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OpenTrials
Completed

NCT Number: NCT01769469

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

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.

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

15 year–22 year

Sex eligibility

Male

Study type

Observational

Primary location

Children's Hopsital of Los Angeles, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

FTC/TDF (Truvada®)

Drug

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.

Other names: Truvada®

Primary outcomes

  1. Magnitude of Change (Fold Change) in Parathyroid Hormone (PTH) From Baseline to Week 48

    Time frame: 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).

Secondary outcomes

  1. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Change From Baseline to Week 48

    Time frame: Baseline and wk 48

  2. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Magnitude of Fold Change

    Time frame: 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).

  3. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Most Extreme Fold Change

    Time frame: 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.

  4. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Time to Most Extreme Fold Change

    Time frame: 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.

  5. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 Dihydroxy Vitamin D (1,25 OHD), Change From Baseline to Week 48

    Time frame: Baseline and wk 48

  6. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Magnitude of Fold Change

    Time frame: 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).

  7. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Most Extreme Fold Change

    Time frame: 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.

  8. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Time to Most Extreme Fold Change

    Time frame: 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.

  9. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Tubular Reabsorption of Phosphate (TRP), Change From Baseline to Week 48

    Time frame: Baseline and wk 48

  10. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Magnitude of Fold Change

    Time frame: 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).

  11. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Most Extreme Fold Change

    Time frame: 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.

  12. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Time to Most Extreme Fold Change

    Time frame: 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.

  13. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Glomerular Filtration Rate (GFR), Change From Baseline to Week 48

    Time frame: Baseline and wk 48

  14. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Magnitude of Fold Change

    Time frame: 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).

  15. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Most Extreme Fold Change

    Time frame: 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.

  16. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Time to Most Extreme Fold Change

    Time frame: 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.

  17. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Most Extreme Fold Change

    Time frame: 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.

  18. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Time to Most Extreme Fold Change

    Time frame: 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.

  19. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Serum Creatinine (SCr), Time to Most Extreme Fold Change

    Time frame: 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.

  20. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Slope of the Curve of Baseline to Most Extreme Fold Change

    Time frame: 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)]

  21. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: FGF23, Slope of the Curve of Baseline to Most Extreme Fold Change

    Time frame: 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)]

  22. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25-OHD, Slope of the Curve of Baseline to Most Extreme Fold Change

    Time frame: 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)]

  23. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Slope of the Curve of Baseline to Most Extreme Fold Change

    Time frame: 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)]

  24. Change From Baseline to Week 48 in Serum Calcium (SCa)

    Time frame: Baseline and wk 48

    Serum calcium Week 48 difference from baseline

  25. Magnitude of Most Extreme Fold Change: Serum Calcium (SCa)

    Time frame: 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.

  26. Time to Most Extreme Fold Change: Serum Calcium (SCa)

    Time frame: 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.

  27. Slope of the Curve of Baseline to Most Extreme Fold Change: Serum Calcium (SCa)

    Time frame: 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)]

  28. Change From Baseline to Week 48 in Urine Calcium (UCa) / Urine Creatinine (UCr)

    Time frame: Baseline and wk 48

    Urine Calcium (UCa) / Urine Creatinine (UCr) ratio Week 48 difference from baseline

  29. Magnitude of Most Extreme Fold Change: UCa/UCr Ratio

    Time frame: 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.

  30. Time to Most Extreme Fold Change: UCa/UCr Ratio

    Time frame: 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.

  31. Slope of the Curve of Baseline to Most Extreme Fold Change: UCa/UCr Ratio

    Time frame: 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)]

  32. Change From Baseline to Week 48 in Serum Phosphate (SPO4)

    Time frame: Baseline and wk 48

    Serum Phosphate (SPO4) Week 48 difference from baseline

  33. Magnitude of Most Extreme Fold Change: SPO4

    Time frame: 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.

  34. Time to Most Extreme Fold Change: SPO4

    Time frame: 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.

  35. Slope of the Curve of Baseline to Most Extreme Fold Change: SPO4

    Time frame: 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)]

  36. Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)

    Time frame: Baseline and wk 48

    URBP/UCr Week 48 difference from baseline

  37. Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Beta-2 Microglobulin (UB2MG)

    Time frame: Baseline and wk 48

    UB2MG Week 48 difference from baseline

  38. Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Protein (UProt) / Urine Creatinine (UCr)

    Time frame: Baseline and wk 48

    UProt/ UCr Week 48 difference from baseline

  39. Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Glucose (UGluc)

    Time frame: Baseline and wk 48

    UGluc Week 48 difference from baseline

  40. Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Serum Creatinine (SCr)

    Time frame: Baseline and wk 48

    SCr Week 48 difference from baseline

  41. Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)

    Time frame: 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).

  42. Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Beta-2 Microglobulin (UB2MG)

    Time frame: 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).

  43. Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Protein (UProt)/ Urine Creatinine (UCr)

    Time frame: 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).

  44. Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Glucose (UGluc)

    Time frame: 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).

  45. Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Serum Creatinine (SCr)

    Time frame: 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).

  46. Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)

    Time frame: 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.

  47. Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UB2MG

    Time frame: 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.

  48. Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UProt/UCr

    Time frame: 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.

  49. Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UGluc

    Time frame: 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.

  50. Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in SCr

    Time frame: 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.

  51. Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)

    Time frame: 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.

  52. Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UB2MG

    Time frame: 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.

  53. Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UProt/UCr

    Time frame: 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.

  54. Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UGluc

    Time frame: 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.

