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NCT Number: NCT01714180

Effect of Body Mass on Acyclovir Pharmacokinetics

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.

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Key information

Conditions

Hematological Malignancy Body Weight Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pharmacokinetics of Acyclovir Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

West Virginia University Hospitals Mary Babb Randolph Cancer Center

Morgantown, West Virginia, 26506, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Systemic clearance of acyclovir in obese and non-obese patients

    Time frame: 12 hours after acyclovir dose

Secondary outcomes

  1. Alpha and beta half-life of acyclovir in obese and non-obese patients

    Time frame: 12 hours after acyclovir dose

  2. Maximum concentration (Cmax) of acyclovir in obese and non-obese patients

    Time frame: 12 hours after acyclovir dose

  3. Time to maximum concentration (Tmax) of acyclovir in obese and non-obese patients

    Time frame: 12 hours after acyclovir dose

  4. Volume of distribution (Vd and Vdss) of acyclovir in obese and non-obese patients

    Time frame: 12 hours after acyclovir dose

  5. 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

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Oct 25, 2012
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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