HIV InfectionsPhase 2NCT06214052
VH4524184 Proof-of-Concept in Treatment-Naïve Adults Living With HIV-1
A Phase 2 study testing VH4524184 and Antiretroviral therapy in people with HIV Infections, run by ViiV Healthcare at 17 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, ability of VH4524184 when given alone to reduce the amount of HIV (viral load) in people with HIV-1 infection who have never received antiretroviral therapy (treatment-naïve). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- VH4524184 and Antiretroviral therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 17 sitesin 5 countries
- Study dates
- 7 Feb 2024to 12 Jun 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be 18 to 65 years of age inclusive at the time of signing the informed consent.
- Participants who are overtly healthy (other than HIV infection) as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Positive HIV antibody test
- Documented HIV infection and Screening plasma HIV-1 RNA ≥ 3,000 copies/mL. A single repeat of this test is allowed within a single Screening period to determine eligibility.
- Screening CD4+ T-cell count ≥200 cells/mm3
- Treatment-naïve: No antiretrovirals (ARVs, in combination or monotherapy) received after the diagnosis of HIV-1 infection.
Show all 13Show fewer
- HIV Pre-exposure or post-exposure prophylaxis: No prior use of any INSTI (including cabotegravir) for HIV pre-exposure or post-exposure prophylaxis.
- Body weight ≥50.0 kg (110 lbs.) for men and ≥45.0 kg (99 lbs) for women and BMI within the range 18.5-31.0 kg/m2 (inclusive - applies to males and females).
- A participant of childbearing potential must have a negative serum hCG test at screening, and negative urine hCG test at Day 1, before the first dose of study intervention.
- If a urine test cannot be confirmed as negative (e.g. 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 risk for inclusion of a female with an early undetected pregnancy.
- Capable of giving signed informed consent
- Participant must be willing and able to start standard-of-care ART as selected with the investigator on Study Day 10.
Who cannot join
- Participants with primary HIV infection. Any evidence of an active CDC Stage 3 disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy during the study. Untreated syphilis infection [positive RPR at screen] without documentation of treatment. Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia; or other localized malignancies
- Any pre-existing physical or mental condition which, in the opinion of the Investigator, 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.
- Any history of significant underlying psychiatric disorder, or a clinical assessment of suicidality based on the responses on the eCSSRS.
- Any history of major depressive disorder with or without suicidal features, or anxiety disorders, that required medical intervention (pharmacologic or not) such as hospitalization or other inpatient treatment and/or chronic (>6 months) outpatient treatment.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome or sudden cardiac death. Treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (such as hydroxyurea or foscarnet) within 30 days of study drug administration.
Show all 19Show fewer
- 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. Specific medications listed in Section 6.9.1 may be allowed.
- 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).
- The participant has ever received an investigational HIV vaccine (immunotherapeutic or immunomodulatory).
- Exposure to an experimental drug or experimental vaccine within either 30 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 intervention.
- Participation in the study would result in donation of blood in excess of 500 mL within 56 days.
- Exposure to more than four new investigational drugs or vaccines within 12 months prior to the first dosing day.
- Current enrollment or past participation within the last 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research.
- Diagnostic Assessments
- Presence of HBsAg or HBcAb at screening
- Positive Hepatitis C antibody test result at Screening
- Positive Hepatitis C RNA test result at Screening.
- Creatinine clearance (eGFR) of < 60 mL/min/1.73 m2 using CKD-EPI equation (2021).
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
Spain6 sites
GSK Investigational Site
Barcelona, 08003
GSK Investigational Site
Barcelona, 08026
GSK Investigational Site
Elche Alicante, 03203
GSK Investigational Site
Madrid, 28020
GSK Investigational Site
Murcia, 30003
GSK Investigational Site
Valencia, 46026
United States5 sites
GSK Investigational Site
Bakersfield, California, 93301
GSK Investigational Site
DeLand, Florida, 32720
GSK Investigational Site
Los Angeles, California, 90027
GSK Investigational Site
Orlando, Florida, 32803
GSK Investigational Site
West Hollywood, California, 90046
Argentina3 sites
GSK Investigational Site
Buenos Aires, C1202
GSK Investigational Site
Buenos Aires, C1425AGC
GSK Investigational Site
Ciudad Autonoma de Bueno, C1405CKC
Canada2 sites
GSK Investigational Site
Montreal, Quebec, H4A 3J1
GSK Investigational Site
Québec, Quebec, G1V 4G2
About this study
Official title: A Phase 2a, Randomized, Double-Blind (Sponsor Unblinded), Placebo-Controlled, Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH4524184 in HIV-1 Infected Treatment Naïve Adults
The purpose of this study is to evaluate the safety, tolerability, ability of VH4524184 when given alone to reduce the amount of HIV (viral load) in people with HIV-1 infection who have never received antiretroviral therapy (treatment-naïve). Data from this study will be used to decide how VH4524184 can be best included in a full-treatment regimen for HIV-1 in the future.
