A Phase II Equivalence Trial of Azithromycin vs. Benzathine Penicillin for the Treatment of Early Syphilis

Protocol Status: Closed to Enrollment

Protocol Title: A Phase II Equivalence Trial of Azithromycin vs. Benzathine Penicillin for the Treatment of Early Syphilis

Study: To evaluate the efficacy of azithromycin, (2.0 grams administered orally as a single dose), as therapy for early syphilis. Specifically, this study will evaluate the efficacy of azithromycin for treatment of syphilis compared to the current recommended treatment, benzathine penicillin G.

Study Design: A multi-center, randomized open-label trial to evaluate the efficacy of azithromycin in treating primary, secondary and early latent syphilis in HIV uninfected volunteers.

Population: Healthy, HIV-negative adult volunteers 18 to 55 years of age with primary, secondary or early latent syphilis.

Study Duration: 24 months

Primary Study Objective: To demonstrate that the rate of cure for treatment of early syphilis with azithromycin is equivalent or superior to that obtained with penicillin as measured at 6 months after initial treatment. Equivalence will be defined as an observed azithromycin cure rate no worse than 12% below the cure rate observed for penicillin.

Study Sites: University of Alabama, Louisiana State University, University of North Carolina, John Hopkins University, Indiana University and the Laboratoire National de Reference sur le VIH/SIDA (LNR), Madagascar