  55. 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)

    Time frame: 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)]

  56. Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UB2MG

    Time frame: 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)]

  57. Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UProt/UCr

    Time frame: 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)]

  58. Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UGluc

    Time frame: 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)]

  59. Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in Scr

    Time frame: 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)]

  60. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Change From Baseline to Week 48 in Osteocalcin (OC)

    Time frame: Baseline and wk 48

    OC Week 48 difference from baseline

  61. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Change From Baseline to Week 48 in C-Telopeptide (CTX)

    Time frame: Baseline and wk 48

    CTX Week 48 difference from baseline

  62. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Most Extreme Fold Change in Osteocalcin (OC)

    Time frame: 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.

  63. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Most Extreme Fold Change in C-telopeptide (CTX)

    Time frame: 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.

  64. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: OC, Time to Most Extreme Fold Change

    Time frame: 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.

  65. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Time to Most Extreme Fold Change in C-telopeptide (CTX)

    Time frame: 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.

  66. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Slope of the Curve of Baseline to Most Extreme Fold Change in OC

    Time frame: 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)]

  67. Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Slope of the Curve of Baseline to Most Extreme Fold Change in CTX

    Time frame: 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)]

  68. Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in PTH, by Overall Drug Exposure

    Time frame: 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.

  69. Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in PTH, by Overall Drug Exposure

    Time frame: 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.

  70. Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in FGF23, by Overall Drug Exposure

    Time frame: 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.

  71. Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in FGF23, by Overall Drug Exposure

    Time frame: 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.

  72. Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in 1,25 OHD, by Overall Drug Exposure

    Time frame: 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.

  73. Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in 1,25 OHD, by Overall Drug Exposure

    Time frame: 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.

  74. Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Osteocalcin (OC), by Overall Drug Exposure

    Time frame: 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.

  75. Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Osteocalcin (OC), by Overall Drug Exposure

    Time frame: 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.

  76. Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in CTX, by Overall Drug Exposure

    Time frame: 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.

  77. Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in CTX, by Overall Drug Exposure

    Time frame: 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.

  78. Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in SCr, by Overall Drug Exposure

    Time frame: 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.

  79. Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in SCr, by Overall Drug Exposure

    Time frame: 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.

  80. Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in TRP, by Overall Drug Exposure

    Time frame: 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.

  81. Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in TRP, by Overall Drug Exposure

    Time frame: 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.

  82. Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UCa/UCr Ratio, by Overall Drug Exposure

    Time frame: 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.

  83. Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UCa/UCr Ratio, by Overall Drug Exposure

    Time frame: 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.

  84. Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UB2MG, by Overall Drug Exposure

    Time frame: 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.

  85. Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UB2MG, by Overall Drug Exposure

    Time frame: 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.

  86. Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UGluc, by Overall Drug Exposure

    Time frame: 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.

  87. Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UGluc, by Overall Drug Exposure

    Time frame: 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.

  88. Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in URBP/UCr Ratio, by Overall Drug Exposure

    Time frame: 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.

  89. Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in URBP/UCr Ratio, by Overall Drug Exposure

    Time frame: 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.

  90. Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Lumbar Spine BMD, by Overall Drug Exposure

    Time frame: 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.

  91. Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Lumbar Spine BMD, by Overall Drug Exposure

    Time frame: 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.

  92. 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

    Time frame: 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.

  93. 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

    Time frame: 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.

  94. Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Femoral Neck BMD, by Overall Drug Exposure

    Time frame: 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.

  95. Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Femoral Neck BMD, by Overall Drug Exposure

    Time frame: 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.

  96. 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

    Time frame: 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.

  97. 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

    Time frame: 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.

  98. Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Total Body BMC, by Overall Drug Exposure

    Time frame: 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.

  99. Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Total Body BMC, by Overall Drug Exposure

    Time frame: 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.

  100. Magnitude of Change in Lumbar Spine BMD at Week 48

    Time frame: 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).

  101. Magnitude of Change in Lumbar Spine BMD Z-score at Week 48

    Time frame: 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.

  102. Magnitude of Change in Femoral Neck BMD at Week 48

    Time frame: 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).

  103. Magnitude of Change in Femoral Neck BMD Z-score at Week 48

    Time frame: 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).

  104. Magnitude of Change in Total Body BMC at Week 48

    Time frame: 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).

  105. Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Baseline

    Time frame: 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)

  106. Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Baseline

    Time frame: 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)

  107. Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Week 48 (or Last Visit on Study)

    Time frame: 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)

  108. Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Week 48 (or Last Visit on Study)

    Time frame: 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)

  109. Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Baseline

    Time frame: 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.

  110. Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Baseline

    Time frame: 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.

  111. Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Week 48 (or Last Visit on Study)

    Time frame: 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.

  112. Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Week 48 (or Last Visit on Study)

    Time frame: 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.

  113. Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Baseline

    Time frame: 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)

  114. Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Baseline

    Time frame: 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)

  115. Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Week 48 (or Last Visit on Study)

    Time frame: 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)

  116. Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Week 48 (or Last Visit on Study)

    Time frame: 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)

  117. Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Baseline

    Time frame: 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.

  118. Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Baseline

    Time frame: 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.

  119. Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Week 48 (or Last Visit on Study)

    Time frame: 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.

  120. Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Week 48 (or Last Visit on Study)

    Time frame: 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.

  121. Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Baseline

    Time frame: 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)

  122. Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Baseline

    Time frame: 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)

  123. Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Week 48 (or Last Visit on Study)

    Time frame: 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)

  124. Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Week 48 (or Last Visit on Study)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Mental Health (NIMH)
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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.

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 16, 2013
Registry last updated
Mar 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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