Compares two syphilis treatments in adults living with HIV
Tests penicillin injection with or without doxycycline pills for early syphilis in HIV.
Plain-language title generated from the registry record
Registry title: Comparisons of Treatment Responses of Early Syphilis to Benzathine Penicillin G With or Without Doxycycline
Key facts
- Where
- Hsinchu, Kaohsiung City, Tainan, Taipei, and Taoyuan, TaiwanSee the 9 sites
Where in Taiwan
- National Taiwan University Hospital Hsin Chu BranchHsinchu, TaiwanTaking people
- Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung City, TaiwanTaking people
- Kaohsiung Veterans General HospitalKaohsiung City, TaiwanTaking people
- Chi Mei Medical HospitalTainan, TaiwanTaking people
- National Cheng Kung University HospitalTainan, TaiwanTaking people
- Far Eastern Memorial HospitalTaipei, TaiwanTaking people
- National Taiwan University HospitalTaipei, TaiwanTaking people
- Taipei Vetetrans General HospitalTaipei, TaiwanTaking people
- Taoyuan General HospitalTaoyuan, TaiwanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Taiwan University Hospital
- Trial code
- NCT06069141
- Record updated
- 6 August 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: People living with HIV (PLWH) aged ≥18 years with early syphilis; Confirmed by a positive RPR titer with a reactive TPPA assay.
Exclusion: 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; 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); PLWH have already participated in this study; Pregnancy.