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Completed

NCT Number: NCT02879630

Prospective Evaluation of Adjusted Body Weight Dosing of Acyclovir in Obesity

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

West Virginia University Hospitals

Morgantown, West Virginia, 26506, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 12 hours

Secondary outcomes

  1. Half-life of acyclovir in obese and non-obese patients

    Time frame: 12 hours

  2. Maximum concentration (Cmax) of acyclovir in obese and non-obese patients

    Time frame: 12 hours

  3. Time to maximum concentration (Tmax) of acyclovir in obese and non-obese patients

    Time frame: 12 hours

  4. Volume of distribution (Vd) of acyclovir in obese and non-obese patients

    Time frame: 12 hours

  5. Systemic Clearance of acyclovir in obese and non-obese patients

    Time frame: 12 hours

  6. Time that concentration is above IC50 for varicella and herpes viruses in obese and non-obese patients

    Time frame: 12 hours

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Aug 25, 2016
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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