Effect of Body Mass on Acyclovir Pharmacokinetics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Systemic clearance of acyclovir in obese and non-obese patients
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Systemic clearance of acyclovir in obese and non-obese patients
时间窗: 12 hours after acyclovir dose
次要结局
- 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)
- Alpha and beta half-life of acyclovir in obese and non-obese patients(12 hours after acyclovir dose)
- Maximum concentration (Cmax) of acyclovir in obese and non-obese patients(12 hours after acyclovir dose)
- Time to maximum concentration (Tmax) of acyclovir in obese and non-obese patients(12 hours after acyclovir dose)
- Volume of distribution (Vd and Vdss) of acyclovir in obese and non-obese patients(12 hours after acyclovir dose)
研究者
Aaron Cumpston, PharmD
Pharmacy Clinical Specialist - BMT/Hematologic Malignancy
West Virginia University