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Clinical Safety and Pharmacology Trial

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Microbicides for Prevention of HIV Infection

Part of the book series: Current Topics in Microbiology and Immunology ((CT MICROBIOLOGY,volume 383))

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Abstract

Guidelines for establishing clinical safety of microbicides in early clinical studies have evolved significantly since the first trials. In addition, because of the difficulty of establishing efficacy of a microbicide prior to Phase III testing, there has been an increasing emphasis on establishing pharmacokinetic (PK)/pharmacodynamic (PD) relationships using genital samples collected in vivo in Phase I studies. A healthy pipeline is critical to success; however, it is unlikely that the majority of microbicide candidates will progress to clinical testing. Those that do enter clinical testing may have different mechanisms of action than early candidates. Given this, drug-specific modifications for early clinical assessment will need to be considered. These emerging issues associated with early clinical trials of microbicides will be reviewed, along with recommendations for future clinical safety and PK/PD evaluation.

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Authors and Affiliations

  1. CONRAD, 1911 North Fort Myer Drive, Suite 900, Arlington, VA, 22209, USA

    Christine Mauck & Jill Schwartz

  2. Department of Obstetrics and Gynecology, CONRAD, Eastern Virginia Medical School, Norfolk, VA, USA

    Andrea Thurman

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  1. Christine Mauck
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  2. Andrea Thurman
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  3. Jill Schwartz
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Correspondence to Christine Mauck .

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Editors and Affiliations

  1. Preclinical Sciences & Product Development, International Partnership for Microbicides, Silver Spring, Maryland, USA

    Jeremy Nuttall

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Mauck, C., Thurman, A., Schwartz, J. (2013). Clinical Safety and Pharmacology Trial. In: Nuttall, J. (eds) Microbicides for Prevention of HIV Infection. Current Topics in Microbiology and Immunology, vol 383. Springer, Berlin, Heidelberg. https://doi.org/10.1007/82_2013_355

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