Comparisons of Treatment Responses of Early Syphilis to Benzathine Penicillin G With or Without Doxycycline
Recruiting now · Not applicable
Conditions studied: Early Syphilis, Latent, Serological Relapse After Treatment
In brief
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.
Key facts
- Study ID
- NCT06069141
- Run by
- National Taiwan University Hospital
- People needed
- 688
- Starts
- 2024-01-01
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- People living with HIV (PLWH) aged ≥18 years with early syphilis
- Confirmed by a positive RPR titer with a reactive TPPA assay
You may not qualify if…
- PWH with RPR titers of <4
- Subject has latent syphilis of unknown duration, late latent syphilis, or evidence of neurosyphilis, including ocular involvement.
- 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 at baseline (penicillin, 3rd cephalosporin, doxycycline, macrolides)
- A history of intolerance to penicillin or doxycycline
- PLWH have already participated in this study
- Pregnancy
Where it is running
- National Taiwan University Hospital Hsin-Chu Branch — Hsinchu, Taiwan, Taiwan (enrolling)
- Far Eastern Memorial Hospital — Taipei, Taiwan, Taiwan (enrolling)
- National Taiwan University Hospital — Taipei, Taiwan, Taiwan (enrolling)
- Taipei Vetetrans General Hospital — Taipei, Taiwan, Taiwan (enrolling)
- Taoyuan General Hospital — Taoyuan, Taiwan, Taiwan (enrolling)
- Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan (enrolling)
- Kaohsiung Veterans General Hospital — Kaohsiung City, Taiwan (enrolling)
- Chi Mei Medical Hospital — Tainan, Taiwan (enrolling)
- National Cheng-Kung University Hospital — Tainan, Taiwan (enrolling)
Full record on ClinicalTrials.gov
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