Vitamin D Reabsorption in Adolescents and Young Adults With HIV Infection

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00490412
• Other study ID #: ATN 063
• Status: Completed
• Phase: N/A
• First received: June 21, 2007
• Last updated: February 27, 2017
• Start date: December 2007
• Est. completion date: January 2010

Study information

• Verified date: February 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Infection

Intervention

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.

Other:
• Placebo
A placebo will be administered orally to subjects in Groups B and D once every four weeks during study visits.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the change in renal tubular reabsorption of phosphate and markers of bone turnover.		Baseline, Week 4, Week 12
Primary	To measure the safety of 50,000 IU dose of vitamin D3		Baseline, Week 4, and Week 8
Secondary	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
Secondary	To measure the relationship of tenofovir exposure to renal tubular reabsorption of phosphate and markers of bone turnover		Baseline, Week 4, and Week 12
Secondary	To measure the change in tenofovir exposure and creatinine clearance		Baseline, Week 4, and Week 12

External Links

•   Website for the Adolescent Trials Network for HIV/AIDS Interventions