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Trial record 62 of 113 for:    acyclovir

Effect of Body Mass on Acyclovir Pharmacokinetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01714180
Recruitment Status : Completed
First Posted : October 25, 2012
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):
Aaron Cumpston, PharmD, West Virginia University

Tracking Information
First Submitted Date October 17, 2012
First Posted Date October 25, 2012
Last Update Posted Date June 3, 2015
Study Start Date October 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 22, 2012)
Systemic clearance of acyclovir in obese and non-obese patients [ Time Frame: 12 hours after acyclovir dose ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01714180 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 22, 2012)
  • Alpha and beta half-life of acyclovir in obese and non-obese patients [ Time Frame: 12 hours after acyclovir dose ]
  • Maximum concentration (Cmax) of acyclovir in obese and non-obese patients [ Time Frame: 12 hours after acyclovir dose ]
  • Time to maximum concentration (Tmax) of acyclovir in obese and non-obese patients [ Time Frame: 12 hours after acyclovir dose ]
  • Volume of distribution (Vd and Vdss) of acyclovir in obese and non-obese patients [ Time Frame: 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 [ Time Frame: 12 hours after acyclovir dose ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Body Mass on Acyclovir Pharmacokinetics
Official Title Effect of Body Mass on Acyclovir Pharmacokinetics
Brief 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Obese and normal weight patients treated with acyclovir in an inpatient setting.
Condition
  • Hematological Malignancy
  • Pharmacokinetics of Acyclovir
Intervention Not Provided
Study Groups/Cohorts
  • Obese Patients
  • Non-obese Patients
Publications * Turner RB, Cumpston A, Sweet M, Briggs F, Slain D, Wen S, Craig M, Hamadani M, Petros W. Prospective, Controlled Study of Acyclovir Pharmacokinetics in Obese Patients. Antimicrob Agents Chemother. 2016 Jan 11;60(3):1830-3. doi: 10.1128/AAC.02010-15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 22, 2012)
14
Original Estimated Enrollment Same as current
Actual Study Completion Date March 2015
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01714180
Other Study ID Numbers WVU 031112
24368 ( Other Identifier: West Virginia University IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Aaron Cumpston, PharmD, West Virginia University
Study Sponsor West Virginia University
Collaborators Not Provided
Investigators
Principal Investigator: Aaron Cumpston, PharmD West Virginia University
PRS Account West Virginia University
Verification Date June 2015