Vitamin D Reabsorption in Adolescents and Young Adults With HIV Infection

Not Applicable

Completed

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.

Detailed Description: ATN 063 tests the hypothesis that in a population of adolescents and young adults with HIV infection who are being treated with tenofovir as part of an antiretroviral (ARV) combination regimen, vitamin D supplementation will decrease renal phosphate loss, increase plasma phosphate, decrease plasma PTH, and improve markers of bone turnover, including a decrease in plasma N-telopeptide and BAP.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
A: tenofovir/vitamin D	Vitamin D supplement	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.
B: tenofovir/placebo	Placebo	A placebo will be administered orally to subjects in Group B (who are already taking Tenofovir).
C: no tenofovir/vitamin D	Vitamin D supplement	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.
D: no tenofovir/placebo	Placebo	A placebo will be administered orally to subjects in Group D (who are not taking Tenofovir).

Primary Outcome Measures

Name	Time	Method
To compare the change in renal tubular reabsorption of phosphate and markers of bone turnover.	Baseline, Week 4, Week 12
To measure the safety of 50,000 IU dose of vitamin D3	Baseline, Week 4, and Week 8

Secondary Outcome Measures

Name	Time	Method
To measure the change in tenofovir exposure and creatinine clearance	Baseline, Week 4, and Week 12
To measure the relationship of tenofovir exposure to renal tubular reabsorption of phosphate and markers of bone turnover	Baseline, Week 4, and Week 12
To measure the relationship of vitamin D plasma concentrations to renal tubular reabsorption of phosphate and markers of bone turnover	Baseline, Week 4, and Week 12

Locations (15): Children's Hopsital of Los Angeles
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Los Angeles, California, United States
University of Miami
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Miami, Florida, United States
Childrens Memorial Hospital
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Chicago, Illinois, United States
Stroger Hospital of Cook County
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Chicago, Illinois, United States
Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, United States
Children's Diagnostic and Treatment Center
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Fort Lauderdale, Florida, United States
Mount Sinai Hospital
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New York, New York, United States
University of Maryland Medical School
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Baltimore, Maryland, United States
University of California at San Francisco
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San Francisco, California, United States
University of South Florida
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Tampa, Florida, United States
St. Jude Childrens Research Hospital
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Memphis, Tennessee, United States
Children's National Medical Center
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Washington, District of Columbia, United States
Tulane University
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New Orleans, Louisiana, United States
University of Puerto Rico
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San Juan, Puerto Rico
Montefiore Medical Center
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Bronx, New York, United States