Treatment Responses of Early Syphilis to Single-dose Ceftriaxone Plus Doxycycline Versus Single-dose Benzathine Penicillin G Plus Doxycycline in People Living With HIV (PLWH)
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Enrollment
- 109
- Locations
- 2
- Primary Endpoint
- Rate of Serologic Response at Month 6
Study Overview
Brief Summary
In a prospective study investigating the prevalence of sexually transmitted infections (STIs) among at-risk people living with HIV (PLWH), the prevalence of Chlamydia trachomatis and Neisseria gonorrhoeae was 24.7% and 12.1%, respectively. Surprisingly, the study found high rates of C. trachomatis and/or N. gonorrhoeae co-infections in PLWH with recent hepatitis C virus (HCV) infection (50%), HBsAg positivity (44%), and early syphilis (36%). Considering the high rate of sexually transmitted co-infections, combination therapy of single-dose ceftriaxone plus 7-day doxycycline for early syphilis may provide convenience and benefit to treatment of N. gonorrhoeae and C. trachomatis co-infections at a single clinic encounter. In the present study, this study aim to compare the efficacy of ceftriaxone plus doxycycline versus benzathine penicillin G (BPG) plus doxycycline as the treatment for early syphilis among PLWH.
Detailed Description
Enrolled criteria:
- PLWH aged 20 years or more
- PLWH with early syphilis (i.e. primary, secondary, or early latent syphilis), confirmed by a positive rapid plasma reagin (RPR) titer with a reactive Treponema pallidum particle agglutination (TPPA) assay.
- PLWH has provided informed consent *A participant with repeated syphilis can be repeated enrolled after signing an informed consent if the previous episode of early syphilis was successfully treated with achieving at least a 4-fold decrease in RPR titers and 48-week follow-up is completed.
Exclusion criteria:
- PLWH with RPR titers of less than 4
- Exposure to antibiotics with activity against T. pallidum, such as penicillins, third-generation cephems, doxycycline, or macrolides, within the preceding 4 weeks
- A known or suspected infection other than syphilis requiring additional treatment with an antimicrobial active against T. pallidum
- A history of intolerance to penicillin, ceftriaxone, or doxycycline
- Pregnancy
Primary outcome:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •PLWH aged 20 years or more
- •PLWH with early syphilis (i.e. primary, secondary, or early latent syphilis), confirmed by a positive rapid plasma reagin (RPR) titer with a reactive Treponema pallidum particle agglutination (TPPA) assay.
- •PLWH has provided informed consent
Exclusion Criteria
- •PLWH with RPR titers of less than 4
- •Exposure to antibiotics with activity against T. pallidum, such as penicillins, third-generation cephems, doxycycline, or macrolides, within the preceding 4 weeks
- •A known or suspected infection other than syphilis requiring additional treatment with an antimicrobial active against T. pallidum
- •A history of intolerance to penicillin, ceftriaxone, or doxycycline
- •Pregnancy
Arms & Interventions
single-dose ceftriaxone plus doxycycline
single-dose ceftriaxone (1g intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days)
Intervention: Doxycycline (Drug)
single-dose ceftriaxone plus doxycycline
single-dose ceftriaxone (1g intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days)
Intervention: Ceftriaxone (Drug)
single-dose BPG plus doxycycline
single-dose BPG (2.4 million unit [MU] intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days)
Intervention: Doxycycline (Drug)
single-dose BPG plus doxycycline
single-dose BPG (2.4 million unit [MU] intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days)
Intervention: benzathine penicillin G (Drug)
Outcomes
Primary Outcomes
Rate of Serologic Response at Month 6
Time Frame: Month 6
Serologic response is defined as either a 4-fold or greater decline in RPR titer compared to baseline or being RPR-nonreactive
Secondary Outcomes
- Rate of Microbiologic Response of Syphilis at Week 4(Week 4)
- Rate of Microbiologic Response of Bacterial STIs at Week 4(Week 4)
- Rate of Serologic Response at Month 3(Month 3)
- Rate of Serologic Response at Month 12(Month 12)