Vitamin D Reabsorption in Adolescents and Young Adults With HIV Infection

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00490412
First received: June 21, 2007
Last updated: October 8, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
HIV Infections
Dietary Supplement: Vitamin D supplement
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • To compare the change in renal tubular reabsorption of phosphate and markers of bone turnover. [ Time Frame: Baseline, Week 4, Week 12 ] [ Designated as safety issue: Yes ]
  • To measure the safety of 50,000 IU dose of vitamin D3 [ Time Frame: Baseline, Week 4, and Week 8 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To measure the relationship of vitamin D plasma concentrations to renal tubular reabsorption of phosphate and markers of bone turnover [ Time Frame: Baseline, Week 4, and Week 12 ] [ Designated as safety issue: Yes ]
  • To measure the relationship of tenofovir exposure to renal tubular reabsorption of phosphate and markers of bone turnover [ Time Frame: Baseline, Week 4, and Week 12 ] [ Designated as safety issue: Yes ]
  • To measure the change in tenofovir exposure and creatinine clearance [ Time Frame: Baseline, Week 4, and Week 12 ] [ Designated as safety issue: Yes ]

Enrollment: 207
Study Start Date: December 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Dietary Supplement: 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 Comparator: B: tenofovir/placebo
A placebo will be administered orally to subjects in Group B (who are already taking Tenofovir).
Other: Placebo
A placebo will be administered orally to subjects in Groups B and D once every four weeks during study visits.
Experimental: 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.
Dietary Supplement: 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 Comparator: D: no tenofovir/placebo
A placebo will be administered orally to subjects in Group D (who are not taking Tenofovir).
Other: Placebo
A placebo will be administered orally to subjects in Groups B and D once every four weeks during study visits.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490412

Locations
United States, California
Children's Hopsital of Los Angeles
Los Angeles, California, United States, 90027
University of California at San Francisco
San Francisco, California, United States, 94143
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, United States, 33316
University of Miami
Miami, Florida, United States, 33101
University of South Florida
Tampa, Florida, United States, 33606
United States, Illinois
Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612
Childrens Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70112
United States, Maryland
University of Maryland Medical School
Baltimore, Maryland, United States, 21204
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Mount Sinai Hospital
New York, New York, United States, 10128
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
St. Jude Childrens Research Hospital
Memphis, Tennessee, United States, 38105
Puerto Rico
University of Puerto Rico
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
Investigators
Study Chair: Peter L Havens, M.S., M.D. Medical College of Wisconsin
  More Information

Additional Information:
No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00490412     History of Changes
Other Study ID Numbers: ATN 063
Study First Received: June 21, 2007
Last Updated: October 8, 2013
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Vitamin D
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Tenofovir
Tenofovir disoproxil
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014