NCT06069141 Comparisons of Treatment Responses of Early Syphilis to Benzathine Penicillin G With or Without Doxycycline
| NCT ID | NCT06069141 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Taiwan University Hospital |
| Condition | Early Syphilis, Latent, Serological Relapse After Treatment |
| Study Type | INTERVENTIONAL |
| Enrollment | 688 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 688 participants in total. It began in 2024-01-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06069141 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Early Syphilis, Latent, Serological Relapse After Treatment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06069141 currently recruiting?
Yes, NCT06069141 is actively recruiting participants. Contact the research team at kuanyin0828@gmail.com for enrollment information.
Where is the NCT06069141 trial being conducted?
This trial is being conducted at Hsinchu, Taiwan, Taipei, Taiwan, Taipei, Taiwan, Taipei, Taiwan and 5 additional locations.
Who is sponsoring the NCT06069141 clinical trial?
NCT06069141 is sponsored by National Taiwan University Hospital. The trial plans to enroll 688 participants.