Please select the eligibility criteria that correspond to the clinical trial below.
Title: Impact of Episodic Acyclovir Therapy on Ulcer Duration and HIV Shedding From Genital Ulcers Among Men in South Africa
Brief Summary: The purpose of this study is to determine if acyclovir episodic treatment has an effect in ulcer healing and if it should be added to the syndromic management of genital ulcer disease.


Options:
A: 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
B: Inclusion Criteria:

Potential index (HIV-infected) participants must meet the following criteria (by self-report, unless otherwise indicated) in order to be eligible for inclusion in the study:

* Of legal age to provide independent informed consent for research per local regulations and guidelines.
* Able and willing to provide written informed consent to be screened for and to take part in the study. (Note: Index participants who are not willing to provide genital tract specimens for HIV viral load quantitation, but are willing to undergo all other study procedures, will be considered eligible for inclusion in the study.)
* Part of a heterosexual couple in which one partner meets the study eligibility criteria for index participants and the other partner meets the study eligibility criteria for partner participants. Couples are defined as partners who are sexually active and plan to remain in the relationship for at least one year. Each site will develop appropriate criteria for determining whether a couple is likely to remain in the relationship (i.e., married, duration of partnership, cohabitation, have children).
* Has had vaginal intercourse with the partner participant at least three times in the last three months.
* Plans to maintain his/her relationship with the partner participant for the next 24 months.
* HIV-infected based on positive EIA.
* HSV-2-seropositive based on the Focus HSV-2 EIA (performed by study staff) with an index ratio of at least 3.5 or if Focus EIA IN 1.1-3.4, confirmed by HSV-2 WB dot-blot performed at the UW.
* CD4 cell count (performed by study staff) of at least 250 cells/mm3.
* No history of any clinical AIDS-defining diagnoses.
* Able and willing to provide adequate locator information for study retention purposes, as defined by local standard operating procedures.

Potential partner (HIV-uninfected at enrollment) participants must meet the following criteria (by self-report, unless otherwise indicated) in order to be eligible for inclusion in the study:

* Of legal age to provide independent informed consent for research per local regulations and guidelines.
* Able and willing to provide written informed consent to be screened for and to take part in the study.
* Part of a heterosexual couple in which one partner meets the study eligibility criteria for index participants and the other partner meets the study eligibility criteria for partner participants.
* Has had vaginal intercourse with the study partner at least three times in the last three months.
* Plans to maintain his/her relationship with the index participant for the next 24 months.
* HIV-uninfected based on negative HIV EIA tests.
* Able and willing to provide adequate locator information for study retention purposes, as defined by local standard operating procedures.

Exclusion Criteria:

Potential index (HIV-infected) participants who meet any of the following criteria (by self-report, unless otherwise indicated) will be excluded from the study:

* Current use of combination antiretroviral therapy
* Known history of adverse reaction to acyclovir.
* Known history of persistent genital ulcers unresponsive to episodic acyclovir therapy.
* Known plans to re-locate or travel away from the study site for more than two consecutive months during the next 24 months.
* Pregnant, based on participant self-report or urine testing performed by study staff. (Note: Self-reported pregnancy is adequate for exclusion from the study. A documented negative test performed by study staff is required for inclusion.)

Potential partner participants who meet any of the following criteria (by self-report, unless otherwise indicated) will be excluded from the study:

* Has had sexual intercourse with a partner other than the index participant in the last two months.
* Known plans to re-locate or travel away from the study site for more than two consecutive months during the next 24 months.
C: Inclusion Criteria:

* HIV-1 seropositive
* HSV-2 seropositive
* Plans to deliver in Nairobi
* Resides and plans to remain in Nairobi for 12 months postpartum
* 18 years of age or older
* CD4 count\>250 cells/μl

Exclusion Criteria:

* indication for highly active antiretroviral therapy (e.g., WHO stage III or IV)
* hypersensitivity to valacyclovir or acyclovir
D: Inclusion Criteria:

* Males presenting at the primary health care clinic with a genital ulcer
* Age 18 years or older
* Willing and able to give informed consent
* Willing to be tested for HSV and HIV
* Willing and able to comply with the study protocol including follow-up visits
* Willing to accept therapy by chance

Exclusion Criteria:

* Extensive ulceration
* Ulceration \>1 month
* History of adverse reaction to acyclovir
* Taking suppressive therapy for genital herpes
* History of renal insufficiency or proteinuria

Answer: D