Actively Recruiting
Comparisons of Treatment Responses of Early Syphilis to Benzathine Penicillin G With or Without Doxycycline
Led by National Taiwan University Hospital · Updated on 2025-11-18
688
Participants Needed
9
Research Sites
260 weeks
Total Duration
On this page
Sponsors
N
National Taiwan University Hospital
Lead Sponsor
N
National Taiwan University Hospital Hsin-Chu Branch
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparisons of Treatment Responses of Early Syphilis to Benzathine Penicillin G With or Without Doxycycline
Who Can Participate
Eligibility Criteria
You may qualify if you...
- People living with HIV aged 6518 years with early syphilis
- Confirmed by a positive rapid plasma reagin (RPR) titer with a reactive TPPA assay
You will not qualify if you...
- People with HIV who have RPR titers less than 4
- Exposure to antibiotics effective against T. pallidum within the last 4 weeks (including penicillin, 3rd cephalosporin, doxycycline, macrolides)
- Known or suspected infections requiring antimicrobial treatment active against T. pallidum
- Positive test for C. trachomatis and M. genitalium treated with doxycycline or macrolides
- History of intolerance to penicillin or doxycycline
- Prior participation in this study
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 9 locations
1
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, Taiwan, Taiwan, 110
Actively Recruiting
2
Far Eastern Memorial Hospital
Taipei, Taiwan, Taiwan, 110
Actively Recruiting
3
National Taiwan University Hospital
Taipei, Taiwan, Taiwan, 110
Actively Recruiting
4
Taipei Vetetrans General Hospital
Taipei, Taiwan, Taiwan, 110
Actively Recruiting
5
Taoyuan General Hospital
Taoyuan, Taiwan, Taiwan, 110
Actively Recruiting
6
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
7
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
Actively Recruiting
8
Chi Mei Medical Hospital
Tainan, Taiwan
Actively Recruiting
9
National Cheng-Kung University Hospital
Tainan, Taiwan
Actively Recruiting
Research Team
K
Kuan-Yin Lin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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