Effect of Body Mass on Acyclovir Pharmacokinetics
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/8/2014 |
| Start Date: | October 2012 |
| End Date: | February 2014 |
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.
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.
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
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