An Exploratory Phase 1b, Multicenter, Randomized, Open-Label Study to Investigate the Impact of the Administration of Intravenous VH3810109 With or Without Oral Fostemsavir in Combination With Integrase Inhibitor-Based Antiretroviral Therapy on the Viral Reservoir in Adults Living With HIV-1
This study investigates the use of VH3810109 with or without FTR to reduce the size and activity of the HIV viral reservoir in two sub-populations of people living with HIV: treatment-naïve adults (Population 1) and treatment-experienced adults currently taking a standard of care (SOC) integrase strand transfer inhibitor (INSTI)-based antiretroviral therapy (ART) regimen (Population 2).
• Age between 18 years and 70 years old at the time of obtaining informed consent.
• Persons of any sex or gender are eligible. Note: Participants of childbearing potential (POCBP) are eligible to participate if not pregnant, not lactating, and agreeing to adhere to study requirements for use of contraception and pregnancy avoidance.
• Participant has a documented diagnosis of HIV-1 infection Note: Participants in Population 1 must have a documented positive HIV antibody result available for Screening.
⁃ Population 1 only:
• Plasma HIV-1 RNA \>=2000 copies/milliliter (c/mL) at Screening.
• CD4+ T cell count \>=300 cells/microliter (μL) at Screening.
• Antiretroviral treatment naïve, defined as no exposure to ART after a diagnosis of HIV-1 infection, prior to enrollment.
⁃ Population 2 only:
• Participant is stably virologically suppressed (plasma HIV-1 RNA \<50 c/mL).
• Documented evidence of uninterrupted treatment with oral non-boosted INSTI-based ART for at least 6 months prior to Screening, as well as uninterrupted treatment with ART (any guideline-recommended oral regimen) for at least 24 months prior to Screening.
• CD4+ T cell count \>=450 cells/μL at Screening.
• Body weight \>=50 kg to \<=115 kg.
• Participant is capable of giving written informed consent, which includes adherence to the requirements and restrictions listed in the consent form and in the protocol.