Vitamin D Reabsorption in Adolescents and Young Adults With HIV Infection

February 27, 2017 updated by: University of North Carolina, Chapel Hill

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, Week 4, and Week 12
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
Baseline, Week 4, and Week 12
To measure the change in tenofovir exposure and creatinine clearance
Time Frame: Baseline, Week 4, and Week 12
Baseline, Week 4, and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)

Investigators

  • Study Chair: Peter L Havens, M.S., M.D., Medical College of Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

June 21, 2007

First Submitted That Met QC Criteria

June 21, 2007

First Posted (Estimate)

June 22, 2007

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATN 063

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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