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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT06061081

Run by

ViiV Healthcare

People needed

21

Starts

2023-12-21

Expected to finish

2024-08-27

Last updated by the study team

2025-10-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Alicante, Spain
• GSK Investigational Site — Granada, Spain
• GSK Investigational Site — Jerez de la Frontera, Spain
• GSK Investigational Site — Madrid, Spain
• GSK Investigational Site — Madrid, Spain
• GSK Investigational Site — Vitoria-Gasteiz, Spain
• GSK Investigational Site — A Coruña, Spain
• GSK Investigational Site — Bakersfield, California, United States
• GSK Investigational Site — Miami, Florida, United States
• 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
• GSK Investigational Site — Warsaw, Poland

Full record on ClinicalTrials.gov

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