A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size … (NCT07053384) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV
United States107 participantsStarted 2025-07-10
Plain-language summary
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).
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
CONCURRENT MEDICAL CONDITIONS \& MEDICAL HISTORY
* Participa…
What they're measuring
1
Change from baseline in cell-associated HIV-1 RNA transcripts per million cluster of differentiation 4 (CD4+) T cells