Evaluating Acyclovir Dosing in Obese Patients
Prospective Evaluation of Adjusted Body Weight Dosing of Acyclovir in Obesity
This study is testing a new way to dose acyclovir in obese patients to see if it works better for them compared to non-obese patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | West Virginia University Academic / other |
| Locations | 1 site (Morgantown, West Virginia) |
| Trial ID | NCT02879630 on ClinicalTrials.gov |
What this trial studies
This study evaluates the pharmacokinetics of acyclovir in obese patients by using an adjusted body weight dosing strategy. Patients receiving intravenous acyclovir as part of their standard care will have blood samples collected before and after dosing to assess drug levels. The study aims to enroll 10 obese patients and 10 matched non-obese controls, all of whom will already be hospitalized for other reasons. The blood draws will occur over a 12-hour period, totaling approximately 4-5 tablespoons of blood.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are receiving intravenous acyclovir and meet specific weight criteria for obesity or normal weight.
Not a fit: Patients with recent acyclovir use, significant renal impairment, or those requiring intensive medical support may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective dosing strategies for acyclovir in obese patients, improving treatment outcomes.
How similar studies have performed: While this approach is novel in the context of acyclovir dosing for obesity, similar pharmacokinetic studies have shown promise in optimizing drug dosing for different populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Morgantown, West Virginia
- West Virginia University Hospitals — Morgantown, West Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Aaron Cumpston, PharmD, BCOP — West Virginia University Medicine
- Study coordinator: Pam Bunner
- Email: bunnerp@wvumedicine.org
- Phone: 304-598-4511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.