Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Equivalence Trial of Azithromycin vs. Benzathine Penicillin for the Treatment of Early Syphilis
Brief Summary: 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.


Options:
A: Inclusion Criteria:

* participants will be HIV and HSV-2 seropositive

Exclusion Criteria:

* pregnancy, CD4 count \<200, on ART
B: Inclusion Criteria:

* The subject is 18 to 55 years of age.
* The subject has signed written informed consent.
* The subject has untreated primary \[darkfield or Treponema (T.) pallidum by a rapid, direct, fluorescent antibody darkfield (DFA-TP)\] positive genital ulcers, secondary (based on classical palmar/plantar rash, condylomata lata, mucous patches, etc. or darkfield or DFA-TP positive lesions), or early latent syphilis (e.g., current reactive serologic tests for syphilis (STS), and a documented non-reactive STS or documented sexual exposure to a known early latent, primary or secondary syphilis patient in last 12 months; identification of this sexual contact must occur within 60 days of admission into the study).
* The subject has laboratory evidence of syphilis, i.e., reactive serologic test for syphilis (RPR).
* The subject is not pregnant, as documented by a negative urine or serum pregnancy test, or lactating.
* The subject is willing to have an HIV test, and, participate in HIV counseling and return to the clinic for follow-up treatment.

Exclusion Criteria:

* The subject does not have reactive serologic tests for syphilis.
* The subject has latent syphilis of unknown duration, late latent syphilis or evidence of neurosyphilis.
* The subject has a known or suspected allergy to macrolide or azalide antibiotics.
* The subject has a known or suspected sexually transmitted disease (STD), other than syphilis requiring treatment with a drug, other than azithromycin, active against T. pallidum.
* The subject has used antibiotics active against T. pallidum in the preceding 30 days. (Note: the use of antimicrobials known to NOT be effective against T. pallidum such as quinolones, sulfonamides, trimethoprim, metronidazole and spectinomycin will be allowed).
* The subject is known to be HIV positive prior to enrollment.
* The subject has suspected or known ongoing drug use that might interfere with study participation and follow-up treatment.
* The subject has a history of cardiovascular disease, known immunosuppression, or known AIDS, which might compromise response to therapy.
* The subject is judged by the investigators to be unlikely to reliably participate in the study follow-up.
* The subject has used any investigational drugs in the past 30 days.
* The subject has any other condition that may impair drug absorption (malabsorption syndrome or active peptic ulcer disease).
C: Inclusion Criteria:

* Greater than 18 years old woman,
* Documented HIV-1 seropositive,
* CD4 count greater than 200,
* Not on HIV antiretroviral therapy,
* HSV-2 seropositive as determined by Focus EIA (IN \>3.5)
* Not intending to move out of the area for the duration of study participation.
* Willing and able to:provide independent written informed consent;undergo clinical evaluations;take study drug as directed;adhere to follow-up schedule.
* Bacterial STDs (symptomatic STD syndromes or laboratory-confirmed asymptomatic gonorrhea and syphilis) are treated within two weeks of study enrollment and random assignment.

Exclusion Criteria:

Women who meet any of the following criteria are not eligible for this study:

* Known history of adverse reaction to valacyclovir, acyclovir or famciclovir;
* Planned open label use of acyclovir, valacyclovir, or famciclovir
* Known medical history of seizures
* Known renal failure, serum creatinine \>2.0mg/dl
* Hematocrit \< 30 %
D: Inclusion Criteria:

* Clinically confirmed ulcer
* Resident of city or planning to stay for 1 month
* Be a women

Exclusion Criteria:

* Pregnant women
* Menstruating women
* Positive protein urine test

Answer: B