<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/NCT01731574</url>
  </required_header>
  <id_info>
    <org_study_id>IPM 028</org_study_id>
    <nct_id>NCT01731574</nct_id>
  </id_info>
  <brief_title>DDI Potential: Dapivirine Vaginal Ring and Miconazole Nitrate</brief_title>
  <official_title>An Open-label, Randomized, Three-period Crossover Trial in Healthy HIV-negative Women to Assess the Drug-drug Interaction Between Dapivirine Vaginal Ring-004 and Miconazole Nitrate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Partnership for Microbicides, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>International Partnership for Microbicides, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial will investigate the potential drug-drug interaction between dapivirine vaginal&#xD;
      Ring-004 and vaginally administered miconazole nitrate, and will evaluate the safety of&#xD;
      co-administration of the dapivirine vaginal ring and miconazole nitrate in healthy,&#xD;
      HIV-negative women.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <phase>Phase 1</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dapivirine Area under the concentration time curve (AUC)</measure>
    <time_frame>24 hr, 14 days, and 28 days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Dapivirine Ring + Miconazole</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dapivirine Ring + miconazole</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dapivirine Ring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dapivirine Ring</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dapivirine</intervention_name>
    <arm_group_label>Dapivirine Ring</arm_group_label>
    <arm_group_label>Dapivirine Ring + Miconazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>miconazole</intervention_name>
    <arm_group_label>Dapivirine Ring + Miconazole</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women between 18 and ≤ 40 years of age who can give written informed consent&#xD;
&#xD;
          2. Available for all visits and consent to follow all procedures scheduled for the trial&#xD;
&#xD;
          3. Healthy, based on medical history, vital signs, physical examination, urinalysis&#xD;
             (dipstick and microscopy (if indicated)), laboratory evaluations for genital&#xD;
             infections (bacterial vaginosis, gonorrhoea, chlamydia and trichomonas), and&#xD;
             laboratory evaluations for haematology and chemistry&#xD;
&#xD;
          4. HIV-negative as determined by an HIV test at the time of enrolment&#xD;
&#xD;
          5. On a stable form of contraception, defined as:&#xD;
&#xD;
               -  A stable oral contraceptive regimen for at least 2 months prior to enrolment, OR&#xD;
&#xD;
               -  Transdermal contraceptive patch for at least 3 months prior to enrolment, OR&#xD;
&#xD;
               -  Long-acting progestins for at least 6 months prior to enrolment, OR&#xD;
&#xD;
               -  An IUD inserted (with no vaginal or gynaecological complaints associated with its&#xD;
                  use) at least 3 months prior to enrolment, OR&#xD;
&#xD;
               -  Have undergone surgical sterilisation at least 3 months prior to enrolment, AND&#xD;
                  willing to use oral contraceptives if necessary to delay menstruation during the&#xD;
                  vaginal sampling period&#xD;
&#xD;
          6. Upon pelvic examination at the time of enrolment, the cervix and vagina appear normal&#xD;
             as determined by the Investigator/Physician&#xD;
&#xD;
          7. Asymptomatic for genital infections at the time of enrolment (if a woman is diagnosed&#xD;
             with any treatable STI, either clinically or by laboratory test at the time of&#xD;
             screening, she must receive treatment at least 2 weeks prior to enrolment)&#xD;
&#xD;
          8. Willing to refrain from the use of topical medications, vaginal products or objects,&#xD;
             including female condoms, tampons, cotton wool, rags, diaphragms, cervical caps (or&#xD;
             any other vaginal barrier method), douches, lubricants, vibrators/dildos, and drying&#xD;
             agents for 14 days prior to enrolment and for the duration of the trial.&#xD;
&#xD;
          9. Documentation of no abnormality on cervical cytology, including grossly bloody smear,&#xD;
             within 90 days prior to screening&#xD;
&#xD;
         10. Willing to refrain from participation in any other research trial for the duration of&#xD;
             this trial&#xD;
&#xD;
         11. Willing to provide adequate locator information for trial retention purposes and be&#xD;
