Prospective Evaluation of Adjusted Body Weight Dosing of Acyclovir in Obesity

Obesity Clinical Trial

Official title:

Prospective Evaluation of Adjusted Body Weight Dosing of Acyclovir in Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02879630
• Other study ID #: 1501531856
• Status: Recruiting
• Start date: August 2016
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: West Virginia University
• Contact: Pam Bunner
• Phone: 304-598-4511
• Email: bunnerp[@]wvumedicine.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity

Locations

Country	Name	City	State
United States	West Virginia University Hospitals	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	Area under the curve (AUC) of systemic acyclovir exposure in obese and non-obese patients		12 hours
Secondary	Half-life of acyclovir in obese and non-obese patients		12 hours
Secondary	Maximum concentration (Cmax) of acyclovir in obese and non-obese patients		12 hours
Secondary	Time to maximum concentration (Tmax) of acyclovir in obese and non-obese patients		12 hours
Secondary	Volume of distribution (Vd) of acyclovir in obese and non-obese patients		12 hours
Secondary	Systemic Clearance of acyclovir in obese and non-obese patients		12 hours
Secondary	Time that concentration is above IC50 for varicella and herpes viruses in obese and non-obese patients		12 hours