Effect of Body Mass on Acyclovir Pharmacokinetics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-03-31

Brief Summary

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Studies have shown that different percentages of body fat can alter the way drugs are distributed in the body. This study will use blood samples taken at different time points for patients taking acyclovir to determine if higher body weights affect drug exposure. The information gathered from this study will help understand if patients with higher body weights need a different dosing plan.

Patients receiving acyclovir as standard of care will be enrolled into this study. They will have blood draws once before they take acyclovir and 10 times after they take the acyclovir (over a total of 12 hours). These patients will be in the hospital already and will not need to make additional trips back to have blood drawn. A total of about 4-5 tablespoons of blood will be drawn for this study. 7 obese patients and 7 matched, non-obese patients will be enrolled into this study.

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Detailed Description

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Conditions

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Hematological Malignancy Pharmacokinetics of Acyclovir

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Obese Patients

No interventions assigned to this group

Non-obese Patients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years of age
* Receiving intravenous acyclovir 5 mg/kg (total body weight \[TBW\] for normal weight patients and ideal body weight \[IBW\] for obese patients) as part of their routine care
* Admitted as an inpatient with an expected stay of at least 24 hours
* 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 similar agents (valacyclovir, ganciclovir, valganciclovir, famciclovir) in the prior 24 hours
* Serum creatinine \> 1.5 mg/dL at time of drug administration
* 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
* Pregnant or breast-feeding
* Significant anatomical deformities that influence body habitus (i.e. amputation)
* Prior inclusion in this study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No