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HIV/AIDS Prevention
HIV prevention drug gets U.S. FDA clearance to advance in phase 1 clinical trial
September 5th, 2004
Starpharma Holdings Limited (SPL) announced that VivaGel, its new drug for the prevention of HIV, is advancing to the next stage of dosing in the current phase 1 study. The U.S. Food and Drug Administration (FDA) has reviewed Starpharma's interim study results and has given clearance to proceed using the highest dosage concentrate planned for this study. This next stage involves administration of VivaGel containing 3.0% of the active dendrimer ingredient, SPL7013, and placebo gel to a group of healthy women. This is the continuation of the U.S. IND Study No. SPL7013-001, investigating escalating formulation strengths of VivaGel. The study is the...
Source: Medical Letter on the CDC & FDA (2004-09-05)
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