Dr. Anton, a member of ARAA's Medical Executive Committee, has a long-standing interest in the involvement of gut-associated lymphoid tissue in the natural course of HIV infection. As detailed in the previous issue of Searchlight, his lab has been developing techniques to measure HIV within gut tissue, as well as to assay immune activation markers.
The gut, which contains the majority of the body's immune cells, is thought to be significantly inflamed in HIV-infected individuals. Inflammation in turn both promotes the ongoing replication of HIV and increases the number of cells that can be infected by the virus. This permissive environment for continuous viral expansion very likely represents a substantial impediment to the success of treatment with antiretroviral therapy.
In theory, an anti-inflammatory treatment for the gut, provided as an adjunct to conventional anti-HIV "cocktail" therapy, would provide improved control of HIV replication. This therapeutic approach could potentially also address symptoms associated with inflamed bowels, such as diarrhea, that are frequently presented by HIV-infected individuals.
Asacol is the brand name for mesalamine, a compound related to aspirin but in a form that is generally non-absorbed, is topically active, and has minimal side effects. Currently, Proctor and Gamble markets it for the treatment of inflammatory bowel disease.
The present study is designed primarily to assess the safety of Asacol as an adjunctive therapy in an HIV-infected population. However, some efficacy data will also be gathered, particularly on the viral responses in both the gut and the blood of participants. These data will then be used to design a subsequent trial to statistically test the efficacy of Asacol in a larger study population.
Consistent with its role as a specialized "niche" contract research organization, ARAA has been helping to design the present trial, in addition to spearheading patient enrollment, and will likely do so again in subsequent trials as well. Furthermore, this study has been largely enrolled with volunteers who participate in ARAA's Clinical Trials Priority Notification Program. The trial is still open to enrollment. For more information, call Marie Fuerst, R.N. at 310.825.9254.