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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: VH3739937
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants receiving VH3739937<br> | Drug: VH3739937<br>* VH3739937 will be administered.<br>|
| Placebo Comparator: Participants receiving Placebo<br> | Drug: Placebo<br>* Placebo will be administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Change from Baseline in Plasma HIV-1 Ribonucleic Acid (RNA) |  | Baseline (Day 1) and up to Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Serious Adverse Events, Deaths, or Adverse Events leading to Discontinuation |  | Up to Day 8 | 
| Maximum observed concentration of VH3739937 at Day 1 |  | Day 1 | 
| Time to maximum observed concentration (Tmax) of VH3739937 at Day 1 |  | Day 1 | 
| Concentration at 24 hours (h) post dose of VH3739937 at Day 1 |  | Day 1 | 
| Area under the concentration-time curve from zero to 24h of VH3739937 at Day 1 |  | Day 1 | 
| Maximum observed concentration of VH3739937 at steady state |  | Day 7 | 
| Time to maximum observed concentration (Tmax) of VH3739937 at steady state |  | Day 7 | 
| Concentration at 24 h post dose of VH3739937 at steady state |  | Day 7 | 
| Area under the concentration-time curve from zero to 24h of VH379937 at steady state |  | Day 7 | 
| Maximum observed concentration of VH3739937 after single dose |  | Up to 168 hours | 
| Time to maximum observed concentration (Tmax) of VH3739937 after single dose |  | Up to 168 hours | 
| Area under the concentration-time curve of VH3739937 from zero to 168h after single dose |  | Up to 168 hours | 
| Concentration of VH3739937 at 168 h after single dose |  | At 168 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VH3739937, Treatment Naïve, HIV-1