HIV InfectionsPhase 1NCT06652958
A Study to Assess the Safety and Pharmacokinetics of a Human Monoclonal Antibody (VH4527079) in Healthy Adults and Persons With HIV
A Phase 1 study testing VH4527079 in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.
Trial summary
This study evaluates the safety, tolerability, and pharmacokinetics (PK) of a single dose administration of VH4527079 by subcutaneous (SC) injection or by intravenous (IV) infusion in healthy adult participants and multiple dose administration by IV infusion in healthy adult participants and in Persons with HIV (PWH). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- VH4527079
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2024to 9 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be 18 to 55 years of age inclusive at the time of signing the informed consent.
- Participants who are overtly healthy based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.
- For Cohort 9 (PWH in Arm B), well controlled HIV on first-line INSTI-based oral antiretroviral therapy without history of virologic failure (will be continued during study).
- Body weight more than or equal to (>=)50.0 kg for men and >=45.0 kg for women and Body Mass Index (BMI) within the range 18.5 to 31.0 kg/m^2.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
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- 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 apply:
- Is not a Participant of childbearing potential (POCBP). OR
- Is a POCBP and agrees to use a highly effective contraceptive method 3 weeks prior to the start of this study and during the study.
- Capable of giving signed informed consent.
- Willing to have samples stored for future research for participants in Arm B; Cohort 8 (Healthy Volunteers) and Cohort 9 (PWH in Arm B).
Who cannot join
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders, or any medical condition capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
- Weight >115.0 kg.
- Any medical condition that is not well controlled.
- Positive HIV testing for participants enrolled in Arm A and in Arm B Cohort 8.
- Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis within the 2 years prior to enrollment that has a reasonable risk of recurrence during the study.
- The participant has an underlying skin disease or disorder, piercing, or tattoos that would interfere with assessment of injection site reactions.
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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.
- Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions.
- Any condition which, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to take oral medication.
- Unstable liver disease, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease).
- Known history of cirrhosis with or without viral hepatitis co-infection.
- History of clinically relevant hepatitis within last 6 months.
- For Cohort 9 (PWH in Arm B), untreated syphilis infection (i.e., positive syphilis testing at screening) without documentation of treatment. Participants who have successfully completed treatment at least 7 days previously are eligible if recruitment is open. Positive syphilis testing at screening for any other Cohort is exclusionary.
- Lymphoma, leukemia, or any malignancy (except for breast cancer) within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Participants who poses a significant suicidality risk.
- Any pre-existing physical or mental condition which, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
- Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting surgery or percutaneous transluminal coronary angioplasty or any clinically significant cardiac disease.
- Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome or sudden cardiac death. Any significant arrhythmia or ECG finding which, will interfere with the safety for the individual participant.
- Exposure to an experimental drug, human blood product, anticoagulants, or experimental vaccine (which does not have emergency, conditional, or standard market authorization) within 30 days, or within 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 intervention or plans to receive live vaccines during the study.
- Any previous use of HIV Pre-exposure prophylaxis (PrEP) or Post-exposure prophylaxis (PEP) in Arm A (Cohorts 1 through 7) or Arm B (Cohort 8 only), either oral or parenteral, is exclusionary.
- Any previous use of Neonatal Fc receptor blockers (e.g., efgartigimod alfa-fcab).
- The participant has ever received an investigational HIV vaccine.
- Any approved or experimental non-HIV vaccination (e.g., severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Hepatitis B virus (HBV), influenza, pneumococcal polysaccharide) received within 2 weeks prior to study enrollment (Day 0).
- Exposure to an experimental drug, human blood product, or vaccine (which does not have emergency, conditional, or standard market authorization) within 28 days prior to the first dose of study treatment or plans to receive live vaccines during the study.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 56 days.
- Exposure to more than 4 new chemical entities or vaccines within 12 months prior to the first dosing day.
- Past or intended use of over-the-counter or prescription medication including herbal medications within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing.
- Participants who require concomitant medications known to be associated with a prolonged QTc.
- Participants receiving any protocol-prohibited medication(s) and who are unwilling or unable to switch to an alternate medication.
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Las Vegas, Nevada, 89113-2235
About this study
Official title: A Phase 1, Open-Label, Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VH4527079, Administered Either Intravenously or Subcutaneously to Healthy Adults and Persons With HIV
This study evaluates the safety, tolerability, and pharmacokinetics (PK) of a single dose administration of VH4527079 by subcutaneous (SC) injection or by intravenous (IV) infusion in healthy adult participants and multiple dose administration by IV infusion in healthy adult participants and in Persons with HIV (PWH).
- Conditions
- HIV Infections
- Being tested
- VH4527079
- Keywords
- Human Immunodeficiency Virus (HIV), VH4527079, Monoclonal Antibody, Safety, Pharmacokinetics (PK), Healthy Adults, Persons with HIV (PWH)
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VH4527079Biological
VH4527079 solution for injection or infusion will be administered either by SC injection or IV infusion respectively.
| Study group | Role | What they receive |
|---|---|---|
| Arm A, Cohort 1 | Experimental | Healthy adult participants receive a single dose of VH4527079 Dose 1 (lowest dose) by IV infusion. Receives: Biological: VH4527079 |
| Arm A, Cohort 2 | Experimental | Healthy adult participants receive a single dose of VH4527079 Dose 2 (low dose) by IV infusion. Receives: Biological: VH4527079 |
| Arm A, Cohort 3 | Experimental | Healthy adult participants receive a single dose of VH4527079 Dose 3 (mid-low dose) by IV infusion. Receives: Biological: VH4527079 |
| Arm A, Cohort 4 | Experimental | Healthy adult participants receive a single dose of VH4527079 Dose 4 (mid-high dose) by IV infusion. Receives: Biological: VH4527079 |
| Arm A, Cohort 5 | Experimental | Healthy adult participants receive a single dose of VH4527079 Dose 5 (high dose) by IV infusion. Receives: Biological: VH4527079 |
| Arm A, Cohort 6 | Experimental | Healthy adult participants receive a single dose of VH4527079 Dose 6 (max dose) by IV infusion. Receives: Biological: VH4527079 |
| Arm A, Cohort 7 | Experimental | Healthy adult participants receive a single dose of VH4527079 Dose 1 (lowest dose) by SC injection. Receives: Biological: VH4527079 |
| Arm B, Cohort 8 | Experimental | Healthy adult participants receive three doses of VH4527079 dose that is selected in Arm A, by IV infusion, separated by a time interval. Receives: Biological: VH4527079 |
| Arm B, Cohort 9 | Experimental | Participants with HIV receive three doses of VH4527079 dose that is selected in Arm A, by IV infusion, separated by a time interval. Receives: Biological: VH4527079 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs) of Grade 2 and above severity
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity of AEs will be assessed using Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life threatening and Grade 5=Death.
Measured: Up to Week 24 follow-up period
Area under the plasma-concentration time curve from time zero to infinity (AUC 0-inf) of VH4527079
Measured: From Day 1 Up to Week 24 follow-up period
Area under the plasma-concentration time curve from time zero to the last quantifiable concentration (AUC 0-tlast) of VH4527079
Measured: From Day 1 Up to Week 24 follow-up period
Area under the plasma-concentration time curve from defined interval between doses (AUCtau) of VH4527079
Measured: From Day 1 Up to Week 24 follow-up period
Maximum observed plasma concentration (Cmax) of VH4527079
Measured: From Day 1 Up to Week 24 follow-up period
Time to maximum observed plasma concentration (Tmax) of VH4527079
Measured: From Day 1 Up to Week 24 follow-up period
Apparent terminal half-life (t1/2) of VH4527079
Measured: From Day 1 Up to Week 24 follow-up period
Secondary outcomes (39)
AUC0-inf of VH4527079 after a single dose administered via SC route relative to IV administration
Measured: From Day 1 Up to Week 24 follow-up period
AUC0-tlast of VH4527079 after a single dose administered via SC route relative to IV administration
Measured: From Day 1 Up to Week 24 follow-up period
Cmax of VH4527079 after a single dose administered via SC route relative to IV administration
Measured: From Day 1 Up to Week 24 follow-up period
Post-baseline values for chemistry panels: Glucose (fasting), Blood Urea Nitrogen, Creatinine, Calcium, Magnesium, Potassium, Phosphate, Direct Bilirubin, Total Bilirubin & Fasting lipid panel (milligrams per deciliter)
Measured: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for chemistry panels: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per liter)
Chemistry panels included Aspartate aminotransferase (AST)/ Serum glutamic-oxalo-acetic transaminase (SGOT), Alanine aminotransferase (ALT)/ Serum glutamic-pyruvic transaminase (SGPT), Alkaline phosphatase (ALP) and Creatinine phosphokinase (CPK)
Measured: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for chemistry panels: Amylase and Lipase (fasting) (Units per Liter)
Measured: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for chemistry panels: Total Protein (Grams per deciliter)
Measured: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for chemistry panels: Sodium chloride and Bicarbonate (milliequivalents per liter)
Measured: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for hematology panels: Platelet count (cells per microliter)
Measured: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for hematology panels: Red Blood Cell (RBC) Count (million cells per microliter)
Measured: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for hematology panels: Hemoglobin (Hgb) (grams per deciliter)
Measured: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for hematology panels: Hematocrit (Proportion of red blood cells in blood)
Measured: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for hematology panels: Mean Corpuscular Volume (MCV) (Femtoliters)
Measured: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for hematology panels: Mean Corpuscular Hemoglobin (MCH) (Picograms)
Measured: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for hematology panels: Reticulocytes (Percentage of reticulocytes)
Measured: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for hematology panels: Differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per liter)
Measured: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for coagulation panels: Prothrombin time (PT) and Partial Thromboplastin Time (PTT) (Seconds)
Measured: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for coagulation panels: International normalized ratio (INR) (Ratio)
Measured: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Change from baseline values for chemistry panels: Glucose (fasting), Blood Urea Nitrogen, Creatinine, Calcium, Magnesium, Potassium, Phosphate, Direct Bilirubin, Total Bilirubin and Fasting lipid panel (milligrams per deciliter)
Measured: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for chemistry panels: AST/ SGOT, ALT/ SGPT, ALP and CPK (International Units per liter)
Measured: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for chemistry panels: Amylase and Lipase (fasting) (Units per Liter)
Measured: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for chemistry panels: Total Protein (Grams per deciliter)
Measured: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for chemistry panels: Sodium chloride and Bicarbonate (milliequivalents per liter)
Measured: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for hematology panels: Platelet count (cells per microliter)
Measured: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for hematology panels: RBC Count (million cells per microliter)
Measured: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for hematology panels: Hgb (grams per deciliter)
Measured: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for hematology panels: Hematocrit (Proportion of red blood cells in blood)
Measured: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for hematology panels: MCV (Femtoliters)
Measured: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for hematology panels: MCH (Picograms)
Measured: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for hematology panels: Reticulocytes (Percentage of reticulocytes)
Measured: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for hematology panels: Differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per liter)
Measured: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for coagulation panels: PT and PTT (Seconds)
Measured: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for coagulation panels: INR (Ratio)
Measured: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Number of participants with maximum post-baseline QT interval corrected (QTc) values compared to baseline by category
QTc values will be categorized as no change= number of participants with QTc values less than or equal to (<=)450 milliseconds (msec), any increase= number of participants with QTc values more than (>)450 - 480 msec, number of participants with QTc values >480 -500 msec, and number of participants with QTc values >500 msec
Measured: Up to Week 24 follow-up period
Number of participants with maximum post-baseline increases in QTc values compared to baseline by category
Post-baseline increase in QTc values will be categorized by number of participants with QTc value increase of <=30 msec, number of participants with QTc value increase of 31 - 60 msec, and number of participants with QTc value increase of >60 msec
Measured: Up to Week 24 follow-up period
Number of participants with worst case post-baseline values relative to potential clinical importance criteria compared to baseline for diastolic and systolic blood pressure
Number of participants with post-baseline changes will be categorized as change to low, change to within range or no change, and change to high
Measured: Up to Week 24 follow-up period
Number of participants with worst case post-baseline values relative to potential clinical importance criteria compared to baseline for pulse rate
Number of participants with post-baseline changes will be categorized as change to low, change to within range or no change, and change to high
Measured: Up to Week 24 follow-up period
Number of participants with any AEs and AEs by severity
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity of AEs will be assessed using Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life threatening and Grade 5=Death.
Measured: Up to Week 24 follow-up period
Number of participants who discontinue treatment due to AEs
Measured: Up to Week 24 follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start2 Oct 2024
- Primary completion9 Sep 2026
- Study completion9 Sep 2026
Why it stopped: Terminated for business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652958
- Sponsor's protocol ID
- 221877
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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 to https://www.viiv-studyregister.com/documents/About\_ViiV\_Patient\_Level\_Data\_Sharing\_Final\_25Sep2023.pdf
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VH4527079, Administered Either Intravenously or Subcutaneously to Healthy Adults and Persons With HIV
- ClinicalTrials.gov ID
- NCT06652958
- Acronym / sponsor ID
- 221877
- Conditions
- HIV Infections
- Keywords
- Human Immunodeficiency Virus (HIV), VH4527079, Monoclonal Antibody, Safety, Pharmacokinetics (PK), Healthy Adults, Persons with HIV (PWH)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated for business reasons
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 9 Sep 2026 (actual)
- Study completion
- 9 Sep 2026 (actual)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the safety, tolerability, and pharmacokinetics (PK) of a single dose administration of VH4527079 by subcutaneous (SC) injection or by intravenous (IV) infusion in healthy adult participants and multiple dose administration by IV infusion in healthy adult participants and in Persons with HIV (PWH).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Arm A, Cohort 1 | Experimental | Biological: VH4527079Healthy adult participants receive a single dose of VH4527079 Dose 1 (lowest dose) by IV infusion. |
| Arm A, Cohort 2 | Experimental | Biological: VH4527079Healthy adult participants receive a single dose of VH4527079 Dose 2 (low dose) by IV infusion. |
| Arm A, Cohort 3 | Experimental | Biological: VH4527079Healthy adult participants receive a single dose of VH4527079 Dose 3 (mid-low dose) by IV infusion. |
| Arm A, Cohort 4 | Experimental | Biological: VH4527079Healthy adult participants receive a single dose of VH4527079 Dose 4 (mid-high dose) by IV infusion. |
| Arm A, Cohort 5 | Experimental | Biological: VH4527079Healthy adult participants receive a single dose of VH4527079 Dose 5 (high dose) by IV infusion. |
| Arm A, Cohort 6 | Experimental | Biological: VH4527079Healthy adult participants receive a single dose of VH4527079 Dose 6 (max dose) by IV infusion. |
| Arm A, Cohort 7 | Experimental | Biological: VH4527079Healthy adult participants receive a single dose of VH4527079 Dose 1 (lowest dose) by SC injection. |
| Arm B, Cohort 8 | Experimental | Biological: VH4527079Healthy adult participants receive three doses of VH4527079 dose that is selected in Arm A, by IV infusion, separated by a time interval. |
| Arm B, Cohort 9 | Experimental | Biological: VH4527079Participants with HIV receive three doses of VH4527079 dose that is selected in Arm A, by IV infusion, separated by a time interval. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Participant must be 18 to 55 years of age inclusive at the time of signing the informed consent.
- Participants who are overtly healthy based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.
- For Cohort 9 (PWH in Arm B), well controlled HIV on first-line INSTI-based oral antiretroviral therapy without history of virologic failure (will be continued during study).
- Body weight more than or equal to (>=)50.0 kg for men and >=45.0 kg for women and Body Mass Index (BMI) within the range 18.5 to 31.0 kg/m^2.
Key exclusion criteria (29 listed)
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders, or any medical condition capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
- Weight >115.0 kg.
- Any medical condition that is not well controlled.
- Positive HIV testing for participants enrolled in Arm A and in Arm B Cohort 8.
- Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis within the 2 years prior to enrollment that has a reasonable risk of recurrence during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VH4527079VH4527079 solution for injection or infusion will be administered either by SC injection or IV infusion respectively. | Biological | Arm A, Cohort 1, Arm A, Cohort 2, Arm A, Cohort 3, Arm A, Cohort 4, Arm A, Cohort 5, Arm A, Cohort 6, Arm A, Cohort 7, Arm B, Cohort 8, Arm B, Cohort 9 |
Primary outcome
Number of participants with adverse events (AEs) of Grade 2 and above severity
Time frame: Up to Week 24 follow-up period
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity of AEs will be assessed using Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life threatening and Grade 5=Death.
