Clinical trial NCT02879630: Prospective Evaluation of Adjusted Body Weight Dosing of Acyclovir in Obesity
Official title: Prospective Evaluation of Adjusted Body Weight Dosing of Acyclovir in Obesity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Keywords: pharmacokinetics
acyclovir
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 20
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 non-obese patients receiving intravenous acyclovir

Brief summary: Patients receiving acyclovir as standard of care will be enrolled into this study. The currently recommended dosing strategy at our institution for obese patients is to receive intravenous acyclovir dosed per an adjusted body weight \[IBW + 0.4(TBW-IBW)\]. They will have blood drawn once prior to the first dose of acyclovir and 10 times thereafter, over a total time period of 12 hours. These patients will already be hospitalized for other reasons, and will not be required to make additional trips to the hospital. A total of approximately 4-5 tablespoons of blood will be drawn for this study. Ten obese patients and 10 matched control (non-obese) patients will be enrolled.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years of age
* Receiving intravenous acyclovir 5 mg/kg (TBW for normal weight patients and ABW40 for obese patients) as part of their routine care
* 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 a pro-drug of acyclovir (valacyclovir, ganciclovir, valganciclovir, famciclovir) in the prior 24 hours
* Serum creatinine \>1.5 mg/dL
* 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
* Significant anatomical deformities that influence body habitus (i.e. amputation)
* Prior inclusion in this study

Primary outcomes:
measure: Area under the curve (AUC) of systemic acyclovir exposure in obese and non-obese patients
timeFrame: 12 hours
Secondary outcomes:
measure: Half-life of acyclovir in obese and non-obese patients
timeFrame: 12 hours
measure: Maximum concentration (Cmax) of acyclovir in obese and non-obese patients
timeFrame: 12 hours
measure: Time to maximum concentration (Tmax) of acyclovir in obese and non-obese patients
timeFrame: 12 hours
measure: Volume of distribution (Vd) of acyclovir in obese and non-obese patients
timeFrame: 12 hours
measure: Systemic Clearance of acyclovir in obese and non-obese patients
timeFrame: 12 hours
measure: Time that concentration is above IC50 for varicella and herpes viruses in obese and non-obese patients
timeFrame: 12 hours
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University Hospitals
state: West Virginia
Study officials:
affiliation: West Virginia University Medicine
name: Aaron Cumpston, PharmD, BCOP
role: PRINCIPAL_INVESTIGATOR
References: