PH2a, VH3739937 Proof-Of-Concept in TN HIV-1 Infected Adults

Trial details

Who runs it

Viiv Healthcare UK Limited

Trial code

EU 2023-505780-37-00

Record updated

2024. november 22.

Original description

To evaluate the antiviral activity of VH3739937 in HIV-1 infected treatment-naive (TN) participants during 7 days of monotherapyRead full original descriptionShow less

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

To evaluate the antiviral activity of VH3739937 in HIV-1 infected treatment-naive (TN) participants during 7 days of monotherapy

Inclusion: Participants aged 18 to 65 years of age inclusive at the time of signing the informed consent; Participant must be willing and able to start a commercially available standard of care antiretroviral treatment regimen on Study Day 8 ; Participants who are overtly healthy (other than HIV infection); Screening CD4+ T-cell count >=200 cells/mm3; Documented HIV infection and Screening plasma HIV-1 RNA >=3000 and <1,000,000 copies/mL; Positive HIV antibody test; Treatment naive: No antiretroviral therapies (in combination or monotherapy) received after HIV-1 diagnosis; Body weight ≥50.0 kg (110 lbs.) for men and ≥45.0 kg (99 lbs) for women and BMI for all participants within the range 18.5-35.0 kg/m2; Participants who were considered female at birth must be of non-childbearing potential; Capable of giving signed informed consent.

Exclusion: Previous exposure to a maturation inhibitor; Has been exposed to any prohibited or exclusionary medication or vaccine; Exposure to an experimental medication or vaccine within 28 days or 5 half-lives (which is longer) before the first dose of study intervention; Has a positive result for illicit drug use, regular use of drugs of abuse; Any evidence of an active CDC Stage 3 disease; History of sensitivity to any of the study interventions or their components; Has untreated syphilis infection; Is positive for Hepatitis B or C; Ongoing malignancy other than certain localized malignancies; History of significant underlying psychiatric disorder or a clinical assessment of suicidality. History of suicidal behavior and/or ideation should be considered when evaluating suicide risk; History of major depressive disorder with or without suicidal features, or anxiety disorders that required medical intervention; Any pre-existing physical or other psychiatric condition (including alcohol or drug abuse) which may interfere with participant's ability to comply with the protocol and dosing schedule; Current or chronic history of liver disease; Primary HIV infection; Pre-existing condition that could interfere with normal gastrointestinal anatomy or motility, hepatic and/or renal function that could impact the absorption, metabolism, and/or excretion of the study interventions; Myocardial infarction, acute coronary syndrome, unstable angina, stroke, TIA, or intermittent claudication in the past 3 months; Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome or sudden cardiac death. Has an exclusionary ECG finding; Has exclusionary safety laboratory test results (e.g., Grade 3 or greater abnormality); Sensitivity to heparin or heparin-induced thrombocytopenia.

EU CTIS 2023-505780-37-00