Area under the plasma-concentration time curve from time zero to infinity (AUC 0-inf) of VH4527079
Time frame: From Day 1 Up to Week 24 follow-up period
Area under the plasma-concentration time curve from time zero to the last quantifiable concentration (AUC 0-tlast) of VH4527079
Time frame: From Day 1 Up to Week 24 follow-up period
Area under the plasma-concentration time curve from defined interval between doses (AUCtau) of VH4527079
Time frame: From Day 1 Up to Week 24 follow-up period
Maximum observed plasma concentration (Cmax) of VH4527079
Time frame: From Day 1 Up to Week 24 follow-up period
Time to maximum observed plasma concentration (Tmax) of VH4527079
Time frame: From Day 1 Up to Week 24 follow-up period
Apparent terminal half-life (t1/2) of VH4527079
Time frame: From Day 1 Up to Week 24 follow-up period
39 secondary outcomes
AUC0-inf of VH4527079 after a single dose administered via SC route relative to IV administration
Time frame: From Day 1 Up to Week 24 follow-up period
AUC0-tlast of VH4527079 after a single dose administered via SC route relative to IV administration
Time frame: From Day 1 Up to Week 24 follow-up period
Cmax of VH4527079 after a single dose administered via SC route relative to IV administration
Time frame: From Day 1 Up to Week 24 follow-up period
Post-baseline values for chemistry panels: Glucose (fasting), Blood Urea Nitrogen, Creatinine, Calcium, Magnesium, Potassium, Phosphate, Direct Bilirubin, Total Bilirubin & Fasting lipid panel (milligrams per deciliter)
Time frame: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for chemistry panels: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per liter)
Time frame: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for chemistry panels: Amylase and Lipase (fasting) (Units per Liter)
Time frame: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for chemistry panels: Total Protein (Grams per deciliter)
Time frame: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for chemistry panels: Sodium chloride and Bicarbonate (milliequivalents per liter)
Time frame: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for hematology panels: Platelet count (cells per microliter)
Time frame: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for hematology panels: Red Blood Cell (RBC) Count (million cells per microliter)
Time frame: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for hematology panels: Hemoglobin (Hgb) (grams per deciliter)
Time frame: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for hematology panels: Hematocrit (Proportion of red blood cells in blood)
Time frame: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for hematology panels: Mean Corpuscular Volume (MCV) (Femtoliters)
Time frame: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for hematology panels: Mean Corpuscular Hemoglobin (MCH) (Picograms)
Time frame: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for hematology panels: Reticulocytes (Percentage of reticulocytes)
Time frame: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for hematology panels: Differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per liter)
Time frame: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for coagulation panels: Prothrombin time (PT) and Partial Thromboplastin Time (PTT) (Seconds)
Time frame: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Post-baseline values for coagulation panels: International normalized ratio (INR) (Ratio)
Time frame: From Day 1 (pre-Dose 1) Up to Week 24 follow-up period
Change from baseline values for chemistry panels: Glucose (fasting), Blood Urea Nitrogen, Creatinine, Calcium, Magnesium, Potassium, Phosphate, Direct Bilirubin, Total Bilirubin and Fasting lipid panel (milligrams per deciliter)
Time frame: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for chemistry panels: AST/ SGOT, ALT/ SGPT, ALP and CPK (International Units per liter)
Time frame: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for chemistry panels: Amylase and Lipase (fasting) (Units per Liter)
Time frame: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for chemistry panels: Total Protein (Grams per deciliter)
Time frame: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for chemistry panels: Sodium chloride and Bicarbonate (milliequivalents per liter)
Time frame: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for hematology panels: Platelet count (cells per microliter)
Time frame: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for hematology panels: RBC Count (million cells per microliter)
Time frame: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for hematology panels: Hgb (grams per deciliter)
Time frame: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for hematology panels: Hematocrit (Proportion of red blood cells in blood)
Time frame: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for hematology panels: MCV (Femtoliters)
Time frame: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for hematology panels: MCH (Picograms)
Time frame: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for hematology panels: Reticulocytes (Percentage of reticulocytes)
Time frame: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for hematology panels: Differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per liter)
Time frame: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for coagulation panels: PT and PTT (Seconds)
Time frame: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Change from baseline values for coagulation panels: INR (Ratio)
Time frame: From Day 1 (pre-Dose 1) up to Week 24 follow-up period
Number of participants with maximum post-baseline QT interval corrected (QTc) values compared to baseline by category
Time frame: Up to Week 24 follow-up period
Number of participants with maximum post-baseline increases in QTc values compared to baseline by category
Time frame: Up to Week 24 follow-up period
Number of participants with worst case post-baseline values relative to potential clinical importance criteria compared to baseline for diastolic and systolic blood pressure
Time frame: Up to Week 24 follow-up period
Number of participants with worst case post-baseline values relative to potential clinical importance criteria compared to baseline for pulse rate
Time frame: Up to Week 24 follow-up period
Number of participants with any AEs and AEs by severity
Time frame: Up to Week 24 follow-up period
Number of participants who discontinue treatment due to AEs
Time frame: Up to Week 24 follow-up period
Results and safety
The study was stopped early (reason given: Terminated for business reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. 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 to https://www.viiv-studyregister.com/documents/About_ViiV_Patient_Level_Data_Sharing_Final_25Sep2023.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VH4527079 in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.
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 11 inclusion and 29 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: stopped early, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated for business reasons). Results are not available in the source record.
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?
Number of participants with adverse events (AEs) of Grade 2 and above severity (time frame: Up to Week 24 follow-up period). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.