SEARCH 024/ RV 397: Safety and Therapeutic Efficacy of the Broadly Neutralizing HIV-1 Specific Monoclonal Antibody VRC01 during Analytic Treatment Interruption in Patients who Initiated Antiretroviral Therapy during Early Acute HIV Infection
Overview
Antiretroviral therapy (ART) is currently the cornerstone of HIV management, as it has been shown to reduce both morbidity and mortality in the setting of chronic HIV. There is a growing body of evidence demonstrating the benefits of ART initiation in acute HIV infection, including preserving immune function, decreasing viral evolution, and limiting viral reservoir formation. Some patients who begin ART at the time of acute HIV infection demonstrate blunted or delayed rebound viremia after treatment interruption, with about 5-16% showing sustained virologic control. Contributing factors to successful virologic control include a shorter duration from HIV onset to ART initiation, a longer duration on ART, and low peripheral blood mononuclear cell-associated HIV DNA.
This placebo-controlled clinical trial is currently recruiting participants aged 20 to 50 years in Bangkok, Thailand who were diagnosed during acute HIV infection and initiated on ART. Study objectives include evaluating the safety of VRC01 and the efficacy of this treatment in maintaining virologic suppression following analytic treatment interruption. Treatment with VRC01 has shown promise in animal studies as a safe and potent therapy that can both reduce HIV viremia in infected animals and prevent HIV acquisition in uninfected animals. We are hoping to find treatment with VRC01 will delay or prevent rebound HIV viremia, and will contribute to our understanding of viral reservoir establishment and eradication.
Antiretroviral therapy (ART) is currently the cornerstone of HIV management, as it has been shown to reduce both morbidity and mortality in the setting of chronic HIV. There is a growing body of evidence demonstrating the benefits of ART initiation in acute HIV infection, including preserving immune function, decreasing viral evolution, and limiting viral reservoir formation. Some patients who begin ART at the time of acute HIV infection demonstrate blunted or delayed rebound viremia after treatment interruption, with about 5-16% showing sustained virologic control. Contributing factors to successful virologic control include a shorter duration from HIV onset to ART initiation, a longer duration on ART, and low peripheral blood mononuclear cell-associated HIV DNA.
This placebo-controlled clinical trial is currently recruiting participants aged 20 to 50 years in Bangkok, Thailand who were diagnosed during acute HIV infection and initiated on ART. Study objectives include evaluating the safety of VRC01 and the efficacy of this treatment in maintaining virologic suppression following analytic treatment interruption. Treatment with VRC01 has shown promise in animal studies as a safe and potent therapy that can both reduce HIV viremia in infected animals and prevent HIV acquisition in uninfected animals. We are hoping to find treatment with VRC01 will delay or prevent rebound HIV viremia, and will contribute to our understanding of viral reservoir establishment and eradication.
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