Effect of Body Mass on Acyclovir Pharmacokinetics

Sponsor

West Virginia University (Other)

Overall Status

Completed

CT.gov ID

NCT01714180

Collaborator

(none)

Enrollment

Location

28.9

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematological Malignancy Pharmacokinetics of Acyclovir

Study Design

Study Type:

Observational

Actual Enrollment :

14 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Effect of Body Mass on Acyclovir Pharmacokinetics

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Obese Patients
Non-obese Patients

Outcome Measures

Primary Outcome Measures

Systemic clearance of acyclovir in obese and non-obese patients [12 hours after acyclovir dose]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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