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Comparisons of Treatment Responses of Early Syphilis to Benzathine Penicillin G With or Without Doxycycline
Sponsor: National Taiwan University Hospital
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.
Official title: Comparisons of Treatment Responses of Early Syphilis to 2.4 Milliunits (MU) Single-dose Benzathine Penicillin G With or Without Doxycycline in People Living With HIV
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
688
Start Date
2024-01-01
Completion Date
2028-12-31
Last Updated
2025-11-18
Healthy Volunteers
No
Interventions
Benzathine Penicillin G
Benzathine Penicillin G (2.4 MU intramuscularly once)
Doxycycline Capsule
doxycycline (100 mg orally twice daily for 7 days)
Locations (9)
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, Taiwan, Taiwan
Far Eastern Memorial Hospital
Taipei, Taiwan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan, Taiwan
Taipei Vetetrans General Hospital
Taipei, Taiwan, Taiwan
Taoyuan General Hospital
Taoyuan District, Taiwan, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
Chi Mei Medical Hospital
Tainan, Taiwan
National Cheng-Kung University Hospital
Tainan, Taiwan