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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: tenofovir/vitamin D | Experimental | 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. |
|
| B: tenofovir/placebo | Placebo Comparator | A placebo will be administered orally to subjects in Group B (who are already taking Tenofovir). |
|
| C: no tenofovir/vitamin D | Experimental | 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. |
|
| D: no tenofovir/placebo | Placebo Comparator | A placebo will be administered orally to subjects in Group D (who are not taking Tenofovir). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D supplement | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter L Havens, M.S., M.D. | Medical College of Wisconsin | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hopsital of Los Angeles | Los Angeles | California | 90027 | United States | ||
| University of California at San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24535626 | Derived | 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. | |
| 24002093 |
| Label | URL |
|---|---|
| Website for the Adolescent Trials Network for HIV/AIDS Interventions | View source |
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| Placebo | Other | A placebo will be administered orally to subjects in Groups B and D once every four weeks during study visits. |
|
| Baseline, Week 4, and Week 12 |
| To measure the change in tenofovir exposure and creatinine clearance | Baseline, Week 4, and Week 12 |
| 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 |
| Derived |
| Havens 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. |
| 22267714 | Derived | Havens 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. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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