SEARCH 025/ RV 412: Safety and Virologic Outcomes after Analytic Treatment Interruption in Thai Patients who Initiated Antiretroviral Therapy during Early Acute HIV Infection
Overview
Although antiretroviral therapy (ART) has been shown to greatly reduce both morbidity and mortality, the CDC estimates that only 36% of persons living with HIV in the U.S. are currently prescribed ART, and only 28% have achieved HIV suppression. Barriers to universal use of ART include the need for lifelong adherence, possible drug toxicities or the development of resistance, and the cost of medication. Due to these limitations, treatment strategies that can confer durable virologic control and delay disease progression while minimizing ART exposure are highly desirable. Various SEARCH010 sub-studies will deploy supplemental treatments, followed by analytic treatment interruption (ATI), as part of a strategy to better understand HIV pathogenesis and to reduce ART-related toxicities and complications. Patients who initiate ART in acute HIV infection are believed to have better preserved immune function and limited viral reservoirs, making them ideal candidates for clinical studies that employ ATI. SEARCH 025 aims to provide a uniform mechanism for ensuring the safety of volunteers who were diagnosed with HIV during early acute HIV infection, received ART, and subsequently completed any clinical study that included ATI.
This study seeks to characterize changes in viral dynamics, CD4 preservation, clinical characteristics of HIV infection, and host innate and cellular immune responses post-ATI. We also aim to identify predictors of sustained viremic control (host genetic alleles, immune responses, viral genetics), as well as to observe HIV reservoirs and their expression post-ATI.
Clinical study visits will take place at the Thai Red Cross AIDS Research Centre, and the optional procedures may occur at the King Chulalongkorn Memorial Hospital. The study is enrolling volunteers aged 18 years and older who have completed clinical studies involving ATI in Bangkok, Thailand.
Although antiretroviral therapy (ART) has been shown to greatly reduce both morbidity and mortality, the CDC estimates that only 36% of persons living with HIV in the U.S. are currently prescribed ART, and only 28% have achieved HIV suppression. Barriers to universal use of ART include the need for lifelong adherence, possible drug toxicities or the development of resistance, and the cost of medication. Due to these limitations, treatment strategies that can confer durable virologic control and delay disease progression while minimizing ART exposure are highly desirable. Various SEARCH010 sub-studies will deploy supplemental treatments, followed by analytic treatment interruption (ATI), as part of a strategy to better understand HIV pathogenesis and to reduce ART-related toxicities and complications. Patients who initiate ART in acute HIV infection are believed to have better preserved immune function and limited viral reservoirs, making them ideal candidates for clinical studies that employ ATI. SEARCH 025 aims to provide a uniform mechanism for ensuring the safety of volunteers who were diagnosed with HIV during early acute HIV infection, received ART, and subsequently completed any clinical study that included ATI.
This study seeks to characterize changes in viral dynamics, CD4 preservation, clinical characteristics of HIV infection, and host innate and cellular immune responses post-ATI. We also aim to identify predictors of sustained viremic control (host genetic alleles, immune responses, viral genetics), as well as to observe HIV reservoirs and their expression post-ATI.
Clinical study visits will take place at the Thai Red Cross AIDS Research Centre, and the optional procedures may occur at the King Chulalongkorn Memorial Hospital. The study is enrolling volunteers aged 18 years and older who have completed clinical studies involving ATI in Bangkok, Thailand.
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