Effect of Body Mass on Acyclovir Pharmacokinetics

Hematological Malignancy Clinical Trial

Official title:

Effect of Body Mass on Acyclovir Pharmacokinetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01714180
• Other study ID #: WVU 031112
• Secondary ID: 24368
• Status: Completed
• Phase: N/A
• First received: October 17, 2012
• Last updated: June 2, 2015
• Start date: October 2012
• Est. completion date: March 2015

Study information

• Verified date: June 2015
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hematological Malignancy
• Pharmacokinetics of Acyclovir

Locations

Country	Name	City	State
United States	West Virginia University Hospitals Mary Babb Randolph Cancer Center	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systemic clearance of acyclovir in obese and non-obese patients		12 hours after acyclovir dose	No
Secondary	Alpha and beta half-life of acyclovir in obese and non-obese patients		12 hours after acyclovir dose	No
Secondary	Maximum concentration (Cmax) of acyclovir in obese and non-obese patients		12 hours after acyclovir dose	No
Secondary	Time to maximum concentration (Tmax) of acyclovir in obese and non-obese patients		12 hours after acyclovir dose	No
Secondary	Volume of distribution (Vd and Vdss) of acyclovir in obese and non-obese patients		12 hours after acyclovir dose	No
Secondary	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	No