Renal, Endocrine, and Bone Changes in Response to FTC/TDF in Uninfected Young Men Who Have Sex With Men (YMSM).
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Observational

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.
    

Intervention name(s): FTC/TDF (Truvada®)
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): Truvada®
Intervention MeSH terms: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
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.
      
Biospecimen description: 
      Blood and urine samples to measure: Calcium-Phosphate Balance, Bone Turnover, Renal
      Glomerular Function, Renal Tubular Function.

      Dried blood spots (DBS) for FTC and Tenofovir (TFV)concentrations; red blood cell (RBC) for
      TFV-diphosphate (DP); plasma for FTC, TFV; peripheral blood mononuclear cells (PBMC) for
      TFV-DP and FTC-triphosphate (TP) collected as part of ATN 110 and ATN 113 will be used in the
      ATN 117 analysis.
    
Keywords: Tenofovir; Emtricitabine; Truvada; Renal, endocrine, bone changes; HIV prevention; PrEP