Comparisons of Treatment Responses of Early Syphilis to Benzathine Penicillin G With or Without Doxycycline
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Benzathine Penicillin G, Doxycycline Capsule.
- Who it may be relevant to
- Registry conditions: Early Syphilis, Latent, Serological Relapse After Treatment. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug Benzathine Penicillin G
Benzathine Penicillin G (2.4 MU intramuscularly once) - Drug Doxycycline Capsule
doxycycline (100 mg orally twice daily for 7 days)
Primary outcome measures
- Serologic response [Time frame: Weeks 24 and week 48]
Secondary outcome measures (4)
- Microbiologic response of syphilis [Time frame: Week 4]
- Microbiologic response of bacterial STIs [Time frame: Week 4]
- Safety of study treatment [Time frame: Week 4]
- Adherence evaluation of tablet intake [Time frame: Week 4]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 9 centers
- National Taiwan University Hospital Hsin-Chu Branch — Hsinchu
- Far Eastern Memorial Hospital — Taipei
- National Taiwan University Hospital — Taipei
- Taipei Vetetrans General Hospital — Taipei
- Taoyuan General Hospital — Taoyuan
- Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City
- Kaohsiung Veterans General Hospital — Kaohsiung City
- Chi Mei Medical Hospital — Tainan
- … and 1 more center
Identifiers
NCT: NCT06069141 · 202305061MINA