Clinical trial NCT06069141: Comparisons of Treatment Responses of Early Syphilis to Benzathine Penicillin G With or Without Doxycycline
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Early Syphilis, Latent, Serological Relapse After Treatment
Keywords: syphilis
rapid plasma reagin
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital Hsin-Chu Branch
name: Far Eastern Memorial Hospital
name: Taipei Veterans General Hospital, Taiwan
name: Taoyuan General Hospital
name: National Cheng-Kung University Hospital
name: Chi Mei Medical Hospital
name: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Kaohsiung Veterans General Hospital.
First posted: 2023-10-05
Enrollment: 688
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Serologic response
timeFrame: Weeks 24 and week 48
Secondary outcomes:
measure: Microbiologic response of syphilis
timeFrame: Week 4
measure: Microbiologic response of bacterial STIs
timeFrame: Week 4
measure: Safety of study treatment
timeFrame: Week 4
measure: Adherence evaluation of tablet intake
timeFrame: Week 4
Other outcomes:
Locations:
city: Hsin-Chu
country: Taiwan
facility: National Taiwan University Hospital Hsin-Chu Branch
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Medical Hospital
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Vetetrans General Hospital
city: Taoyuan
country: Taiwan
facility: Taoyuan General Hospital
Study officials:
References: