Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Acyclovir for the Reduction of HIV Acquisition Among High-Risk HSV-2 Seropositive, HIV Seronegative Individuals
Brief Summary: Genital herpes (HSV-2) is the most common cause of genital sores worldwide, and the presence of genital sores is a significant risk factor for becoming infected with HIV. This study will test the effectiveness of twice-daily dosing of acyclovir, a commonly prescribed anti-herpes drug, in preventing HIV infection in HSV-2 infected women who sleep with men (WSM) and men who sleep with men (MSM).

Study hypothesis: Given that genital herpes is a significant risk factor to HIV acquisition, twice-daily HSV-2 suppressive therapy - 400 mg of acyclovir - will prevent HIV infection among high risk, HSV-2 seropositive WSM and MSM.


Options:
A: Inclusion Criteria:

* Infection with HIV-1 and HSV-2
* If required to take antiretrovirals according to WHO recommendations, should be on HAART for at least 4 months
* Written informed consent

Exclusion Criteria:

* Pregnancy or willing to be pregnant during the next 6 months
* Breastfeeding
* Renal failure
* Expected non-compliance with follow-up or study treatment
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 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
D: Inclusion Criteria:

* HIV uninfected
* Willing to receive HIV results
* Willing to be circumcised
* Parent or guardian willing to provide informed consent if applicable
* Hemoglobin of 8 grams/dl or less
* Intend to stay in Rakai, Uganda, for at least 1 year and are available for follow-up for 1 year

Exclusion Criteria:

* Already circumcised or partially circumcised
* Anatomical abnormality of the penis (e.g., hypospadias, severe phimosis) that may put the participant at risk if circumcised
* Medical conditions that require therapeutic circumcision
* Medical condition that contraindicates surgery or use of local anesthesia

Answer: C