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Prospective Evaluation of Adjusted Body Weight Dosing of Acyclovir in Obesity

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by West Virginia University
Sponsor:
Information provided by (Responsible Party):
Aaron Cumpston, PharmD, BCOP, West Virginia University
ClinicalTrials.gov Identifier:
NCT02879630
First received: August 18, 2016
Last updated: August 22, 2016
Last verified: August 2016
  Purpose
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.

Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Evaluation of Adjusted Body Weight Dosing of Acyclovir in Obesity

Resource links provided by NLM:


Further study details as provided by West Virginia University:

Primary Outcome Measures:
  • Area under the curve (AUC) of systemic acyclovir exposure in obese and non-obese patients [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Half-life of acyclovir in obese and non-obese patients [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Maximum concentration (Cmax) of acyclovir in obese and non-obese patients [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Time to maximum concentration (Tmax) of acyclovir in obese and non-obese patients [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Volume of distribution (Vd) of acyclovir in obese and non-obese patients [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Systemic Clearance of acyclovir in obese and non-obese patients [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Time that concentration is above IC50 for varicella and herpes viruses in obese and non-obese patients [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2016
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Obese Patients
Non-obese Patients

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Obese and non-obese patients receiving intravenous acyclovir
Criteria

Inclusion Criteria:

  • Age ≥18 years of age
  • Receiving intravenous acyclovir 5 mg/kg (TBW for normal weight patients and ABW40 for obese patients) as part of their routine care
  • 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 a pro-drug of acyclovir (valacyclovir, ganciclovir, valganciclovir, famciclovir) in the prior 24 hours
  • Serum creatinine >1.5 mg/dL
  • 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
  • Significant anatomical deformities that influence body habitus (i.e. amputation)
  • Prior inclusion in this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02879630

Contacts
Contact: Pam Bunner 304-598-4511 bunnerp@wvumedicine.org

Locations
United States, West Virginia
West Virginia University Hospitals Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Pam Bunner    304-598-4511    bunnerp@wvumedicine.org   
Sponsors and Collaborators
West Virginia University
Investigators
Principal Investigator: Aaron Cumpston, PharmD, BCOP West Virginia University Medicine
  More Information

Responsible Party: Aaron Cumpston, PharmD, BCOP, Pharmacy Clinical Specialist, West Virginia University
ClinicalTrials.gov Identifier: NCT02879630     History of Changes
Other Study ID Numbers: 1501531856 
Study First Received: August 18, 2016
Last Updated: August 22, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by West Virginia University:
pharmacokinetics
acyclovir

Additional relevant MeSH terms:
Obesity
Body Weight
Overnutrition
Nutrition Disorders
Overweight
Signs and Symptoms
Acyclovir
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 24, 2016