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:

* female parolees or probationers enrolled in a six-month program at one of two residential treatment (RDT) programs,
* convicted for a drug crime, and
* reported homeless on their RDT entry form

Exclusion Criteria:

* female parolees or probationers not currently enrolled in a six-month program at one of two residential treatment (RDT) programs,
* not recently convicted for a drug crime, and
* not reported homeless on their RDT entry form
C: Inclusion Criteria:

In order to participate in the study, subjects must

* Be at least 18 years of age and no older than 55 years of age.
* Weigh more than 100 pounds.
* Have a DSM-IV diagnosis of cocaine dependence.
* Be seeking treatment for cocaine dependence.
* Have a urine sample positive for qualitative cocaine toxicology at initial screening.
* Have the ability to understand, and having understood, provide written informed consent to comply with the treatment protocol.
* Have a history and brief physical examination that demonstrate no clinically significant contraindication for participating in the study, in the judgment of the admitting physician and the Principal Investigator.
* Have normal, or, if necessary, corrected visual acuity, visual fields, and normal fundoscopy findings

Exclusion Criteria:

* In order to participate in the study, subjects must not:

  * Meet DSM-IV criteria for current dependence on any psychoactive substance other than cocaine, alcohol, nicotine, or marijuana or physiological dependence on alcohol requiring medical detoxification.
  * Have neurological or psychiatric disorders such as: psychosis, bipolar illness, major depression, organic brain disease, dementia, any disorder which would require ongoing treatment or which would make study agent compliance difficult, history of suicide attempts assessed and/or current suicidal ideation/plan.
  * Have serious medical illnesses or other potentially life threatening or progressive medical illness other than addiction that may compromise subject safety or study conduct.
  * Have a history of traumatic head injury.
  * Be mandated by a court to obtain treatment for cocaine dependence.
  * Have been treated for cocaine addiction, or abstained from cocaine use for a significant period, within the 6 months preceding screening.
  * Be unable to complete the study protocol because of probable incarceration or relocation from the clinical area.
  * Have AIDS (although AIDS is an exclusion criterion, a positive antibody titer to HIV is not).
  * Have active syphilis that has not been treated or refuse treatment for syphilis
  * Have a history of neuroleptic malignant syndrome.
  * Have known or suspected hypersensitivity to vigabatrin or any other GABAergic drug.
  * Have received a drug with known potential for toxicity to a major organ system within 30 days prior to study entry (e.g., isoniazid, methotrexate).
  * Have participated in any experimental study within 4 weeks, or participated in any clinical trial utilizing vigabatrin.
  * Be pregnant or lactating.
  * Have any clinically significant abnormal laboratory value.
  * Have had electroconvulsive therapy with the 3 months preceding screening.
  * Have had any opiate-substitutes (methadone, LAAM, buprenorphine) within 2 months preceding screening.
  * Have a history of i.v. cocaine (or other psychoactive drug) use within 2 months preceding screening.
  * Have a current or past history of seizure disorder, including alcohol- or stimulant related seizure, febrile seizure, or significant family history of idiopathic seizure disorder.
  * Have a visual field defect, or factor predisposing to visual field defects, including glaucoma, severe myopia, retinal disorder, cataracts, diabetes or uncontrolled hypertension.
  * Have my illness, condition, and use of medications, in the opinion of the Principal Investigator and the admitting physician, which would preclude safe or successful completion of the study.
  * Be using vigabatrin or any medication that could interact adversely with vigabatrin administration, based on the longest time interval of A or B below:

    * A) Five half-lives of other medication or active metabolite(s), whichever is longer;
    * B) Two weeks.
  * Be lactose intolerant.
D: Inclusion Criteria

Volunteers may be eligible for this study if they:

* Are 20 to 60 years old.
* Are HIV-negative.
* Have used intravenous drugs in the previous 12 months.
* Are available and commit to 3 years of follow-up.
* Have a Thai National ID or its equivalent such as government official ID or state enterprise ID.
* Are able to understand the study and pass a test showing they understand it, and give written informed consent.

Exclusion Criteria

Volunteers will not be eligible for this study if they:

* Have a serious disease or condition, or history of a serious disease or condition such as lymphoma, that would interfere with the study.
* Are HIV-positive.
* Have ever received an experimental HIV-1 vaccine.
* Have had or expect to have any treatments or medications that interfere with the immune system (e.g., long-term use of systemic steroids, chemotherapy, or radiation).
* Have received a vaccine or immunoglobulin within 2 weeks of receiving the first study injection, or other vaccines within 4 weeks of the first study injection.
* Have received immunoglobulins for a long time.
* Have received non-licensed, research agents within 4 weeks of the first study injection.
* Expect to miss study visits or plan to move within 36 months.
* Are pregnant or breast-feeding or plan to become pregnant during the 36-month study period.
* Are women who have sex with men and do not plan to use effective birth control.

Answer: A