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

Phase 2TerminatedNCT06061081

ViiV Healthcare21 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

HIV Infections

Interventions

VH3739937DRUG

VH3739937 will be administered.

PlaceboDRUG

Placebo will be administered.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (18)

GSK Investigational Site

Bakersfield, California, United States

GSK Investigational Site

Miami, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: From Day 1 to Day 8

Secondary Outcomes

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.

Time frame: From Day 1 to Day 8

Number of Reported Deaths

Time frame: 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.

Time frame: From Day 1 to Day 8

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

Data from ClinicalTrials.gov

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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

...and 8 more locations

Blood samples were collected at indicated timepoints for PK analysis.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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)