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1 October 2006

Volume 194, Number 7
The Journal of Infectious Diseases 2006;194:904–911
© 2006 by the Infectious Diseases Society of America. All rights reserved.
0022-1899/2006/19407-0006$15.00
DOI: 10.1086/507306
MAJOR ARTICLE

Chemoprophylaxis with Tenofovir Disoproxil Fumarate Provided Partial Protection against Infection with Simian Human Immunodeficiency Virus in Macaques Given Multiple Virus Challenges

Shambavi Subbarao,1

Ronald A. Otten,1

Artur Ramos,1

Caryn Kim,1

Eddie Jackson,2

Michael Monsour,1

Debra R. Adams,1

Sheila Bashirian,1

Jeffrey Johnson,1

Vincent Soriano,4

Ana Rendon,4

Michael G. Hudgens,3

Salvatore Butera,1

Robert Janssen,1

Lynn Paxton,1

Alan E. Greenberg,1 and

Thomas M. Folks1

1Division of HIV/AIDS Prevention, National Center for HIV, STD, & TB Prevention, and 2Scientific Resources Program, National Center for Infectious Diseases, Coordinating Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; 3University of North Carolina at Chapel Hill, Chapel Hill; 4Department of Infectious Diseases, Hospital Carlos III, Madrid, Spain

We examined the efficacy of tenofovir disoproxil fumarate (TDF) in blocking simian human immunodeficiency virus (SHIV) infection in Chinese rhesus macaques. Once weekly for 14 weeks or until a macaque became infected, 12 male macaques were inoculated intrarectally with amounts of SHIVSF162P3 (10 median tissue culture infective doses; virus particles) that were 5‐fold higher than the human immunodeficiency virus type 1 RNA levels noted in human semen during an acute infection. Of the 12 macaques, 4 received oral TDF daily, 4 received oral TDF once weekly, and 4 (control animals) received no TDF. The control animals became infected after receiving a median of 1.5 virus inoculations; macaques receiving TDF daily (1 macaque remained uninfected after 14 inoculations) and those receiving TDF weekly became infected after a median duration of 6.0 and 7.0 weeks, respectively. Although infection was delayed in treated macaques, compared with control macaques, the differences were not statistically significant ( ); however, the study was limited by the small numbers of animals evaluated and the variability in blood levels of TDF that resulted from oral dosing. These data demonstrate that treatment with oral TDF provided partial protection against SHIV infection but ultimately did not protect all TDF treated animals against multiple virus challenges.

Received 23 January 2006; accepted 15 April 2006; electronically published 29 August 2006.

Reprints or correspondence: Dr. Shambavi Subbarao, HIV/AIDS and Retrovirology Branch, MS G‐19, 1600 Clifton Rd. NE, Atlanta, GA 30333 ().

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  • Presented in part: 12th Conference on Retroviruses and Opportunistic Infections, Boston, Massachusetts, 22–25 February 2005 (abstract 136LB).

    Financial support: National Institutes of Health (grant P30 AI50410‐08 to M.G.H. [for research on statistical methods]).

    Potential conflicts of interest: none reported.

    The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention.

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