- Conditions
- HIV Infections
- Being tested
- VH4524184, Matching Placebo, Antiretroviral therapy
- Keywords
- Human immunodeficiency virus, Proof of concept, Antiviral Agents, Virus Diseases
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VH4524184Drug
VH4524184 was administered as tablets orally at Day 1.
Matching PlaceboDrug
VH4524184 Matching Placebo was administered as tablets orally at Day 1.
Antiretroviral therapyDrug
Antiretroviral therapy was administered as available and as per investigator's recommendation.
| Study group | Role | What they receive |
|---|---|---|
| VH4524184 Dose 1 | Experimental | Participants received VH4524184, administered as Dose 1 (low dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label standard-of-care (SOC) antiretroviral therapy (ART), which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38. Receives: Drug: VH4524184; Drug: Antiretroviral therapy |
| VH4524184 Dose 2 | Experimental | Participants received VH4524184, administered as Dose 2 (medium dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38. Receives: Drug: VH4524184; Drug: Antiretroviral therapy |
| VH4524184 Dose 3 | Experimental | Participants received VH4524184, administered as Dose 3 (high dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38. Receives: Drug: VH4524184; Drug: Antiretroviral therapy |
| Placebo | Placebo comparator | Participants received matching Placebo to the study intervention on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38. Receives: Drug: Matching Placebo; Drug: Antiretroviral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monotherapy: Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA)
Plasma samples were collected for the quantitative analysis of plasma HIV-1 RNA. The maximum change from baseline was calculated by determining the largest change from baseline value across all assessment timepoints during the monotherapy period. This is identified by subtracting the lowest post-dose visit value up to Day 10 (inclusive) from the baseline value. The baseline was defined as the most recent pre-dose assessment with a valid, non-missing value, including measurements from any unscheduled visits.
Measured: At Day 10
Secondary outcomes (15)
Monotherapy and Follow-up: Number of Participants With Any Adverse Event (AE)
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. An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Any AEs = occurrence of the symptom regardless of intensity grade.
Measured: Day 1 to Day 38
Monotherapy and Follow-up: Number of Participants With AEs by Severity
The severity was assessed using The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) Version 2.1 where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening and Grade 5 = Death.
Measured: Day 1 to Day 38
Monotherapy: Number of Participants With AEs Leading to Study Treatment Discontinuation
Measured: Day 1 to Day 7
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
Blood samples were collected at the indicated timepoints.
Measured: At Baseline (Day 1), Day 2, Day 4, Day 7, Day 10, Day 17, Day 24, Day 31 and Day 38
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameter: Bilirubin
Blood samples were collected at the indicated timepoints.
Measured: At Baseline (Day 1), Day 2, Day 4, Day 7, Day 10, Day 17, Day 24, Day 31 and Day 38
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameter: Protein
Blood samples were collected at the indicated timepoints.
Measured: At Baseline (Day 1), Day 2, Day 4, Day 7, Day 10, Day 17, Day 24, Day 31 and Day 38
Monotherapy and Follow-up: Number of Participants With Maximum Toxicity Grade Increase Relative to Baseline in Liver Panel Laboratory Parameters: ALT, AST, ALP, Bilirubin
Liver panel parameters assessed were: ALT, AST, ALP, bilirubin. The parameters were graded according to DAIDS grading table Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. An increase is defined as an increase in grade relative to baseline grade.
Measured: From Baseline (Day 1) and up to Day 38
Monotherapy and Follow-up: Number of Participants With Maximum Toxicity Grade Increase Relative to Baseline in Liver Panel Laboratory Parameters: Protein
Participants are categorized based on changes in their liver panel laboratory parameters (protein) to 'Low,' 'Normal,' or 'High,' unless there is no change in their initial category. Participants whose lab values remain unchanged (e.g., 'High' to 'High') or whose values return to normal are recorded in the 'To Normal or No Change' category. Participants may be counted in both the 'To Low' and 'To High' categories if their values fluctuate between these states. As a result, the percentages may exceed 100% due to dual categorization. Participants with a missing baseline value are assumed to have a normal baseline value.
Measured: From Baseline (Day 1) and up to Day 38
Monotherapy: Maximum Observed Plasma Drug Concentration (Cmax) of VH4524184
Blood samples were collected at indicated time points for Pharmacokinetic (PK) analysis of VH4524184.
Measured: At Day 1 and Day 7
Monotherapy: Time to Maximum Observed Plasma Drug Concentration (Tmax) of VH4524184
Blood samples were collected at indicated time points for PK analysis of VH4524184.
