<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/NCT02968576</url>
  </required_header>
  <id_info>
    <org_study_id>16-1478</org_study_id>
    <nct_id>NCT02968576</nct_id>
  </id_info>
  <brief_title>Bioequivalence of Tenofovir and Emtricitabine Following Overencapsulation</brief_title>
  <acronym>A-TEAM</acronym>
  <official_title>Bioequivalence of Tenofovir and Emtricitabine Following Overencapsulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Poor adherence to tenofovir (TDF) and emtricitabine (FTC) for Human Immunodeficiency Virus&#xD;
      (HIV) pre-exposure prophylaxis (PrEP) is common and the leading cause of therapeutic failure.&#xD;
      The investigators need better ways to measure adherence in patients on PrEP. This application&#xD;
      will address the need to measure adherence by evaluating an integrated technology system,&#xD;
      Proteus Discover, when combined with Truvada. The Proteus Sensor System (PSS) will confirm&#xD;
      that Truvada was taken, monitor adherence in both recent and long term dosing, and provides&#xD;
      feedback to encourage adherence. The goal of this study is to determine whether the use of&#xD;
      the PSS with Truvada will vary the drug concentrations of FTC/TDF. Participants will have 2&#xD;
      study visits where they will be randomized to either start with the combined PSS with Truvada&#xD;
      or just Truvada alone. Study participants will come to the Clinical &amp; Translational Research&#xD;
      Center (CTRC) in the morning and take the assigned dose and will then have blood drawn at&#xD;
      about .25, 0.5, 1, 2, 4, 6, and 10 hours after medication is taken. Participants will then&#xD;
      return to the CTRC for blood draws 24, 48, and 72 hours after they took the dose on the first&#xD;
      day. The second visit will mimic the first except that the participant will take the other&#xD;
      dose form.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak Plasma Concentration (Cmax)</measure>
    <time_frame>0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose</time_frame>
    <description>Tenofovir and emtricitabine concentration max (Cmax) following FTC/TDF in the overencapsulated versus non-encapsulated form. Drug concentrations will be assayed with validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methodology.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Concentration-time Curve (AUC)</measure>
    <time_frame>0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose</time_frame>
    <description>Tenofovir and emtricitabine area under the concentration-time curve (AUC) following FTC/TDF in the overencapsulated versus non-encapsulated form. Drug concentrations will be assayed with validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methodology.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Healthy Volunteers</condition>
  <condition>Pharmacokinetics</condition>
  <arm_group>
    <arm_group_label>Truvada</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Naked form Truvada (drug)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PSS-Truvada</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Proteus Sensor System (PSS) (device) encapsulated Truvada (drug)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TENOFOVIR DISOPROXIL FUMARATE 300 Mg / EMTRICITABINE 200 Mg ORAL TABLET [TRUVADA]</intervention_name>
    <arm_group_label>PSS-Truvada</arm_group_label>
    <arm_group_label>Truvada</arm_group_label>
    <other_name>Truvada</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Proteus Sensor System</intervention_name>
    <arm_group_label>PSS-Truvada</arm_group_label>
    <other_name>PSS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ambulatory 18-45 year old adults.&#xD;
&#xD;
          2. Ability to comply with study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to give informed consent&#xD;
&#xD;
          2. Pregnancy or planning to become pregnant within 3 months of study completion&#xD;
&#xD;
          3. Currently breastfeeding&#xD;
&#xD;
          4. High risk of HIV-1 infection (for example: sexually active with an HIV infected&#xD;
             partner; men who have sex with men who may engage in condom-less intercourse with&#xD;
             HIV-infected partners or partner of unknown status during the study; males or females&#xD;
             who exchange sex for money, shelter, or gifts; active injection drug use or during the&#xD;
             last 12 months; newly diagnosed sexually transmitted infections in last 6 months)&#xD;
&#xD;
          5. Positive HIV+ ELISA or suspected acute HIV infection in the opinion of the clinician.&#xD;
             (example signs and symptoms of acute HIV infection include combinations of fever,&#xD;
             headache, fatigue, arthralgia, vomiting, myalgia, diarrhea, pharyngitis, rash, night&#xD;
             sweats, and adenopathy cervical or inguinal)&#xD;
&#xD;
          6. Positive hepatitis B virus (HBV) surface antigen test.&#xD;
&#xD;
          7. Uncontrolled or symptomatic bone disease or history of non-traumatic bone fractures&#xD;
&#xD;
          8. Active psychiatric illness or alcohol/drug abuse that, in the opinion of the&#xD;
             investigators, would interfere with study requirements&#xD;
&#xD;
          9. Creatinine clearance &lt; 60 ml/min, or history of serious renal disease&#xD;
&#xD;
         10. Urine dipstick protein ≥ 2+&#xD;
&#xD;
         11. Total bilirubin and/or hepatic transaminases (ALT and AST) ≥ 2.5x upper limit of&#xD;
             normal&#xD;
&#xD;
         12. Absolute neutrophil count ≤ 1,500/mm3, platelets count ≤ 100,000/mm3, or hemoglobin ≤&#xD;
             10 g/dL.&#xD;
&#xD;
         13. Any laboratory value or uncontrolled medical conditions that, in the opinion of&#xD;
             investigators, would interfere with the study conditions or increase risk to the&#xD;
             participant&#xD;
&#xD;
         14. &gt; Grade I abnormalities in screening laboratory tests (Complete Blood Count,&#xD;
             Comprehensive Metabolic Panel, Lipase, Phosphorus) per Division of AIDS (DAIDS)&#xD;
             Grading Table&#xD;
&#xD;
         15. Contraindicated concomitant medications based upon product information or that, in the&#xD;
             opinion of the investigators, would interact with the study medications or increase&#xD;
             risk to participant such as: investigational agents (within 30 days of enrollment),&#xD;
             aminoglycosides, ganciclovir/valganciclovir, chronic high-dose acyclovir/valacyclovir&#xD;
             (&gt;800mg acyclovir or &gt; 500mg valacyclovir for &gt; 7 days), cyclosporine, amphotericin B,&#xD;
             foscarnet, and cidofovir, and products with same or similar active ingredients as the&#xD;
             study medications including TRUVADA®, ATRIPLA®, COMPLERA®, EMTRIVA®, VIREAD®; or drugs&#xD;
             containing lamivudine or adefovir, which are close analogs of FTC and tenofovir.&#xD;
&#xD;
         16. Current participation in other interventional research studies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Anderson, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <reference>
    <citation>Ibrahim ME, Brooks KM, Castillo-Mancilla JR, McHugh C, Morrow M, Brothers J, MaWhinney S, Hosek S, Huhn G, Anderson PL. Short Communication: Bioequivalence of Tenofovir and Emtricitabine After Coencapsulation with the Proteus Ingestible Sensor. AIDS Res Hum Retroviruses. 2018 Oct;34(10):835-837. doi: 10.1089/AID.2018.0081. Epub 2018 Sep 5.</citation>
    <PMID>30047286</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 8, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <results_first_submitted>April 24, 2019</results_first_submitted>
  <results_first_submitted_qc>April 24, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 14, 2019</results_first_posted>
  <last_update_submitted>February 24, 2020</last_update_submitted>
  <last_update_submitted_qc>February 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>healthy volunteers</keyword>
  <keyword>pharmacokinetics</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tenofovir</mesh_term>
    <mesh_term>Emtricitabine</mesh_term>
    <mesh_term>Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 21, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT02968576/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>IRB approval was obtained for 48 subjects to allow for screen failures, withdrawals, lost to follow up, etc.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Truvada First, Then Coencapsulated PSS-Truvada</title>
          <description>Single dose of unencapsulated Truvada (Tenofovir disoproxil fumarate 300mg/Emtricitabine 200mg), 14-day washout followed by single dose of Truvada coencapsulated with the Proteus Sensor System (PSS) (device).</description>
        </group>
        <group group_id="P2">
          <title>Coencapsulated PSS-Truvada First, Then Truvada</title>
          <description>Single dose of Truvada (Tenofovir disoproxil fumarate 300mg/Emtricitabine 200mg) coencapsulated with the Proteus Sensor System (PSS) (device), 14-day washout followed by single dose of unencapsulated Truvada.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
          <description>Single dose of unencapsulated and coencapsulated TDF/FTC. A 14-day washout separated each dosing.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race/Ethnicity</title>
              <category_list>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Peak Plasma Concentration (Cmax)</title>
        <description>Tenofovir and emtricitabine concentration max (Cmax) following FTC/TDF in the overencapsulated versus non-encapsulated form. Drug concentrations will be assayed with validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methodology.</description>
        <time_frame>0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose</time_frame>
        <population>All subjects who completed the study: single dose of unencapsulated and coencapsulated TDF/FTC. A 14-day washout separated each dosing.</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>Single dose of unencapsulated and coencapsulated TDF/FTC. A 14-day washout separated each dosing.</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Plasma Concentration (Cmax)</title>
          <description>Tenofovir and emtricitabine concentration max (Cmax) following FTC/TDF in the overencapsulated versus non-encapsulated form. Drug concentrations will be assayed with validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methodology.</description>
          <population>All subjects who completed the study: single dose of unencapsulated and coencapsulated TDF/FTC. A 14-day washout separated each dosing.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <units_analyzed>PK timepoint samples</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>PK timepoint samples</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="477"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TFV Cmax-unencapsulated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="222" spread="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TFV Cmax-coencapsulated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="229" spread="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FTC Cmax-unencapsulated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1567" spread="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FTC Cmax-coencapsulated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1684" spread="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Concentration-time Curve (AUC)</title>
        <description>Tenofovir and emtricitabine area under the concentration-time curve (AUC) following FTC/TDF in the overencapsulated versus non-encapsulated form. Drug concentrations will be assayed with validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methodology.</description>
        <time_frame>0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose</time_frame>
        <population>All subjects who completed the study: single dose of unencapsulated and coencapsulated TDF/FTC. A 14-day washout separated each dosing.</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>Single dose of unencapsulated and coencapsulated TDF/FTC. A 14-day washout separated each dosing.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve (AUC)</title>
