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Effect of Body Mass on Acyclovir Pharmacokinetics


N/A
18 Years
N/A
Open (Enrolling)
Both
Hematological Malignancy, Pharmacokinetics of Acyclovir

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Trial Information

Effect of Body Mass on Acyclovir Pharmacokinetics


Inclusion Criteria:



- Age ≥18 years of age

- Receiving intravenous acyclovir 5 mg/kg (total body weight [TBW] for normal weight
patients and ideal body weight [IBW] for obese patients) as part of their routine
care

- Admitted as an inpatient with an expected stay of at least 24 hours

- Weight > 190% of ideal body weight (IBW) for "obese" patients or weight 80-120% of
IBW for matched control patients.

Exclusion Criteria:

- Receipt of acyclovir or similar agents (valacyclovir, ganciclovir, valganciclovir,
famciclovir) in the prior 24 hours

- Serum creatinine > 1.5 mg/dL at time of drug administration

- Hypersensitivity to acyclovir

- Patients requiring ventilator support or vasopressors in the prior 24 hours

- Receipt of probenecid, mycophenolate, tenofovir, or zidovudine in the prior 7 days

- Pregnant or breast-feeding

- Significant anatomical deformities that influence body habitus (i.e. amputation)

- Prior inclusion in this study

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Systemic clearance of acyclovir in obese and non-obese patients

Outcome Time Frame:

12 hours after acyclovir dose

Safety Issue:

No

Principal Investigator

Aaron Cumpston, PharmD

Investigator Role:

Principal Investigator

Investigator Affiliation:

West Virginia University

Authority:

United States: Institutional Review Board

Study ID:

WVU 031112

NCT ID:

NCT01714180

Start Date:

October 2012

Completion Date:

January 2014

Related Keywords:

  • Hematological Malignancy
  • Pharmacokinetics of Acyclovir
  • Acyclovir
  • Pharmacokinetics
  • Obese
  • Non-obese
  • Weight
  • Distribution
  • Clearance
  • Neoplasms
  • Hematologic Neoplasms

Name

Location

West Virginia University Hospitals Mary Babb Randolph Cancer CenterMorgantown, West Virginia  26506