<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/NCT03255915</url>
  </required_header>
  <id_info>
    <org_study_id>17-0131</org_study_id>
    <secondary_id>1U19AI113048-01</secondary_id>
    <nct_id>NCT03255915</nct_id>
  </id_info>
  <brief_title>PrEP-Pod-IVR (TDF-FTC/Placebo IVR 28 Day Crossover Study)</brief_title>
  <acronym>PrEP-Pod-IVR</acronym>
  <official_title>Randomized Order, Controlled, Double Blind, Crossover Early Phase 1 Pilot Study to Assess Safety and Pharmacokinetics of a Tenofovir Disoproxil Fumarate and Emtricitabine (TDF-FTC) Releasing IVR Over 28 Days Compared to Placebo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oak Crest Institute of Science</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Miriam Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The University of Texas Medical Branch, Galveston</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Oak Crest Institute of Science</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Participants will have a 28-day pre-ring baseline assessment period (Stage 1) followed by&#xD;
      randomization to order with 5 participants per study arm. All participants will sequentially&#xD;
      receive both study products for 28-days with at least a 2-week washout period between&#xD;
      products. Arm 1 will receive the TDF-FTC pod-IVR for Stage 2 followed by the placebo pod-IVR&#xD;
      during Stage 3. Arm 2 will receive the placebo pod-IVR for Stage 2 followed by the TDF-FTC&#xD;
      pod-IVR during Stage 3. During Stages 2 &amp; 3 participants will also complete brief phone&#xD;
      surveys (&lt;3 min), computer-assisted self-interviews (CASIs), and in-depth interviews (IDIs)&#xD;
      regarding perceptibility and acceptability. If willing, participants' male sexual partners&#xD;
      will be invited to complete IDIs as well.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 20, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</primary_completion_date>
  <phase>Early 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>
    <intervention_model_description>Randomized order, placebo-controlled, double blind, crossover</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety of Vaginal IVRs releasing TDF-FTC by reports of Adverse Events</measure>
    <time_frame>From date of enrollment until the date of study completion or date of study withdrawal from any cause, whichever came first, assessed up to 6 months</time_frame>
    <description>Adverse events Grade 2 or higher as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017, Addendum 1 Female Genital Grading Tables for Use in Microbicide Studies (November 2007), and/or Addendum 3 Rectal Grading Table for Use in Microbicide Studies (Clarification dated May 2012) to this table</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Characterization of pharmacokinetics of TDF-FTC released by an IVR - plasma</measure>
    <time_frame>From date of enrollment until the date of study completion or date of study withdrawal from any cause, whichever came first, assessed up to 6 months</time_frame>
    <description>To characterize the local and systemic pharmacokinetics (PK) of TDF-FTC delivered via a pod-IVR, including drug concentration in plasma.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Characterization of pharmacokinetics of TDF-FTC released by an IVR - vagina</measure>
    <time_frame>From date of enrollment until the date of study completion or date of study withdrawal from any cause, whichever came first, assessed up to 6 months</time_frame>
    <description>To characterize the local and systemic pharmacokinetics (PK) of TDF-FTC delivered via a pod-IVR, including drug concentration in vaginal secretions and tissue.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Characterization of pharmacokinetics of TDF-FTC released by an IVR - rectum</measure>
    <time_frame>From date of enrollment until the date of study completion or date of study withdrawal from any cause, whichever came first, assessed up to 6 months</time_frame>
    <description>To characterize the local and systemic pharmacokinetics (PK) of TDF-FTC delivered via a pod-IVR, including drug concentration in rectal secretions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability of IVR assessed via computer assisted self interviews</measure>
    <time_frame>28 days after use of each IVR</time_frame>
    <description>Self-reported attitudes of participants about experience and product attributes via computer assisted self interviews</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability of IVR assessed via in depth interviews</measure>
    <time_frame>28 days after use of each IVR</time_frame>
    <description>Self-reported attitudes of participants about experience and product attributes via in depth interviews</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence</measure>
    <time_frame>From date of IVR insertion until the date of IVR removal or date of study withdrawal from any cause, whichever came first, assessed up to 6 months</time_frame>
    <description>Measured by vaginal fluid PK drug levels, vaginal tissue PK drug and drug metabolite levels, and residual drug levels in returned, used pod-IVRs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability of IVR assessed via in depth interviews - male partners</measure>
    <time_frame>28 days after subject use of each IVR</time_frame>
    <description>Self-reported attitudes of participant's male sexual partner(s) about experience and product attributes via in-depth interviews.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>HIV Prevention</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm 1 will receive the Tenofovir Disoproxil Fumarate (TDF)-Emtricitabine (FTC) pod-IVR for Stage 2 followed by the placebo pod-IVR during Stage 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm 2 will receive the placebo pod-IVR for Stage 2 followed by the Tenofovir Disoproxil Fumarate (TDF)-Emtricitabine (FTC) pod-IVR during Stage 3.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tenofovir Disoproxil Fumarate (TDF)-Emtricitabine (FTC)</intervention_name>
    <description>TDF-FTC pod-IVR designed to deliver TDF at a target rate of 1 mg d-1 and FTC at a target rate of 2 mg d-1.</description>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_label>Arm 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>A placebo pod-IVR containing microcrystalline cellulose pods.</description>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_label>Arm 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age of 18 through 45 years at screening, verified per site SOP&#xD;
&#xD;
          2. Female participants, born female&#xD;
&#xD;
          3. Not pregnant or breastfeeding&#xD;
&#xD;
          4. Availability to return for all study visits, barring unforeseen circumstances&#xD;
&#xD;
          5. Willing and able to&#xD;
&#xD;
               -  communicate in English&#xD;
&#xD;
               -  provide written informed consent to take part in the study&#xD;
&#xD;
               -  provide adequate locator information, as defined in site SOP&#xD;
&#xD;
               -  complete all required study procedures, including phone surveys, daily vaginal&#xD;
                  swabs, and reliably store swabs in freezer&#xD;
&#xD;
          6. Must agree&#xD;
&#xD;
               -  not to participate in other concurrent interventional and/or drug trials&#xD;
&#xD;
               -  to use study-provided condoms for vaginal or anal intercourse for the duration of&#xD;
                  the study&#xD;
&#xD;
               -  to abstain from use of any vaginal products (e.g., lubricants, feminine hygiene&#xD;
                  products, vaginally administered contraceptive products, sex toys) other than&#xD;
                  study products for the duration of the study beginning at enrollment Note:&#xD;
                  Tampons may be used during menses, but must be discontinued 72 hours prior to&#xD;
                  study visits and for 7 days after biopsy procedures. Menstrual pads will be&#xD;
                  provided to participants.&#xD;
&#xD;
               -  to abstain from receptive oral, vaginal, or anal intercourse during the first&#xD;
                  week after each pod-IVR insertion and for 2 days before and 7 days after biopsy&#xD;
                  procedures&#xD;
&#xD;
               -  to abstain from insertion of anything in the vagina (e.g., tampon, finger, sex&#xD;
                  toy, lubricants, medication, douche) during the first week after each pod-IVR&#xD;
                  insertion and for 2 days before and 7 days after biopsy procedures&#xD;
&#xD;
          7. Understands and agrees to local STI reporting requirements&#xD;
&#xD;
          8. HIV-1 seronegative at screening&#xD;
&#xD;
          9. Must be in general good health in the opinion of the investigator&#xD;
&#xD;
         10. Regular menstrual cycles of approximately 21 to 35 days apart with no untreated&#xD;
             intermenstrual menstrual bleeding Note: This criterion is not applicable to&#xD;
             participants using continuous combination oral contraceptive pills or progestin-only&#xD;
             methods (such as Depo-Provera or levonorgestrel-releasing IUD), as the absence of&#xD;
             regular menstrual cycles is an expected, normal consequence in this context.&#xD;
&#xD;
         11. Satisfactory cervical Pap result in the 36 calendar months prior to Enrollment&#xD;
             consistent with Grade 0 according to the Female Genital Grading Table for Use in&#xD;
