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
| Registry | NCT06069141 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 688 (Estimated) |
| Sponsor | National Taiwan University Hospital (Other); collaborators: National Taiwan University Hospital Hsin-Chu Branch, Far Eastern Memorial Hospital, Taipei Veterans General Hospital, Taiwan, Taoyuan General Hospital, National Cheng-Kung University Hospital, Chi Mei Medical Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Veterans General Hospital. |
| Conditions | Early Syphilis, Latent, Serological Relapse After Treatment |
| Interventions | Benzathine Penicillin G, Doxycycline Capsule (Drug) |
| Dates | start 2024-01-01, primary completion 2027-12-31 (estimated), completion 2028-12-31 (estimated), first posted 2023-10-05, last updated 2026-08-06 |
| Locations | 9 sites in Taiwan |
Related Papers Related Patents Related Grants Related Experts
All trials for Early Syphilis, Latent, Serological Relapse After Treatment All trials of Benzathine Penicillin G All trials of Doxycycline Capsule
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| single-dose BPG plus doxycycline | Active comparator | Drug: Benzathine Penicillin G; Drug: 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 | Placebo comparator | Drug: Benzathine Penicillin G | single-dose benzathine penicillin G (2.4 MU intramuscularly once) |
Sex: All, ages: 18 Years to any
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 * Subject has latent syphilis of unknown duration, late latent syphilis, or evidence of neurosyphilis, including ocular involvement. * 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 at baseline (penicillin, 3rd cephalosporin, doxycycline, macrolides) * A history of intolerance to penicillin or doxycycline * PLWH have already participated in this study * Pregnancy
| Facility | City | Country | Status |
|---|---|---|---|
| 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 |