Prospective Evaluation of Adjusted Body Weight Dosing of Acyclovir in Obesity

NCT02879630 | Completed DMC

• 1 other identifier: 1501531856
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

pharmacokinetics; acyclovir

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUC) of systemic acyclovir exposure in obese and non-obese patients

  12 hours

Secondary Outcomes (6)

• 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

Study Arms (2)

Obese Patients

Obese patients (patients whose weight is \>190% of ideal body weight) will be receive a single dose of I.V. acyclovir sodium 5mg/kg dosed by adjusted body weight as part of their routine care.

Non-obese Patients

Normal weigh patients (patients whose weight is 80-120% of ideal body weight) will be receive a single dose of I.V. acyclovir sodium 5mg/kg dosed by total body weight as part of their routine care.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese and non-obese patients receiving intravenous acyclovir

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University Hospitals

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aaron Cumpston, PharmD, BCOP

  West Virginia University Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacy Clinical Specialist

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: August 25, 2016
• Study Start: November 28, 2016
• Primary Completion: February 16, 2026
• Study Completion: February 16, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)