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Hematological Malignancy | Effect of Body Mass on Acyclovir Pharmacokinetics

Hematological Malignancy research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hematological Malignancy

Pharmacokinetics of Acyclovir

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Obese Patients

Non-obese Patients

Study Status

Completed

Start Date: October 2012

Completed Date: March 2015

Phase: N/A

Type: Observational

Design:

Primary Outcome: Systemic clearance of acyclovir in obese and non-obese patients

Secondary Outcome: Alpha and beta half-life of acyclovir in obese and non-obese patients

Study sponsors, principal investigator, and references

Principal Investigator: Aaron Cumpston, PharmD

Lead Sponsor: West Virginia University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01714180

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