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Antimicrobial Agents and Chemotherapy, May 2006, p. 1696-1700, Vol. 50, No. 5
0066-4804/06/$08.00+0     doi:10.1128/AAC.50.5.1696-1700.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

Preclinical Safety and Efficacy Assessments of Dendrimer-Based (SPL7013) Microbicide Gel Formulations in a Nonhuman Primate Model

D. L. Patton,1* Y. T. Cosgrove Sweeney,1 T. D. McCarthy,2 and S. L. Hillier3

University of Washington, Seattle, Washington,1 Starpharma Pty Limited, Melbourne, Australia,2 Magee-Womens Hospital, University of Pittsburgh, Pittsburgh, Pennsylvania3

Received 22 September 2005/ Returned for modification 30 January 2006/ Accepted 11 February 2006

Three gel formulations (1%, 3%, and 5% [wt/wt]) of SPL7013, a dendrimer known to have antiviral (anti-human immunodeficiency virus and anti-herpes simplex virus) activities, completed a range of preclinical tests in the pigtailed macaque models for vaginally and rectally applied topical microbicide safety assessments. The vaginal safety profile of the 3% SPL7013 gel formulation was equal to that of the 1% formulation but was superior to that of the 5% formulation. The 3% SPL7013 gel was further evaluated for rectal safety and for antichlamydial efficacy with cervical challenge with Chlamydia trachomatis. This first-generation dendrimer-based product was shown to be safe to the vaginal and rectal microenvironments with repeated daily use. However, a single intravaginal application of the 3% (wt/wt) SPL7013 gel did not provide protection from the acquisition of cervical chlamydial infection.

* Corresponding author. Mailing address: Department of Obstetrics and Gynecology, Box 356460, University of Washington, Seattle, WA 98195-6460. Phone: (206) 543-5554. Fax: (206) 616-9479. E-mail: dpatton{at}u.washington.edu.

Antimicrobial Agents and Chemotherapy, May 2006, p. 1696-1700, Vol. 50, No. 5
0066-4804/06/$08.00+0     doi:10.1128/AAC.50.5.1696-1700.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.



This article has been cited by other articles:

  • Sonza, S., Johnson, A., Tyssen, D., Spelman, T., Lewis, G. R., Paull, J. R. A., Tachedjian, G. (2009). Enhancement of Human Immunodeficiency Virus Type 1 Replication Is Not Intrinsic to All Polyanion-Based Microbicides. Antimicrob. Agents Chemother. 53: 3565-3568 [Abstract] [Full Text]  
  • McGowan, I (2008). Rectal microbicides: a new focus for HIV prevention. Sex. Transm. Infect. 84: 413-417 [Full Text]  


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