Please select the eligibility criteria that correspond to the clinical trial below.
Title: Anti-Herpetic Treatment Associated With Syndromic Management of Genital Ulcer in Africa: Clinical and Biological Evaluation on HIV-1 and HSV-2 Shedding (ANRS 1212)
Brief Summary: Herpes virus type 2 (HSV-2) infection - as a cofactor of human immunodeficiency virus (HIV) transmission - can be targeted by anti-herpetic specific drugs, either as a continuous prophylactic treatment during its asymptomatic shedding phase, or as an episodic treatment during clinically-apparent genital ulcerations. The main objective of this trial will be to demonstrate that acyclovir treatment given during clinical episodes (primary infection or recurrences) can reduce genital shedding of HIV, thereby contributing to a reduction of HIV infectiousness of dually infected individuals (HIV+/HSV+).


Options:
A: Inclusion Criteria:

* Greater than 18 years old,
* 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:

MSM 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 %
B: 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 %
C: 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).
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: D