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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - People living with HIV (PLWH) aged ≥18 years with early syphilis - Confirmed by a positive RPR titer with a reactive TPPA assay Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Benzathine Penicillin G

Benzathine Penicillin G (2.4 MU intramuscularly once)

DRUG

Doxycycline 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 District, 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