Clinical trial NCT01769469: Renal, Endocrine, and Bone Changes in Response to FTC/TDF in Uninfected Young Men Who Have Sex With Men (YMSM).
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: Tenofovir
Emtricitabine
Truvada
Renal, endocrine, bone changes
HIV prevention
PrEP
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-01-16
Enrollment: 101
Sex: MALE
Minimum age (years): 15
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals between the ages 15 years 0 days to 22 years 364 days, who are enrolled in ATN 110 (NCT01772823) or ATN 113 (NCT01769456) , and agree to enter this sub-study at the same time they begin ATN 110 or ATN 113.

Brief summary: This is a prospective observational cohort sub-study of subjects enrolled in the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 110 (NCT01772823) or ATN 113 (NCT01769456), which is a prospective interventional trial.

Detailed description: 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.

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).

Primary outcomes:
measure: Magnitude of Change (Fold Change) in Parathyroid Hormone (PTH) From Baseline to Week 48
timeFrame: Baseline and Week (wk) 48
Secondary outcomes:
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Change From Baseline to Week 48
timeFrame: Baseline and wk 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Magnitude of Fold Change
timeFrame: Baseline and wk 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Most Extreme Fold Change
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Time to Most Extreme Fold Change
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 Dihydroxy Vitamin D (1,25 OHD), Change From Baseline to Week 48
timeFrame: Baseline and wk 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Magnitude of Fold Change
timeFrame: Baseline and wk 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Most Extreme Fold Change
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Time to Most Extreme Fold Change
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Tubular Reabsorption of Phosphate (TRP), Change From Baseline to Week 48
timeFrame: Baseline and wk 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Magnitude of Fold Change
timeFrame: Baseline and wk 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Most Extreme Fold Change
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Time to Most Extreme Fold Change
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Glomerular Filtration Rate (GFR), Change From Baseline to Week 48
timeFrame: Baseline and wk 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Magnitude of Fold Change
timeFrame: Baseline and wk 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Most Extreme Fold Change
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Time to Most Extreme Fold Change
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Most Extreme Fold Change
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Time to Most Extreme Fold Change
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Serum Creatinine (SCr), Time to Most Extreme Fold Change
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Slope of the Curve of Baseline to Most Extreme Fold Change
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: FGF23, Slope of the Curve of Baseline to Most Extreme Fold Change
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25-OHD, Slope of the Curve of Baseline to Most Extreme Fold Change
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Slope of the Curve of Baseline to Most Extreme Fold Change
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Change From Baseline to Week 48 in Serum Calcium (SCa)
timeFrame: Baseline and wk 48
measure: Magnitude of Most Extreme Fold Change: Serum Calcium (SCa)
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Time to Most Extreme Fold Change: Serum Calcium (SCa)
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Slope of the Curve of Baseline to Most Extreme Fold Change: Serum Calcium (SCa)
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Change From Baseline to Week 48 in Urine Calcium (UCa) / Urine Creatinine (UCr)
timeFrame: Baseline and wk 48
measure: Magnitude of Most Extreme Fold Change: UCa/UCr Ratio
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Time to Most Extreme Fold Change: UCa/UCr Ratio
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Slope of the Curve of Baseline to Most Extreme Fold Change: UCa/UCr Ratio
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Change From Baseline to Week 48 in Serum Phosphate (SPO4)
timeFrame: Baseline and wk 48
measure: Magnitude of Most Extreme Fold Change: SPO4
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Time to Most Extreme Fold Change: SPO4
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Slope of the Curve of Baseline to Most Extreme Fold Change: SPO4
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)
timeFrame: Baseline and wk 48
measure: Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Beta-2 Microglobulin (UB2MG)
timeFrame: Baseline and wk 48
measure: Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Protein (UProt) / Urine Creatinine (UCr)
timeFrame: Baseline and wk 48
measure: Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Glucose (UGluc)
timeFrame: Baseline and wk 48
measure: Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Serum Creatinine (SCr)
timeFrame: Baseline and wk 48
measure: Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)
timeFrame: Baseline and wk 48
measure: Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Beta-2 Microglobulin (UB2MG)
timeFrame: Baseline and wk 48
measure: Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Protein (UProt)/ Urine Creatinine (UCr)
timeFrame: Baseline and wk 48
measure: Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Glucose (UGluc)
timeFrame: Baseline and wk 48
measure: Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Serum Creatinine (SCr)
timeFrame: Baseline and wk 48
measure: Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
measure: Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UB2MG
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
measure: Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UProt/UCr
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
measure: Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UGluc
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
measure: Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in SCr
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
measure: Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UB2MG
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UProt/UCr
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UGluc
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: 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)
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UB2MG
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UProt/UCr
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UGluc
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in Scr
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Change From Baseline to Week 48 in Osteocalcin (OC)
timeFrame: Baseline and wk 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Change From Baseline to Week 48 in C-Telopeptide (CTX)
timeFrame: Baseline and wk 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Most Extreme Fold Change in Osteocalcin (OC)
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Most Extreme Fold Change in C-telopeptide (CTX)
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36 and 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: OC, Time to Most Extreme Fold Change
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Time to Most Extreme Fold Change in C-telopeptide (CTX)
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Slope of the Curve of Baseline to Most Extreme Fold Change in OC
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
