Effect of Body Mass on Acyclovir Pharmacokinetics

June 2, 2015 updated by: Aaron Cumpston, PharmD, West Virginia University

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Hospitals Mary Babb Randolph Cancer Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Obese Patients
Non-obese Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Systemic clearance of acyclovir in obese and non-obese patients
Time Frame: 12 hours after acyclovir dose
12 hours after acyclovir dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Alpha and beta half-life of acyclovir in obese and non-obese patients
Time Frame: 12 hours after acyclovir dose
12 hours after acyclovir dose
Maximum concentration (Cmax) of acyclovir in obese and non-obese patients
Time Frame: 12 hours after acyclovir dose
12 hours after acyclovir dose
Time to maximum concentration (Tmax) of acyclovir in obese and non-obese patients
Time Frame: 12 hours after acyclovir dose
12 hours after acyclovir dose
Volume of distribution (Vd and Vdss) of acyclovir in obese and non-obese patients
Time Frame: 12 hours after acyclovir dose
12 hours after acyclovir dose
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
12 hours after acyclovir dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West Virginia University

Investigators

  • Principal Investigator: Aaron Cumpston, PharmD, West Virginia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

October 17, 2012

First Submitted That Met QC Criteria

October 22, 2012

First Posted (Estimate)

October 25, 2012

Study Record Updates

Last Update Posted (Estimate)

June 3, 2015

Last Update Submitted That Met QC Criteria

June 2, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WVU 031112
  • 24368 (Other Identifier: West Virginia University IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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