Effect of Body Mass on Acyclovir Pharmacokinetics
This study is currently recruiting participants.
Verified April 2013 by West Virginia University
Sponsor:
West Virginia University
Information provided by (Responsible Party):
Aaron Cumpston, PharmD, West Virginia University
ClinicalTrials.gov Identifier:
NCT01714180
First received: October 17, 2012
Last updated: April 30, 2013
Last verified: April 2013
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Purpose
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.
| Condition |
|---|
|
Hematological Malignancy Pharmacokinetics of Acyclovir |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Effect of Body Mass on Acyclovir Pharmacokinetics |
Resource links provided by NLM:
Further study details as provided by West Virginia University:
Primary Outcome Measures:
- Systemic clearance of acyclovir in obese and non-obese patients [ Time Frame: 12 hours after acyclovir dose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Alpha and beta half-life of acyclovir in obese and non-obese patients [ Time Frame: 12 hours after acyclovir dose ] [ Designated as safety issue: No ]
- Maximum concentration (Cmax) of acyclovir in obese and non-obese patients [ Time Frame: 12 hours after acyclovir dose ] [ Designated as safety issue: No ]
- Time to maximum concentration (Tmax) of acyclovir in obese and non-obese patients [ Time Frame: 12 hours after acyclovir dose ] [ Designated as safety issue: No ]
- Volume of distribution (Vd and Vdss) of acyclovir in obese and non-obese patients [ Time Frame: 12 hours after acyclovir dose ] [ Designated as safety issue: No ]
- Time that concentration is above IC50 for varicella and herpes viruses 4,5,6,7 for acyclovir in obese and non-obese patients [ Time Frame: 12 hours after acyclovir dose ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 14 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Obese Patients |
| Non-obese Patients |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Obese and normal weight patients treated with acyclovir in an inpatient setting.
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714180
Locations
| United States, West Virginia | |
| West Virginia University Hospitals Mary Babb Randolph Cancer Center | Recruiting |
| Morgantown, West Virginia, United States, 26506 | |
| Contact: Pam Bunner, MT 304-598-4511 bunnerp@wvuhealthcare.com | |
| Contact: Crystal Street, MT 304-598-4512 streetc@wvuhealthcare.com | |
| Principal Investigator: Aaron Cumpston, PharmD | |
| Sub-Investigator: R. Brigg Turner, PharmD | |
| Sub-Investigator: Frank Briggs, PharmD | |
| Sub-Investigator: Michael Craig, MD | |
| Sub-Investigator: William Petros, PharmD | |
| Sub-Investigator: Michael Sweet, PharmD | |
| Sub-Investigator: Mehdi Hamadani, MD | |
| Sub-Investigator: Soumit Basu, MD,PhD | |
Sponsors and Collaborators
West Virginia University
Investigators
| Principal Investigator: | Aaron Cumpston, PharmD | West Virginia University |
More Information
No publications provided
| Responsible Party: | Aaron Cumpston, PharmD, Pharmacy Clinical Specialist - BMT/Hematologic Malignancy, West Virginia University |
| ClinicalTrials.gov Identifier: | NCT01714180 History of Changes |
| Other Study ID Numbers: | WVU 031112, 24368 |
| Study First Received: | October 17, 2012 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by West Virginia University:
|
Acyclovir Pharmacokinetics Obese Non-obese |
Weight Distribution Clearance |
Additional relevant MeSH terms:
|
Neoplasms Hematologic Neoplasms Neoplasms by Site Hematologic Diseases Acyclovir |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013