Renal, Endocrine, and Bone Changes in Response to FTC/TDF in Uninfected Young Men Who Have Sex With Men (YMSM).
1 other identifier
observational
101
1 country
12
Brief Summary
This is a prospective observational cohort sub-study of subjects enrolled in the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 110 (NCT01772823) or ATN 113 (NCT01769456), which is a prospective interventional trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2012
Typical duration for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 14, 2013
CompletedFirst Posted
Study publicly available on registry
January 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedResults Posted
Study results publicly available
March 11, 2019
CompletedMarch 27, 2019
November 1, 2018
3 years
January 14, 2013
November 21, 2016
March 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Magnitude of Change (Fold Change) in Parathyroid Hormone (PTH) From Baseline to Week 48
The magnitude of change in PTH will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).
Baseline and Week (wk) 48
Secondary Outcomes (124)
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Change From Baseline to Week 48
Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Magnitude of Fold Change
Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Most Extreme Fold Change
Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Time to Most Extreme Fold Change
Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 Dihydroxy Vitamin D (1,25 OHD), Change From Baseline to Week 48
Baseline and wk 48
- +119 more secondary outcomes
Study Arms (1)
Subjects Enrolled in ATN 110 or ATN 113
A subset of 100 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.
Interventions
There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.
Eligibility Criteria
Individuals between the ages 15 years 0 days to 22 years 364 days, who are enrolled in ATN 110 (NCT01772823) or ATN 113 (NCT01769456) , and agree to enter this sub-study at the same time they begin ATN 110 or ATN 113.
You may qualify if:
- Has been enrolled in ATN 110 (NCT01772823) or ATN 113 (NCT01769456) , and
- Willing and able to provide written informed consent
You may not qualify if:
- Subjects exempted from undergoing DXA scans in ATN 110 (NCT01772823) or ATN 113 (NCT01769456) are not eligible to enroll in ATN 117 (NCT01769469).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Children's Hopsital of Los Angeles
Los Angeles, California, 90027, United States
Children's Hospital of Denver
Aurora, Colorado, 80045, United States
University of Miami
Miami, Florida, 33101, United States
University of South Florida
Tampa, Florida, 33606, United States
Stroger Hospital and the CORE Center
Chicago, Illinois, 60612, United States
Tulane University
New Orleans, Louisiana, 70112, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Fenway Institute
Boston, Massachusetts, 02215, United States
Wayne State University
Detroit, Michigan, 48201, United States
Children's Hopsital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
St. Jude Childrens Research Hospital
Memphis, Tennessee, 38105, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Related Publications (3)
Havens PL, Stephensen CB, Van Loan MD, Schuster GU, Woodhouse LR, Flynn PM, Gordon CM, Pan CG, Rutledge B, Liu N, Wilson CM, Hazra R, Hosek SG, Anderson PL, Seifert SM, Kapogiannis BG, Mulligan K; Adolescent Medicine Trials Network for HIV/AIDS Interventions 117 study team. Decline in Bone Mass With Tenofovir Disoproxil Fumarate/Emtricitabine Is Associated With Hormonal Changes in the Absence of Renal Impairment When Used by HIV-Uninfected Adolescent Boys and Young Men for HIV Preexposure Prophylaxis. Clin Infect Dis. 2017 Feb 1;64(3):317-325. doi: 10.1093/cid/ciw765. Epub 2016 Nov 15.
PMID: 28013265RESULTHavens PL, Tamhane A, Stephensen CB, Schuster GU, Gordon CM, Liu N, Wilson CM, Hosek SG, Anderson PL, Kapogiannis BG, Mulligan K. Short Communication: Association of Vitamin D Insufficiency and Protective Tenofovir Diphosphate Concentrations with Bone Toxicity in Adolescent Boys and Young Men Using Tenofovir Disoproxil Fumarate/Emtricitabine for HIV Pre-Exposure Prophylaxis. AIDS Res Hum Retroviruses. 2019 Feb;35(2):123-128. doi: 10.1089/AID.2018.0096. Epub 2018 Nov 5.
PMID: 30280906DERIVEDHavens PL, Long D, Schuster GU, Gordon CM, Price G, Wilson CM, Kapogiannis BG, Mulligan K, Stephensen CB; Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 117 and 109 study teams. Tenofovir disoproxil fumarate appears to disrupt the relationship of vitamin D and parathyroid hormone. Antivir Ther. 2018;23(7):623-628. doi: 10.3851/IMP3269. Epub 2018 Sep 27.
PMID: 30260797DERIVED
Related Links
Biospecimen
Blood and urine samples to measure: Calcium-Phosphate Balance, Bone Turnover, Renal Glomerular Function, Renal Tubular Function. Dried blood spots (DBS) for FTC and Tenofovir (TFV)concentrations; red blood cell (RBC) for TFV-diphosphate (DP); plasma for FTC, TFV; peripheral blood mononuclear cells (PBMC) for TFV-DP and FTC-triphosphate (TP) collected as part of ATN 110 and ATN 113 will be used in the ATN 117 analysis.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Since high and low drug exposure groups were not assigned by the study team, but rather "chosen" by the participants and categorized post hoc for analysis, there may be unidentified variables confounding our findings.
Results Point of Contact
- Title
- Dr. Bob Harris
- Organization
- Westat
Study Officials
- STUDY CHAIR
Peter Havens, MD
MACC Fund Research Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2013
First Posted
January 16, 2013
Study Start
November 1, 2012
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
March 27, 2019
Results First Posted
March 11, 2019
Record last verified: 2018-11