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

NCT06069141

RecruitingNA

Sponsor: National Taiwan University Hospital

Conditions: Early Syphilis, Latent, Serological Relapse After Treatment

Interventions: Benzathine Penicillin G, Doxycycline Capsule

Countries: Taiwan

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (9)
  • Hsinchu, Taiwan, Taiwan
  • Taipei, Taiwan, Taiwan
  • Taipei, Taiwan, Taiwan
  • Taipei, Taiwan, Taiwan
  • Taoyuan, Taiwan, Taiwan
  • Kaohsiung City, Taiwan
  • Kaohsiung City, Taiwan
  • Tainan, Taiwan
  • Tainan, Taiwan