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Renal, Endocrine, and Bone Changes in Response to FTC/TDF in Uninfected Young Men Who Have Sex With Men (YMSM).

2019. március 25. frissítette: University of North Carolina, Chapel Hill

Renal, Endocrine, and Bone Changes in Response to Treatment With Coformulated Emtricitabine-Tenofovir for Pre-Exposure HIV Prophylaxis (PrEP) in HIV Uninfected Young Men Who Have Sex With Men.

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.

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

HIV fertőzés

Beavatkozás / kezelés

Drog: FTC/TDF (Truvada®)

Részletes leírás

This is a prospective observational cohort sub-study of subjects enrolled in the ATN 110 (NCT01772823) or ATN 113 (NCT01769456) study. All subjects will be followed for at least 48 weeks. Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 (NCT01772823) or ATN 113 (NCT01769456) study will be followed for an additional 48 weeks in the Extension Phase of ATN 110 (NCT01772823) or ATN 113 (NCT01769456) and ATN 117 (NCT01769469). The maximum duration of participation will be 96 weeks.

There is no therapeutic intervention specific to this sub-study, and there are no extra study visits required for participation in this sub-study. Questionnaires will be administered and blood and urine samples for laboratory evaluation of potential emtricitabine (FTC)/tenofovir (TDF) (Truvada®) toxicities will be obtained for this sub-study at visits that are required by the ATN 110 (NCT01772823) or ATN 113 (NCT01769456) study. Measurement of bone mineral density (BMD) and bone mineral content (BMC) by dual-energy X-ray absorptiometry (DXA) scan are planned as a part of the ATN 110 (NCT01772823) and ATN 113 (NCT01769456) studies, and results will be utilized for the analysis in this study. This study does not require extra BMD or BMC measurements.

Tanulmány típusa

Megfigyelő

Beiratkozás (Tényleges)

101

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

Egyesült Államok
- California
  - Los Angeles, California, Egyesült Államok, 90027
    - Children's Hopsital of Los Angeles
- Colorado
  - Aurora, Colorado, Egyesült Államok, 80045
    - Children's Hospital of Denver
- Florida
  - Miami, Florida, Egyesült Államok, 33101
    - University of Miami
  - Tampa, Florida, Egyesült Államok, 33606
    - University of South Florida
- Illinois
  - Chicago, Illinois, Egyesült Államok, 60612
    - Stroger Hospital and the CORE Center
- Louisiana
  - New Orleans, Louisiana, Egyesült Államok, 70112
    - Tulane University
- Maryland
  - Baltimore, Maryland, Egyesült Államok, 21287
    - Johns Hopkins University
- Massachusetts
  - Boston, Massachusetts, Egyesült Államok, 02215
    - Fenway Institute
- Michigan
  - Detroit, Michigan, Egyesült Államok, 48201
    - Wayne State University
- Pennsylvania
  - Philadelphia, Pennsylvania, Egyesült Államok, 19104
    - Children's Hopsital of Philadelphia
- Tennessee
  - Memphis, Tennessee, Egyesült Államok, 38105
    - St. Jude Childrens Research Hospital
- Texas
  - Houston, Texas, Egyesült Államok, 77030
    - Baylor College of Medicine

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

15 év (Gyermek, Felnőtt)

Egészséges önkénteseket fogad

Igen

Tanulmányozható nemek

Férfi

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

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.

Leírás

Inclusion Criteria:

Has been enrolled in ATN 110 (NCT01772823) or ATN 113 (NCT01769456) , and
Willing and able to provide written informed consent

Exclusion Criteria:

-Subjects exempted from undergoing DXA scans in ATN 110 (NCT01772823) or ATN 113 (NCT01769456) are not eligible to enroll in ATN 117 (NCT01769469).

