Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Study to Determine the Safety and Efficacy of Famciclovir in the Episodic and Suppressive Treatment of Recurrent Genital Herpes (RGH). The Study Will Also Evaluate Quality of Life and Patient Satisfaction
Brief Summary: This trial will assess whether RGH patients who have two recurrent episodes within a three month period would benefit from suppressive treatment and whether patients prefer episodic therapy or suppressive therapy for the treatment of their RGH.


Options:
A: Inclusion Criteria:

* • Patients who are immunocompetent and who have had 4 or more episodes of Recurrent Genital Herpes (RGH) in the last 12 months.

  * Patients with active HSV-2 or HSV-1 infection as confirmed by Polymerase Chain Reaction (PCR).
  * Patients with active symptoms (i.e., itching, burning, tingling, aching, tenderness, rash or pain) associated with a recurrent episode of genital herpes

Exclusion Criteria:

* • Female patients who are pregnant or breast-feeding.

  * Current, history or suspicion of liver disease or kidney disease.
  * HIV infected (as confirmed by positive HIV serology).

Other protocol-defined inclusion/exclusion criteria may apply.
B: Inclusion Criteria:

* At least 18 years old
* History of at least 4 recurrences of genital herpes in the preceding 12 months
* Lesions located on the external genitalia or anogenital region
* Willing to discontinue suppressive treatment
* Documented positive herpes simplex virus (HSV)
* General good health, and history of normal renal function

Exclusion Criteria:

* Women of childbearing potential not using approved form of contraceptive
* Pregnant or nursing women
* History of hypersensitivity to famciclovir, valacyclovir, or acyclovir
* Known to be immunosuppressed
* Known to have renal dysfunction
* Receiving anti-herpes therapy
* Known to have other genital tract disorders
* Known to have condition which could interfere with drug absorption

Additional protocol-defined inclusion/exclusion criteria may apply.
C: Inclusion Criteria:

1. 18 years or older;
2. HSV-2 seropositive by Western Blot;
3. not receiving any drugs with known anti-HSV-2 activity for study duration;
4. history of primary genital herpes infection within past 6 months OR history of 4 or more HSV recurrences per year during the past year OR 4 or more recurrences per year prior to initiation of suppressive antiviral therapy;
5. able to comply with the study protocol;
6. women of child bearing potential who are sexually active with men must be using a medically accepted method of contraception as judged by the investigator;
7. women of child-bearing potential must have a negative pregnancy test (urine) at screening visit;
8. in general good health, without other serious medical conditions and specifically with normal renal and hepatic function, as determined by the patient's medical history;
9. planning to remain resident in the area of the study center for the duration of the study participation;
10. HIV seronegative.

Exclusion Criteria:

1. hypersensitivity to acyclovir or valacyclovir;
2. pregnant women;
3. HIV positive or other immunosuppressed state, including chronic steroid use. Intermittent nasal or topical steroids are acceptable
D: Inclusion Criteria For All Participants:

* HIV-uninfected
* HSV-2 infected
* Plans to stay in the area for the duration of study participation
* Willing and able to provide consent, undergo clinical evaluations, take study drugs, adhere to follow-up schedule, and provide adequate locator information

Inclusion Criteria for MSM:

* At least 1 episode of anal intercourse with another man within 6 months of study entry

Inclusion Criteria for WSM:

* At least 1 episode of unprotected vaginal sex within 6 months of study entry

Exclusion Criteria For All Participants:

* Current enrollment in another HIV vaccine or prevention trial
* History of adverse reaction to acyclovir
* Current or planned use of famiciclovir, valacyclovir, or acyclovir for genital HSV. Use of short-course antiviral therapy for herpes zoster after enrollment is allowed.
* Known plans for travel away from study site for more than 2 months

Exclusion Criteria for MSM:

* In a mutually monogamous relationship with an HIV uninfected partner throughout the past 2 years
* Reported sex at birth as female

Exclusion Criteria for WSM:

* Pregnancy at screening or enrollment

Answer: A