RECRUITING

Prospective Evaluation of Adjusted Body Weight Dosing of Acyclovir in Obesity

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Patients receiving acyclovir as standard of care will be enrolled into this study. The currently recommended dosing strategy at our institution for obese patients is to receive intravenous acyclovir dosed per an adjusted body weight \[IBW + 0.4(TBW-IBW)\]. They will have blood drawn once prior to the first dose of acyclovir and 10 times thereafter, over a total time period of 12 hours. These patients will already be hospitalized for other reasons, and will not be required to make additional trips to the hospital. A total of approximately 4-5 tablespoons of blood will be drawn for this study. Ten obese patients and 10 matched control (non-obese) patients will be enrolled.

Official Title

Prospective Evaluation of Adjusted Body Weight Dosing of Acyclovir in Obesity

Quick Facts

Study Start:2016-08
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02879630

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥18 years of age
  2. * Receiving intravenous acyclovir 5 mg/kg (TBW for normal weight patients and ABW40 for obese patients) as part of their routine care
  3. * Weight \> 190% of ideal body weight (IBW) for "obese" patients or weight 80-120% of IBW for matched control patients.
  1. * Receipt of acyclovir or a pro-drug of acyclovir (valacyclovir, ganciclovir, valganciclovir, famciclovir) in the prior 24 hours
  2. * Serum creatinine \>1.5 mg/dL
  3. * Hypersensitivity to acyclovir
  4. * Patients requiring ventilator support or vasopressors in the prior 24 hours
  5. * Receipt of probenecid, mycophenolate, tenofovir, or zidovudine in the prior 7 days
  6. * Significant anatomical deformities that influence body habitus (i.e. amputation)
  7. * Prior inclusion in this study

Contacts and Locations

Study Contact

Pam Bunner
CONTACT
304-598-4511
bunnerp@wvumedicine.org

Principal Investigator

Aaron Cumpston, PharmD, BCOP
PRINCIPAL_INVESTIGATOR
West Virginia University Medicine

Study Locations (Sites)

West Virginia University Hospitals
Morgantown, West Virginia, 26506
United States

Collaborators and Investigators

Sponsor: West Virginia University

  • Aaron Cumpston, PharmD, BCOP, PRINCIPAL_INVESTIGATOR, West Virginia University Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-08
Study Completion Date2024-12

Study Record Updates

Study Start Date2016-08
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • pharmacokinetics
  • acyclovir

Additional Relevant MeSH Terms

  • Obesity