FDA Antiviral Drugs Advisory
Committee Meeting
1
May 19, 2005
Question 1
Do the data demonstrate that tipranavir/ritonavir
(TPV/r)
is safe and effective for the multi-drug resistant HIV-1
infected
population?
•If no, what additional
data are needed to provide evidence of safety and efficacy?
•If yes, please address
the appropriate population for TPV/r use considering the following:
–limited inclusion
criteria of the RESIST trials
–drug-drug interactions
–resistance information
and patterns associated with optimal use
–safety considerations