RecruitingNot ApplicableNCT06069141

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


Sponsor

National Taiwan University Hospital

Enrollment

688 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two antibiotic treatments — benzathine penicillin G alone vs. benzathine penicillin G plus doxycycline — for treating early syphilis in people living with HIV (PLWH). Syphilis can be harder to treat in people with HIV, and this study aims to find the most effective approach. **You may be eligible if...** - You are living with HIV and are 18 or older - You have been diagnosed with early syphilis (primary, secondary, or early latent) - Your syphilis has been confirmed by a positive RPR blood test with a reactive TPPA assay - Your RPR titer is 4 or higher **You may NOT be eligible if...** - Your RPR titer is below 4 - You have taken antibiotics active against syphilis in the past 4 weeks - You have another concurrent infection (like chlamydia or Mycoplasma genitalium) that requires overlapping antibiotic treatment with syphilis-active drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBenzathine Penicillin G

Benzathine Penicillin G (2.4 MU intramuscularly once)

DRUGDoxycycline Capsule

doxycycline (100 mg orally twice daily for 7 days)


Locations(9)

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Taiwan, Taiwan

Far Eastern Memorial Hospital

Taipei, Taiwan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Taipei Vetetrans General Hospital

Taipei, Taiwan, Taiwan

Taoyuan General Hospital

Taoyuan, Taiwan, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Chi Mei Medical Hospital

Tainan, Taiwan

National Cheng-Kung University Hospital

Tainan, Taiwan

View Full Details on ClinicalTrials.gov

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NCT06069141