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RECRUITING
NCT06069141
NA

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

Sponsor: National Taiwan University Hospital

View on ClinicalTrials.gov

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

DRUG

Benzathine Penicillin G

Benzathine Penicillin G (2.4 MU intramuscularly once)

DRUG

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