Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized, Placebo-controlled Trial of the Safety and Effectiveness of Vitamin D Supplement to Improve Tubular Reabsorption of Phosphate and Decrease Bone Turnover in Adolescents and Young Adults With HIV Infection Being Treated With Antiretroviral Therapy Containing Tenofovir Compared to Those Being Treated With Antiretroviral Therapy Not Containing Tenofovir
Brief Summary: The purpose of this study is to test the effects of Vitamin D on renal phosphate and bone loss, which are common in HIV infected adolescents and young adults being treated with tenofovir.


Options:
A: Inclusion Criteria:

* HIV positive
* On stable HAART regimen for at least 6 months prior to study entry
* T-cell count greater than 100 and viral load less than 1,000 for at least 6 months prior to study entry
* Fasting triglyceride level greater than 150 mg/dl
* Body mass index (BMI) greater than 18.5 and less than 30
* Uses barrier contraception

Exclusion Criteria:

* Fasting triglyceride level greater than 1000 mg/dl
* BMI less than 18.5 or greater than 30
* Taking diabetic medication or HbA1c less than 7.0
* Use of lipid lowering medication in the 30 days prior to study entry
* Unable to exercise
* T-cell count less than 100
* Current medical condition that makes exercise unadvisable
* History of coronary artery disease (CAD)
* Use of dietary supplements (within 30 days of study entry) that may affect lipid levels including, but not limited to, the following:

  1. Omega-3 fatty acids
  2. L-Carnitine
  3. Soluble fiber supplements
  4. Guggul
  5. Garlic supplements
  6. Niacin greater than 25mg/d
  7. Oral liquid supplements
* Use of steroids, hormones, or testosterone (without diagnosis of hypogonadism, testosterone less than 300 ng/dl)
* Irregular periods
* Depo-Provera
* Hypo- or Hyperthyroidism
* Adrenal insufficiency
* Serum alanine or aspartate aminotransferase level greater than 3 times the upper limit of normal
* Alcohol abuse
* Renal insufficiency (creatinine level greater than 1.5 mg/dl)
* Coumadin therapy
* Pregnancy
* Peptic ulcer disease
* Cholelithiasis
* History of hyperuricemia
* History of myositis or rhabdomyolysis
* Known adverse reaction to niacin or fibrates
* Hepatitis C therapy
B: Inclusion Criteria:

* male
* HIV-positive
* at least 18 years old
* receiving HiglyActiveAntiRetroviral Therapy (HAART)

Exclusion Criteria:

* hypercalcemia
* tuberculosis
* osteoporosis or other bone disease
* cancer with bone metastasis
C: 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
D: 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

Answer: D