Key consideration on the clinical trial design of therapeutic drugs for immunological non-responder with AIDS
With the widespread application of combination antiretroviral therapy(cART),the majority of HIV-infected individuals have achieved viral control,effectively prevented disease progression.Nowadays,HIV infection has been transformed from a fatal disease into a chronic disease.However,following the attainment of virological suppression,a subset of patients exhibits inadequate recovery of CD4+T cells,and can not achieve immunological response,which results in higher incidences and mortality rates associated with opportunistic infections,non-AIDS-related complications,and malignancies.In response to the challenge of incomplete immune reconstitution,several novel therapeutic agents are currently undergoing clinical development.Nevertheless,there exists a lack of clinical trial guidances both domestically and internationally.This paper reviews the landscape of clinical trials evaluating therapies for immunological non-responder,discussing key elements of clinical trial design,trail population,primary efficacy variable,treatment period,etc.,with the aim of providing insights to inform the clinical development of these drugs.
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