11.0 Evaluation of Results 
11.1 Criteria for Response 
There are three primary clinical endpoints in this study. 
First, we will determine whether CD4 + T cells which express the 
Rev M10 gene have enhanced survival in patients with chronic HIV 
infection. The presence of these genetically modified cells will 
be quantitated using a limiting dilution PCR technique in which 
cells from the patient are diluted with a fixed number of 
untransfected control cells and the frequency of positive cells 
is determined as a function of time. Since a parallel population 
of cells will be transduced with a control vector in which the 
Rev M10 gene product is not synthesized, the survival of the two 
populations can be compared. 
A second endpoint is to characterize the immune response of 
the host against the Rev M10 gene product. We will determine 
whether antibodies are generated to Rev M10 by Western blot and 
immunoprecipitation analyses. In addition, we will determine 
whether cytolytic T cells are induced in patients which recognize 
cells containing Rev M10. Although Rev M10 is a nuclear protein 
and no immune cells have been detected previously in animal 
models, it is not known whether the expression of this gene might 
affect the immune system differently in man. Such a response 
would interfere with the constitutive expression of the dominant 
negative protective gene. Should this occur, however, it would 
be important to know it, since it might provide a strategy to 
enhance immune recognition of cells latently infected with HIV. 
[28] 
Recombinant DNA Research, Volume 18 