Measured: At Day 1 and Day 7
Monotherapy: Plasma Concentration of VH4524184 at Day 10
Blood samples was collected at indicated time point for PK analysis of VH4524184.
Measured: At Day 10
Monotherapy: Correlation of VH4524184 Cmax With Maximum Plasma HIV-1 RNA Log 10 Change From Baseline Through Day 10
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value was the latest pre-dose assessment with a non-missing value. Change from baseline is defined as post-dose visit value minus baseline value. Statistical analysis for relationship between PK parameter (Cmax) and PD measure (change from baseline in logarithm to base 10 (log10) values for maximum plasma HIV-1 RNA) were explored using an Emax non-linear mixed-effects model. The model parameters estimated were maximum response (Emax) which is defined as the maximum change (at infinite exposure) and EC50 which defines the PK parameter value that attains 50 percent (%) of the maximal effect
Measured: From Day 1 to Day 10
Monotherapy: Number of Participants With Treatment-emergent Genotypic Resistance
Plasma samples were collected to assess treatment emergent Genotypic Resistance.
Measured: At Baseline (Day 1) and Day 10
Monotherapy: Number of Participants With Treatment-emergent Phenotypic Resistance
Plasma samples were collected to assess treatment emergent Phenotypic Resistance.
Measured: At Baseline (Day 1) and Day 10
Monotherapy: Change From Baseline in Cluster of Differentiation 4 (CD4+) T-cell Counts at Day 10
Blood samples were collected for assessment of T-cells subsets (CD4+ T-cells count) by flow cytometry at Day 10 compared to Baseline.
Measured: At Day 10 compared to Baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start7 Feb 2024
- Primary completion12 Jun 2024
- Study completion12 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214052
- Sponsor's protocol ID
- 218806
- Other IDs
- 2023-507173-18-00, 2023
- Status last verified
- Jun 2025
- First submitted
- 9 Jan 2024
- Last updated
- 29 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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
Publications
Rogg L, Nunez SA, Mingrone MV, Domingo P, Rolle CP, Guerri-Fernandez R, Estrada V, Lopez M, Hanan N, Ghita GL, Jeffrey JL, Underwood M, Castillo-Mancilla JR, Halliday F, Ezeadi E, Gartland M. Proof-of-Concept Phase 2a Trial of VH4524184 (VH-184), an Emerging Third-Generation Integrase Strand Transfer Inhibitor With an Enhanced Resistance Profile. Clin Infect Dis. 2026 Jun 12:ciag357. doi: 10.1093/cid/ciag357. Online ahead of print.
PubMed 42283218
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-Blind (Sponsor Unblinded), Placebo-Controlled, Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH4524184 in HIV-1 Infected Treatment Naïve Adults
- ClinicalTrials.gov ID
- NCT06214052
- Acronym / sponsor ID
- 218806
- Conditions
- HIV Infections
- Keywords
- Human immunodeficiency virus, Proof of concept, Antiviral Agents, Virus Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 12 Jun 2024 (actual)
- First posted
- 19 Jan 2024 (actual)
- Results
- Posted 29 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, ability of VH4524184 when given alone to reduce the amount of HIV (viral load) in people with HIV-1 infection who have never received antiretroviral therapy (treatment-naïve). Data from this study will be used to decide how VH4524184 can be best included in a full-treatment regimen for HIV-1 in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VH4524184 Dose 1 | Experimental | Drug: VH4524184, Drug: Antiretroviral therapyParticipants received VH4524184, administered as Dose 1 (low dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label standard-of-care (SOC) antiretroviral therapy (ART), which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38. |
| VH4524184 Dose 2 | Experimental | Drug: VH4524184, Drug: Antiretroviral therapyParticipants received VH4524184, administered as Dose 2 (medium dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38. |
| VH4524184 Dose 3 | Experimental | Drug: VH4524184, Drug: Antiretroviral therapyParticipants received VH4524184, administered as Dose 3 (high dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38. |
| Placebo | Placebo comparator | Drug: Matching Placebo, Drug: Antiretroviral therapyParticipants received matching Placebo to the study intervention on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participant must be 18 to 65 years of age inclusive at the time of signing the informed consent.
- Participants who are overtly healthy (other than HIV infection) as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Positive HIV antibody test
- Documented HIV infection and Screening plasma HIV-1 RNA ≥ 3,000 copies/mL. A single repeat of this test is allowed within a single Screening period to determine eligibility.
- Screening CD4+ T-cell count ≥200 cells/mm3
Key exclusion criteria (19 listed)
- Participants with primary HIV infection. Any evidence of an active CDC Stage 3 disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy during the study. Untreated syphilis infection [positive RPR at screen] without documentation of treatment. Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia; or other localized malignancies
- Any pre-existing physical or mental condition which, in the opinion of the Investigator, 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.
