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

Not Applicable

Not yet recruiting

• Conditions: Early Syphilis, Latent, Serological Relapse After Treatment
• Interventions: Drug: Benzathine Penicillin G; Drug: Doxycycline Capsule

• Registration Number: NCT06069141
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study Start: 2023-10
• Study First Submitted: 2023-10-01
• Study First Submitted QC: 2023-10-01
• Last Update Submitted: 2023-10-01
• Study First Posted: 2023-10-05
• Last Update Posted: 2023-10-05
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 688

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single-dose BPG plus doxycycline	Benzathine Penicillin G	single-dose benzathine penicillin G (2.4 MU intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days)
single-dose BPG plus doxycycline	Doxycycline Capsule	single-dose benzathine penicillin G (2.4 MU intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days)
single-dose BPG	Benzathine Penicillin G	single-dose benzathine penicillin G (2.4 MU intramuscularly once)

Primary Outcome Measures

Name	Time	Method
Serologic response	Weeks 24 and week 48	Either a 4-fold or greater decline in RPR titer compared to baseline or being RPR-nonreactive

Secondary Outcome Measures

Name	Time	Method
Microbiologic response of syphilis	Week 4	T. pallidum PCR Ct value \>38
Microbiologic response of bacterial STIs	Week 4	negative STI PCR results
Safety of study treatment	Week 4
Adherence evaluation of tablet intake	Week 4

Trial Locations

Locations (9)

National Taiwan University Hospital Hsin-Chu Branch; 🇨🇳 Hsin-Chu, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan

Chi Mei Medical Hospital; 🇨🇳 Tainan, Taiwan

National Cheng-Kung University Hospital; 🇨🇳 Tainan, Taiwan

Far Eastern Memorial Hospital; 🇨🇳 Taipei, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Taipei Vetetrans General Hospital; 🇨🇳 Taipei, Taiwan

Taoyuan General Hospital; 🇨🇳 Taoyuan, Taiwan