A randomized trial of enhanced therapy for early syphilis in patients with and without human immunodeficiency virus infection

Robert T. Rolfs, M. Riduan Joesoef, Edward F. Hendershot, Anne Marie Rompalo, Michael H. Augenbraun, Michael Chiu, Gail Bolan, Steven C. Johnson, Pamela French, Eric Steen, Justin D. Radolf, Sandra Larsen, William E. Brady, Kenneth F. Wagner, Debra A. D'Aquilante

Research output: Contribution to journalArticle

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 end 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 bad 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.

Original languageEnglish (US)
Pages (from-to)307-314
Number of pages8
JournalNew England Journal of Medicine
Volume337
Issue number5
DOIs
StatePublished - Jul 31 1997

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Virus Diseases
Syphilis
HIV
Treponema pallidum
Treatment Failure
Therapeutics
Penicillin G Benzathine
Neurosyphilis
Cerebrospinal Fluid
Probenecid
Amoxicillin
Chancre
Fluid Therapy
Exanthema

ASJC Scopus subject areas

  • Medicine(all)

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A randomized trial of enhanced therapy for early syphilis in patients with and without human immunodeficiency virus infection. / Rolfs, Robert T.; Joesoef, M. Riduan; Hendershot, Edward F.; Rompalo, Anne Marie; Augenbraun, Michael H.; Chiu, Michael; Bolan, Gail; Johnson, Steven C.; French, Pamela; Steen, Eric; Radolf, Justin D.; Larsen, Sandra; Brady, William E.; Wagner, Kenneth F.; D'Aquilante, Debra A.

In: New England Journal of Medicine, Vol. 337, No. 5, 31.07.1997, p. 307-314.

Research output: Contribution to journalArticle

Rolfs, RT, Joesoef, MR, Hendershot, EF, Rompalo, AM, Augenbraun, MH, Chiu, M, Bolan, G, Johnson, SC, French, P, Steen, E, Radolf, JD, Larsen, S, Brady, WE, Wagner, KF & D'Aquilante, DA 1997, 'A randomized trial of enhanced therapy for early syphilis in patients with and without human immunodeficiency virus infection', New England Journal of Medicine, vol. 337, no. 5, pp. 307-314. https://doi.org/10.1056/NEJM199707313370504
Rolfs, Robert T. ; Joesoef, M. Riduan ; Hendershot, Edward F. ; Rompalo, Anne Marie ; Augenbraun, Michael H. ; Chiu, Michael ; Bolan, Gail ; Johnson, Steven C. ; French, Pamela ; Steen, Eric ; Radolf, Justin D. ; Larsen, Sandra ; Brady, William E. ; Wagner, Kenneth F. ; D'Aquilante, Debra A. / A randomized trial of enhanced therapy for early syphilis in patients with and without human immunodeficiency virus infection. In: New England Journal of Medicine. 1997 ; Vol. 337, No. 5. pp. 307-314.
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AU - Rolfs, Robert T.

AU - Joesoef, M. Riduan

AU - Hendershot, Edward F.

AU - Rompalo, Anne Marie

AU - Augenbraun, Michael H.

AU - Chiu, Michael

AU - Bolan, Gail

AU - Johnson, Steven C.

AU - French, Pamela

AU - Steen, Eric

AU - Radolf, Justin D.

AU - Larsen, Sandra

AU - Brady, William E.

AU - Wagner, Kenneth F.

AU - D'Aquilante, Debra A.

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N2 - 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 end 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 bad 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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