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

Prior treatment

• 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

Other illness

• 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.

Lab values

• 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)

Other

• Sensitivity to heparin or heparin-induced thrombocytopenia

• 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