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www.fdanews.com/articles/83198-samaritan-reaches-concluding-stages-of-hiv-monotherapy-trial

SAMARITAN REACHES CONCLUDING STAGES OF HIV MONOTHERAPY TRIAL

December 16, 2005

Samaritan Pharmaceuticals announced today that it has nearly completed enrollment in its Phase II double-blind, placebo-controlled, multidose, 10-day monotherapy study. The trial assessed the safety and effect of monotherapy with SP01A, on viral load in HIV-positive individuals with evidence of increasing viral load, despite treatment with other antiretroviral therapy.

The trial involved 32 evaluable patients split into four dose groups. The treatment groups consisted of placebo, 200mg SP01A daily, 400mg SP01A daily, 800mg SP01A daily. The primary analysis for the study is the reduction of viral load within each of the four arms, as measured from baseline to Day 10.