Phase III trial of Italian HIV vaccine to begin in October
Phase III testing of an experimental HIV vaccine developed by researchers at Italy's University of Milan is scheduled to begin in October, with results due in about two years, Reuters Health reports. The vaccine uses an altered form of tat, an HIV protein, to prompt an immune system response that can keep HIV replication rates under control in people already infected with the virus. It is not designed to prevent infection. The Phase III trial will involve 120 HIV-positive adults and 40 HIV-negative adults.
"So far, the results are very encouraging," said Pier Mannuci, director of the Hemophilia and Thrombosis Center at the university. "We can claim that all patients enrolled in the [previous] trials are in good condition."
The trial will mark only the second Phase III trial--the final step before submitting a compound to regulators for marketing approval--for an experimental HIV vaccine. VaxGen's AIDSVAX is the only other experimental HIV vaccine to be in final-stage testing.