Comparisons of Treatment Responses of Early Syphilis to Benzathine Penicillin G With or Without Doxycycline
Recruiting · NCT06069141 · Interventional (participants receive a specific treatment) · Lead sponsor: National Taiwan University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- People living with HIV (PLWH) aged ≥18 years with early syphilis
- Confirmed by a positive RPR titer with a reactive TPPA assay
Exclusion criteria
- PWH with RPR titers of \<4
- Subject has latent syphilis of unknown duration, late latent syphilis, or evidence of neurosyphilis, including ocular involvement.
- 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 at baseline (penicillin, 3rd cephalosporin, doxycycline, macrolides)
- A history of intolerance to penicillin or doxycycline
- PLWH have already participated in this study
- Pregnancy
Where it is running
9 locations listed.
- 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
- 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, Taiwan, Taiwan