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The results of the ACTG Phase II/III study will be submitted by Unimed to the FDA.
We are pleased that after an extensive review of NTZ, the ACTG chose to study it in treating cryptosporidial diarrhea," said Stephen M.
ACTG 116B/117 investigators reported that patients who were randomized to VIDEX at 500 mg/day -- which correlates to the currently recommended dose -- had a statistically significant delay in time to first new AIDS defining event or death compared to those randomized to AZT.
In April 1992, an FDA advisory panel reviewed the preliminary results of ACTG 116B/117 and agreed that the clinical benefits of VIDEX had been confirmed.
In ACTG 116B/117, VIDEX was well tolerated in the majority of patients.