Report of a WHO informal consultation on preclinical and clinical aspects of the use of immunomodulators in HIV infection. Geneva, 3-5 April 1989. World Health Organization Global Programme on AIDS.
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.
D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004341:Drug Evaluation; D015658:HIV Infections / Q000276:immunology / Q000628:therapy*; D006801:Humans; D007167:Immunotherapy; D014944:World Health Organization
D000276:Adjuvants, Immunologic