Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Phase II Proof-of-Concept Study to Evaluate the Safety and Efficacy of a 3-Dose Regimen of the Merck Adenovirus Serotype 5 HIV-1 Gag/Pol/Nef Vaccine (MRK AD5 HIV-1 Gag/Pol/Nef) in Adults at High Risk of HIV-1 Infection
Brief Summary: This study will test the safety and efficacy of an investigational Human Immunodeficiency Virus (HIV) vaccine. Efficacy will be measured by either prevention of HIV infection or control of HIV viral load in subjects who become HIV infected.

On September 18, 2007 the Protocol V520-023 DSMB (Data \& Safety Monitoring Board) reviewed data from a planned interim analysis. These data demonstrated that the investigational vaccine candidate was not effective, and all vaccinations in the study were halted.

Participants were encouraged to continue to come to the clinic for scheduled visits and ongoing risk reduction counseling since the vaccine was not effective.


Options:
A: 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
B: Inclusion Criteria:

* participants will be HIV and HSV-2 seropositive

Exclusion Criteria:

* pregnancy, CD4 count \<200, on ART
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:

* Healthy, HIV seronegative adults at high risk of acquiring HIV infection
* Cannot have previously received an investigational vaccine

Exclusion Criteria:

* In a monogamous relationship with an HIV-1 seronegative partner for \> 1 year
* History of anaphylaxis and/or allergy to vaccine components, including Tris buffer, MgCl2, and polysorbate 80 (TWEEN)
* Received an immune globulin or blood derived products 3 months before injection with the first dose of vaccine/placebo or scheduled within 14 days after injection
* Previously vaccinated with a live virus vaccine within 30 days before injection with the first dose of vaccine or scheduled within 14 days after injection
* Previously vaccinated with an inactivated vaccine within 5 days before injection with the first dose of vaccine or scheduled within 14 days after injection
* Known history of immunodeficiency
* History of malignancy (with some exceptions)
* Contraindication to intramuscular (IM) injection such as anticoagulant therapy or thrombocytopenia
* Female subject who is pregnant or breast feeding, or expecting to conceive or donate eggs through Week 30 of the study
* Male subject who is planning to impregnate or provide sperm donation through Week 30 of the study
* Previously received an investigational HIV vaccine
* Has active drug or alcohol abuse or dependence that would interfere with adherence to study requirements, or endanger the subject's health while on the study
* Has a condition that might endanger the subject's health or interfere with the evaluation of the study objectives

Answer: D