             Microbicide Studies [Addendum 1, Dated November 2007], or if Grade 1 or higher Pap&#xD;
             result has had a satisfactory evaluation with no treatment required per American&#xD;
             Society for Colposcopy and Cervical Pathology (ASCCP) guidelines in the 12 calendar&#xD;
             months prior to Enrollment&#xD;
&#xD;
         12. Using an effective method of contraception and intending to continue use of an&#xD;
             effective method for the duration of study participation. Acceptable methods include:&#xD;
&#xD;
               -  hormonal methods (except contraceptive vaginal rings)&#xD;
&#xD;
               -  IUD&#xD;
&#xD;
               -  sterilization of participant or partner&#xD;
&#xD;
             In addition to the criteria listed above, participants who agree to have rectal&#xD;
             biopsies collected must meet the following criteria:&#xD;
&#xD;
         13. Must agree to abstain from insertion of anything in the rectum (e.g., finger, sex toy,&#xD;
             lubricants, medication, enema) during the first week after each pod-IVR insertion and&#xD;
             for 2 days before and 7 days after biopsy procedures&#xD;
&#xD;
        Male sexual partner(s) who meet the following criteria are eligible for inclusion in the&#xD;
        study:&#xD;
&#xD;
          1. Age of 18 years or over&#xD;
&#xD;
          2. Has a female sexual partner enrolled in the study&#xD;
&#xD;
          3. Willing and able to&#xD;
&#xD;
               -  communicate in English&#xD;
&#xD;
               -  provide written informed consent to take part in the study&#xD;
&#xD;
               -  provide adequate locator information, as defined in site SOP&#xD;
&#xD;
               -  complete in-depth interview via video conference&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Individuals who meet any of the following criteria will be excluded from the study:&#xD;
&#xD;
          1. Undergoing or completed gender reassignment&#xD;
&#xD;
          2. Participant reports any of the following at Screening:&#xD;
&#xD;
               1. Has plans to relocate away from the study site area during the period of study&#xD;
                  participation&#xD;
&#xD;
               2. Pregnant, less than 3 months post-partum, or lactating&#xD;
&#xD;
               3. Intends to become pregnant during the period of study participation&#xD;
&#xD;
               4. Current or planned use of an IVR&#xD;
&#xD;
               5. Known HIV-infected partners&#xD;
&#xD;
               6. Non-therapeutic injection drug use in the 6 months prior to screening&#xD;
&#xD;
               7. History of autoimmune disease&#xD;
&#xD;
               8. History of toxic shock syndrome&#xD;
&#xD;
               9. History of adverse reaction to TDF, FTC, silicone, or microcrystalline cellulose&#xD;
&#xD;
              10. PrEP or Post-exposure prophylaxis for HIV exposure within 6 months prior to&#xD;
                  screening&#xD;
&#xD;
              11. Use of systemic immunomodulatory medications within the 4 weeks prior to the&#xD;
                  Enrollment&#xD;
&#xD;
              12. Use of vaginally or rectally administered medications or products (including&#xD;
                  condoms) containing Nonoxynol-9 (N-9) within the 4 weeks prior to the Enrollment&#xD;
&#xD;
              13. Participating in another research study involving drugs or medical devices within&#xD;
                  the 4 weeks or 5 half-lives (if known) prior to the Enrollment&#xD;
&#xD;
              14. Gynecologic or genital procedure (e.g., tubal ligation, dilation and curettage,&#xD;
                  piercing) within 60 days prior to Enrollment&#xD;
&#xD;
             Note: Colposcopy and cervical biopsies for evaluation of an abnormal Pap smear as well&#xD;
             as IUD removal are not exclusionary&#xD;
&#xD;
          3. Per participant report at screening, anticipated use and/or unwillingness to abstain&#xD;
             from the following medications during the period of study participation:&#xD;
&#xD;
               1. Heparin, including Lovenox® (enoxaparin sodium)&#xD;
&#xD;
               2. Warfarin&#xD;
&#xD;
               3. Plavix® (clopidogrel bisulfate)&#xD;
&#xD;
               4. Any other drugs that are associated with increased likelihood of bleeding&#xD;
                  following mucosal biopsy (e.g., daily high dose aspirin, Pradaxa®)&#xD;
&#xD;
               5. NSAID use for 5 half-lives prior to biopsy (e.g. ibuprofen for 1 day, naproxen&#xD;
                  for 4 days).&#xD;
&#xD;
               6. Rectally or vaginally administered medications (including over-the-counter&#xD;
                  products)&#xD;
&#xD;
