Clinical trial NCT01714180: Effect of Body Mass on Acyclovir Pharmacokinetics
Official title: Effect of Body Mass on Acyclovir Pharmacokinetics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematological Malignancy
Pharmacokinetics of Acyclovir
Keywords: Acyclovir
Pharmacokinetics
Obese
Non-obese
Weight
Distribution
Clearance
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2012-10-25
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese and normal weight patients treated with acyclovir in an inpatient setting.

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.


Eligibility 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

Primary outcomes:
measure: Systemic clearance of acyclovir in obese and non-obese patients
timeFrame: 12 hours after acyclovir dose
Secondary outcomes:
measure: Alpha and beta half-life of acyclovir in obese and non-obese patients
timeFrame: 12 hours after acyclovir dose
measure: Maximum concentration (Cmax) of acyclovir in obese and non-obese patients
timeFrame: 12 hours after acyclovir dose
measure: Time to maximum concentration (Tmax) of acyclovir in obese and non-obese patients
timeFrame: 12 hours after acyclovir dose
measure: Volume of distribution (Vd and Vdss) of acyclovir in obese and non-obese patients
timeFrame: 12 hours after acyclovir dose
measure: Time that concentration is above IC50 for varicella and herpes viruses 4,5,6,7 for acyclovir in obese and non-obese patients
timeFrame: 12 hours after acyclovir dose
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University Hospitals Mary Babb Randolph Cancer Center
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Aaron Cumpston, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.