Status:
TERMINATED
A Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in in Treatment-Naive Adults Living With HIV-1
Lead Sponsor:
ViiV Healthcare
Conditions:
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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
- 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
- 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
Key Trial Info
Start Date :
December 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06061081
Start Date
December 21 2023
End Date
August 27 2024
Last Update
October 20 2025
Active Locations (18)
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1
GSK Investigational Site
Bakersfield, California, United States, 93301
2
GSK Investigational Site
Miami, Florida, United States, 33136
3
GSK Investigational Site
Dallas, Texas, United States, 75246
4
GSK Investigational Site
Buenos Aires, Argentina, C1181ACH