Vitamin D Reabsorption in Adolescents and Young Adults With HIV Infection
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
1 other identifier
interventional
207
2 countries
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv-infections
Started Dec 2007
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2007
CompletedFirst Posted
Study publicly available on registry
June 22, 2007
CompletedStudy Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedFebruary 28, 2017
February 1, 2016
2.1 years
June 21, 2007
February 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
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
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 change in tenofovir exposure and creatinine clearance
Baseline, Week 4, and Week 12
Study Arms (4)
A: tenofovir/vitamin D
EXPERIMENTALVitamin 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 COMPARATORA placebo will be administered orally to subjects in Group B (who are already taking Tenofovir).
C: no tenofovir/vitamin D
EXPERIMENTALVitamin 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 COMPARATORA placebo will be administered orally to subjects in Group D (who are not taking Tenofovir).
Interventions
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.
A placebo will be administered orally to subjects in Groups B and D once every four weeks during study visits.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Children's Hopsital of Los Angeles
Los Angeles, California, 90027, United States
University of California at San Francisco
San Francisco, California, 94143, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, 33316, United States
University of Miami
Miami, Florida, 33101, United States
University of South Florida
Tampa, Florida, 33606, United States
Stroger Hospital of Cook County
Chicago, Illinois, 60612, United States
Childrens Memorial Hospital
Chicago, Illinois, 60614, United States
Tulane University
New Orleans, Louisiana, 70112, United States
University of Maryland Medical School
Baltimore, Maryland, 21204, United States
Mount Sinai Hospital
New York, New York, 10128, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
St. Jude Childrens Research Hospital
Memphis, Tennessee, 38105, United States
University of Puerto Rico
San Juan, 00936, Puerto Rico
Related Publications (3)
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.
PMID: 24535626DERIVEDHavens 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.
PMID: 24002093DERIVEDHavens 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.
PMID: 22267714DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Peter L Havens, M.S., M.D.
Medical College of Wisconsin
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2007
First Posted
June 22, 2007
Study Start
December 1, 2007
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
February 28, 2017
Record last verified: 2016-02