Please select the eligibility criteria that correspond to the clinical trial below.
Title: Adjunct Vitamin A Therapy for Tuberculosis and HIV/AIDS
Brief Summary: The study will determine whether a daily vitamin and mineral supplement (a multivitamin including Vitamin A) will improve health when added to standard chemotherapy for tuberculosis. This study will compare the effectiveness of the multivitamin in HIV infected and HIV uninfected patients.


Options:
A: Inclusion Criteria:

* Sputum-confirmed pulmonary tuberculosis
* Resident of Zomba or Blantyre Districts, Malawi
* Willing to take tuberculosis chemotherapy as recommended by the National Tuberculosis Control Programme

Exclusion Criteria:

* Prior treatment for tuberculosis
B: Inclusion Criteria:

1. HIV seropositive diagnosed with standard techniques
2. Age for PA Group: 5.0 to 24.9 y
3. Age for BA Group: 15.0 to 24.9 y
4. In usual state of good health (no hospitalizations, emergency room or unscheduled acute illness visits for 2 weeks prior to enrollment)
5. Subject and/or family commitment to the 12-month study

Exclusion Criteria:

1. Other chronic health conditions that may affect growth, dietary intake, and/or nutritional status
2. Pregnancy
3. Participation in another HIV intervention study with impact on 25D serum concentrations
4. Use of vit D3 supplementation for the purpose of treating vit D deficiency
5. Use of vit D3 supplementation not part of a prescribed treatment plan for vit D deficiency (subjects willing to discontinue supplementation will become eligible after a minimum of a 2 month washout period)
6. Non-English Speaking
C: Inclusion Criteria:

* Age 18 years and 0 days through 24 years and 364 days
* HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA at any time prior to study entry
* Currently being treated with a stable FDA-approved ARV combination therapy, containing \> 3 antiretrovirals, for \> 28 days, according to HRSA guidelines. Treatment regimen will not be started or changed for the purposes of participation in this study. Subjects will be receiving therapy at the direction of their treating physician
* Willingness to remain on the same ARV combination therapy for the 12-week duration of the study
* Ability and willingness to participate in the study by providing written informed consent
* Willingness to be randomized to receive either vitamin D or placebo

Exclusion Criteria:

* Prior hypersensitivity to vitamin D
* History of arteriosclerosis, renal stones, glomerulonephritis, nephrotic syndrome, or hypercalcemia
* Lactation or current pregnancy
* Active therapy for malignancy
* Known presence of gastrointestinal disease that would interfere with drug administration or absorption
* Serological evidence of Hepatitis B surface antigen (HBsAg)
* Confirmed creatinine clearance \< 90 ml/min (calculated GFR from serum creatinine using the MDRD formula)
* Grade 3 or higher clinical toxicity
D: Participants must meet all of the following criteria within four weeks prior to the Week 0 (Baseline) Visit to be considered eligible for entry into the study:

1. Documented HIV infection by Western Blot, EIA assays or viral load assay
2. Aged 21 or older
3. Viral load \< 50 copies/mL for the last 3 months
4. CD4 cell count \< 350 cells/µL
5. On stable ART, i.e., ART unchanged for treatment failure (rebound in viral load) for more than 12 months
6. Able to communicate adequately in either French or English
7. Able and willing to give written informed consent prior to enrolment including access to relevant medical records.

Participants are not eligible to participate in the study if any of the following conditions are met:

1. Pregnant, breastfeeding or planning to become pregnant during the course of the study. All fecund female participants must undergo a pregnancy test, with a negative result, prior to being eligible to participate in the study
2. Prior history of hypersensitivity reaction to niacin or any other component of the study drug
3. Prior history of flushing
4. Active liver disease or unexplained persistent elevations of serum transaminases
5. Co-infection with active Hepatitis B or C virus (positive HBs Ag or positive anti HBc antibodies with a detectable HBV DNA viral load or positive anti HCV antibodies with a detectable HCV RNA viral load)
6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or alkaline phosphatase \>2.5 x upper limit of normal (ULN)
7. Active duodenal or gastric peptic ulcer
8. Active bleeding disorders
9. History of gout
10. Active AIDS events in the last 3 months as determined by the treating physician
11. Unstable angina or acute phase myocardial infarction, with or without vasodilator agents
12. Diabetic or potentially diabetic with hypercholesterolaemia
13. Renal dysfunction.

Answer: A