<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01714180</url>
  </required_header>
  <id_info>
    <org_study_id>WVU 031112</org_study_id>
    <secondary_id>24368</secondary_id>
    <nct_id>NCT01714180</nct_id>
  </id_info>
  <brief_title>Effect of Body Mass on Acyclovir Pharmacokinetics</brief_title>
  <official_title>Effect of Body Mass on Acyclovir Pharmacokinetics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West Virginia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West Virginia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Studies have shown that different percentages of body fat can alter the way drugs are&#xD;
      distributed in the body. This study will use blood samples taken at different time points for&#xD;
      patients taking acyclovir to determine if higher body weights affect drug exposure. The&#xD;
      information gathered from this study will help understand if patients with higher body&#xD;
      weights need a different dosing plan.&#xD;
&#xD;
      Patients receiving acyclovir as standard of care will be enrolled into this study. They will&#xD;
      have blood draws once before they take acyclovir and 10 times after they take the acyclovir&#xD;
      (over a total of 12 hours). These patients will be in the hospital already and will not need&#xD;
      to make additional trips back to have blood drawn. A total of about 4-5 tablespoons of blood&#xD;
      will be drawn for this study. 7 obese patients and 7 matched, non-obese patients will be&#xD;
      enrolled into this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Systemic clearance of acyclovir in obese and non-obese patients</measure>
    <time_frame>12 hours after acyclovir dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alpha and beta half-life of acyclovir in obese and non-obese patients</measure>
    <time_frame>12 hours after acyclovir dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum concentration (Cmax) of acyclovir in obese and non-obese patients</measure>
    <time_frame>12 hours after acyclovir dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum concentration (Tmax) of acyclovir in obese and non-obese patients</measure>
    <time_frame>12 hours after acyclovir dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution (Vd and Vdss) of acyclovir in obese and non-obese patients</measure>
    <time_frame>12 hours after acyclovir dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time that concentration is above IC50 for varicella and herpes viruses 4,5,6,7 for acyclovir in obese and non-obese patients</measure>
    <time_frame>12 hours after acyclovir dose</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">14</enrollment>
  <condition>Hematological Malignancy</condition>
  <condition>Pharmacokinetics of Acyclovir</condition>
  <arm_group>
    <arm_group_label>Obese Patients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-obese Patients</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Obese and normal weight patients treated with acyclovir in an inpatient setting.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years of age&#xD;
&#xD;
          -  Receiving intravenous acyclovir 5 mg/kg (total body weight [TBW] for normal weight&#xD;
             patients and ideal body weight [IBW] for obese patients) as part of their routine care&#xD;
&#xD;
          -  Admitted as an inpatient with an expected stay of at least 24 hours&#xD;
&#xD;
          -  Weight &gt; 190% of ideal body weight (IBW) for &quot;obese&quot; patients or weight 80-120% of IBW&#xD;
             for matched control patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receipt of acyclovir or similar agents (valacyclovir, ganciclovir, valganciclovir,&#xD;
             famciclovir) in the prior 24 hours&#xD;
&#xD;
          -  Serum creatinine &gt; 1.5 mg/dL at time of drug administration&#xD;
&#xD;
          -  Hypersensitivity to acyclovir&#xD;
&#xD;
          -  Patients requiring ventilator support or vasopressors in the prior 24 hours&#xD;
&#xD;
          -  Receipt of probenecid, mycophenolate, tenofovir, or zidovudine in the prior 7 days&#xD;
&#xD;
          -  Pregnant or breast-feeding&#xD;
&#xD;
          -  Significant anatomical deformities that influence body habitus (i.e. amputation)&#xD;
&#xD;
          -  Prior inclusion in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aaron Cumpston, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West Virginia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>West Virginia University Hospitals Mary Babb Randolph Cancer Center</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>June 2, 2015</last_update_submitted>
  <last_update_submitted_qc>June 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West Virginia University</investigator_affiliation>
    <investigator_full_name>Aaron Cumpston, PharmD</investigator_full_name>
    <investigator_title>Pharmacy Clinical Specialist - BMT/Hematologic Malignancy</investigator_title>
  </responsible_party>
  <keyword>Acyclovir</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Obese</keyword>
  <keyword>Non-obese</keyword>
  <keyword>Weight</keyword>
  <keyword>Distribution</keyword>
  <keyword>Clearance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01714180
org study id: WVU 031112
secondary id: 24368
nct id: NCT01714180
lead sponsor: 
has dmc: Yes
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.
observational model: Case-Control
time perspective: Prospective
measure: Systemic clearance of acyclovir in obese and non-obese patients
time frame: 12 hours after acyclovir dose
measure: Alpha and beta half-life of acyclovir in obese and non-obese patients
time frame: 12 hours after acyclovir dose
measure: Maximum concentration (Cmax) of acyclovir in obese and non-obese patients
time frame: 12 hours after acyclovir dose
measure: Time to maximum concentration (Tmax) of acyclovir in obese and non-obese patients
time frame: 12 hours after acyclovir dose
measure: Volume of distribution (Vd and Vdss) of acyclovir in obese and non-obese patients
time frame: 12 hours after acyclovir dose
measure: 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
arm group label: Obese Patients
arm group label: Non-obese Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aaron Cumpston, PharmD
role: Principal Investigator
affiliation: West Virginia University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: West Virginia University
investigator full name: Aaron Cumpston, PharmD
investigator title: Pharmacy Clinical Specialist - BMT/Hematologic Malignancy
mesh term: Hematologic Neoplasms