Status:
RECRUITING
Comparisons of Treatment Responses of Early Syphilis to Benzathine Penicillin G With or Without Doxycycline
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
National Taiwan University Hospital Hsin-Chu Branch
Far Eastern Memorial Hospital
Conditions:
Early Syphilis, Latent, Serological Relapse After Treatment
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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. Particip...
Eligibility Criteria
Inclusion
- People living with HIV (PLWH) aged ≥18 years with early syphilis
- Confirmed by a positive RPR titer with a reactive TPPA assay
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
688 Patients enrolled
Trial Details
Trial ID
NCT06069141
Start Date
January 1 2024
End Date
December 31 2028
Last Update
November 18 2025
Active Locations (9)
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1
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, Taiwan, Taiwan, 110
2
Far Eastern Memorial Hospital
Taipei, Taiwan, Taiwan, 110
3
National Taiwan University Hospital
Taipei, Taiwan, Taiwan, 110
4
Taipei Vetetrans General Hospital
Taipei, Taiwan, Taiwan, 110