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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06061081
• Other study ID #: 212580
• Secondary ID: 2023-505780-37-0
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 3, 2023
• Est. completion date: June 26, 2024

Study information

• Verified date: September 2023
• Source: ViiV Healthcare
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: June 26, 2024
• Est. primary completion date: June 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• VH3739937
VH3739937 will be administered.
• Placebo
Placebo will be administered.

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Cordoba	Córdova
Argentina	GSK Investigational Site	Rosario	Santa Fe
Argentina	GSK Investigational Site	Villa María	Cordoba
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Italy	GSK Investigational Site	Brescia	Lombardia
Italy	GSK Investigational Site	Genova	Liguria
Italy	GSK Investigational Site	Milano
Italy	GSK Investigational Site	Modena	Emilia Romagna
Italy	GSK Investigational Site	Roma	Lazio
Poland	GSK Investigational Site	Szczecin
Poland	GSK Investigational Site	Warszawa
United States	GSK Investigational Site	Bakersfield	California
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Newark	New Jersey
United States	GSK Investigational Site	Santa Fe	New Mexico
United States	GSK Investigational Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ViiV Healthcare

Countries where clinical trial is conducted

United States,  Argentina,  Greece,  Italy,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Change from Baseline in Plasma HIV-1 Ribonucleic Acid (RNA)		Baseline (Day 1) and up to Day 8
Secondary	Number of Participants with Serious Adverse Events, Deaths, or Adverse Events leading to Discontinuation		Up to Day 8
Secondary	Maximum observed concentration of VH3739937 at Day 1		Day 1
Secondary	Time to maximum observed concentration (Tmax) of VH3739937 at Day 1		Day 1
Secondary	Concentration at 24 hours (h) post dose of VH3739937 at Day 1		Day 1
Secondary	Area under the concentration-time curve from zero to 24h of VH3739937 at Day 1		Day 1
Secondary	Maximum observed concentration of VH3739937 at steady state		Day 7
Secondary	Time to maximum observed concentration (Tmax) of VH3739937 at steady state		Day 7
Secondary	Concentration at 24 h post dose of VH3739937 at steady state		Day 7
Secondary	Area under the concentration-time curve from zero to 24h of VH379937 at steady state		Day 7
Secondary	Maximum observed concentration of VH3739937 after single dose		Up to 168 hours
Secondary	Time to maximum observed concentration (Tmax) of VH3739937 after single dose		Up to 168 hours
Secondary	Area under the concentration-time curve of VH3739937 from zero to 168h after single dose		Up to 168 hours
Secondary	Concentration of VH3739937 at 168 h after single dose		At 168 hours