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RecruitingNot ApplicableNCT06069141

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

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

Sponsor

National Taiwan University Hospital

Enrollment

688 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Early Syphilis, Latent, Serological Relapse After Treatment

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • People living with HIV (PLWH) aged ≥18 years with early syphilis
  • Confirmed by a positive RPR titer with a reactive TPPA assay

Exclusion Criteria7

  • PWH with RPR titers of \<4
  • 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 (penicillin, 3rd cephalosporin, doxycycline, macrolides)
  • Testing positive for C. trachomatis and M. genitalium, for which doxycycline or macrolide was administered
  • A history of intolerance to penicillin or doxycycline
  • PLWH have already participated in this study
  • Pregnancy

Interventions

DRUGBenzathine Penicillin G

Benzathine Penicillin G (2.4 MU intramuscularly once)

DRUGDoxycycline 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

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NCT06069141