Comparisons of Treatment Responses of Early Syphilis to Benzathine Penicillin G With or Without Doxycycline

Condition(s) studied

Investigational drug(s) / intervention(s)

Benzathine Penicillin G: Benzathine Penicillin G (2.4 MU intramuscularly once)

Doxycycline Capsule: doxycycline (100 mg orally twice daily for 7 days)

Study 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

Primary outcome measure(s)

• Serologic response — Weeks 24 and week 48
  Either a 4-fold or greater decline in RPR titer compared to baseline or being RPR-nonreactive

Trial sites (9)

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