title: Single Dose Versus 3 Doses of Intramuscular Benzathine Penicillin for Early Syphilis in HIV: A Randomized Clinical Trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  NCT02611765.
authors.affiliation: Section of Infectious Diseases, Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.
authors.forename: Roberto
authors.initials: R
authors.lastname: Andrade
authors.affiliation: Section of Infectious Diseases, Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.|Section of Infectious Diseases, Department of Medicine, Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas, USA.
authors.forename: Maria C
authors.initials: MC
authors.lastname: Rodriguez-Barradas
authors.affiliation: Department of Medicine, Alpert Medical School, Brown University, Providence, Rhode Island, USA.
authors.forename: Kosuke
authors.initials: K
authors.lastname: Yasukawa
authors.affiliation: Section of Infectious Diseases, Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.
authors.forename: Erick
authors.initials: E
authors.lastname: Villarreal
authors.affiliation: Department of Family Medicine and Community Health, University of Minnesota Medical School, Minneapolis, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Ross
authors.affiliation: Section of Infectious Diseases, Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.
authors.forename: Jose A
authors.initials: JA
authors.lastname: Serpa
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D005260:Female; D015658:HIV Infections / Q000150:complications*; D006801:Humans; D007273:Injections, Intramuscular; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010401:Penicillin G Benzathine / Q000008:administration & dosage*; D011446:Prospective Studies; D011935:Reagins / Q000097:blood; D013587:Syphilis / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D011935:Reagins; D010401:Penicillin G Benzathine
keywords: HIV; benzathine penicillin; clinical trial.; syphilis