measure: Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Slope of the Curve of Baseline to Most Extreme Fold Change in CTX
timeFrame: Baseline, Weeks (wks) 4, 8, 12, 24, 36, and 48
measure: Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in PTH, by Overall Drug Exposure
timeFrame: Baseline and wk 48
measure: Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in PTH, by Overall Drug Exposure
timeFrame: Baseline and wk 24
measure: Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in FGF23, by Overall Drug Exposure
timeFrame: Baseline and wk 24
measure: Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in FGF23, by Overall Drug Exposure
timeFrame: Baseline and wk 48
measure: Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in 1,25 OHD, by Overall Drug Exposure
timeFrame: Baseline and wk 24
measure: Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in 1,25 OHD, by Overall Drug Exposure
timeFrame: Baseline and wk 48
measure: Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Osteocalcin (OC), by Overall Drug Exposure
timeFrame: Baseline and wk 24
measure: Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Osteocalcin (OC), by Overall Drug Exposure
timeFrame: Baseline and wk 48
measure: Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in CTX, by Overall Drug Exposure
timeFrame: Baseline and wk 24
measure: Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in CTX, by Overall Drug Exposure
timeFrame: Baseline and wk 48
measure: Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in SCr, by Overall Drug Exposure
timeFrame: Baseline and wk 24
measure: Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in SCr, by Overall Drug Exposure
timeFrame: Baseline and wk 48
measure: Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in TRP, by Overall Drug Exposure
timeFrame: Baseline and wk 24
measure: Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in TRP, by Overall Drug Exposure
timeFrame: Baseline and wk 48
measure: Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UCa/UCr Ratio, by Overall Drug Exposure
timeFrame: Baseline and wk 24
measure: Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UCa/UCr Ratio, by Overall Drug Exposure
timeFrame: Baseline and wk 48
measure: Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UB2MG, by Overall Drug Exposure
timeFrame: Baseline and wk 24
measure: Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UB2MG, by Overall Drug Exposure
timeFrame: Baseline and wk 48
measure: Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UGluc, by Overall Drug Exposure
timeFrame: Baseline and wk 24
measure: Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UGluc, by Overall Drug Exposure
timeFrame: Baseline and wk 48
measure: Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in URBP/UCr Ratio, by Overall Drug Exposure
timeFrame: Baseline and wk 24
measure: Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in URBP/UCr Ratio, by Overall Drug Exposure
timeFrame: Baseline and wk 48
measure: Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Lumbar Spine BMD, by Overall Drug Exposure
timeFrame: Baseline and wk 24
measure: Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Lumbar Spine BMD, by Overall Drug Exposure
timeFrame: Baseline and wk 48
measure: 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
timeFrame: Baseline and wk 24
measure: 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
timeFrame: Baseline and wk 48
measure: Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Femoral Neck BMD, by Overall Drug Exposure
timeFrame: Baseline and wk 24
measure: Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Femoral Neck BMD, by Overall Drug Exposure
timeFrame: Baseline and wk 48
measure: 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
timeFrame: Baseline and wk 24
measure: 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
timeFrame: Baseline and wk 48
measure: Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Total Body BMC, by Overall Drug Exposure
timeFrame: Baseline and wk 24
measure: Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Total Body BMC, by Overall Drug Exposure
timeFrame: Baseline and wk 48
measure: Magnitude of Change in Lumbar Spine BMD at Week 48
timeFrame: Baseline and wk 48
measure: Magnitude of Change in Lumbar Spine BMD Z-score at Week 48
timeFrame: Baseline and wk 48
measure: Magnitude of Change in Femoral Neck BMD at Week 48
timeFrame: Baseline and wk 48
measure: Magnitude of Change in Femoral Neck BMD Z-score at Week 48
timeFrame: Baseline and wk 48
measure: Magnitude of Change in Total Body BMC at Week 48
timeFrame: Baseline and wk 48
measure: Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Baseline
timeFrame: Baseline and wk 72
measure: Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Baseline
timeFrame: Baseline and wk 96
measure: Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Week 48 (or Last Visit on Study)
timeFrame: Wk 48 (or last available measurement on study), Wk 72
measure: Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Week 48 (or Last Visit on Study)
timeFrame: Wk 48 (or last available measurement on study), Wk 96
measure: Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Baseline
timeFrame: Baseline and wk 72
measure: Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Baseline
timeFrame: Baseline and wk 96
measure: Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Week 48 (or Last Visit on Study)
timeFrame: Wk 48 (or last available measurement on study), Wk 72
measure: Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Week 48 (or Last Visit on Study)
timeFrame: Wk 48 (or last available measurement on study), Wk 96
measure: Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Baseline
timeFrame: Baseline and wk 72
measure: Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Baseline
timeFrame: Baseline and wk 96
measure: Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Week 48 (or Last Visit on Study)
timeFrame: Wk 48 (or last available measurement on study), Wk 72
measure: Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Week 48 (or Last Visit on Study)
timeFrame: W 48 (or last available measurement on study), Wk 96
measure: Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Baseline
timeFrame: Baseline and wk 72
measure: Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Baseline
timeFrame: Baseline, Week 96
measure: Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Week 48 (or Last Visit on Study)
timeFrame: Week 48 (or last available measurement on study), Week 72
measure: Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Week 48 (or Last Visit on Study)
timeFrame: Wk 48 (or last available measurement on study), Wk 96
measure: Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Baseline
timeFrame: Baseline and wk 72
measure: Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Baseline
timeFrame: Baseline and wk 96
measure: Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Week 48 (or Last Visit on Study)
timeFrame: Wk 48 (or last available measurement on study), Wk 72
measure: Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Week 48 (or Last Visit on Study)
timeFrame: Wk 48 (or last available measurement on study), Wk 96
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hopsital of Los Angeles
state: California
city: Aurora
country: United States
facility: Children's Hospital of Denver
state: Colorado
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Chicago
country: United States
facility: Stroger Hospital and the CORE Center
state: Illinois
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Fenway Institute
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Philadelphia
country: United States
facility: Children's Hopsital of Philadelphia
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Childrens Research Hospital
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: MACC Fund Research Center
name: Peter Havens, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.