          <description>Tenofovir and emtricitabine area under the concentration-time curve (AUC) following FTC/TDF in the overencapsulated versus non-encapsulated form. Drug concentrations will be assayed with validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methodology.</description>
          <population>All subjects who completed the study: single dose of unencapsulated and coencapsulated TDF/FTC. A 14-day washout separated each dosing.</population>
          <units>ng*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <units_analyzed>PK timepoint samples</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>PK timepoint samples</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="477"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TFV AUC-unencapsulated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1978" spread="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TFV AUC-coencapsulated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2042" spread="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FTC AUC-unencapsulated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9342" spread="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FTC AUC-coencapsulated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9512" spread="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Time of consenting to study exit, Max. 54 days</time_frame>
      <desc>AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0, November, 2014. Available on the DAIDS RSC Web site: http://rsc.tech-res.com/safetyandpharmacovigilance/</desc>
      <group_list>
        <group group_id="E1">
          <title>All Subjects</title>
          <description>Overall, the study showed an unremarkable and expected AE profile. At study initiation Truvada was FDA approved thus, the AE profile was already established. This study was not designed to collect new safety data or to update the established AE/Safety profiles for Truvada. Therefore AE data was combined for all dosing regimens since AEs reported per arm/group are not meaningful for research or clinical applications.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Vomitting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Common Cold</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Facial Swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Peter Anderson</name_or_title>
      <organization>University of Colorado | Skaggs School of Pharmacy and Pharmaceutical Sciences</organization>
      <phone>3037246128</phone>
      <email>peter.anderson@ucdenver.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02968576
org study id: 16-1478
nct id: NCT02968576
lead sponsor: 
has dmc: Yes
Poor adherence to tenofovir (TDF) and emtricitabine (FTC) for Human Immunodeficiency Virus
      (HIV) pre-exposure prophylaxis (PrEP) is common and the leading cause of therapeutic failure.
      The investigators need better ways to measure adherence in patients on PrEP. This application
      will address the need to measure adherence by evaluating an integrated technology system,
      Proteus Discover, when combined with Truvada. The Proteus Sensor System (PSS) will confirm
      that Truvada was taken, monitor adherence in both recent and long term dosing, and provides
      feedback to encourage adherence. The goal of this study is to determine whether the use of
      the PSS with Truvada will vary the drug concentrations of FTC/TDF. Participants will have 2
      study visits where they will be randomized to either start with the combined PSS with Truvada
      or just Truvada alone. Study participants will come to the Clinical & Translational Research
      Center (CTRC) in the morning and take the assigned dose and will then have blood drawn at
      about .25, 0.5, 1, 2, 4, 6, and 10 hours after medication is taken. Participants will then
      return to the CTRC for blood draws 24, 48, and 72 hours after they took the dose on the first
      day. The second visit will mimic the first except that the participant will take the other
      dose form.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Peak Plasma Concentration (Cmax)
time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
description: Tenofovir and emtricitabine concentration max (Cmax) following FTC/TDF in the overencapsulated versus non-encapsulated form. Drug concentrations will be assayed with validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methodology.
measure: Area Under the Concentration-time Curve (AUC)
time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
description: Tenofovir and emtricitabine area under the concentration-time curve (AUC) following FTC/TDF in the overencapsulated versus non-encapsulated form. Drug concentrations will be assayed with validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methodology.
arm group label: Truvada
arm group type: Active Comparator
description: Naked form Truvada (drug)
arm group label: PSS-Truvada
arm group type: Experimental
description: Proteus Sensor System (PSS) (device) encapsulated Truvada (drug)
intervention type: Drug
intervention name: TENOFOVIR DISOPROXIL FUMARATE 300 Mg / EMTRICITABINE 200 Mg ORAL TABLET [TRUVADA]
arm group label: PSS-Truvada
arm group label: Truvada
other name: Truvada
intervention type: Device
intervention name: Proteus Sensor System
arm group label: PSS-Truvada
other name: PSS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Peter Anderson, PharmD
role: Principal Investigator
affiliation: University of Colorado, Denver
citation: Ibrahim ME, Brooks KM, Castillo-Mancilla JR, McHugh C, Morrow M, Brothers J, MaWhinney S, Hosek S, Huhn G, Anderson PL. Short Communication: Bioequivalence of Tenofovir and Emtricitabine After Coencapsulation with the Proteus Ingestible Sensor. AIDS Res Hum Retroviruses. 2018 Oct;34(10):835-837. doi: 10.1089/AID.2018.0081. Epub 2018 Sep 5.
PMID: 30047286
responsible party type: Sponsor
mesh term: Tenofovir
mesh term: Emtricitabine
mesh term: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 