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Csoportok/kohorszok száma

Kohorszok és beavatkozások

Csoport / Kohorsz	Beavatkozás / kezelés
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.	Drog: FTC/TDF (Truvada®) 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. Más nevek: Truvada®

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő	Intézkedés leírása	Időkeret
Magnitude of Change (Fold Change) in Parathyroid Hormone (PTH) From Baseline to Week 48 Időkeret: Baseline and Week (wk) 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

Másodlagos eredményintézkedések

Eredménymérő	Intézkedés leírása	Időkeret
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Change From Baseline to Week 48 Időkeret: Baseline and wk 48		Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Magnitude of Fold Change Időkeret: Baseline and wk 48	The magnitude of change in FGF23 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 wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Most Extreme Fold Change Időkeret: Baseline, Weeks 4, 8, 12, 24, 36 and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.	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 Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.	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 Időkeret: Baseline and wk 48		Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Magnitude of Fold Change Időkeret: Baseline and wk 48	The magnitude of change in 1,25 OHD 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 wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Most Extreme Fold Change Időkeret: Baseline, Weeks 4, 8, 12, 24, 36 and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.	Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Time to Most Extreme Fold Change Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Tubular Reabsorption of Phosphate (TRP), Change From Baseline to Week 48 Időkeret: Baseline and wk 48		Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Magnitude of Fold Change Időkeret: Baseline and wk 48	The magnitude of change in TRP 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 wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Most Extreme Fold Change Időkeret: Baseline, Weeks 4, 8, 12, 24, 36 and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.	Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Time to Most Extreme Fold Change Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Glomerular Filtration Rate (GFR), Change From Baseline to Week 48 Időkeret: Baseline and wk 48		Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Magnitude of Fold Change Időkeret: Baseline and wk 48	The magnitude of change in GFR 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 wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Most Extreme Fold Change Időkeret: Baseline, Weeks 4, 8, 12, 24, 36 and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.	Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Time to Most Extreme Fold Change Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Most Extreme Fold Change Időkeret: Baseline, Weeks 4, 8, 12, 24, 36 and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.	Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Time to Most Extreme Fold Change Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Serum Creatinine (SCr), Time to Most Extreme Fold Change Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Slope of the Curve of Baseline to Most Extreme Fold Change Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: FGF23, Slope of the Curve of Baseline to Most Extreme Fold Change Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25-OHD, Slope of the Curve of Baseline to Most Extreme Fold Change Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Slope of the Curve of Baseline to Most Extreme Fold Change Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change From Baseline to Week 48 in Serum Calcium (SCa) Időkeret: Baseline and wk 48	Serum calcium Week 48 difference from baseline	Baseline and wk 48
Magnitude of Most Extreme Fold Change: Serum Calcium (SCa) Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Time to Most Extreme Fold Change: Serum Calcium (SCa) Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Slope of the Curve of Baseline to Most Extreme Fold Change: Serum Calcium (SCa) Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change From Baseline to Week 48 in Urine Calcium (UCa) / Urine Creatinine (UCr) Időkeret: Baseline and wk 48	Urine Calcium (UCa) / Urine Creatinine (UCr) ratio Week 48 difference from baseline	Baseline and wk 48
Magnitude of Most Extreme Fold Change: UCa/UCr Ratio Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Time to Most Extreme Fold Change: UCa/UCr Ratio Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Slope of the Curve of Baseline to Most Extreme Fold Change: UCa/UCr Ratio Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change From Baseline to Week 48 in Serum Phosphate (SPO4) Időkeret: Baseline and wk 48	Serum Phosphate (SPO4) Week 48 difference from baseline	Baseline and wk 48
Magnitude of Most Extreme Fold Change: SPO4 Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Time to Most Extreme Fold Change: SPO4 Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Slope of the Curve of Baseline to Most Extreme Fold Change: SPO4 Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr) Időkeret: Baseline and wk 48	URBP/UCr Week 48 difference from baseline	Baseline and wk 48
Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Beta-2 Microglobulin (UB2MG) Időkeret: Baseline and wk 48	UB2MG Week 48 difference from baseline	Baseline and wk 48
Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Protein (UProt) / Urine Creatinine (UCr) Időkeret: Baseline and wk 48	UProt/ UCr Week 48 difference from baseline	Baseline and wk 48
Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Glucose (UGluc) Időkeret: Baseline and wk 48	UGluc Week 48 difference from baseline	Baseline and wk 48
Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Serum Creatinine (SCr) Időkeret: Baseline and wk 48	SCr Week 48 difference from baseline	Baseline and wk 48
Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr) Időkeret: Baseline and wk 48	The magnitude of change in URBP/UCr 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 wk 48
Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Beta-2 Microglobulin (UB2MG) Időkeret: Baseline and wk 48	The magnitude of change in UB2MG 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 wk 48
Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Protein (UProt)/ Urine Creatinine (UCr) Időkeret: Baseline and wk 48	The magnitude of change in UProt/UCr 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 wk 48
Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Glucose (UGluc) Időkeret: Baseline and wk 48	The magnitude of change in UGluc 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 wk 48
Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Serum Creatinine (SCr) Időkeret: Baseline and wk 48	The magnitude of change in SCr 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 wk 48
Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr) Időkeret: Baseline, Weeks 4, 8, 12, 24, 36 and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.	Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UB2MG Időkeret: Baseline, Weeks 4, 8, 12, 24, 36 and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.	Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UProt/UCr Időkeret: Baseline, Weeks 4, 8, 12, 24, 36 and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.	Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UGluc Időkeret: Baseline, Weeks 4, 8, 12, 24, 36 and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.	Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in SCr Időkeret: Baseline, Weeks 4, 8, 12, 24, 36 and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.	Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr) Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UB2MG Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UProt/UCr Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UGluc Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr) Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UB2MG Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UProt/UCr Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UGluc Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in Scr Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Change From Baseline to Week 48 in Osteocalcin (OC) Időkeret: Baseline and wk 48	OC Week 48 difference from baseline	Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Change From Baseline to Week 48 in C-Telopeptide (CTX) Időkeret: Baseline and wk 48	CTX Week 48 difference from baseline	Baseline and wk 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Most Extreme Fold Change in Osteocalcin (OC) Időkeret: Baseline, Weeks 4, 8, 12, 24, 36 and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.	Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Most Extreme Fold Change in C-telopeptide (CTX) Időkeret: Baseline, Weeks 4, 8, 12, 24, 36 and 48	Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.	Baseline, Weeks 4, 8, 12, 24, 36 and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: OC, Time to Most Extreme Fold Change Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Time to Most Extreme Fold Change in C-telopeptide (CTX) Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Slope of the Curve of Baseline to Most Extreme Fold Change in OC Időkeret: Baseline, Weeks 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]	Baseline, Weeks 4, 8, 12, 24, 36, and 48
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Slope of the Curve of Baseline to Most Extreme Fold Change in CTX Időkeret: Baseline, Weeks (wks) 4, 8, 12, 24, 36, and 48	The slope from baseline to most extreme fold change can be expressed as: Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]	Baseline, Weeks (wks) 4, 8, 12, 24, 36, and 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in PTH, by Overall Drug Exposure Időkeret: Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.	Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in PTH, by Overall Drug Exposure Időkeret: Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, and 24.	Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in FGF23, by Overall Drug Exposure Időkeret: Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, and 24.	Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in FGF23, by Overall Drug Exposure Időkeret: Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.	Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in 1,25 OHD, by Overall Drug Exposure Időkeret: Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, and 24.	Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in 1,25 OHD, by Overall Drug Exposure Időkeret: Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.	Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Osteocalcin (OC), by Overall Drug Exposure Időkeret: Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, and 24.	Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Osteocalcin (OC), by Overall Drug Exposure Időkeret: Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.	Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in CTX, by Overall Drug Exposure Időkeret: Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, and 24.	Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in CTX, by Overall Drug Exposure Időkeret: Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.	Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in SCr, by Overall Drug Exposure Időkeret: Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, and 24.	Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in SCr, by Overall Drug Exposure Időkeret: Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.	Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in TRP, by Overall Drug Exposure Időkeret: Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, and 24.	Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in TRP, by Overall Drug Exposure Időkeret: Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.	Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UCa/UCr Ratio, by Overall Drug Exposure Időkeret: Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, and 24.	Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UCa/UCr Ratio, by Overall Drug Exposure Időkeret: Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.	Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UB2MG, by Overall Drug Exposure Időkeret: Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, and 24.	Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UB2MG, by Overall Drug Exposure Időkeret: Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.	Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UGluc, by Overall Drug Exposure Időkeret: Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, and 24.	Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UGluc, by Overall Drug Exposure Időkeret: Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.	Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in URBP/UCr Ratio, by Overall Drug Exposure Időkeret: Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, and 24.	Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in URBP/UCr Ratio, by Overall Drug Exposure Időkeret: Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.	Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Lumbar Spine BMD, by Overall Drug Exposure Időkeret: Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, and 24.	Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Lumbar Spine BMD, by Overall Drug Exposure Időkeret: Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.	Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Lumbar Spine BMD Z-score, by Overall Drug Exposure Időkeret: Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure. The time points at which data were collected were: weeks 4, 8, 12, and 24.	Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Lumbar Spine BMD Z-score, by Overall Drug Exposure Időkeret: Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure. The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.	Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Femoral Neck BMD, by Overall Drug Exposure Időkeret: Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, and 24.	Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Femoral Neck BMD, by Overall Drug Exposure Időkeret: Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.	Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Femoral Neck BMD Z-score, by Overall Drug Exposure Időkeret: Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure. The time points at which data were collected were: weeks 4, 8, 12, and 24.	Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Femoral Neck BMD Z-score, by Overall Drug Exposure Időkeret: Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure. The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.	Baseline and wk 48
Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Total Body BMC, by Overall Drug Exposure Időkeret: Baseline and wk 24	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, and 24.	Baseline and wk 24
Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Total Body BMC, by Overall Drug Exposure Időkeret: Baseline and wk 48	Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group. The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.	Baseline and wk 48
Magnitude of Change in Lumbar Spine BMD at Week 48 Időkeret: Baseline and wk 48	The magnitude of change 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 wk 48
Magnitude of Change in Lumbar Spine BMD Z-score at Week 48 Időkeret: Baseline and wk 48	The magnitude of change 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). The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.	Baseline and wk 48
Magnitude of Change in Femoral Neck BMD at Week 48 Időkeret: Baseline and wk 48	The magnitude of change 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 wk 48
Magnitude of Change in Femoral Neck BMD Z-score at Week 48 Időkeret: Baseline and wk 48	The magnitude of change 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 wk 48
Magnitude of Change in Total Body BMC at Week 48 Időkeret: Baseline and wk 48	The magnitude of change 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 wk 48
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Baseline Időkeret: Baseline and wk 72	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit). This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)	Baseline and wk 72
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Baseline Időkeret: Baseline and wk 96	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit). This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)	Baseline and wk 96
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Week 48 (or Last Visit on Study) Időkeret: Wk 48 (or last available measurement on study), Wk 72	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit). This measure shows the difference between the last measure on study and the first Extension Phase visit (Last - EPH1)	Wk 48 (or last available measurement on study), Wk 72
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Week 48 (or Last Visit on Study) Időkeret: Wk 48 (or last available measurement on study), Wk 96	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit). This measure shows the difference between the last measure on study and the second Extension Phase visit (Last - EPH2)	Wk 48 (or last available measurement on study), Wk 96
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Baseline Időkeret: Baseline and wk 72	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit). This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1). The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.	Baseline and wk 72
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Baseline Időkeret: Baseline and wk 96	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit). This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2) The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.	Baseline and wk 96
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Week 48 (or Last Visit on Study) Időkeret: Wk 48 (or last available measurement on study), Wk 72	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit). This measure shows the difference between the last measure on study and the first Extension Phase visit (Last - EPH1) The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.	Wk 48 (or last available measurement on study), Wk 72
Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Week 48 (or Last Visit on Study) Időkeret: Wk 48 (or last available measurement on study), Wk 96	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit). This measure shows the difference between the last measure on study and the second Extension Phase visit (Last - EPH2) The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.	Wk 48 (or last available measurement on study), Wk 96
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Baseline Időkeret: Baseline and wk 72	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit). This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)	Baseline and wk 72
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Baseline Időkeret: Baseline and wk 96	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit). This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)	Baseline and wk 96
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Week 48 (or Last Visit on Study) Időkeret: Wk 48 (or last available measurement on study), Wk 72	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit). This measure shows the difference between the last measure on study and the first Extension Phase visit (Last- EPH1)	Wk 48 (or last available measurement on study), Wk 72
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Week 48 (or Last Visit on Study) Időkeret: W 48 (or last available measurement on study), Wk 96	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit). This measure shows the difference between the last measure on study and the second Extension Phase visit (Last- EPH2)	W 48 (or last available measurement on study), Wk 96
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Baseline Időkeret: Baseline and wk 72	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit). This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1) The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.	Baseline and wk 72
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Baseline Időkeret: Baseline, Week 96	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit). This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2) The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.	Baseline, Week 96
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Week 48 (or Last Visit on Study) Időkeret: Week 48 (or last available measurement on study), Week 72	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit). This measure shows the difference between the last measure on study and the first Extension Phase visit (Last - EPH1) The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.	Week 48 (or last available measurement on study), Week 72
Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Week 48 (or Last Visit on Study) Időkeret: Wk 48 (or last available measurement on study), Wk 96	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit). This measure shows the difference between the last measure on study and the second Extension Phase visit (Last - EPH2). The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.	Wk 48 (or last available measurement on study), Wk 96
Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Baseline Időkeret: Baseline and wk 72	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit). This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)	Baseline and wk 72
Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Baseline Időkeret: Baseline and wk 96	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit). This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)	Baseline and wk 96
Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Week 48 (or Last Visit on Study) Időkeret: Wk 48 (or last available measurement on study), Wk 72	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit). This measure shows the difference between the last measure on study and the first Extension Phase visit (Last- EPH1)	Wk 48 (or last available measurement on study), Wk 72
Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Week 48 (or Last Visit on Study) Időkeret: Wk 48 (or last available measurement on study), Wk 96	For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit). This measure shows the difference between the last measure on study and the second Extension Phase visit (Last- EPH2)	Wk 48 (or last available measurement on study), Wk 96

