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Original Article
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Volume 337:307-314 July 31, 1997 Number 5
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A Randomized Trial of Enhanced Therapy for Early Syphilis in Patients with and without Human Immunodeficiency Virus Infection
Robert T. Rolfs, M.D., M. Riduan Joesoef, M.D., Ph.D., Edward F. Hendershot, M.D., Anne M. Rompalo, M.D., Michael H. Augenbraun, M.D., Michael Chiu, M.D., Gail Bolan, M.D., Steven C. Johnson, M.D., Pamela French, M.D., Eric Steen, M.D., Justin D. Radolf, M.D., Sandra Larsen, Ph.D., William E. Brady, Kenneth F. Wagner, Debra A. D'Aquilante, for The Syphilis and HIV Study Group

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ABSTRACT

Background Reports of neurosyphilis and invasion of cerebrospinal fluid by Treponema pallidum in patients with human immunodeficiency virus (HIV) infection have led to doubts about the adequacy of the recommended penicillin G benzathine therapy for early syphilis.

Methods In a multicenter, randomized, double-blind trial, we assessed two treatments for early syphilis: 2.4 million units of penicillin G benzathine and that therapy enhanced with a 10-day course of amoxicillin and probenecid. The serologic and clinical responses of patients with and without HIV infection were studied during one year of follow-up.

Results From 1991 through 1994, 541 patients were enrolled, including 101 patients (19 percent) who had HIV infection but differed little from the uninfected patients in their clinical presentations. The rates at which chancres and rashes resolved did not differ significantly according to treatment assignment or HIV status. Serologically defined treatment failures were more common among the HIV-infected patients. The single clinically defined treatment failure was in an HIV-infected patient. Rates of serologically defined treatment failure did not differ according to treatment group (18 percent at six months with usual therapy; 17 percent with enhanced therapy). T. pallidum was found at enrollment in the cerebrospinal fluid of 32 of 131 patients (24 percent) and after therapy in 7 of 35 patients tested. None had clinically evident neurosyphilis, and the rate of detection of T. pallidum did not differ according to HIV status.

Conclusions After treatment for primary or secondary syphilis, the HIV-infected patients responded less well serologically than the patients without HIV infection, but clinically defined failure was uncommon in both groups. Enhanced treatment with amoxicillin and probenecid did not improve the outcomes. Although T. pallidum was detected in cerebrospinal fluid before therapy in a quarter of the patients tested, such a finding did not predict treatment failure. The current recommendations for treating early syphilis appear adequate for most patients, whether or not they have HIV infection.


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From the Division of STD Prevention, National Center for HIV, STD, and Tuberculosis Prevention (R.T.R., M.R.J.), and the Division of STD Laboratory Research, National Center for Infectious Diseases (S.L.), Centers for Disease Control and Prevention, Atlanta; the Philadelphia Department of Public Health and the Medical College of Pennsylvania–Hahnemann University, Philadelphia (E.F.H., P.F.); the Baltimore Health Department and Johns Hopkins University Medical Center, Baltimore (A.M.R.); State University of New York Health Sciences Center at Brooklyn, Brooklyn (M.H.A.); the University of Texas Southwestern Medical Center, Dallas (M.C., E.S., J.D.R.); the San Francisco Department of Public Health, San Francisco (G.B.); Walter Reed Army Medical Center, Washington, D.C. (S.C.J.); and the National Naval Medical Center, Bethesda, Md. (S.L.). Other authors were William E. Brady, M.P.H. (National Center for HIV, STD, and Tuberculosis Prevention, Atlanta), Kenneth F. Wagner, D.O. (National Naval Medical Center, Bethesda, Md.), and Debra A. D'Aquilante, M.D. (Philadelphia Department of Public Health and Medical College of Pennsylvania–Hahnemann University, Philadelphia).

Address reprint requests to the Communications Office, National Center for HIV, STD, and Tuberculosis Prevention, Centers for Disease Control and Prevention, Mailstop E-06, Atlanta, GA 30333.

Full Text of this Article


Related Letters:

Treatment of Early Syphilis
Fantry L., Tramont E. C., Marra C. M., Rolfs R. T., Radolf J. D., Augenbraun M. H., Joesoef M. R.
Extract | Full Text  
N Engl J Med 1997; 337:1697-1698, Dec 4, 1997. Correspondence

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