Prospective Evaluation of Adjusted Body Weight Dosing of Acyclovir in Obesity

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02879630

Enrollment

Registered

2016-08-25

Start date

2016-11-28

Completion date

2026-02-16

Last updated

2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

pharmacokinetics, 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Area under the curve (AUC) of systemic acyclovir exposure in obese and non-obese patients	12 hours

Secondary

Measure	Time frame
Half-life of acyclovir in obese and non-obese patients	12 hours
Maximum concentration (Cmax) of acyclovir in obese and non-obese patients	12 hours
Time to maximum concentration (Tmax) of acyclovir in obese and non-obese patients	12 hours
Volume of distribution (Vd) of acyclovir in obese and non-obese patients	12 hours
Systemic Clearance of acyclovir in obese and non-obese patients	12 hours
Time that concentration is above IC50 for varicella and herpes viruses in obese and non-obese patients	12 hours

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAaron Cumpston, PharmD, BCOP

West Virginia University Medicine

Outcome results