Comparing treatments for early syphilis in people living with HIV
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
This study is testing if combining benzathine penicillin G with doxycycline works better than just benzathine penicillin G alone to treat early syphilis in adults living with HIV.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 688 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 9 sites (Hsinchu, Taiwan and 8 other locations) |
| Trial ID | NCT06069141 on ClinicalTrials.gov |
What this trial studies
This randomized controlled study aims to evaluate the effectiveness of benzathine penicillin G combined with doxycycline versus benzathine penicillin G alone in treating early syphilis among adults living with HIV. Participants will be randomly assigned to receive either treatment and will be monitored for serologic and microbiologic responses over a period of 48 weeks. The primary outcome is a significant decline in rapid plasma reagin (RPR) titer, while secondary outcomes include the assessment of other sexually transmitted infections. The study is set to take place from 2023 to 2025.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are living with HIV and have been newly diagnosed with early syphilis.
Not a fit: Patients who have a history of intolerance to penicillin or doxycycline, or those who are pregnant, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment regimen for early syphilis in individuals living with HIV.
How similar studies have performed: Other studies have shown varying success with similar antibiotic combinations for treating syphilis, but this specific approach is being evaluated for the first time in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hsinchu, Taiwan and 8 other locations
- National Taiwan University Hospital Hsin-Chu Branch — Hsinchu, Taiwan, Taiwan (Recruiting)
- Far Eastern Memorial Hospital — Taipei, Taiwan, Taiwan (Recruiting)
- National Taiwan University Hospital — Taipei, Taiwan, Taiwan (Recruiting)
- Taipei Vetetrans General Hospital — Taipei, Taiwan, Taiwan (Recruiting)
- Taoyuan General Hospital — Taoyuan, Taiwan, Taiwan (Recruiting)
- Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan (Recruiting)
- Kaohsiung Veterans General Hospital — Kaohsiung City, Taiwan (Recruiting)
- Chi Mei Medical Hospital — Tainan, Taiwan (Recruiting)
- National Cheng-Kung University Hospital — Tainan, Taiwan (Recruiting)
Study contacts
- Study coordinator: Kuan-Yin Lin, MD
- Email: kuanyin0828@gmail.com
- Phone: +886-975607715
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.