A randomized trial of enhanced therapy for early syphilis in patients with and without human immunodeficiency virus infection.
Open accessAbstract
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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Available data demonstrate that use of additional doses of benzathine penicillin G, amoxicillin, or other antibiotics do not enhance efficacy of the recommended regimen when used to treat primary and secondary syphilis, regardless of HIV status.
“Available data demonstrate that use of additional doses of benzathine penicillin G, amoxicillin, or other antibiotics do not enhance efficacy of this recommended regimen when used to treat primary and secondary syphilis, regardless of HIV status (591–593).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [591]
Clinical trial data demonstrate that 10%-20% of persons with primary and secondary syphilis treated with recommended therapy will not achieve a fourfold decrease in nontreponemal titer within 12 months after treatment.
“However, clinical trial data have demonstrated that 10%–20% of persons with primary and secondary syphilis treated with the recommended therapy will not achieve the fourfold decrease in nontreponemal titer within 12 months after treatment (591,596,597).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [591]
Additional doses of benzathine penicillin G, amoxicillin, or other antibiotics in primary and secondary syphilis among persons with HIV infection do not result in enhanced efficacy.
“Available data demonstrate that additional doses of benzathine penicillin G, amoxicillin, or other antibiotics in primary and secondary syphilis among persons with HIV infection do not result in enhanced efficacy (592,593,609).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [609]
No treatment regimens for syphilis have been demonstrated to be more effective in preventing neurosyphilis among persons with HIV infection than the syphilis regimens recommended for persons without HIV.
“Although long-term (>1 year) comparative data are lacking, no treatment regimens for syphilis have been demonstrated to be more effective in preventing neurosyphilis among persons with HIV infection than the syphilis regimens recommended for persons without HIV (609).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [609]
Additional doses of benzathine penicillin G, amoxicillin, or other antibiotics in early latent syphilis do not enhance efficacy, regardless of HIV status.
“Available data demonstrate that additional doses of benzathine penicillin G, amoxicillin, or other antibiotics in early latent syphilis do not enhance efficacy, regardless of HIV status (592,593,609).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [609]
Prolonged treatment or additional antibiotic therapy has not been associated with significantly better outcomes.
“Prolonged treatment or additional antibiotic therapy has not been associated with significantly better outcomes.138,139”
From BASHH UK guidelines for the management of syphilis 2024 (2024) · cites this paper as [138]
For all stages of syphilis, there is no evidence to suggest that people living with HIV need to be treated differently compared to HIV-negative individuals.
“For all stages of syphilis, there is no evidence to suggest that people living with HIV need to be treated differently compared to HIV-negative individuals134–138: 1B.”
From BASHH UK guidelines for the management of syphilis 2024 (2024) · cites this paper as [138]
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BackgroundAntibiotic therapy for adults with neurosyphilis
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- Authors
- Rolfs, R. T., Joesoef, M. R., Hendershot, E. F., Rompalo, A. M., Augenbraun, M. H., Chiu, M., Bolan, G., Johnson, S. C., French, P., Steen, E., Radolf, J. D., Larsen, S., Brady, W. E., Wagner, K. F., & D'Aquilante, D. A.
- Affiliations
- Centers for Disease Control and Prevention (US)
- National Center for HIV/AIDS Viral Hepatitis STD and TB Prevention (US)
- Philadelphia Department of Public Health (US)
- Johns Hopkins University (US)
- State University of New York (US)
- The University of Texas Southwestern Medical Center (US)
- San Francisco Department of Public Health (US)
- Walter Reed National Military Medical Center (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 1997-07-31
- Volume
- 337
- Issue
- 5
- Pages
- 307-314
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2325386765
- Cited by
- 550
- References
- 57
- Citations by year
- 2026: 12 · 2025: 11 · 2024: 16 · 2023: 24 · 2022: 9 · 2021: 16 · 2020: 23 · 2019: 16 · 2018: 20 · 2017: 17 · 2016: 12 · 2015: 30 · 2014: 31 · 2013: 24 · 2012: 19
- FWCI
- 6.92
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Syphilis Diagnosis and Treatment
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Historical Medical Research and Treatments
- Life Sciences › Immunology and Microbiology › Parasitology › Vector-borne infectious diseases
- Keywords
- early syphilis, HIV infection, benzathine penicillin G, amoxicillin, probenecid, Treponema pallidum, cerebrospinal fluid, neurosyphilis, treatment failure, chancre, serological response
- MeSH terms
- Adult, Amoxicillin, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Male, Penicillin G Benzathine, Penicillins, Probenecid, Syphilis, Syphilis Serodiagnosis, Treponema pallidum, HIV Infections, Treatment Failure
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Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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