Please select the eligibility criteria that correspond to the clinical trial below.
Title: Study of the Safety and Efficacy of Daily Oral Antiretroviral Use for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana
Brief Summary: This study tested whether taking a pill of tenofovir and emtricitabine (two antiretroviral medicines) was safe for sexually-active young adults in Botswana without HIV infection and whether it reduced their risk of getting an HIV infection.


Options:
A: 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
B: Inclusion Criteria:

* citizen of Botswana 18-39 years old
* sexually active
* HIV uninfected
* Hepatitis B and C uninfected
* Calculated creatinine clearance \>= 60 mL/min
* hemoglobin \>= 8 gm/dL
* ALT and AST \<= 2x ULN
* total bilirubin \<= 1.5 mg/dL
* total serum amylase \<= 1.5x ULN
* Serum phosphorus \>= 2.2 mg/dL
* willing to use hormonal contraception (females)
* living within 1 hours travel of study clinic
* pass comprehension test
* willing and able to give informed consent

Exclusion Criteria:

* 18-20 without parent/guardian consent
* history of significant renal or bone disease
* any chronic illness requiring ongoing prescription medication
* pregnant or breastfeeding
* planning to move away from site in the next year
* participating in another HIV prevention or vaccine safety trial
* any other clinical condition or prior therapy that, in the opinion of the study physician, would make the volunteer unsuitable for the study or unable to comply with the dosing requirements
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: B