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

University of North Carolina, Chapel Hill

Együttműködők

National Institute on Drug Abuse (NIDA)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of Mental Health (NIMH)

Nyomozók

Tanulmányi szék: Peter Havens, MD, MACC Fund Research Center

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Hasznos linkek

ATN Website

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete

2012. november 1.

Elsődleges befejezés (Tényleges)

2015. november 1.

A tanulmány befejezése (Tényleges)

2015. november 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2013. január 14.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2013. január 14.

Első közzététel (Becslés)

2013. január 16.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2019. március 27.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2019. március 25.

Utolsó ellenőrzés

2018. november 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

Egyéb vizsgálati azonosító számok

ATN 117 Version 2.0

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

Klinikai vizsgálatok a HIV fertőzés

University of Alabama at Birmingham
Mobile County Health Deparment; Alabama Department of Public Health

Toborzás

Megvalósítási kísérlet a populációegészségügyi kombinált beavatkozás értékelésére a HIV-tesztelési, kapcsolódási és víruselnyomási célok elérése érdekében Alabamában (COAST-AL)

HIV | HIV-tesztelés | HIV kapcsolat az ellátással | HIV kezelés

Egyesült Államok
French National Agency for Research on AIDS and...
Elizabeth Glaser Pediatric AIDS Foundation

Befejezve

Pár-orientált prenatális HIV-tanácsadás alacsony és közepes HIV-prevalenciájú országokban (Prenahtest)

Partner HIV-teszt | Páros HIV-tanácsadás | Párkapcsolat | HIV incidencia

Kamerun, Dominikai Köztársaság, Grúzia, India
ANRS, Emerging Infectious Diseases
Hopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement; Centre... és más munkatársak

Ismeretlen

A 4–7 éves HIV-fertőzött vagy HIV-fertőzött gyermekek fejlődésének keresztmetszeti értékelése az ANRS 12140 kohorszból (Pediacam) (PediacamDEV)

HIV | HIV-fertőzött gyermekek | HIV-fertőzésnek kitett gyermekek

Kamerun
University of Minnesota

Visszavont

N-803 kombinálva a széles körben semlegesítő antitestekkel, plusz vagy mínusz haNK sejtekkel a HIV számára

HIV fertőzések | HIV/AIDS | Hiv | AIDS | AIDS/HIV probléma | AIDS és fertőzések

Egyesült Államok
CDC Foundation
Gilead Sciences

Ismeretlen

Fenntartható Egészségügyi Központ megvalósítása PrEP kísérleti tanulmány (SHIPP)

