NCT01714180

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 25, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2015

Enrollment Period

1.4 years

First QC Date

October 17, 2012

Last Update Submit

June 2, 2015

Conditions

Hematological MalignancyPharmacokinetics of Acyclovir

Keywords

AcyclovirPharmacokineticsObeseNon-obeseWeightDistributionClearance

Outcome Measures

Primary Outcomes (1)

  • Systemic clearance of acyclovir in obese and non-obese patients

    12 hours after acyclovir dose

Secondary Outcomes (5)

  • Alpha and beta half-life of acyclovir in obese and non-obese patients

    12 hours after acyclovir dose

  • Maximum concentration (Cmax) of acyclovir in obese and non-obese patients

    12 hours after acyclovir dose

  • Time to maximum concentration (Tmax) of acyclovir in obese and non-obese patients

    12 hours after acyclovir dose

  • Volume of distribution (Vd and Vdss) of acyclovir in obese and non-obese patients

    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

    12 hours after acyclovir dose

Study Arms (2)

Obese Patients

Non-obese Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Virginia University Hospitals Mary Babb Randolph Cancer Center

Morgantown, West Virginia, 26506, United States

Location

Related Publications (1)

  • Turner RB, Cumpston A, Sweet M, Briggs F, Slain D, Wen S, Craig M, Hamadani M, Petros W. Prospective, Controlled Study of Acyclovir Pharmacokinetics in Obese Patients. Antimicrob Agents Chemother. 2016 Jan 11;60(3):1830-3. doi: 10.1128/AAC.02010-15.

    PMID: 26824940DERIVED

MeSH Terms

Conditions

Hematologic NeoplasmsObesityBody Weight

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aaron Cumpston, PharmD

    West Virginia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pharmacy Clinical Specialist - BMT/Hematologic Malignancy

Study Record Dates

First Submitted

October 17, 2012

First Posted

October 25, 2012

Study Start

October 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2015

Last Updated

June 3, 2015

Record last verified: 2015-06

Locations

US(1)