Vitamin D Reabsorption in Adolescents and Young Adults With HIV Infection
HIV Infections

About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Vitamin D, Treatment Experienced
Eligibility Criteria
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
Sites / Locations
- Children's Hopsital of Los Angeles
- University of California at San Francisco
- Children's National Medical Center
- Children's Diagnostic and Treatment Center
- University of Miami
- University of South Florida
- Stroger Hospital of Cook County
- Childrens Memorial Hospital
- Tulane University
- University of Maryland Medical School
- Montefiore Medical Center
- Mount Sinai Hospital
- Children's Hospital of Philadelphia
- St. Jude Childrens Research Hospital
- University of Puerto Rico
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
A: tenofovir/vitamin D
B: tenofovir/placebo
C: no tenofovir/vitamin D
D: no tenofovir/placebo
Vitamin D3 (cholecalciferol), 50,000 IU as a single capsule, will be administered orally to subjects in Group A (who are already taking Tenofovir) once every four weeks during study visits.
A placebo will be administered orally to subjects in Group B (who are already taking Tenofovir).
Vitamin D3 (cholecalciferol), 50,000 IU as a single capsule, will be administered orally to subjects in Group C (who are not taking Tenofovir) once every four weeks during study visits.
A placebo will be administered orally to subjects in Group D (who are not taking Tenofovir).