Clinical trial NCT06061081: A Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in in Treatment-Naive Adults Living With HIV-1
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: HIV Infections
Keywords: VH3739937
Treatment Naïve
HIV-1
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
First posted: 2023-09-29
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Change from Baseline in Plasma HIV-1 Ribonucleic Acid (RNA)
timeFrame: Baseline (Day 1) and up to Day 8
Secondary outcomes:
measure: Number of Participants with Serious Adverse Events, Deaths, or Adverse Events leading to Discontinuation
timeFrame: Up to Day 8
measure: Maximum observed concentration of VH3739937 at Day 1
timeFrame: Day 1
measure: Time to maximum observed concentration (Tmax) of VH3739937 at Day 1
timeFrame: Day 1
measure: Concentration at 24 hours (h) post dose of VH3739937 at Day 1
timeFrame: Day 1
measure: Area under the concentration-time curve from zero to 24h of VH3739937 at Day 1
timeFrame: Day 1
measure: Maximum observed concentration of VH3739937 at steady state
timeFrame: Day 7
measure: Time to maximum observed concentration (Tmax) of VH3739937 at steady state
timeFrame: Day 7
measure: Concentration at 24 h post dose of VH3739937 at steady state
timeFrame: Day 7
measure: Area under the concentration-time curve from zero to 24h of VH379937 at steady state
timeFrame: Day 7
measure: Maximum observed concentration of VH3739937 after single dose
timeFrame: Up to 168 hours
measure: Time to maximum observed concentration (Tmax) of VH3739937 after single dose
timeFrame: Up to 168 hours
measure: Area under the concentration-time curve of VH3739937 from zero to 168h after single dose
timeFrame: Up to 168 hours
measure: Concentration of VH3739937 at 168 h after single dose
timeFrame: At 168 hours
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: GSK Investigational Site
state: California
city: Fort Pierce
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Newark
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Cordoba Argentina
country: Argentina
facility: GSK Investigational Site
city: Cordoba
country: Argentina
facility: GSK Investigational Site
city: Rosario
country: Argentina
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Brescia
country: Italy
facility: GSK Investigational Site
city: Genova
country: Italy
facility: GSK Investigational Site
city: Milano
country: Italy
facility: GSK Investigational Site
city: Modena
country: Italy
facility: GSK Investigational Site
city: Roma
country: Italy
facility: GSK Investigational Site
city: Warsaw
country: Poland
facility: GSK Investigational Site
city: Alicante
country: Spain
facility: GSK Investigational Site
city: Granada
country: Spain
facility: GSK Investigational Site
city: Jerez de la Frontera
country: Spain
facility: GSK Investigational Site
city: La CoruNa
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Vitoria
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: