Site

    Southfield, Michigan, 48075

  • GSK Investigational Site

    Springfield, Massachusetts, 01105

  • GSK Investigational Site

    The Bronx, New York, 10461-1119

  • GSK Investigational Site

    The Bronx, New York, 10467

  • GSK Investigational Site

    Vero Beach, Florida, 32960-6541

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20007-2113

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20037

  • GSK Investigational Site

    West Palm Beach, Florida, 33409

Other trials in United States

Puerto Rico2 sites

  • GSK Investigational Site

    San Juan, 00909

  • GSK Investigational Site

    San Juan, 909

Other trials in Puerto Rico

About this study

Official title: A Phase 2b Multicenter, Randomized, Open-Label Study Comparing the Efficacy, Safety, PK, and Tolerability of VH3810109, Administered Either Intravenously Or As A Subcutaneous Infusion With rHuPH20, in Combination With CAB LA to Standard of Care in Virologically Suppressed Adults Living With HIV

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
Being tested
VH3810109, Cabotegravir, Standard of care (SOC), rHuPH20
Keywords
VH3810109, Cabotegravir, Standard of care, HIV, Long acting, Virologically Suppressed
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VH3810109Biological

    VH3810109 will be administered.

  • CabotegravirDrug

    Cabotegravir will be administered.

  • Standard of care (SOC)Drug

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

  • rHuPH20Biological

    rHuPH20 will be administered.

Study groups in NCT05996471
Study groupRoleWhat they receive
Part 1A: Participants Receiving VH3810109 Formulation 1 plus CabotegravirExperimentalParticipants 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.
Receives: Biological: VH3810109; Drug: Cabotegravir
Part 1B: Participants Receiving VH3810109 plus rHuPH20 plus CabotegravirExperimentalParticipants 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.
Receives: Biological: VH3810109; Drug: Cabotegravir; Biological: rHuPH20
Part 1C: Participants Receiving SOC ARTActive comparatorParticipants in this arm will either transition to Part 2B or Part 2C or discontinue from the study.
Receives: Drug: Standard of care (SOC)
Part 2A: Participants Receiving VH3810109 Formulation 2 plus Cabotegravir Q2MExperimentalParticipants 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.
Receives: Biological: VH3810109; Drug: Cabotegravir
Part 2B: Participants Receiving VH3810109 Formulation 2 plus CabotegravirExperimentalParticipants 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.
Receives: Biological: VH3810109; Drug: Cabotegravir
Part 2C: Participants continuing SOC ARTActive comparatorParticipants in this arm will either transition to Part 3B or discontinue from the study.
Receives: Drug: Standard of care (SOC)
Part 3A: Participants continuing VH3810109 Formulation 2 plus Cabotegravir Q2MExperimentalParticipants will continue to receive VH3810109 formulation 2 intravenously (IV) and Cabotegravir intramuscularly (IM) every 2 months (Q2M).
Receives: Biological: VH3810109; Drug: Cabotegravir
Part 3B: Participants receiving VH3810109 Formulation 2 plus CabotegravirExperimentalParticipants will receive VH3810109 formulation 2 intravenously (IV) and Cabotegravir intramuscularly (IM) at Day 1, Month 1, Month 2 and then Q2M.
Receives: Biological: VH3810109; Drug: Cabotegravir

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Month 6

Secondary outcomes (18)

  1. 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)

    Measured: Up to Month 24

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

    Measured: Up to Month 24

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

    Measured: Up to Month 24

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

    Measured: Up to Month 24

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

    Measured: Up to Month 24

  6. Part 1, 2 and 3: Number of Participants with Plasma HIV-1 RNA ≥50 c/mL per Snapshot Algorithm Over Time

    Measured: Up to Month 24

  7. Part 1, 2 and 3: Number of Participants with Plasma HIV-1 RNA Less Than (<)50 c/mL per Snapshot Algorithm Over Time

    Measured: Up to Month 24

  8. Part 1, 2 and 3: Number of Participants with HIV Disease Progression

    Measured: Up to Month 24

  9. Part 1, 2 and 3: Serum Concentrations of VH3810109

    Measured: Up to Month 24

  10. Part 1, 2 and 3: Plasma Concentrations of Cabotegravir

    Measured: Up to Month 24

  11. Part 1, 2 and 3: Absolute Value for Cluster of Differentiation 4 (CD4+) T-Cell Count

    Measured: Up to Month 24

  12. Part 1, 2 and 3: Change from Baseline in CD4+ T-Cell Count

    Measured: Baseline (Day 1) and up to Month 24

  13. Part 1, 2 and 3: Absolute Value for Cluster of Differentiation 8 (CD8+) T-Cell Count

    Measured: Up to Month 24

  14. Part 1, 2 and 3: Change from Baseline in CD8+ T-Cell Count

    Measured: Baseline (Day 1) up to Month 24

  15. Part 1, 2 and 3: Number of Participants with Anti-VH3810109 Antibodies

    Measured: Up to Month 24

  16. Part 1, 2 and 3: Number of Participants with Neutralizing Antibodies Against VH3810109

    Measured: Up to Month 24

  17. Part 1, 2 and 3: Number of Participants with Treatment-emergent Genotypic Resistance

    Measured: Up to Month 24

  18. Part 1, 2 and 3: Number of Participants with Treatment-emergent Phenotypic Resistance

    Measured: Up to Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2023
  2. Study start17 Aug 2023
  3. Primary completion27 May 2026
  4. Study completion9 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
185 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05996471
Sponsor's protocol ID
209639
Acronym
EMBRACE
Status last verified
Nov 2026
First submitted
9 Aug 2023
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Publications

  • Leone PA, Losos J, Wannamaker P, D'Agostino R, Warwick-Sanders M, Ghita GL, Wilches V, Donatti C, Brown K, Gandhi Y. VH3810109 (N6LS) broadly neutralizing antibody safety, pharmacokinetics, and anti-drug antibody incidence in adults without HIV: phase 1 SPAN study results. Antimicrob Agents Chemother. 2025 Sep 3;69(9):e0025825. doi: 10.1128/aac.00258-25. Epub 2025 Jul 23.

    PubMed 40698814

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VH3810109, Cabotegravir and rHuPH20 in people with HIV Infections, run by ViiV Healthcare at 45 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05996471, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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