Therapeutic Vaccine With No Known Side Effects:Why Delayed?
May 2, 2005
The AIDS Clinical Trials Group has been developing a Phase I study of DermaVir, which will be enroll 24 HIV-infected individuals receiving antiretroviral therapy. The study is AACTG 5176, chaired by Richard Pollard, with Julianna Lisziewicz as one of the investigators. The study is set to open to enrollment on August 15, 2005.
Do you know why The FDA forced the removal of the integrase gene from the trial? The FDA insisted on rabbit tests, delaying human tests, after monkey tests already showed excellent results? Patients not on HAART will not be included in the studies, although in monkeys "DermaVir alone somewhat blunted viral load"?
Response from Dr. Henry
Good questions for which I have do not have the answer(s). KH
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