First phase 1 double-blind, placebo-controlled, randomized rectal microbicide trial using UC781 gel with a novel index of ex vivo efficacy.

The treatment effect was highly significant for the 0.25% UC781 in vivo treated biopsies exposed ex vivo to 10 4 TCID 50 virus ( p<0.001 ).

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The same paired before-after comparisons for the 0.1% UC781 formulation demonstrate a trend toward suppression but with marginally significant or non-significant differences (10 2 virus: p = 0.69 at 10 cm, p = 0.038 at 30 cm; for 10 4 virus: p = 0.051 at 10 cm, p = 0.035 at 30 cm).

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