HIV preexpozíciós profilaxis | HIV kemoprofilaxis

Egyesült Államok
Africa Health Research Institute
London School of Hygiene and Tropical Medicine; University College, London; University... és más munkatársak

Toborzás

Otthoni beavatkozás a teszteléshez és elindításhoz (HITS)

HIV | HIV-tesztelés | Kapcsolat a gondozással

Dél-Afrika
University of Maryland, Baltimore

Visszavont

A szirolimusz és a maravirok hatása a CCR5 expressziójára és a HIV-1 tartályra HIV-fertőzött vesetranszplantált recipiensekben

Hiv | Veseátültetés | HIV-tározó | CCR5

Egyesült Államok
Hospital Clinic of Barcelona

Befejezve

Kettős terápia raltegravirral és darunavirral/ritonavirrel HIV-fertőzött betegeknél. (RALDAR)

Integráz inhibitorok, HIV; HIV PROTEÁZ INHIB

Spanyolország
University of Washington
National Institute of Mental Health (NIMH)

Toborzás

A PrEP megvalósítás hatékonyságának ésszerűsítése (Efficiency)

HIV megelőzés | HIV preexpozíciós profilaxis | Végrehajtás

Kenya
Erasmus Medical Center

Még nincs toborzás

A topiramát tanulmányozása a HIV-1 tartály újraaktiválására (STAR)

HIV fertőzések | Hiv | HIV-1 fertőzés | HIV I fertőzés

Hollandia

Klinikai vizsgálatok a FTC/TDF (Truvada®)

University of Washington
Eunice Kennedy Shriver National Institute of Child Health and Human Development... és más munkatársak

Befejezve

A Kampalai Női Csontkutatás

Hipoösztrogenizmus | Csont demineralizáció | Szubklinikai vesekárosodás | Csont mikroarchitektúra

Uganda
Yale University

Befejezve

EMPOWERING projekt: Bizonyítékokon alapuló PREP az igazságszolgáltatásban érintett nők és kockázati hálózataik számára

HIV fertőzések

Egyesült Államok
Gilead Sciences

Befejezve

Vizsgálat a TDF-tartalmú kombinációs kezelésről a TAF-tartalmú fix dózisú kombinációra (FDC) való átállás értékelésére virológiailag szuppresszált, HIV-1-pozitív résztvevőknél

HIV fertőzések | HIV

Kanada, Egyesült Államok, Spanyolország, Puerto Rico, Franciaország, Svájc, Ausztrália, Németország, Egyesült Királyság, Svédország, Brazília, Ausztria, Thaiföld, Hollandia, Belgium, Dominikai Köztársaság, Portugália, Olasz... és több
Gilead Sciences

Befejezve

Váltson át a vizsgálatra az F/TAF értékelésére olyan HIV-1-pozitív résztvevőknél, akik virológiailag elnyomták az FTC/TDF-et tartalmazó kezelések során

HIV-1 fertőzés

Egyesült Államok, Egyesült Királyság, Kanada, Franciaország, Olaszország, Puerto Rico, Belgium
Gilead Sciences

Befejezve

Az E/C/F/TDF biztonsága és hatékonysága az RTV-vel megerősített ATV Plus FTC/TDF-fel szemben HIV-1-fertőzött, antiretrovirális kezelésben nem részesült nőknél (WAVES)

HIV fertőzések | Szerzett immunhiányos szindróma

Egyesült Államok, Thaiföld, Franciaország, Uganda, Egyesült Királyság, Belgium, Portugália, Mexikó, Dominikai Köztársaság, Olaszország, Puerto Rico, Orosz Föderáció
French National Agency for Research on AIDS and...
Merck Sharp & Dohme LLC

Befejezve

Az enfuvirtinről a raltegravirra való váltás hatékonysága és toleranciája az antiretrovirális terápiában olyan HIV-betegeknél, akiknél nem észlelhető a vírusterhelés (EASIER)

