AIDS. 1990 Dec;4(12):WHO1-14.
A wide spectrum of immunomodulatory strategies offer promise for treating people with HIV infection; however, numerous gaps still exist in our understanding of the normal regulation of the immune system during the progression of HIV infection. Preclinical development of immunomodulators must include a strong rationale for the use of the immunomodulating substance substantiated by appropriate laboratory studies, in vitro as well as in vivo. Preclinical studies must demonstrate the safety of the proposed therapeutic agent, including an assessment of the potential for adverse effects on immune function and virus replication. Combined therapeutic modalities should also be appropriately evaluated at the preclinical level. Clinical evaluations should be instituted only after a strong rationale is substantiated and safety concerns are fully considered. Initial studies should be conducted with patients at an intermediate stage of HIV disease progression. Immunomodulators may exhibit unusual dose-response patterns, and this should be considered when designing the trials. The consultation recommended that WHO continue to provide a forum for the timely exchange and validation of information related to the development and clinical evaluation of immunomodulators for the treatment of individuals infected with HIV.
一系列免疫调节策略为治疗HIV感染者带来了希望；然而，在我们对HIV感染进展过程中免疫系统正常调节的理解方面，仍然存在许多空白。免疫调节剂的临床前开发必须包括使用该免疫调节物质的有力理论依据，并通过适当的实验室研究（包括体外和体内研究）加以证实。临床前研究必须证明所提议治疗药物的安全性，包括评估其对免疫功能和病毒复制的潜在不良影响。联合治疗方式也应在临床前水平进行适当评估。只有在有充分的理论依据且充分考虑安全问题之后，才应开展临床评估。初始研究应在HIV疾病进展的中期阶段患者中进行。免疫调节剂可能表现出不寻常的剂量反应模式，在设计试验时应予以考虑。该咨询建议世卫组织继续提供一个论坛，以便及时交流和验证与用于治疗HIV感染者的免疫调节剂的开发和临床评估相关的信息。
