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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 688
- 试验地点
- 16
- 主要终点
- Serologic response
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People living with HIV (PLWH) aged ≥18 years with early syphilis
- •Confirmed by a positive RPR titer with a reactive TPPA assay
排除标准
- •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
研究组 & 干预措施
single-dose BPG plus doxycycline
single-dose benzathine penicillin G (2.4 MU intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days)
干预措施: Benzathine Penicillin G (Drug)
single-dose BPG
single-dose benzathine penicillin G (2.4 MU intramuscularly once)
干预措施: Benzathine Penicillin G (Drug)
single-dose BPG plus doxycycline
single-dose benzathine penicillin G (2.4 MU intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days)
干预措施: Doxycycline Capsule (Drug)
结局指标
主要结局
Serologic response
时间窗: Weeks 24 and week 48
Either a 4-fold or greater decline in RPR titer compared to baseline or being RPR-nonreactive
次要结局
- Microbiologic response of syphilis(Week 4)
- Microbiologic response of bacterial STIs(Week 4)
- Safety of study treatment(Week 4)
- Adherence evaluation of tablet intake(Week 4)