N/A
Completed N=101
Renal, Endocrine, and Bone Changes in Response to FTC/TDF in Uninfected Young Men Who Have Sex With Men (YMSM).
Source: ClinicalTrials.gov NCT01769469 ↗Enrolled (actual)
101
Serious AEs
—
Results posted
Mar 2019
Primary outcomePrimary: Magnitude of Change (Fold Change) in Parathyroid Hormone (PTH) From Baseline to Week 48 — 1.08 fold change
Summary
This is a prospective observational cohort sub-study of subjects enrolled in the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 110 (NCT01772823) or ATN 113 (NCT01769456), which is a prospective interventional trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Magnitude of Change (Fold Change) in Parathyroid Hormone (PTH) From Baseline to Week 48 |
1.08 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Change From Baseline to Week 48 |
-1.50 | 0.2085 |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Magnitude of Fold Change |
0.96 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Most Extreme Fold Change |
1.18 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Time to Most Extreme Fold Change |
12.00 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 Dihydroxy Vitamin D (1,25 OHD), Change From Baseline to Week 48 |
-8.61 | 0.2452 |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Magnitude of Fold Change |
0.95 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Most Extreme Fold Change |
1.33 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Time to Most Extreme Fold Change |
12.00 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Tubular Reabsorption of Phosphate (TRP), Change From Baseline to Week 48 |
-0.57 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Magnitude of Fold Change |
0.99 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Most Extreme Fold Change |
1.05 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Time to Most Extreme Fold Change |
24.00 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Glomerular Filtration Rate (GFR), Change From Baseline to Week 48 |
3.06 | .0806 |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Magnitude of Fold Change |
1.02 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Most Extreme Fold Change |
1.10 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Time to Most Extreme Fold Change |
24.00 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Most Extreme Fold Change |
1.35 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Time to Most Extreme Fold Change |
24.00 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Serum Creatinine (SCr), Time to Most Extreme Fold Change |
8.00 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Slope of the Curve of Baseline to Most Extreme Fold Change |
0.51 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: FGF23, Slope of the Curve of Baseline to Most Extreme Fold Change |
0.39 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25-OHD, Slope of the Curve of Baseline to Most Extreme Fold Change |
4.27 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Slope of the Curve of Baseline to Most Extreme Fold Change |
0.21 | — |
| SECONDARY Change From Baseline to Week 48 in Serum Calcium (SCa) |
-0.07 | 0.6545 |
| SECONDARY Magnitude of Most Extreme Fold Change: Serum Calcium (SCa) |
1.03 | — |
| SECONDARY Time to Most Extreme Fold Change: Serum Calcium (SCa) |
12.00 | — |
| SECONDARY Slope of the Curve of Baseline to Most Extreme Fold Change: Serum Calcium (SCa) |
0.02 | — |
| SECONDARY Change From Baseline to Week 48 in Urine Calcium (UCa) / Urine Creatinine (UCr) |
0.00 | 0.8739 |
| SECONDARY Magnitude of Most Extreme Fold Change: UCa/UCr Ratio |
1.95 | — |
| SECONDARY Time to Most Extreme Fold Change: UCa/UCr Ratio |
12.00 | — |
| SECONDARY Slope of the Curve of Baseline to Most Extreme Fold Change: UCa/UCr Ratio |
0.00 | — |
| SECONDARY Change From Baseline to Week 48 in Serum Phosphate (SPO4) |
0.00 | — |
| SECONDARY Magnitude of Most Extreme Fold Change: SPO4 |
1.14 | — |
| SECONDARY Time to Most Extreme Fold Change: SPO4 |
12.00 | — |
| SECONDARY Slope of the Curve of Baseline to Most Extreme Fold Change: SPO4 |
0.01 | — |
| SECONDARY Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr) |
-601.14 | 0.5014 |
| SECONDARY Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Beta-2 Microglobulin (UB2MG) |
-34.78 | 0.2431 |
| SECONDARY Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Protein (UProt) / Urine Creatinine (UCr) |
0.00 | 0.7209 |
| SECONDARY Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Glucose (UGluc) |
-0.01 | 0.5379 |
| SECONDARY Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Serum Creatinine (SCr) |
-0.01 | 0.7986 |
| SECONDARY Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr) |
0.81 | — |
| SECONDARY Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Beta-2 Microglobulin (UB2MG) |
0.72 | — |
| SECONDARY Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Protein (UProt)/ Urine Creatinine (UCr) |
1.01 | — |
| SECONDARY Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Glucose (UGluc) |
0.94 | — |
| SECONDARY Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Serum Creatinine (SCr) |
0.99 | — |
| SECONDARY Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr) |
1.80 | — |
| SECONDARY Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UB2MG |
2.59 | — |
| SECONDARY Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UProt/UCr |
1.36 | — |
| SECONDARY Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UGluc |
1.56 | — |
| SECONDARY Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in SCr |
1.09 | — |
| SECONDARY Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr) |
12.00 | — |
| SECONDARY Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UB2MG |
12.00 | — |
| SECONDARY Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UProt/UCr |
24.00 | — |
| SECONDARY Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UGluc |
24.00 | — |
| SECONDARY 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) |
270.70 | — |
| SECONDARY Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UB2MG |
12.45 | — |
| SECONDARY Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UProt/UCr |
0.00 | — |
| SECONDARY Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UGluc |
0.00 | — |
| SECONDARY Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in Scr |
0.01 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Change From Baseline to Week 48 in Osteocalcin (OC) |
0.05 | 0.8507 |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Change From Baseline to Week 48 in C-Telopeptide (CTX) |
25.90 | 0.3483 |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Most Extreme Fold Change in Osteocalcin (OC) |
