Please select the eligibility criteria that correspond to the clinical trial below.
Title: Chemoprophylaxis for HIV Prevention in Men
Brief Summary: The purpose of this study is to determine whether daily use of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) can prevent HIV infection in men who also receive HIV counseling, condoms, and treatment for other sexually transmitted infections (STIs).


Options:
A: Inclusion Criteria:

* Male sex (at birth)
* HIV uninfected
* Age having reached the local age of consent
* High risk for HIV infection including any of the following: 1) No condom use during anal intercourse with a male HIV-positive partner or a male partner of unknown HIV status during the last 6 months; (2) anal intercourse with more than 3 male sex partners during the last 6 months; (3) exchange of money, gifts, shelter, or drugs for anal sex with a male partner during the last 6 months; (4) sex with a male partner and STI diagnosis during the last 6 months or at screening, or (5) sexual partner of an HIV-infected man with whom condoms are not consistently used in the last 6 months.
* Able to provide a street address of residence for themselves and one personal contact who would know their whereabouts during the study period
* Healthy enough to work, as indicated by score of 80 or greater on the Karnofsky scale
* Certain laboratory values
* A urine dipstick with a negative or trace result for both glucose and protein within 28 days of enrollment.
* Ability to understand and local language for which an informed consent form has been approved by a local IRB and registered with the study sponsor.

Inclusion Criteria for Open-Label Extension:

* Participated in a randomized, placebo-controlled, PrEP trail
* Has been unblinded
* Has provided informed consent

Exclusion Criteria:

* Previously diagnosed active and serious infections, including tuberculosis infection, osteomyelitis, or infections requiring parenteral antibiotic therapy
* Active clinically significant medical problems including heart disease (e.g., symptoms of ischemia, congestive heart failure, arrhythmia), lung disease (steroid-dependent chronic obstructive pulmonary disease), diabetes requiring hypoglycemic medication, or previously diagnosed cancer expected to require further treatment
* Acute HBV infection at the screening visit or presence of treatment indications for hepatitis B based on local practice standards; or clinical signs of hepatic cirrhosis
* History of pathological bone fractures not related to trauma
* Receiving ongoing therapy with certain HIV/AIDS-related medications or other medications as determined by the investigator
* Definitely or possibly received an anti-HIV vaccine while participating in a blinded clinical trial
* Current alcohol or drug use that, in the opinion of the investigator, may interfere with the study
* Current participation in a clinical trial or cohort study other than sub-studies of this protocol
* Any condition at enrollment that, in the opinion of the investigator, would make participation in the study unsafe or would interfere with the study
* Sites may utilize additional criteria that restrict enrollment to a subset of people who meet the protocol-defined enrollment criteria.

Exclusion Criteria for Open-Label Extension:

- Site leadership believes participant will have difficulty completing requirements
B: Inclusion Criteria for HIV-1 uninfected partner:

* Partner within an HIV-1 discordant heterosexual relationship
* One partner meets study eligibility for HIV-1 uninfected study participant and the other partner meets study eligibility criteria for HIV-1 infected participant
* Plan to remain in the relationship for the duration of the study period
* Adequate renal, hepatic \& hematologic function
* Negative Hepatitis B surface antigen test
* Willing and able to provide written informed consent \& locator information

Exclusion Criteria for HIV-1 uninfected partner:

* Current pregnancy, or planning to become pregnant during the study period
* Currently breastfeeding
* Concurrent enrollment in another HIV-1 vaccine or prevention trial
* Receiving ongoing antiretroviral therapy
* Repeated positive urine dipstick tests for glycosuria or proteinuria
* Active and serious infections
* History of pathological bone fractures not related to trauma

Inclusion Criteria for HIV-1 infected partner:

* Partner within an HIV-1 discordant heterosexual relationship
* One partner meets study eligibility for HIV-1 uninfected study participant and the other partner meets study eligibility criteria for HIV-1 infected participant
* HIV-1 infected based on positive EIA
* No history of any clinical AIDS-defining diagnoses
* Plan to remain in the relationship for the duration of the study period
* Willing and able to provide written informed consent \& locator information

Exclusion Criteria for HIV-1 infected partner:

* Current use of antiretroviral therapy
* Concurrent enrollment in another HIV-1 treatment trial
C: Inclusion Criteria for HIV Infected Partner:

* Positive HIV test within 60 days of study entry
* CD4 count between 350 and 550 cells/mm3 within 30 days of study entry
* If pregnant or breastfeeding, willing to be randomized to either arm of the study

Inclusion Criteria for HIV Uninfected Partner:

