The purpose of this Phase 2b study is to evaluate the efficacy and therapeutic window of chronically dosed VH4011499 paired with an integrase strand transfer inhibitor (INSTI). This study will explore 4 different regimens of VH4011499 when paired with cabotegravir (CAB) as an initial two-drug regimen.
Participant must be at least 18 years of age (or older, if required for adults by local regulations).
Screening CD4+ T-cell count ≥ 200 cells/µL.
Documented HIV-1 infection and screening plasma HIV-1 RNA ≥
Treatment-naïve. Prior use of oral pre-exposure prophylaxis (PrEP) or oral post-exposure prophylaxis (PEP) that is not INSTI or CAI based is permitted.
Participants with acute HIV-1 infection
Prior exposure to any HIV-1 capsid inhibitor or any HIV-1 INSTI for any reason is prohibited.
Participants with known or suspected presence of major virologic resistance mutations to study drugs
Unstable liver disease
Parallel
VH4011499
DrugParticipants receive injectable VH4011499 at different dose groups.
CAB
DrugParticipants receive injectable CAB.
DTG/3TC
DrugParticipants receive DTG/3TC orally once daily.
Number of participants with plasma HIV-1 RNA <50 copies/mL as per FDA snapshot algorithm
Number of participants with plasma HIV-1 RNA <50 copies/mL as per FDA snapshot algorithm
Number of participants with plasma HIV-1 RNA <50 copies/mL as per observed data
Change from baseline (Day 1) in cluster of differentiation (CD) 4+ T-cell count
Number of participants with injection site reaction adverse events of special interest (ISR AESIs) by grade
The ISR AESIs will be graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading table Version 2.1, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening.
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This trial is not recruiting at the moment. You can still explore other options:
