Vitamin D Reabsorption in Adolescents and Young Adults With HIV Infection

Completed · Not applicable · Has a placebo group

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00490412

Run by

University of North Carolina, Chapel Hill

People needed

207

Starts

2007-12-01

Expected to finish

2010-01-01

Last updated by the study team

2017-02-28

Who can join

Age: 18 and older, up to 24. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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