Effect of Body Mass on Acyclovir Pharmacokinetics
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
West Virginia
-
Morgantown, West Virginia, Forenede Stater, 26506
- West Virginia University Hospitals Mary Babb Randolph Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Obese Patients
|
|
Non-obese Patients
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Systemic clearance of acyclovir in obese and non-obese patients
Tidsramme: 12 hours after acyclovir dose
|
12 hours after acyclovir dose
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Alpha and beta half-life of acyclovir in obese and non-obese patients
Tidsramme: 12 hours after acyclovir dose
|
12 hours after acyclovir dose
|
|
Maximum concentration (Cmax) of acyclovir in obese and non-obese patients
Tidsramme: 12 hours after acyclovir dose
|
12 hours after acyclovir dose
|
|
Time to maximum concentration (Tmax) of acyclovir in obese and non-obese patients
Tidsramme: 12 hours after acyclovir dose
|
12 hours after acyclovir dose
|
|
Volume of distribution (Vd and Vdss) of acyclovir in obese and non-obese patients
Tidsramme: 12 hours after acyclovir dose
|
12 hours after acyclovir dose
|
|
Time that concentration is above IC50 for varicella and herpes viruses 4,5,6,7 for acyclovir in obese and non-obese patients
Tidsramme: 12 hours after acyclovir dose
|
12 hours after acyclovir dose
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Aaron Cumpston, PharmD, West Virginia University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- WVU 031112
- 24368 (Anden identifikator: West Virginia University IRB)
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