Please select the eligibility criteria that correspond to the clinical trial below.
Title: Study of the Safety and Efficacy of Daily Tenofovir to Prevent HIV Infection Among Injection Drug Users in Bangkok, Thailand
Brief Summary: The primary goals of this study are to assess the safety and efficacy of daily tenofovir to prevent parenteral HIV infection among injection drug users (IDUs). Assessment of changes in HIV associated risk behaviors, adherence to study drug, and, among IDU who become HIV-infected during the trial, evaluation of HIV viral load set point, CD4 counts, genetic characterization of infecting HIV viruses, and antiretroviral resistance will also be done.


Options:
A: Inclusion Criteria:

* Report injection drug use in the 6 months before screening
* Possess a Thai National Identification Card
* Laboratory values as follows within 2 weeks before enrollment:
* HIV oral fluid test non-reactive at screening and pre-enrollment visits
* Hemoglobin 9 gm/dL
* ALT and AST 2.5 x upper limit of normal (ULN)
* Total bilirubin 1.5 mg/dL
* Serum amylase 1.5 x ULN
* Serum phosphorus 2.2 mg/dL
* No evidence of current or chronic Hepatitis B infection by serology
* Calculated creatinine clearance 60 mL/min by the Cockcroft-Gault formula where creatinine clearance in mL/min = Male: (140 - age in years) x (wt in kg)/72 x (serum creatinine in mg/dL) Female:(140 - age in years) x (wt in kg) x 0.85/72 x (serum creatinine in mg/dL)
* Willing to abstain from sexual intercourse or use effective contraception during the trial (oral, injection, or barrier), for women
* Willing and able to provide informed consent for study participation
* Available and committed to DOT or monthly follow-up for at least 12 months

Exclusion Criteria:

* Clinic physicians will determine if a subject with chronic illness requiring prescription medication can not enroll (medication used for drug treatment is allowed)
* Positive urine pregnancy test
* Breastfeeding
* History of significant renal, liver, or bone disease
* Any other clinical condition or prior therapy that, in the opinion of the clinic physician, would make the subject unsuitable for the study or unable to comply with the dosing requirements
* Concurrent participation in any other HIV prevention trial or drug/vaccine safety trial. AIDSVAX B/E HIV vaccine trial (CDC protocol #2076) participants and Extension Study (CDC protocol #3750) participants may be screened for enrollment in the Bangkok Tenofovir Study.
B: Inclusion Criteria:

* The sample for the study will be drawn from an offender population who are within 2-3 weeks of their release from MCJ or CRDF in Los Angeles County. In addition, subjects must be:

  * At least 18 years of age
  * English or Spanish speaking
  * Not subject to extended jail or prison sentence
  * Able to provide informed consent to participate in the study

Exclusion Criteria:

* Study exclusion criteria:

  * Inability to provide informed consent to study participation because of cognitive impairment.
  * Inability to communicate in either English or Spanish
  * Refusal to complete Locator form for follow-up.
C: Inclusion Criteria:

1. Parolees enrolled in Amity's Amistad's program;
2. Age 18-60;
3. Discharged from prison or jail within the last six months;
4. History of drug use 12 months prior to most recent incarceration;
5. Previously homeless prior to most recent incarceration; and
6. Willing to provide informed consent

Exclusion Criteria:

1. Monolingual speakers of languages other than English; and
2. Persons judged to be cognitively impaired by the research staff.
D: Inclusion Criteria:

* Male, 18-65 years, imprisoned at Norrtalje Prison
* WURS-score of 36 or more and fulfilling at least 4 out of 6 criteria on ASRS Screener in an initial screening preceding the trial
* Can read and understand Swedish well enough to participate in the evaluation preceding the trial
* Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition, (DSM-IV) and confirmed by the neuropsychiatric assessment including structured diagnostic interviews and neuropsychological measurements.
* At least 14 months left to conditional release.
* Informed Consent Form to participate in the study signed by the subject.
* Subject agrees to take only the supplied study drug as treatment for ADHD during the study
* Subject is able to comply with the study visit schedule and willing and able to complete the protocol-specified assessments.
* Healthy on the basis of a physical examination and the results of blood biochemistry tests. If the results of the biochemistry tests are not within the normal reference ranges, the subject may be included if the investigator considers the deviations are not clinically relevant.

Exclusion Criteria:

* Known to be a non-responder to methylphenidate.
* Known allergy or hypersensitivity to methylphenidate.
* Any clinically unstable psychiatric condition including, but not limited to, acute mood disorder, bipolar disorder, acute OCD.
* A diagnosis of substance use disorder (abuse/dependence) according to DSM-IV criteria within 3 months prior to screening evaluation for the study.
* Known mental retardation.
* Subjects with history of epileptic seizures, glaucoma, uncontrolled hypertension, angina pectoris, cardiac arrhythmias or structural heart abnormalities.
* Use of monoamine oxidase inhibitors, fluoxetine, venlafaxine, reboxetine, duloxetine.
* Use of alpha-2-receptor agonists, neuroleptics, theophylline, coumarin anticoagulants or anticonvulsants.
* Liver or renal insufficiency. Subjects with hepatitis C without liver insufficiency don´t have to be excluded as long as liver enzymes are followed through the study.
* Subjects who are suicidal.
* Lactose intolerance.

Answer: A