- Any history of significant underlying psychiatric disorder, or a clinical assessment of suicidality based on the responses on the eCSSRS.
- Any history of major depressive disorder with or without suicidal features, or anxiety disorders, that required medical intervention (pharmacologic or not) such as hospitalization or other inpatient treatment and/or chronic (>6 months) outpatient treatment.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
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 |
|---|---|---|
| VH4524184VH4524184 was administered as tablets orally at Day 1. | Drug | VH4524184 Dose 1, VH4524184 Dose 2, VH4524184 Dose 3 |
| Matching PlaceboVH4524184 Matching Placebo was administered as tablets orally at Day 1. | Drug | Placebo |
| Antiretroviral therapyAntiretroviral therapy was administered as available and as per investigator's recommendation. | Drug | Placebo, VH4524184 Dose 1, VH4524184 Dose 2, VH4524184 Dose 3 |
Primary outcome
Monotherapy: Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA)
Time frame: At Day 10
Plasma samples were collected for the quantitative analysis of plasma HIV-1 RNA. The maximum change from baseline was calculated by determining the largest change from baseline value across all assessment timepoints during the monotherapy period. This is identified by subtracting the lowest post-dose visit value up to Day 10 (inclusive) from the baseline value. The baseline was defined as the most recent pre-dose assessment with a valid, non-missing value, including measurements from any unscheduled visits.
15 secondary outcomes
Monotherapy and Follow-up: Number of Participants With Any Adverse Event (AE)
Time frame: Day 1 to Day 38
Monotherapy and Follow-up: Number of Participants With AEs by Severity
Time frame: Day 1 to Day 38
Monotherapy: Number of Participants With AEs Leading to Study Treatment Discontinuation
Time frame: Day 1 to Day 7
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
Time frame: At Baseline (Day 1), Day 2, Day 4, Day 7, Day 10, Day 17, Day 24, Day 31 and Day 38
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameter: Bilirubin
Time frame: At Baseline (Day 1), Day 2, Day 4, Day 7, Day 10, Day 17, Day 24, Day 31 and Day 38
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameter: Protein
Time frame: At Baseline (Day 1), Day 2, Day 4, Day 7, Day 10, Day 17, Day 24, Day 31 and Day 38
Monotherapy and Follow-up: Number of Participants With Maximum Toxicity Grade Increase Relative to Baseline in Liver Panel Laboratory Parameters: ALT, AST, ALP, Bilirubin
Time frame: From Baseline (Day 1) and up to Day 38
Monotherapy and Follow-up: Number of Participants With Maximum Toxicity Grade Increase Relative to Baseline in Liver Panel Laboratory Parameters: Protein
Time frame: From Baseline (Day 1) and up to Day 38
Monotherapy: Maximum Observed Plasma Drug Concentration (Cmax) of VH4524184
Time frame: At Day 1 and Day 7
Monotherapy: Time to Maximum Observed Plasma Drug Concentration (Tmax) of VH4524184
Time frame: At Day 1 and Day 7
Monotherapy: Plasma Concentration of VH4524184 at Day 10
Time frame: At Day 10
Monotherapy: Correlation of VH4524184 Cmax With Maximum Plasma HIV-1 RNA Log 10 Change From Baseline Through Day 10
Time frame: From Day 1 to Day 10
Monotherapy: Number of Participants With Treatment-emergent Genotypic Resistance
Time frame: At Baseline (Day 1) and Day 10
Monotherapy: Number of Participants With Treatment-emergent Phenotypic Resistance
Time frame: At Baseline (Day 1) and Day 10
Monotherapy: Change From Baseline in Cluster of Differentiation 4 (CD4+) T-cell Counts at Day 10
Time frame: At Day 10 compared to Baseline (Day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42283218Rogg L, Nunez SA, Mingrone MV, Domingo P, Rolle CP, Guerri-Fernandez R, Estrada V, Lopez M, Hanan N, Ghita GL, Jeffrey JL, Underwood M, Castillo-Mancilla JR, Halliday F, Ezeadi E, Gartland M. Proof-of-Concept Phase 2a Trial of VH4524184 (VH-184), an Emerging Third-Generation Integrase Strand Transfer Inhibitor With an Enhanced Resistance Profile. Clin Infect Dis. 2026 Jun 12:ciag357. doi: 10.1093/cid/ciag357. Online ahead of print.
- 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
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VH4524184 and Antiretroviral therapy in people with HIV Infections, run by ViiV Healthcare at 17 sites in 5 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 13 inclusion and 19 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: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Spain, United States, Argentina, Canada, Italy. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 29 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Monotherapy: Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) (time frame: At Day 10). 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 NCT06214052, 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 29 Jun 2025.