The purpose of this study is to determine if azithromycin, a drug approved for treatment of
other infections, is as effective for syphilis (a sexually transmitted disease) as the
standard treatment. Approximately 600 healthy adults, who are HIV-negative, ages 18 to 55
years of age, with primary, secondary or early latent syphilis, will participate in this
research study. Volunteers will be enrolled in 5 U.S. cities and in Madagascar. Participants
will be chosen randomly (by chance) to receive 1 of 2 study drugs: benzathine penicillin
given (2 shots in the buttocks) or 4 tablets of azithromycin. Subjects who report a history
of a penicillin allergy will be given either 2.0 g of oral azithromycin or 100 mg doxycycline
taken orally, twice a day for 14 days. Over 2 years, 10 visits will be required. Procedures
will include blood samples, physical exams, and swabs of sores.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Azithromycin Doxycycline Penicillin G Penicillin G Benzathine Penicillin G Procaine Penicillins