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
Background Reports of neurosyphilis and invasion of cerebrospinalfluid by Treponema pallidum in patients with human immunodeficiencyvirus (HIV) infection have led to doubts about the adequacyof the recommended penicillin G benzathine therapy for earlysyphilis.
Methods In a multicenter, randomized, double-blind trial, weassessed two treatments for early syphilis: 2.4 million unitsof penicillin G benzathine and that therapy enhanced with a10-day course of amoxicillin and probenecid. The serologic andclinical responses of patients with and without HIV infectionwere 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 butdiffered little from the uninfected patients in their clinicalpresentations. The rates at which chancres and rashes resolveddid not differ significantly according to treatment assignmentor HIV status. Serologically defined treatment failures weremore common among the HIV-infected patients. The single clinicallydefined treatment failure was in an HIV-infected patient. Ratesof serologically defined treatment failure did not differ accordingto treatment group (18 percent at six months with usual therapy;17 percent with enhanced therapy). T. pallidum was found atenrollment in the cerebrospinal fluid of 32 of 131 patients(24 percent) and after therapy in 7 of 35 patients tested. Nonehad clinically evident neurosyphilis, and the rate of detectionof T. pallidum did not differ according to HIV status.
Conclusions After treatment for primary or secondary syphilis,the HIV-infected patients responded less well serologicallythan the patients without HIV infection, but clinically definedfailure was uncommon in both groups. Enhanced treatment withamoxicillin and probenecid did not improve the outcomes. AlthoughT. pallidum was detected in cerebrospinal fluid before therapyin a quarter of the patients tested, such a finding did notpredict treatment failure. The current recommendations for treatingearly syphilis appear adequate for most patients, whether ornot they have HIV infection.
Source Information
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 PennsylvaniaHahnemann 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 PennsylvaniaHahnemann 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.
Treatment of Early Syphilis
Fantry L., Tramont E. C., Marra C. M., Rolfs R. T., Radolf J. D., Augenbraun M. H., Joesoef M. R.
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N Engl J Med 1997;
337:1697-1698, Dec 4, 1997.
Correspondence
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