Step 1—Discuss the potential request informally with the Program Officer
Investigators with a promising topical microbicide and/or barrier device should contact the Project Officer and complete a Request for Access form. Products may be in the early stage of formulation. Your request will be considered vis a vis the standard criteria listed below.
Step 2—Applications will be prioritized by a joint committee of staff from the Division of Microbiology and Infectious Diseases and the Division of AIDS according to the standard criteria noted above. Preliminary data is considered in the decision making process. Requests supported by preliminary initial safety testing data, such as in vitro cellular safety testing and /or toxicity testing in one small animal model toxicity testing, such as the rabbit vaginal irritation test, may be authorized for further safety testing and may be followed by efficacy testing.
Last Updated January 06, 2014