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: February 12, 2015
Last verified: December 2014
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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490412
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 | |
| Childrens Memorial Hospital | |
| Chicago, Illinois, United States, 60614 | |
| Stroger Hospital of Cook County | |
| Chicago, Illinois, United States, 60612 | |
| 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: | February 12, 2015 |
| 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:
|
Acquired Immunodeficiency Syndrome Communicable Diseases HIV Infections Infection Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases Cholecalciferol Ergocalciferols |
Tenofovir Tenofovir disoproxil Vitamin D Vitamins Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents Bone Density Conservation Agents Enzyme Inhibitors Growth Substances Micronutrients Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions |
ClinicalTrials.gov processed this record on February 27, 2015