          4. History of significant gastrointestinal bleeding in the opinion of the investigator&#xD;
&#xD;
          5. Abnormalities of the cervical, vaginal, or colorectal mucosa, or significant&#xD;
             symptom(s), which in the opinion of the clinician represents a contraindication to&#xD;
             protocol-required biopsies (including but not limited to presence of any unresolved&#xD;
             injury, infectious or inflammatory condition of the local mucosa, and presence of&#xD;
             symptomatic external hemorrhoids). Erythema is not exclusionary.&#xD;
&#xD;
             • Includes any clinically apparent Grade 2 or higher pelvic examination finding&#xD;
             (observed by study staff) at Screening or Enrollment, as per the Female Genital&#xD;
             Grading Table for Use in Microbicide Studies [Addendum 1, Dated November 2007]&#xD;
&#xD;
          6. At screening: participant-reported symptoms and/or clinical or laboratory diagnosis of&#xD;
             active rectal or reproductive tract infection requiring treatment per current CDC&#xD;
             guidelines or symptomatic urinary tract infection (UTI). Infections requiring&#xD;
             treatment include symptomatic bacterial vaginosis, symptomatic vaginal candidiasis,&#xD;
             trichomoniasis, chlamydia (CT), gonorrhea (GC), syphilis, active HSV lesions,&#xD;
             chancroid, pelvic inflammatory disease, genital sores or ulcers, cervicitis, or&#xD;
             symptomatic genital warts requiring treatment (i.e., those that cause undue burden or&#xD;
             discomfort to the participant).&#xD;
&#xD;
             Note:&#xD;
&#xD;
               -  An HSV-1 or HSV-2 seropositive diagnosis with no active lesions is allowed, since&#xD;
                  treatment is not required&#xD;
&#xD;
               -  One re-screening after documented treatment will be allowed&#xD;
&#xD;
          7. Has any of the following laboratory abnormalities at Screening:&#xD;
&#xD;
             Note: Grade is per Version 2.1 of the DAIDS Toxicity Table&#xD;
&#xD;
               1. Hemoglobin Grade 1 or higher&#xD;
&#xD;
               2. Platelet count Grade 1 or higher&#xD;
&#xD;
               3. International Normalized Ratio (INR) Grade 2 or higher&#xD;
&#xD;
               4. White blood cell count Grade 2 or higher&#xD;
&#xD;
               5. Calculated creatinine clearance ≤ 80 mL/minute using the Cockcroft-Gault equation&#xD;
&#xD;
               6. Grade 2 or higher ALT and/or AST (i.e., ≥ 2.5x the site laboratory upper limit of&#xD;
                  normal [ULN])&#xD;
&#xD;
               7. Positive for Hepatitis B surface antigen (HBsAg)&#xD;
&#xD;
               8. Positive for Hepatitis C antibody (HCV Ab)&#xD;
&#xD;
          8. Has any other condition that, in the opinion of the Principal Investigator or&#xD;
             designee, would preclude informed consent, make study participation unsafe, complicate&#xD;
             interpretation of study outcome data, or otherwise interfere with achieving study&#xD;
             objectives&#xD;
&#xD;
        Male sexual partner(s) who meet the following criteria are not eligible for inclusion in&#xD;
        the study:&#xD;
&#xD;
        1) Female partner did not utilize study product&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>Kathleen L Vincent, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas Medical Branch</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>April 20, 2022</last_update_submitted>
  <last_update_submitted_qc>April 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV Prevention</keyword>
  <keyword>Intravaginal Ring</keyword>
  <keyword>Tenofovir Disoproxil Fumarate</keyword>
  <keyword>Emtricitabine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tenofovir</mesh_term>
    <mesh_term>Emtricitabine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form: Screening Consent</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 27, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03255915/ICF_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Enrollment Consent</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 27, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03255915/ICF_004.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Male Partner Consent</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 27, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03255915/ICF_005.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03255915
org study id: 17-0131
secondary id: 1U19AI113048-01
nct id: NCT03255915
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
Participants will have a 28-day pre-ring baseline assessment period (Stage 1) followed by
      randomization to order with 5 participants per study arm. All participants will sequentially
