CAPRISA 095 Study: Phase 1 study to assess the effect of broadly neutralizing monoclonal antibodiesCAP256V2LS and VRC07-523LS combined with antiretroviral therapy on the HIV-1 latent reservoir (NeutART) - Trial PACTR202309578224660

Timeline & Enrollment

Summary

The advent of antiretroviral therapy (ART) has both slowed the transmission of HIV-1 and prolonged the lives of those infected. However, HIV-1 remains incurable due to a latent viral reservoir that exists during suppressive therapy. In addition, the virus rebounds upon therapy interruption. The best-characterized reservoir is the circulating resting, memory CD4+ T cells where replication competent virus is found in a very low frequency of cells at ~1-10 per million CD4+ cells. HIV-1 can persist in other anatomical sites including lymph nodes in B cell follicles, the genital tract, the brain, and gut. Prior to treatment, the virus is rapidly eliminated (half-life of days),with a population of virus-infected cells where the turn-over is slower (half-life of weeks). Long-lived CD4+Tcells containing integrated latent virus occur at much lower frequency than these first two components and have a half-life of approximately four years. The major obstacle in curing HIV is the viral reservoir. We propose that reduction in the size of the reservoir using a combination of monoclonal antibodies and ART will lower the barrier to eradicating HIV-1 from an infected person. We propose that this regime will reduce the reservoir size by (i) clearing circulating virus and preventing infection of transitioning CD4 T-cells; (ii) antibody-mediated killing of virus infected cells; and (iii) lastly by enhancing of autologous antibody responses. Primary objective : 1. To determine whether monoclonal antibodies CAP256V2LS and VRC07-523LS, combined with ART affects time to viral load rebound and time to ART re-initiation post ATI 2. To assess the safety of CAP256V2LS and VRC07-523LS administered IV to HIV positive participants in combination with ART. Secondary objectives: 1. To understand whether, and how CAP256V2LS and VRC07-523LS, combined with ART, affects the formation and size of the HIV-1 latent reservoir

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