             reachable per local standard procedures, e.g. by home visit or telephone, or via&#xD;
             family or close neighbour contacts (confidentiality to be maintained)&#xD;
&#xD;
         12. Willing to agree to abstain from all the following for a total of 2 days (48 hours)&#xD;
             prior to each trial visit:&#xD;
&#xD;
               -  Penile-vaginal intercourse&#xD;
&#xD;
               -  Oral contact with her genitalia&#xD;
&#xD;
         13. Hepatitis B and C negative at the time of enrolment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Currently pregnant or had their last pregnancy outcome within 3 months prior to&#xD;
             screening&#xD;
&#xD;
          2. Currently breast-feeding&#xD;
&#xD;
          3. Currently or within two months of participation in any other clinical research trial&#xD;
             involving investigational or marketed products prior to screening&#xD;
&#xD;
          4. Untreated symptomatic urogenital infections, e.g. urinary tract or other sexually&#xD;
             transmitted infections, or other gynaecological conditions such as vaginal itching,&#xD;
             pain, or discharge, within 2 weeks prior to enrolment&#xD;
&#xD;
          5. Have a Grade 2 or higher pelvic examination finding, according to the DAIDS Table for&#xD;
             Grading the Severity of Adult and Pediatric Adverse Events; Addendum 1 Female Genital&#xD;
             Grading Table for Use in Microbicide Studies&#xD;
&#xD;
          6. History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding,&#xD;
             urethral obstruction, incontinence or urge incontinence&#xD;
&#xD;
          7. Current vulvar or vaginal symptoms/abnormalities that could influence the trial&#xD;
             results&#xD;
&#xD;
          8. Cervical cytology at screening that requires cryotherapy, biopsy, treatment (other&#xD;
             than for infection), or further evaluation&#xD;
&#xD;
          9. Symptomatic genital herpes simplex virus (HSV) infection or a history of genital&#xD;
             herpetic infection&#xD;
&#xD;
         10. Any Grade 2, 3 or 4 haematology, biochemistry or urinalysis laboratory abnormality at&#xD;
             baseline (screening) according to the DAIDS Table for Grading the Severity of Adult&#xD;
             and Pediatric Adverse Events; Addendum 1 Female Genital Grading Table for Use in&#xD;
             Microbicide Studies&#xD;
&#xD;
         11. Unexplained, abnormal bleeding per vagina during or following vaginal intercourse, or&#xD;
             gynaecologic surgery within 90 days prior to enrolment&#xD;
&#xD;
         12. Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of&#xD;
             sensitivity/allergy to latex or silicone&#xD;
&#xD;
         13. Any serious acute, chronic or progressive disease (e.g. any known history of neoplasm,&#xD;
             cancer, diabetes, epilepsy, cardiac disease, autoimmune disease, HIV, AIDS, or blood&#xD;
             dyscrasias), or signs of cardiac disease, renal failure, or severe malnutrition&#xD;
&#xD;
         14. Have undergone a hysterectomy&#xD;
&#xD;
         15. Any condition(s) that, in the opinion of the Investigator, might interfere with&#xD;
             adherence to trial requirements or evaluation of the trial objectives.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>SGS Life Sciences</name>
      <address>
        <city>Lange Beeldekensstraat 267</city>
        <state>Antwerpen</state>
        <zip>B-2060</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dapivirine</mesh_term>
    <mesh_term>Miconazole</mesh_term>
  </intervention_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/NCT01731574
org study id: IPM 028
nct id: NCT01731574
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This trial will investigate the potential drug-drug interaction between dapivirine vaginal
      Ring-004 and vaginally administered miconazole nitrate, and will evaluate the safety of
      co-administration of the dapivirine vaginal ring and miconazole nitrate in healthy,
      HIV-negative women.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Dapivirine Area under the concentration time curve (AUC)
time frame: 24 hr, 14 days, and 28 days
arm group label: Dapivirine Ring + Miconazole
arm group type: Active Comparator
description: Dapivirine Ring + miconazole
arm group label: Dapivirine Ring
arm group type: Experimental
description: Dapivirine Ring
intervention type: Drug
intervention name: dapivirine
arm group label: Dapivirine Ring
arm group label: Dapivirine Ring + Miconazole
intervention type: Drug
intervention name: miconazole
arm group label: Dapivirine Ring + Miconazole
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Dapivirine
mesh term: Miconazole