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.
Studieoversikt
Status
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
West Virginia
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Morgantown, West Virginia, Forente stater, 26506
- West Virginia University Hospitals Mary Babb Randolph Cancer Center
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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Obese Patients
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Non-obese Patients
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Hva måler studien?
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
|
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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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Aaron Cumpston, PharmD, West Virginia University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- WVU 031112
- 24368 (Annen identifikator: West Virginia University IRB)
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