Single Dose Versus 3 Doses of Intramuscular Benzathine Penicillin for Early Syphilis in HIV: A Randomized Clinical Trial

Roberto Andrade, Maria C. Rodriguez-Barradas, Kosuke Yasukawa, Erick Villarreal, Michael W Ross, Jose A. Serpa

Research output: Contribution to journalArticlepeer-review

10 Scopus citations

Abstract

Background.: Patients coinfected with syphilis and human immunodeficiency virus (HIV) may have a slower decrease in rapid plasma reagin (RPR) titers. Currently a single dose of 2.4 million units of intramuscular benzathine penicillin G (BPG) is recommended for the treatment of early syphilis. Some observational studies have suggested that this regimen may lead to high failure rates in coinfected patients.

Methods.: We conducted an open-label randomized clinical trial to compare the efficacy of single-dose and 3-dose regimens of BPG for the treatment of early syphilis in HIV-infected individuals. RPR titers were monitored every 3 months. Treatment success was defined as a decrease in RPR titers of ≥2 dilutions (4-fold) during a 12-month follow-up period.

Results.: Sixty-four patients were included. In the intention-to-treat analysis, treatment success rates were 80% (28 of 35 subjects) and 93% (27 of 29 subjects) in the single-dose and 3-dose regimens, respectively (absolute difference, 13% [95% confidence interval {CI}, -5% to 30%; P = .17). In the per-protocol analysis, success rates were 93% (27 of 29) and 100% in the single-dose and 3-dose regimens, respectively (absolute difference, 7% [95% CI, -7% to 22%]; P = .49). CD4 T-cell count, RPR titer and syphilis stage did not affect treatment results.

Conclusions.: When compared with a single dose of BPG, a 3-dose regimen did not improve syphilis serological outcomes. Our results support the Centers for Disease Control and Prevention recommendation of a single dose of BPG in HIV-infected patients with early syphilis.

Clinical Trials Registration.: NCT02611765.

Original languageEnglish (US)
Pages (from-to)759-764
Number of pages6
JournalClinical infectious diseases : an official publication of the Infectious Diseases Society of America
Volume64
Issue number6
DOIs
StatePublished - Mar 15 2017

Keywords

  • HIV
  • benzathine penicillin
  • clinical trial.
  • syphilis

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