NCT06069141

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 688 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Early Syphilis, Latent, Serological Relapse After Treatment

Interventions

Type	Name	Description
DRUG	Benzathine Penicillin G	Benzathine Penicillin G (2.4 MU intramuscularly once)
DRUG	Doxycycline Capsule	doxycycline (100 mg orally twice daily for 7 days)

Timeline

• Start date: 2024-01-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2023-10-05
• Last updated: 2025-11-18

Locations

9 sites across 1 country: Taiwan