HIV fertőzések

Franciaország
Gilead Sciences

Befejezve

Tenofovir-dizoproxil-fumarát (tenofovir DF) versus emtricitabin/tenofovir DF lamivudinnal szemben rezisztens alanyokban

Hepatitisz B

Kanada, Németország, Pulyka, Egyesült Államok, Görögország, Új Zéland, Magyarország, Románia, Bulgária, Szerbia, Ausztria, Lengyelország, Cseh Köztársaság, Spanyolország
Auritec Pharmaceuticals
Eunice Kennedy Shriver National Institute of Child Health and Human Development... és más munkatársak

Befejezve

A HIV-profilaxis biztonságossági és farmakokinetikai vizsgálata antiretrovirális intravaginális gyűrűkkel egészséges nőknél

Humán immunhiány vírus (HIV) megelőzése

Egyesült Államok
Gilead Sciences

Befejezve

Vizsgálat az efavirenz/emtricitabin/tenofovir-dizoproxil-fumarát (EFV/FTC/TDF) fix dózisú kombinációból (FDC) az emtricitabin/rilpivirin/tenofovir-alafenamidra (FTC/RPV/TAF in Virologically, FDCup/TAF) álló kezelési rendről való váltás értékelésére -1 fertőzött felnőtt

HIV-1 fertőzés

Spanyolország, Egyesült Államok, Egyesült Királyság, Svájc, Németország, Kanada, Franciaország, Belgium, Puerto Rico
Gilead Sciences

Befejezve

Váltási vizsgálat az emtricitabin/rilpivirin/tenofovir-alafenamid (FTC/RPV/TAF) fix dózisú kombináció (FDC) biztonságosságának és hatékonyságának értékelésére olyan HIV-1-pozitív felnőtteknél, akiknél az emtricitabin/rilpivirin/tenofovir-fumarát (proFTC/Tenoilfovir-fumarát) virológiailag elnyomott. /TDF)

HIV-1 fertőzés

Egyesült Államok, Spanyolország, Egyesült Királyság, Hollandia, Németország, Kanada, Svédország, Svájc, Olaszország, Belgium, Puerto Rico, Franciaország

Renal, Endocrine, and Bone Changes in Response to FTC/TDF in Uninfected Young Men Who Have Sex With Men (YMSM).

Renal, Endocrine, and Bone Changes in Response to Treatment With Coformulated Emtricitabine-Tenofovir for Pre-Exposure HIV Prophylaxis (PrEP) in HIV Uninfected Young Men Who Have Sex With Men.

A tanulmány áttekintése

Állapot

Körülmények

Beavatkozás / kezelés

Részletes leírás

Tanulmány típusa

Beiratkozás (Tényleges)

Kapcsolatok és helyek

Tanulmányi helyek

Részvételi kritériumok

Jogosultsági kritériumok

Tanulmányozható életkorok

Egészséges önkénteseket fogad

Tanulmányozható nemek

Mintavételi módszer

Tanulmányi populáció

Leírás

Tanulási terv

Hogyan készül a tanulmány?

Tervezési részletek

Csoportok/kohorszok száma

Kohorszok és beavatkozások

Csoport / Kohorsz

Beavatkozás / kezelés

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő

Intézkedés leírása

Időkeret

Másodlagos eredményintézkedések

Eredménymérő

Intézkedés leírása

Időkeret

Együttműködők és nyomozók

Szponzor

Együttműködők

Nyomozók

Publikációk és hasznos linkek

Általános kiadványok

Hasznos linkek

Tanulmányi rekorddátumok

Tanulmány főbb dátumok

Tanulmány kezdete

Elsődleges befejezés (Tényleges)

A tanulmány befejezése (Tényleges)

Tanulmányi regisztráció dátumai

Először benyújtva

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

Első közzététel (Becslés)

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

Utolsó ellenőrzés

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

Klinikai vizsgálatok a HIV fertőzés

Klinikai vizsgálatok a FTC/TDF (Truvada®)

Keressen hasonló próbaverziókban

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

CROs by country

CROs in United Kingdom

Körülmények

Ritka betegségek

Kábítószer-beavatkozások

Táplálék-kiegészítők

Szponzor / közreműködők

Helyek