Comparisons of Treatment Responses of Early Syphilis to Benzathine Penicillin G With or Without Doxycycline

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized controlled superiority study will be conducted during 2023-2025. The eligible participants are adult people living with HIV (PLWH) who are newly diagnosed with early syphilis. Participants will be randomized in a 1:1 ratio to receive single-dose benzathine penicillin G (BPG) (2.4 MU intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days) or single-dose BPG. The primary outcome is serologic response, defined as a decline of rapid plasma reagin (RPR) titer by 4-fold or greater, at week 24 and week 48; and the secondary outcomes include microbiologic response of syphilis and bacterial sexually transmitted infections (STIs) assessed by nucleic-acid amplification test (NAAT) at week 4.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Collaborators: Chi Mei Medical Hospital; Chiayi Christian Hospital; China Medical University Hospital; Far Eastern Memorial Hospital; Kaohsiung Medical University Chung-Ho Memorial Hospital; Kaohsiung Veterans General Hospital.; National Cheng-Kung University Hospital; National Taiwan University Hospital Hsin-Chu Branch; National Taiwan University Hospital, Yun-Lin Branch; Taipei Veterans General Hospital, Taiwan; Taoyuan General Hospital
• Treatments: Doxycycline; Penicillin G; Penicillin G Benzathine; Penicillin G Procaine; Penicillins

Criteria

Inclusion Criteria:

• People living with HIV (PLWH) aged ≥18 years with early syphilis

• Confirmed by a positive RPR titer with a reactive TPPA assay

Exclusion Criteria:

• PWH with RPR titers of <4

• Exposure to antibiotics with activity against T. pallidum within the preceding 4 weeks (penicillin, 3rd cephalosporin, doxycycline, macrolides)

• A known or suspected infection requiring additional treatment with an antimicrobial active against T. pallidum (penicillin, 3rd cephalosporin, doxycycline, macrolides)

• Testing positive for C. trachomatis and M. genitalium, for which doxycycline or macrolide was administered

• A history of intolerance to penicillin or doxycycline

• PLWH have already participated in this study

• Pregnancy