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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
688
Benzathine Penicillin G (2.4 MU intramuscularly once)
doxycycline (100 mg orally twice daily for 7 days)
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, Taiwan, Taiwan
RECRUITINGFar Eastern Memorial Hospital
Taipei, Taiwan, Taiwan
RECRUITINGNational Taiwan University Hospital
Taipei, Taiwan, Taiwan
RECRUITINGTaipei Vetetrans General Hospital
Taipei, Taiwan, Taiwan
RECRUITINGTaoyuan General Hospital
Taoyuan District, Taiwan, Taiwan
RECRUITINGKaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
RECRUITINGKaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
RECRUITINGChi Mei Medical Hospital
Tainan, Taiwan
RECRUITINGNational Cheng-Kung University Hospital
Tainan, Taiwan
RECRUITINGSerologic response
Either a 4-fold or greater decline in RPR titer compared to baseline or being RPR-nonreactive
Time frame: Weeks 24 and week 48
Microbiologic response of syphilis
T. pallidum PCR Ct value \>38
Time frame: Week 4
Microbiologic response of bacterial STIs
negative STI PCR results
Time frame: Week 4
Safety of study treatment
Time frame: Week 4
Adherence evaluation of tablet intake
Time frame: Week 4
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