Phase 4 Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects With or Without HIV Infection

Summary

This is a phase 4, randomized, open-label, multicenter trial to evaluate the efficacy of a single injected dose of Benzathine Penicillin G (BPG) 2.4 MU (Arm 1) compared to three successive weekly injected doses of BPG 2.4 MU (Arm 2) for treatment of early syphilis in human immunodeficiency virus (HIV)-infected and HIV-uninfected subjects. The study will enroll 560 adults (to achieve 420 evaluable subjects) aged 18 years or older with untreated early syphilis (primary, secondary, or early latent). It will be conducted at 9 sites in the US and last for 48 months with patient participation duration of 12 months. The primary objective is to compare the serological response to therapy in subjects with early (primary, secondary, or early latent) syphilis treated with Benzathine Penicillin G (BPG) 2.4 million units (MU) once or weekly for three successive weeks.

Timeline

Start

2018-10-31

Primary completion

2022-09-07

Completion

2023-03-20

Publications

• Hook EW 3rd, Dionne JA, Workowski K, McNeil CJ, Taylor SN, Batteiger TA, Dombrowski JC, Mayer KH, Sena AC, Hamill MM, Wiesenfeld HC, Zhu C, Perlowski C, Mejia-Galvis JE, Newman LM. One Dose versus Three Doses of Benzathine Penicillin G in Early Syphilis. N Engl J Med. 2025 Sep 4;393(9):869-878. doi: 10.1056/NEJMoa2401802.
• Dionne JA, Zhu C, Mejia-Galvis J, Workowski K, Batteiger TA, Dombrowski JC, Mayer KH, McNeil CJ, Sena AC, Taylor S, Wiesenfeld HC, Hamill MM, Perlowski C, Hook EW 3rd. Jarisch-Herxheimer Reaction After Benzathine Penicillin G Treatment in Adults With Early Syphilis: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2459490. doi: 10.1001/jamanetworkopen.2024.59490.
• Dionne JA, Giacani L, Tamhane A, Workowski K, Lieberman NAP, Greninger AL, Perlowski C, Newman L, Hook EW 3rd. Prevalence and Predictors of Oral Treponema pallidum Detection by Quantitative Polymerase Chain Reaction in Early Syphilis. J Infect Dis. 2024 Jun 14;229(6):1628-1636. doi: 10.1093/infdis/jiad582.
• Dionne-Odom J, Workowski K, Perlowski C, Taylor SN, Mayer KH, McNeil CJ, Hamill MM, Dombrowski JC, Batteiger TA, Sena AC, Wiesenfeld HC, Newman L, Hook EW 3rd. Coinfection With Chlamydial and Gonorrheal Infection Among US Adults With Early Syphilis. Sex Transm Dis. 2022 Aug 1;49(8):e87-e89. doi: 10.1097/OLQ.0000000000001605. Epub 2022 Jan 24.

Drugs

Indications