International Journal of STD & AIDS > Volume 20, Number 6 > Pp. 384-386

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Original research articles

Safety evaluation of 1% tenofovir gel in healthy men

J L Schwartz MD ^* , A Poindexter MD , A Wheeless BSPH , C K Mauck MD ^* and M M Callahan M.Ed ^*

^* Department of Obstetrics and Gynecology, CONRAD, Eastern Virginia Medical School, Arlington, VA 22209; Advances in Health, Inc., Houston, TX 77030; Family Health International, Research Triangle Park, NC 27713, USA

Correspondence to: Dr J L Schwartz, CONRAD, 1911 Fort Meyer Drive, Suite 900, Arlington, VA 22209, USA Email: jschwartz{at}conrad.org

This study was conducted to determine the safety of tenofovir (TFV) gel, a potential microbicide, following seven consecutive daily penile applications. Eighteen circumcised and 18 uncircumcised healthy men were randomly assigned to TFV gel versus K-Y^® Jelly in a 2:1 ratio within circumcision group. TFV gel or K-Y Jelly was applied onto the penis at bedtime and washed off 6–10 hours later. Safety was assessed by reported symptoms, findings and laboratory tests. Three of 24 (13%) men in the TFV group reported mild genital symptoms compared with two of 11 (18%) men in the K-Y group. Few mild genital findings were observed and no significant systemic toxicities were reported or observed. TFV gel applied to the penis for seven days was well tolerated locally and systemically and it is unlikely that male partners exposed to small amounts of TFV gel will experience significant genital or systemic toxicity.

Key Words: microbicides • HIV prevention • tenofovir gel • antiretroviral

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