Prospective Evaluation of Adjusted Body Weight Dosing of Acyclovir in Obesity

RECRUITING

I'm interested ...!!

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

🗓️ Study Start (Actual) August 2016

🗓️ Primary Completion (Estimated) December 2024

✅ Study Completion (Estimated) December 2024

👥 Enrollment (Estimated) 20

🔬 Study Type OBSERVATIONAL

📊 Phase N/A

Locations:

📍 Morgantown, West Virginia, United States

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 18 August 2016
First Submitted that Met QC Criteria 22 August 2016
First Posted 25 August 2016

Study Record Updates

Last Update Submitted that Met QC Criteria 10 January 2024
Last Update Posted 11 January 2024
Last Verified January 2024