A Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in in Treatment-Naive Adults Living With HIV-1
NCT ID: NCT06061081
Last Updated: 2025-10-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
21 participants
INTERVENTIONAL
2023-12-21
2024-08-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
VH3739937
VH3739937 will be administered.
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.
VH3739937
VH3739937 will be administered.
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.
VH3739937
VH3739937 will be administered.
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.
Placebo
Placebo will be administered.
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.
Placebo
Placebo will be administered.
Interventions
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VH3739937
VH3739937 will be administered.
Placebo
Placebo will be administered.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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ViiV Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
ViiV Healthcare
Locations
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GSK Investigational Site
Bakersfield, California, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Buenos Aires, , Argentina
GSK Investigational Site
Rosario, , Argentina
GSK Investigational Site
Athens, , Greece
GSK Investigational Site
Brescia, , Italy
GSK Investigational Site
Genova, , Italy
GSK Investigational Site
Milan, , Italy
GSK Investigational Site
Roma, , Italy
GSK Investigational Site
Warsaw, , Poland
GSK Investigational Site
A Coruña, , Spain
GSK Investigational Site
Alicante, , Spain
GSK Investigational Site
Granada, , Spain
GSK Investigational Site
Jerez de la Frontera, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Vitoria-Gasteiz, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2023-505780-37-00
Identifier Type: OTHER
Identifier Source: secondary_id
212580
Identifier Type: -
Identifier Source: org_study_id
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