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

NCT06061081 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 2125802023-505780-37-00
• Study Type: interventional
• Target: 21
• Locations: 6 countries
• Sites: 18

Brief Summary

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.

Conditions

HIV Infections

Keywords

VH3739937; Treatment Naïve; HIV-1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Number of Participants With Serious Adverse Events (SAEs) During Study Intervention Period

  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

  From Day 1 to Day 8

• Maximum Observed Plasma Concentration (Cmax) of VH3739937 on QD Dosing

  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

  Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 1

Study Arms (5)

VH3739937 Low Dose Group

EXPERIMENTAL

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 Medium Dose Group

EXPERIMENTAL

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 High Dose Group

EXPERIMENTAL

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

Placebo once daily (QD)

PLACEBO COMPARATOR

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 single dose (SD)

PLACEBO COMPARATOR

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

Interventions

VH3739937 DRUG

VH3739937 will be administered.

VH3739937 High Dose Group; VH3739937 Low Dose Group; VH3739937 Medium Dose Group

Placebo DRUG

Placebo will be administered.

Placebo once daily (QD); Placebo single dose (SD)

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (18)

GSK Investigational Site

Bakersfield, California, 93301, United States

Location

GSK Investigational Site

Miami, Florida, 33136, United States

Location

GSK Investigational Site

Dallas, Texas, 75246, United States

Location

GSK Investigational Site

Buenos Aires, C1181ACH, Argentina

Location

GSK Investigational Site

Rosario, 2000, Argentina

Location

GSK Investigational Site

Athens, 12462, Greece

Location

GSK Investigational Site

Brescia, 25123, Italy

Location

GSK Investigational Site

Genova, 16132, Italy

Location

GSK Investigational Site

Milan, 20142, Italy

Location

GSK Investigational Site

Roma, 00133, Italy

Location

GSK Investigational Site

Warsaw, 01-201, Poland

Location

GSK Investigational Site

A Coruña, 15006, Spain

Location

GSK Investigational Site

Alicante, 03010, Spain

Location

GSK Investigational Site

Granada, 18014, Spain

Location

GSK Investigational Site

Jerez de la Frontera, 11407, Spain

Location

GSK Investigational Site

Madrid, 28006, Spain

Location

GSK Investigational Site

Madrid, 28222, Spain

Location

GSK Investigational Site

Vitoria-Gasteiz, 1009, Spain

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 29, 2023
• Study Start: December 21, 2023
• Primary Completion: August 27, 2024
• Study Completion: August 27, 2024
• Last Updated: October 20, 2025
• Results First Posted: October 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

PL (1); AR (2); GR (1); ES (7); US (3); IT (4)