Syphilis, Human Immunodeficiency Virus
Conditions
Keywords
Cefixime, Treponema pallidum, Penicillin, Early Syphilis
Brief summary
This study aims to evaluate the efficacy of cefixime compared to benzathine penicillin G in the treatment of syphilis.
Detailed description
This will be a randomized, multisite, open-label, non-inferiority clinical trial to evaluate the effectiveness of cefixime (400mg orally, twice a day, for 10 days) compared to benzathine penicillin G (2.4 million units, intramuscularly) in patients with and without HIV infection. In total, 400 participants with early syphilis will be enrolled from 9 clinical sites in the U.S. and Peru. Participants will participate in follow-ups to monitor clinical outcomes and serological response (RPR titer) every 3 months for 9 months. Study findings may identify an efficacious alternative syphilis treatment to penicillin, effective for people living with HIV infection, to help address the crisis of penicillin shortages and offer options for those with penicillin allergy.
Interventions
DRUGCefixime 400mg
Oral cefixime 400 mg, one capsule, twice a day for 10 days
Standard of care benzathine penicillin G, one intramuscular injection, 2.4MU
Sponsors
AIDS Healthcare Foundation
Universidad Peruana Cayetano Heredia
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed cases of primary, secondary, or early latent syphilis with RPR titer ≥1:8 within 3 weeks prior to enrollment * 18 years of age or older * Able to provide informed consent * Individuals with HIV infection must be on treatment for HIV infection and virologically suppressed (viral load \<200 copies/mL) or have a CD4 count ≥ 350 cells/mm3 according to most recent labs before study enrollment
Exclusion criteria
* Pregnancy or a positive pregnancy test on the day of enrollment * Patients showing signs and symptoms of neurosyphilis * Serofast RPR titer, defined as persistently positive RPR titer without more than 4-fold (2-titer level) change for 12 months or greater * Recent (within the past 7 days) or concomitant antimicrobial therapy with activity against syphilis, namely azithromycin, doxycycline, ceftriaxone, or other beta-lactam antibiotics (e.g. amoxicillin) * Individuals with HIV infection who report HIV treatment interruption for more than 4 weeks since their most recent viral load or CD4 test * Self-reported allergy to cephalosporins or penicillin * Unwilling or unable to attend follow-up visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response to treatment | 6 months | Percentage of cefixime participants with a 4-fold decrease or greater in the serum RPR titer 3 or 6 months after treatment completion |
Countries
United States
Contacts
Primary ContactJeffrey D Klausner
Outcome results
None listed