Phase 4 Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects … (NCT03637660) | Clinical Trial Compass
CompletedPhase 4
Phase 4 Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects With or Without HIV Infection
United States249 participantsStarted 2018-10-31
Plain-language summary
This is a phase 4, randomized, open-label, multicenter trial to evaluate the efficacy of a single injected dose of Benzathine Penicillin G (BPG) 2.4 MU (Arm 1) compared to three successive weekly injected doses of BPG 2.4 MU (Arm 2) for treatment of early syphilis in human immunodeficiency virus (HIV)-infected and HIV-uninfected subjects. The study will enroll 560 adults (to achieve 420 evaluable subjects) aged 18 years or older with untreated early syphilis (primary, secondary, or early latent). It will be conducted at 9 sites in the US and last for 48 months with patient participation duration of 12 months. The primary objective is to compare the serological response to therapy in subjects with early (primary, secondary, or early latent) syphilis treated with Benzathine Penicillin G (BPG) 2.4 million units (MU) once or weekly for three successive weeks.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. Subject is aged 18 years or older.
✓. Subject has provided informed consent.
✓. Subject has untreated primary\*, secondary\*\*, or early latent\*\*\* syphilis.
✓. Subject either has a newly reactive non-treponemal test (such as an RPR test) or a history of syphilis and a current increase in RPR titer of two or more dilutions (i.e., four-fold).
✓. If subject is of childbearing potential, subject has a negative urine or serum pregnancy test.
✓. Subject is willing to have an human immunodeficiency virus (HIV) test, participate in HIV counseling, and return to clinic for follow-up.
✓. In the opinion of the investigator, subject is able and willing to comply with study procedures, including receipt of three Benzathine Penicillin G (BPG) injected doses if randomized to Arm 2.
✓. If female, subject must be of non-childbearing potential\* or must be using an acceptable method of birth control\*\* to avoid becoming pregnant.
Exclusion criteria
What they're measuring
1
The Number of Participants With a Serological Response by Month 6.
Timeframe: Day 1 to Day 180
Trial details
NCT IDNCT03637660
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✕. Subject has latent syphilis of unknown duration, late latent syphilis, or evidence of neurosyphilis, including ocular syphilis.\*
✕. Subject has a known or suspected allergy or hypersensitivity to penicillin or other beta-lactam antibiotics.
✕. Subject has a known or suspected sexually transmitted infection (STI) other than syphilis requiring treatment with a drug active against T. pallidum.
✕. Subject has used antibiotics\* active against T. pallidum in the preceding 30 days.
✕. Subject has suspected or known ongoing drug use that might interfere with study participation and follow-up treatment.
✕. Subject is breastfeeding.
✕. Subject has used an investigational drug in the past 30 days that might interfere with safety or efficacy assessment.