The purpose of this study is to determine if azithromycin (2.0 grams administered orally as a single dose), a drug approved for treatment of other infections, is as effective for syphilis therapy as the usual penicillin treatment (Benzathine G penicillin- 2.4 million units). This study is considered research because azithromycin is not licensed for the treatment of syphilis. In addition, in a substudy population of subjects allergic to penicillin, the efficacy of azithromycin will be compared with the currently recommended alternative treatment, doxycycline (100 mg twice daily for 14 days).

Condition	Treatment or Intervention	Phase
Syphilis	Drug: Bicillin L-A (penicillin G benzathine suspension) injection  Drug: Doxycycline Hyclate (100 mg)  Drug: Zithromax (azithromycin)	Phase III

Syphilis is a disease with a worldwide distribution. It causes genital ulceration, thereby amplifying risk for HIV acquisition and transmission; may cause congenital infection, spontaneous abortion, and stillbirth if untreated in pregnant women; and about one third of all cases, if untreated, result in late sequelae which include neurosyphilis, gumma formation and cardiovascular involvement. The purpose of this study is to evaluate the efficacy of azithromycin 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.

Ages Eligible for Study:  18 Years   -   55 Years,  Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA:

• Age 18 to 55.
• Must sign written informed consent.
• Have untreated primary, secondary, or early latent syphilis.
• Are not pregnant or lactating.
• Are willing to have an HIV test and participate in HIV counseling and return to the clinic for follow-up treatment.

EXCLUSION CRITERIA:

• Have a known or suspected allergy to macrolide or azalide antibiotics.
• Have a known or suspected STD, other than syphilis, requiring treatment.
• Have used antibiotics active against T. pallidum in the preceding 30 days.
• Are known to be HIV positive prior to enrollment.
• Have suspected or known drug use that might interfere with study participation and follow-up treatment.
• Have used any investigational drugs in the past 30 days.

Edward W Hook      205-975-5504    ehook@uab.edu

Alabama
      University of Alabama at Birmingham, Birmingham,  Alabama,  35294,  United States; Recruiting
Indiana
      Indiana University, Indianapolis,  Indiana,  46202,  United States; Recruiting
Louisiana
      Louisiana State University Medical Center, New Orleans,  Louisiana,  70112,  United States; Recruiting
Maryland
      Johns Hopkins University, Baltimore,  Maryland,  21287,  United States; Recruiting
North Carolina
      University of North Carolina Chapel Hill, Chapel Hill,  North Carolina,  27599-70,  United States; Recruiting
      Durham County Health Department Laboratory, Durham,  North Carolina,  27701,  United States; Recruiting
      Wake County Human Services Laboratory, UNC, Raleigh,  North Carolina,  27610,  United States; Recruiting
Madagascar
      Madagascar Hospital Kely, Tamatave,  Madagascar; Recruiting
      Institut d'Hygiene Sociale, Antananarivo,  Madagascar; Recruiting

Study ID Numbers:  99-005
Record last reviewed:  May 2004
Record first received:  March 6, 2002
ClinicalTrials.gov Identifier:  NCT00031499
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-08