* Negative HIV test within 14 days of study entry

Inclusion Criteria for Both Partners:

* Plans to maintain sexual relationship with partner
* Reports having sex (vaginal or anal) with partner at least three times in the last 3 months
* Willing to disclose HIV test results to partner
* Plans to stay in the area and does not have a job or other obligations that may require long absences during the duration of the study

Exclusion Criteria for HIV Infected Partner:

* Current or previous use of any ART. Participants who previously took a short-term course of ART for prevention of mother-to-child transmission of HIV are not excluded.
* Documented or suspected acute hepatitis within 30 days of study entry, if the infected partner's starting regimen in the study contains nevirapine or atazanavir
* Current or previous AIDS-defining illness or opportunistic infection
* Documented or suspected acute hepatitis within 30 days prior to study entry
* Acute therapy of serious medical illnesses within 14 days prior to study entry
* Radiation therapy or systemic chemotherapy within 45 days prior to study entry
* Immunomodulatory or investigational therapy within 30 days prior to study entry
* Active drug or alcohol dependence that, in the opinion of the investigator, would interfere with the study
* Vomiting or inability to swallow medications
* Require certain medications
* Allergy or sensitivity to any of the study drugs

Exclusion Criteria for Both Partners:

* History of injection drug use within 5 years of study entry
* Previous and/or current participation in an HIV vaccine study
* Currently detained in jail or for treatment of a psychiatric or physical illness
* Any condition that, in the opinion of the study staff, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
* Certain abnormal laboratory values
D: Inclusion Criteria:

1. Willing and able (see criterion 2) to provide written informed consent to be screened for and to participate in the trial
2. Able to answer a percentage of informed consent screening (75%) and enrollment (100%) comprehension quiz questions correctly
3. Between 18-35 years old, inclusive
4. At higher risk of becoming HIV infected
5. Have a final negative result according to the site-specific screening HIV testing algorithm and a final negative result at enrollment according to the study HIV testing algorithm
6. Willing to participate in all aspects of the study and to comply with study procedures, for up to 60 weeks, including:

   * Be randomized
   * Use study product as directed
   * Adhere to follow-up schedule and willing to be contacted by site staff between study visits (by phone and/or in person)
   * Use a study-approved effective non-barrier method of contraception for the duration of the study
   * Take study product, as evidenced by swallowing a vitamin tablet that is similar in size to the study product at enrollment
   * Provide contact information and agrees to some form of contact method throughout the study
7. Not intending to relocate out of the area for the duration of the study participation and does not have a job or other obligations that may require long absences from the area ( \> 1 month at a time)
8. In general good health and have no condition (social or medical) which, in the opinion of the Site Investigator, would make study participation unsafe or complicate data interpretation
9. Not pregnant or breastfeeding, and does not anticipate a desire for pregnancy during the 52 weeks of on-product participation
10. Medically eligible at screening including:

    * Adequate renal function (serum creatinine ≤ upper limit of normal (ULN) of local range and creatinine clearance ≥ 60ml/min estimated by the Cockcroft-Gault Creatinine Clearance Formula
    * Adequate hepatic function (hepatic transaminases ALT and AST \< 2x ULN \[according to local normal ranges\])
    * HBsAg negative
    * Serum phosphorus levels above the lower limit of the local normal range (according to local normal ranges - grade 3 \& 4 hypophosphatemia will be excluded even if within normal local ranges)
11. Not received or receiving an experimental HIV vaccine, participating in another HIV prevention study or participating in any other clinical trial with a biomedical intervention
12. No clinical signs of liver disease (e.g., ascites, spider angiomata, hepatomegaly, jaundice)
13. No definite evidence of glycosuria or proteinuria (i.e., no repeated positive \[ ≥ + 1 \] urine dipstick). If a urine dipstick is positive for either glucose and/or protein at the first test, a second urine sample will be tested.
14. No history of pathological bone fractures
15. No history of adverse reaction to latex
16. Not taking any of the following medications: nephrotoxic agents; aminoglycoside antibiotics (including gentamicin); intravenous (IV) amphotericin B; cidofovir; cisplatin; foscarnet; IV pentamidine; oral or IV vancomycin; oral or IV gancyclovir; other agents with significant nephrotoxic potential; drugs that slow renal excretion; probenecid; immune system modulators; systemic chemotherapeutic agents (i.e. cancer treatment medications); systemic corticosteroids; interleukin-2 (IL-2); immunomodulators; interferon (alpha, beta, or gamma); other antiretrovirals (including nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents)

Answer: A