Cell Culture Assays. It is desirable that new cell culture models be developed for HIV replication and AIDS-related malignancies that more closely simulate the in vivo state. For example, models that mimic the three dimensional, multicellular environment or those based on single cycle replication kinetics would be of utility. In Vivo Models. Models that reflect the current state of knowledge of HIV pathogenesis and are simpler, safer, more relevant and less expensive than currently available models are urgently needed for the evaluation of therapies for HIV disease and AIDS- related malignancies.
Novel approaches using transgenic and gene knockout animals are especially encouraged.
Although the use of small animals such as mice is most practical because of their availability and low cost, other animal models may be proposed. However, non-lentivirus models are not encouraged. For the models of both HIV disease and AIDS-related malignancies, the development of valid surrogate endpoints for survival is favored in the interest of conserving resources and reducing assay time and animal discomfort. New paradigms of HIV pathogenesis that can provide alternative treatment strategies are encouraged. Relevance to the in vivo disease state, reproducibility using appropriate statistical analysis, and other important parameters of the assay should be documented.