Vitamin D Reabsorption in Adolescents and Young Adults With HIV Infection
NCT ID: NCT00490412
Last Updated: 2017-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
207 participants
INTERVENTIONAL
2007-12-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A: tenofovir/vitamin D
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.
Vitamin D supplement
Vitamin D3 (cholecalciferol), 50,000 IU as a single capsule, will be administered orally to subjects in Groups A and C once every four weeks during study visits.
B: tenofovir/placebo
A placebo will be administered orally to subjects in Group B (who are already taking Tenofovir).
Placebo
A placebo will be administered orally to subjects in Groups B and D once every four weeks during study visits.
C: no tenofovir/vitamin D
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.
Vitamin D supplement
Vitamin D3 (cholecalciferol), 50,000 IU as a single capsule, will be administered orally to subjects in Groups A and C once every four weeks during study visits.
D: no tenofovir/placebo
A placebo will be administered orally to subjects in Group D (who are not taking Tenofovir).
Placebo
A placebo will be administered orally to subjects in Groups B and D once every four weeks during study visits.
Interventions
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Vitamin D supplement
Vitamin D3 (cholecalciferol), 50,000 IU as a single capsule, will be administered orally to subjects in Groups A and C once every four weeks during study visits.
Placebo
A placebo will be administered orally to subjects in Groups B and D once every four weeks during study visits.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
24 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
National Institute of Mental Health (NIMH)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Peter L Havens, M.S., M.D.
Role: STUDY_CHAIR
Medical College of Wisconsin
Locations
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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
Countries
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References
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Havens PL, Hazra R, Stephensen CB, Kiser JJ, Flynn PM, Wilson CM, Rutledge B, Bethel J, Pan CG, Woodhouse LR, Van Loan MD, Liu N, Lujan-Zilbermann J, Baker A, Kapogiannis BG, Gordon CM, Mulligan K; Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 063 study team. Vitamin D3 supplementation increases fibroblast growth factor-23 in HIV-infected youths treated with tenofovir disoproxil fumarate. Antivir Ther. 2014;19(6):613-8. doi: 10.3851/IMP2755. Epub 2014 Feb 17.
Havens PL, Kiser JJ, Stephensen CB, Hazra R, Flynn PM, Wilson CM, Rutledge B, Bethel J, Pan CG, Woodhouse LR, Van Loan MD, Liu N, Lujan-Zilbermann J, Baker A, Kapogiannis BG, Gordon CM, Mulligan K; Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 063 Study Team. Association of higher plasma vitamin D binding protein and lower free calcitriol levels with tenofovir disoproxil fumarate use and plasma and intracellular tenofovir pharmacokinetics: cause of a functional vitamin D deficiency? Antimicrob Agents Chemother. 2013 Nov;57(11):5619-28. doi: 10.1128/AAC.01096-13. Epub 2013 Sep 3.
Havens PL, Stephensen CB, Hazra R, Flynn PM, Wilson CM, Rutledge B, Bethel J, Pan CG, Woodhouse LR, Van Loan MD, Liu N, Lujan-Zilbermann J, Baker A, Kapogiannis BG, Mulligan K; Adolescent Medicine Trials Network (ATN) for HIV/AIDS Interventions 063 study team. Vitamin D3 decreases parathyroid hormone in HIV-infected youth being treated with tenofovir: a randomized, placebo-controlled trial. Clin Infect Dis. 2012 Apr;54(7):1013-25. doi: 10.1093/cid/cir968. Epub 2012 Jan 19.
Related Links
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Website for the Adolescent Trials Network for HIV/AIDS Interventions
Other Identifiers
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ATN 063
Identifier Type: -
Identifier Source: org_study_id
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