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

NCT ID: NCT06069141

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

688 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Early Syphilis, Latent, Serological Relapse After Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single-dose BPG plus doxycycline

single-dose benzathine penicillin G (2.4 MU intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days)

Group Type ACTIVE_COMPARATOR

Benzathine Penicillin G

Intervention Type DRUG

Benzathine Penicillin G (2.4 MU intramuscularly once)

Doxycycline Capsule

Intervention Type DRUG

doxycycline (100 mg orally twice daily for 7 days)

single-dose BPG

single-dose benzathine penicillin G (2.4 MU intramuscularly once)

Group Type PLACEBO_COMPARATOR

Benzathine Penicillin G

Intervention Type DRUG

Benzathine Penicillin G (2.4 MU intramuscularly once)

Interventions

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Benzathine Penicillin G

Benzathine Penicillin G (2.4 MU intramuscularly once)

Intervention Type DRUG

Doxycycline Capsule

doxycycline (100 mg orally twice daily for 7 days)

Intervention Type DRUG

Eligibility Criteria

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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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital Hsin-Chu Branch

OTHER

Sponsor Role collaborator

Far Eastern Memorial Hospital

OTHER

Sponsor Role collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role collaborator

Taoyuan General Hospital

OTHER_GOV

Sponsor Role collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role collaborator

Chi Mei Medical Hospital

OTHER

Sponsor Role collaborator

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role collaborator

Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Taiwan, Taiwan

Site Status RECRUITING

Far Eastern Memorial Hospital

Taipei, Taiwan, Taiwan

Site Status RECRUITING

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Site Status RECRUITING

Taipei Vetetrans General Hospital

Taipei, Taiwan, Taiwan

Site Status RECRUITING

Taoyuan General Hospital

Taoyuan District, Taiwan, Taiwan

Site Status RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Chi Mei Medical Hospital

Tainan, , Taiwan

Site Status RECRUITING

National Cheng-Kung University Hospital

Tainan, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Kuan-Yin Lin, MD

Role: CONTACT

+886-975607715

Facility Contacts

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Kai-Hsiang Chen

Role: primary

+886-975607715

Chia-Hui Yang

Role: primary

+886-975607715

Kuan-Yin Lin

Role: backup

Kuan-Yin Lin

Role: primary

886-975-607715

Po-Liang Chen

Role: primary

+886-975607715

Cheng-pin Chen

Role: primary

+886-975607715

Po-Liang Lu

Role: primary

+886-975607715

Ya-Wei Weng

Role: primary

+886-975607715

Hung-Jen Tang

Role: primary

+886-975607715

Chin-Shiang Tsai

Role: primary

+886-975607715

Other Identifiers

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202305061MINA

Identifier Type: -

Identifier Source: org_study_id

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