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LETTER |
The author is the Journals associate editor for HIV/AIDS and lesbian-gay-bisexual-transgender health.
Correspondence: Requests for reprints should be sent to Michael Gross, PhD, 1601 18th St NW, #716, Washington DC 20009 (e-mail: m144{at}earthlink.net).
In the June 2003 issue of the Journal, I posed the rhetorical question of why clinical trials of "pre-exposure prophylaxis" against sexual transmission were being planned for populations in developing countries, but not for men who have sex with men (MSM) who are at high risk of contracting HIV in the United States.1 As that issue of the Journal was in press, the Centers for Disease Control and Prevention (CDC) published plans to support a randomized, placebo-controlled trial of the extended safety and preliminary efficacy of once-daily oral administration of the antiretroviral drug tenofovir disoproxil fumarate (Viread) among high-risk MSM.2
In its announcement, the CDC cited animal data supporting the plausibility of using this strategy on uninfected high-risk individuals. Other considerations mentioned include a favorable safety profile to date for this relatively new drug, including low potential for selection of resistant strains of HIV. The planned study would address the critical question of potential adverse behavioral outcomes, such as increased rates of unprotected sex and exposure to other sexually transmitted diseases preventable by condoms. Other research objectives include obtaining a fuller safety profile and determining the acceptability of daily pill taking in a population not infected with HIV. The CDC deserves credit for having the vision and courage to initiate research that entails substantial risk yet can offer tremendous benefits in advancing our understanding and, perhaps, our arsenal of effective means of prevention.
References
1. Gross M. The second wave will drown us. Am J Public Health 2003;93:872881.
2. Extended safety and preliminary efficacy trial for HIV prevention among MSM. FedBizOpps Daily No. 0534. May 17, 2003. Available at: http://www.fbodaily.com/archive/2003/05-May/17-May-2003/FBO-00324723.htm. Accessed May 23, 2003.
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