1.14 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Most Extreme Fold Change in C-telopeptide (CTX) |
1.37 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: OC, Time to Most Extreme Fold Change |
12.00 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Time to Most Extreme Fold Change in C-telopeptide (CTX) |
12.00 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Slope of the Curve of Baseline to Most Extreme Fold Change in OC |
0.07 | — |
| SECONDARY Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Slope of the Curve of Baseline to Most Extreme Fold Change in CTX |
17.98 | — |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in PTH, by Overall Drug Exposure |
-0.09; 3.59 | 0.4043 |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in PTH, by Overall Drug Exposure |
0.46; 0.47 | 0.2927 |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in FGF23, by Overall Drug Exposure |
-6.88; 0.79 | 0.1134 |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in FGF23, by Overall Drug Exposure |
1.66; 0.60 | 0.5782 |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in 1,25 OHD, by Overall Drug Exposure |
10.80; 7.07 | 0.8658 |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in 1,25 OHD, by Overall Drug Exposure |
-12.55; -8.60 | 0.5491 |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Osteocalcin (OC), by Overall Drug Exposure |
0.87; -1.03 | 0.0238 sig |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Osteocalcin (OC), by Overall Drug Exposure |
1.12; -0.10 | 0.1172 |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in CTX, by Overall Drug Exposure |
105.89; -25.90 | 0.1220 |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in CTX, by Overall Drug Exposure |
50.64; -20.72 | 1.000 |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in SCr, by Overall Drug Exposure |
0.02; 0.00 | — |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in SCr, by Overall Drug Exposure |
0.01; -0.02 | 0.7785 |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in TRP, by Overall Drug Exposure |
0.57; 1.14 | 0.4933 |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in TRP, by Overall Drug Exposure |
0.03; -1.28 | 0.5491 |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UCa/UCr Ratio, by Overall Drug Exposure |
0.00; -0.01 | 0.5161 |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UCa/UCr Ratio, by Overall Drug Exposure |
0.00; 0.00 | 0.5990 |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UB2MG, by Overall Drug Exposure |
-7.28; -23.29 | 0.8579 |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UB2MG, by Overall Drug Exposure |
-0.21; -79.82 | 0.0719 |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UGluc, by Overall Drug Exposure |
-0.02; 0.01 | 0.3148 |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UGluc, by Overall Drug Exposure |
-0.01; 0.02 | 0.1390 |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in URBP/UCr Ratio, by Overall Drug Exposure |
-2281.71; 808.53 | 0.2726 |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in URBP/UCr Ratio, by Overall Drug Exposure |
-710.86; 1606.38 | 0.5370 |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Lumbar Spine BMD, by Overall Drug Exposure |
-0.33; 0.00 | 0.2926 |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Lumbar Spine BMD, by Overall Drug Exposure |
-0.32; 0.88 | 0.1906 |
| SECONDARY 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 |
-0.10; 0.00 | 0.2255 |
| SECONDARY 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 |
-0.20; -0.10 | 0.6285 |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Femoral Neck BMD, by Overall Drug Exposure |
-0.80; 0.62 | 0.0148 sig |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Femoral Neck BMD, by Overall Drug Exposure |
-1.89; 1.14 | 0.0166 sig |
| SECONDARY 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 |
-0.10; 0.00 | 0.0277 sig |
| SECONDARY 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 |
-0.10; 0.10 | 0.2610 |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Total Body BMC, by Overall Drug Exposure |
-0.40; -0.24 | 0.4154 |
| SECONDARY Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Total Body BMC, by Overall Drug Exposure |
-0.60; -1.24 | 0.7125 |
| SECONDARY Magnitude of Change in Lumbar Spine BMD at Week 48 |
1.00 | — |
| SECONDARY Magnitude of Change in Lumbar Spine BMD Z-score at Week 48 |
1.04 | — |
| SECONDARY Magnitude of Change in Femoral Neck BMD at Week 48 |
1.00 | — |
| SECONDARY Magnitude of Change in Femoral Neck BMD Z-score at Week 48 |
1.00 | — |
| SECONDARY Magnitude of Change in Total Body BMC at Week 48 |
1.00 | — |
| SECONDARY Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Baseline |
-0.01 | — |
| SECONDARY Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Baseline |
-0.01 | — |
| SECONDARY Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Week 48 (or Last Visit on Study) |
-0.01 | — |
| SECONDARY Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Week 48 (or Last Visit on Study) |
-0.01 | — |
| SECONDARY Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Baseline |
0.10 | — |
| SECONDARY Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Baseline |
0.20 | — |
| SECONDARY Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Week 48 (or Last Visit on Study) |
0.00 | — |
| SECONDARY Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Week 48 (or Last Visit on Study) |
0.00 | — |
| SECONDARY Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Baseline |
0.01 | — |
| SECONDARY Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Baseline |
0.00 | — |
| SECONDARY Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Week 48 (or Last Visit on Study) |
0.00 | — |
| SECONDARY Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Week 48 (or Last Visit on Study) |
-0.01 | — |
| SECONDARY Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Baseline |
0.10 | — |
| SECONDARY Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Baseline |
0.10 | — |
| SECONDARY Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Week 48 (or Last Visit on Study) |
0.00 | — |
| SECONDARY Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Week 48 (or Last Visit on Study) |
-0.05 | — |
| SECONDARY Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Baseline |
7.90 | — |
| SECONDARY Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Baseline |
-17.49 | — |
| SECONDARY Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Week 48 (or Last Visit on Study) |
-27.80 | — |
| SECONDARY Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Week 48 (or Last Visit on Study) |
-46.83 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT01769469). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.