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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01714180
Other study ID # WVU 031112
Secondary ID 24368
Status Completed
Phase N/A
First received October 17, 2012
Last updated June 2, 2015
Start date October 2012
Est. completion date March 2015

Study information

Verified date June 2015
Source West Virginia University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date March 2015
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
United States West Virginia University Hospitals Mary Babb Randolph Cancer Center Morgantown West Virginia

Sponsors (1)

Lead Sponsor Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Systemic clearance of acyclovir in obese and non-obese patients 12 hours after acyclovir dose No
Secondary Alpha and beta half-life of acyclovir in obese and non-obese patients 12 hours after acyclovir dose No
Secondary Maximum concentration (Cmax) of acyclovir in obese and non-obese patients 12 hours after acyclovir dose No
Secondary Time to maximum concentration (Tmax) of acyclovir in obese and non-obese patients 12 hours after acyclovir dose No
Secondary Volume of distribution (Vd and Vdss) of acyclovir in obese and non-obese patients 12 hours after acyclovir dose No
Secondary Time that concentration is above IC50 for varicella and herpes viruses 4,5,6,7 for acyclovir in obese and non-obese patients 12 hours after acyclovir dose No
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