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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
California
-
Los Angeles, California, Estados Unidos, 90027
- Children's Hopsital of Los Angeles
-
-
Colorado
-
Aurora, Colorado, Estados Unidos, 80045
- Children's Hospital of Denver
-
-
Florida
-
Miami, Florida, Estados Unidos, 33101
- University of Miami
-
Tampa, Florida, Estados Unidos, 33606
- University of South Florida
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60612
- Stroger Hospital and the CORE Center
-
-
Louisiana
-
New Orleans, Louisiana, Estados Unidos, 70112
- Tulane University
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins University
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02215
- Fenway Institute
-
-
Michigan
-
Detroit, Michigan, Estados Unidos, 48201
- Wayne State University
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19104
- Children's Hopsital of Philadelphia
-
-
Tennessee
-
Memphis, Tennessee, Estados Unidos, 38105
- St. Jude Childrens Research Hospital
-
-
Texas
-
Houston, Texas, Estados Unidos, 77030
- Baylor College of Medicine
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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.
|
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.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Magnitude of Change (Fold Change) in Parathyroid Hormone (PTH) From Baseline to Week 48
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Change From Baseline to Week 48
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline and wk 48
|
Baseline and wk 48
|
|
|
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Magnitude of Fold Change
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline and wk 48
|
Baseline and wk 48
|
|
|
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Magnitude of Fold Change
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline and wk 48
|
Baseline and wk 48
|
|
|
Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Magnitude of Fold Change
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: Baseline and wk 48
|
Serum calcium Week 48 difference from baseline
|
Baseline and wk 48
|
|
Magnitude of Most Extreme Fold Change: Serum Calcium (SCa)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: Baseline and wk 48
|
Serum Phosphate (SPO4) Week 48 difference from baseline
|
Baseline and wk 48
|
|
Magnitude of Most Extreme Fold Change: SPO4
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Peter Havens, MD, MACC Fund Research Center
Publicações e links úteis
Publicações Gerais
- Havens 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.
- 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.
- Havens 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.
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Infecções por vírus de RNA
- Doenças Virais
- Infecções
- Infecções transmitidas pelo sangue
- Doenças Transmissíveis
- Doenças Sexualmente Transmissíveis, Virais
- Doenças Sexualmente Transmissíveis
- Infecções por Lentivírus
- Infecções por Retroviridae
- Síndromes de Deficiência Imunológica
- Doenças do sistema imunológico
- Infecções por HIV
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Anti-Infecciosos
- Antivirais
- Inibidores da transcriptase reversa
- Inibidores da Síntese de Ácido Nucleico
- Inibidores Enzimáticos
- Agentes anti-HIV
- Antirretrovirais
- Emtricitabina, Fumarato de Tenofovir Disoproxil Combinação de Medicamentos
Outros números de identificação do estudo
- ATN 117 Version 2.0
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .