A Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in in Treatment-Naive Adults Living With HIV-1

A Randomized, Double-Blind (Sponsor-Unblinded), Placebo-Controlled, Adaptive Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in Treatment-Naïve Adults Living With HIV-1

The primary purpose of this study is to assess the antiviral activity of VH3739937 in Human Immunodeficiency Virus Type-1 (HIV-1) infected treatment naive (TN) participants during monotherapy.

Study Overview

• Status: Terminated
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Placebo; Drug: VH3739937

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1181ACH
    • GSK Investigational Site
  • Rosario, Argentina, 2000
    • GSK Investigational Site
• Greece
  • Athens, Greece, 12462
    • GSK Investigational Site
• Italy
  • Brescia, Italy, 25123
    • GSK Investigational Site
  • Genova, Italy, 16132
    • GSK Investigational Site
  • Milan, Italy, 20142
    • GSK Investigational Site
  • Roma, Italy, 00133
    • GSK Investigational Site
• Poland
  • Warsaw, Poland, 01-201
    • GSK Investigational Site
• Spain
  • A Coruña, Spain, 15006
    • GSK Investigational Site
  • Alicante, Spain, 03010
    • GSK Investigational Site
  • Granada, Spain, 18014
    • GSK Investigational Site
  • Jerez de la Frontera, Spain, 11407
    • GSK Investigational Site
  • Madrid, Spain, 28006
    • GSK Investigational Site
  • Madrid, Spain, 28222
    • GSK Investigational Site
  • Vitoria-Gasteiz, Spain, 1009
    • GSK Investigational Site
• United States
  • California
    • Bakersfield, California, United States, 93301
      • GSK Investigational Site
  • Florida
    • Miami, Florida, United States, 33136
      • GSK Investigational Site
  • Texas
    • Dallas, Texas, United States, 75246
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• Treatment-naïve: No Antiretrovirals (ARVs) (in combination or monotherapy) received after the diagnosis of HIV-1 infection
• Body weight ≥50.0 kilogram (kg) (110 pounds [lbs]) for men and ≥45.0 kg (99 lbs) for women and BMI for all participants within the range 18.5-35.0 kilogram per meter square (kg/m^2).
• Capable of giving signed informed consent
• Participant must be willing and able to start Combination Antiretrovial Therapy (cART) as selected with the Investigator on Study Day 8 (except in the case of early termination, clinically relevant AE/SAE, lab abnormality, the withdrawal of consent, lost to follow-up, etc., where circumstances could dictate otherwise).

Exclusion Criteria:

• Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
• Participants with primary HIV infection, evidenced by acute retroviral syndrome (e.g., fever, malaise, fatigue, etc) and/or evidence of recent (within 3 months) documented viremia without antibody production and/or evidence of recent (within 3 months) documented seroconversion
• Myocardial infarction, acute coronary syndrome, unstable angina, stroke, transient ischemic attack, or intermittent claudication in the past 3 months
• The participant has received an investigational HIV vaccine (immunotherapeutic or immunomodulatory)
• Regular use of drugs of abuse
• Sensitivity to heparin or heparin-induced thrombocytopenia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VH3739937 Low Dose Group; Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25.	Drug: VH3739937; VH3739937 will be administered.
Experimental: VH3739937 Medium Dose Group; Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.	Drug: VH3739937; VH3739937 will be administered.
Experimental: VH3739937 High Dose Group; Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.	Drug: VH3739937; VH3739937 will be administered.
Placebo Comparator: Placebo once daily (QD); Participants received Placebo QD from Day 1 through Day 7. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.	Drug: Placebo; Placebo will be administered.
Placebo Comparator: Placebo single dose (SD); Participants received Placebo SD on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25.	Drug: Placebo; Placebo will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. This is identified by subtracting the lowest post-dose visit value up to Day 8 (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.	From Day 1 to Day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Serious Adverse Events (SAEs) During Study Intervention Period	An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.	From Day 1 to Day 8
Number of Reported Deaths		From Day 1 to Day 8
Number of Participants With Adverse Events (AEs) Leading to Discontinuation	An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. A participant is considered to have discontinued from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of last contact.	From Day 1 to Day 8
Maximum Observed Plasma Concentration (Cmax) of VH3739937 on QD Dosing	Blood samples were collected at indicated timepoints for PK analysis.	Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 1
Time to Maximum Concentration (Tmax) of VH3739937 on QD Dosing	Blood samples were collected at indicated timepoints for PK analysis. Tmax is defined as the time to reach maximum observed plasma concentration (Cmax).	Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 1
Concentration at 24 Hours (C24) Post Dose of VH3739937 on QD Dosing	C24 is defined as concentration at nominal time of 24 hours after dosing. Blood samples were collected at indicated timepoints for PK analysis.	At 24h post-dose on Day 1
Area Under the Concentration-time Curve From Zero to 24h (AUC[0-24]) of VH3739937 on QD Dosing.	Blood samples were collected at indicated timepoints for PK analysis.	Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h post-dose on Day 1
Cmax of VH3739937 at Steady State (Cmax, ss) on QD Dosing	Blood samples were collected at indicated timepoints for PK analysis.	Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 7
Tmax of VH3739937 at Steady State (Tmax, ss) on QD Dosing	Blood samples were collected at indicated timepoints for PK analysis. Tmax is defined as the time to reach the maximum observed plasma concentration (Cmax).	Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 7
C24 of VH3739937 at Steady State (C24, ss) on QD Dosing	Blood samples were collected at indicated timepoints for PK analysis.	At 24h post-dose on Day 7
AUC(0-24) of VH3739937 at Steady State (AUC[0-24], ss) on QD Dosing	Blood samples were collected at indicated timepoints for PK analysis.	Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h post-dose on Day 7
Cmax Post Single Dose of VH3739937	Blood samples were collected at indicated timepoints for PK analysis.	Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h post-dose (single dose administered on Day 1)
Tmax Post Single Dose of VH3739937	Blood samples were collected at indicated timepoints for PK analysis.	Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h post-dose (single dose administered on Day 1)
Concentration at 168 Hours (C168) Post Single Dose of VH3739937	C168 is defined as concentration of VH3739937 at a nominal time of 168 hours after dosing. Blood samples were collected at indicated timepoints for PK analysis.	At 168 hours post-dose (single dose administered on Day 1)
Area Under the Concentration-time Curve From Zero to 168h [AUC(0-168)] Post Single Dose of VH3739937	Blood samples were collected at indicated timepoints for analysis.	Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h post-dose (single dose administered on Day 1)

Collaborators and Investigators

• Sponsor: ViiV Healthcare
• Investigators: Study Director: GSK Clinical Trials, ViiV Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2023
• Primary Completion (Actual): August 27, 2024
• Study Completion (Actual): August 27, 2024

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Estimated): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: HIV-1; Treatment Naïve; VH3739937
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: 212580; 2023-505780-37-00 (Other Identifier: European Medicines Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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/
• IPD Sharing Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• IPD Sharing Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No