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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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