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Effect of Body Mass on Acyclovir Pharmacokinetics

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Aaron Cumpston, PharmD, West Virginia University
ClinicalTrials.gov Identifier:
NCT01714180
First received: October 17, 2012
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

Studies have shown that different percentages of body fat can alter the way drugs are distributed in the body. This study will use blood samples taken at different time points for patients taking acyclovir to determine if higher body weights affect drug exposure. The information gathered from this study will help understand if patients with higher body weights need a different dosing plan.

Patients receiving acyclovir as standard of care will be enrolled into this study. They will have blood draws once before they take acyclovir and 10 times after they take the acyclovir (over a total of 12 hours). These patients will be in the hospital already and will not need to make additional trips back to have blood drawn. A total of about 4—5 tablespoons of blood will be drawn for this study. 7 obese patients and 7 matched, non—obese patients will be enrolled into this study.


Condition
Hematological Malignancy
Pharmacokinetics of Acyclovir

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effect of Body Mass on Acyclovir Pharmacokinetics

Resource links provided by NLM:


Further study details as provided by West Virginia University:

Primary Outcome Measures:
  • Systemic clearance of acyclovir in obese and non-obese patients [ Time Frame: 12 hours after acyclovir dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Alpha and beta half-life of acyclovir in obese and non-obese patients [ Time Frame: 12 hours after acyclovir dose ] [ Designated as safety issue: No ]
  • Maximum concentration (Cmax) of acyclovir in obese and non-obese patients [ Time Frame: 12 hours after acyclovir dose ] [ Designated as safety issue: No ]
  • Time to maximum concentration (Tmax) of acyclovir in obese and non-obese patients [ Time Frame: 12 hours after acyclovir dose ] [ Designated as safety issue: No ]
  • Volume of distribution (Vd and Vdss) of acyclovir in obese and non-obese patients [ Time Frame: 12 hours after acyclovir dose ] [ Designated as safety issue: No ]
  • Time that concentration is above IC50 for varicella and herpes viruses 4,5,6,7 for acyclovir in obese and non-obese patients [ Time Frame: 12 hours after acyclovir dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 14
Study Start Date: October 2012
Estimated Study Completion Date: February 2015
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Obese Patients
Non-obese Patients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Obese and normal weight patients treated with acyclovir in an inpatient setting.

Criteria

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
  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: NCT01714180

Locations
United States, West Virginia
West Virginia University Hospitals Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
West Virginia University
Investigators
Principal Investigator: Aaron Cumpston, PharmD West Virginia University
  More Information

No publications provided

Responsible Party: Aaron Cumpston, PharmD, Pharmacy Clinical Specialist - BMT/Hematologic Malignancy, West Virginia University
ClinicalTrials.gov Identifier: NCT01714180     History of Changes
Other Study ID Numbers: WVU 031112, 24368
Study First Received: October 17, 2012
Last Updated: September 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by West Virginia University:
Acyclovir
Pharmacokinetics
Obese
Non-obese
Weight
Distribution
Clearance

Additional relevant MeSH terms:
Acyclovir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014