      receive both study products for 28-days with at least a 2-week washout period between
      products. Arm 1 will receive the TDF-FTC pod-IVR for Stage 2 followed by the placebo pod-IVR
      during Stage 3. Arm 2 will receive the placebo pod-IVR for Stage 2 followed by the TDF-FTC
      pod-IVR during Stage 3. During Stages 2 & 3 participants will also complete brief phone
      surveys (<3 min), computer-assisted self-interviews (CASIs), and in-depth interviews (IDIs)
      regarding perceptibility and acceptability. If willing, participants' male sexual partners
      will be invited to complete IDIs as well.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomized order, placebo-controlled, double blind, crossover
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Safety of Vaginal IVRs releasing TDF-FTC by reports of Adverse Events
time frame: From date of enrollment until the date of study completion or date of study withdrawal from any cause, whichever came first, assessed up to 6 months
description: Adverse events Grade 2 or higher as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017, Addendum 1 Female Genital Grading Tables for Use in Microbicide Studies (November 2007), and/or Addendum 3 Rectal Grading Table for Use in Microbicide Studies (Clarification dated May 2012) to this table
measure: Characterization of pharmacokinetics of TDF-FTC released by an IVR - plasma
time frame: From date of enrollment until the date of study completion or date of study withdrawal from any cause, whichever came first, assessed up to 6 months
description: To characterize the local and systemic pharmacokinetics (PK) of TDF-FTC delivered via a pod-IVR, including drug concentration in plasma.
measure: Characterization of pharmacokinetics of TDF-FTC released by an IVR - vagina
time frame: From date of enrollment until the date of study completion or date of study withdrawal from any cause, whichever came first, assessed up to 6 months
description: To characterize the local and systemic pharmacokinetics (PK) of TDF-FTC delivered via a pod-IVR, including drug concentration in vaginal secretions and tissue.
measure: Characterization of pharmacokinetics of TDF-FTC released by an IVR - rectum
time frame: From date of enrollment until the date of study completion or date of study withdrawal from any cause, whichever came first, assessed up to 6 months
description: To characterize the local and systemic pharmacokinetics (PK) of TDF-FTC delivered via a pod-IVR, including drug concentration in rectal secretions.
measure: Acceptability of IVR assessed via computer assisted self interviews
time frame: 28 days after use of each IVR
description: Self-reported attitudes of participants about experience and product attributes via computer assisted self interviews
measure: Acceptability of IVR assessed via in depth interviews
time frame: 28 days after use of each IVR
description: Self-reported attitudes of participants about experience and product attributes via in depth interviews
measure: Adherence
time frame: From date of IVR insertion until the date of IVR removal or date of study withdrawal from any cause, whichever came first, assessed up to 6 months
description: Measured by vaginal fluid PK drug levels, vaginal tissue PK drug and drug metabolite levels, and residual drug levels in returned, used pod-IVRs.
measure: Acceptability of IVR assessed via in depth interviews - male partners
time frame: 28 days after subject use of each IVR
description: Self-reported attitudes of participant's male sexual partner(s) about experience and product attributes via in-depth interviews.
arm group label: Arm 1
arm group type: Experimental
description: Arm 1 will receive the Tenofovir Disoproxil Fumarate (TDF)-Emtricitabine (FTC) pod-IVR for Stage 2 followed by the placebo pod-IVR during Stage 3.
arm group label: Arm 2
arm group type: Experimental
description: Arm 2 will receive the placebo pod-IVR for Stage 2 followed by the Tenofovir Disoproxil Fumarate (TDF)-Emtricitabine (FTC) pod-IVR during Stage 3.
intervention type: Drug
intervention name: Tenofovir Disoproxil Fumarate (TDF)-Emtricitabine (FTC)
description: TDF-FTC pod-IVR designed to deliver TDF at a target rate of 1 mg d-1 and FTC at a target rate of 2 mg d-1.
arm group label: Arm 1
arm group label: Arm 2
intervention type: Other
intervention name: Placebo
description: A placebo pod-IVR containing microcrystalline cellulose pods.
arm group label: Arm 1
arm group label: Arm 2
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kathleen L Vincent, MD
role: Principal Investigator
affiliation: University of Texas
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tenofovir
mesh term: Emtricitabine
sharing ipd: No
provided document: 
provided document: 
provided document: 