<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/NCT01719627</url>
  </required_header>
  <id_info>
    <org_study_id>MARAVIPREX</org_study_id>
    <nct_id>NCT01719627</nct_id>
  </id_info>
  <brief_title>First Study to Evaluate the Capacity of Maraviroc Drug to Protect Against HIV Infection in Samples of Rectal Mucosa From Healthy Volunteers</brief_title>
  <official_title>PILOT STUDY OF PROTECTION AGAINST ex Vivo HIV INFECTION IN RECTAL MUCOSA IN HEALTHY VOLUNTEERS AFTER ADMINISTRATION OF MARAVIROC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of&#xD;
      antiretroviral (ARV) medications before exposure to HIV. This study will assess the potential&#xD;
      of MVC as a &quot;on demand&quot; pre-exposure prophylaxis, within a strategy for the prevention of HIV&#xD;
      infection in men who have sex with men (MSM).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several clinical trials are currently under way evaluating the safety and effectiveness of&#xD;
      ARV-based PrEP for preventing HIV infection. The results of the first efficacy trials of&#xD;
      ARV-based PrEP showed fewer HIV infections among study participants receiving the study drugs&#xD;
      compared to those receiving placebo. Although the results are promising, concerns about&#xD;
      adherence, pharmacokinetics, and toxicity still needs further exploration so new and more&#xD;
      effective preventive pharmacological approaches should be evaluated. This trial will evaluate&#xD;
      the safety, pharmacokinetics and efficacy of ex vivo HIV infection of rectal mucosa by the&#xD;
      CCR5 antagonist drug maraviroc (Selzentry) administered to healthy volunteers. This trial&#xD;
      will last approximately one year. Twenty-one volunteers will receive MVC 300 mg orally in a&#xD;
      single dose. Study visits will occur at enrollment and at days 0, 7, 9, 14 and 16. All study&#xD;
      visits will include a physical examination, blood collection and storage and in the basal&#xD;
      visit and a day 7 or 9 the participants will undergo a colonoscopy. Ex vivo HIV infectivity&#xD;
      in rectal mucosa biopsies and plasma/mucosa MVC levels will be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Infectivity of HIV: p24 production</measure>
    <time_frame>Baseline</time_frame>
    <description>HIV replication will be measured by the determination of HIV p24 production in culture supernatant after 12 days of culture. The HIV production in ex vivo cultures from the basal and after drug administration will be compared and the results will be expressed as a measure of Maraviroc efficacy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infectivity of HIV: p24 production</measure>
    <time_frame>Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9)</time_frame>
    <description>HIV replication will be measured by the determination of HIV p24 production in culture supernatant after 12 days of culture. The HIV production in ex vivo cultures from the basal and after drug administration will be compared and the results will be expressed as a measure of Maraviroc efficacy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maraviroc plasmatic levels</measure>
    <time_frame>Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maraviroc levels in rectal mucosa</measure>
    <time_frame>Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Truvada plasmatic levels</measure>
    <time_frame>Visit 1 (day 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Truvada levels in rectal mucosa</measure>
    <time_frame>Visit 1 (day 7)</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>MVC 300 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MVC 300 mg in unique dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TVD 300/200 QD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TVD 300/200 QD during 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maraviroc 600mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MVC 600mg in unique dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Maraviroc</intervention_name>
    <description>Unique dose of Maraviroc 300mg</description>
    <arm_group_label>MVC 300 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TVD 300/200 QD</intervention_name>
    <description>TVD 300/200 QD during 7 days</description>
    <arm_group_label>TVD 300/200 QD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Maraviroc</intervention_name>
    <description>Unique dose of Maraviroc 600mg</description>
    <arm_group_label>Maraviroc 600mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men who have sex with men (MSM)&#xD;
&#xD;
          2. Age 18 years or above&#xD;
&#xD;
          3. HIV negative at the time of inclusion 4. Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Existence of sexually transmitted infection (STI) or active systemic infection&#xD;
&#xD;
          2. Submit a contraindication to rectal biopsy&#xD;
&#xD;
          3. Take any drugs concomitantly with interactions with the MVC&#xD;
&#xD;
          4. Subject unable to follow protocol&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Germans Trias i Pujol Hospital</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>March 4, 2015</last_update_submitted>
  <last_update_submitted_qc>March 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 5, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV, Maraviroc, PrEP, Ex vivo infection, rectal mucosa.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Maraviroc</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/NCT01719627
org study id: MARAVIPREX
nct id: NCT01719627
lead sponsor: 
has dmc: No
Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of
      antiretroviral (ARV) medications before exposure to HIV. This study will assess the potential
      of MVC as a "on demand" pre-exposure prophylaxis, within a strategy for the prevention of HIV
      infection in men who have sex with men (MSM).
Several clinical trials are currently under way evaluating the safety and effectiveness of
      ARV-based PrEP for preventing HIV infection. The results of the first efficacy trials of
      ARV-based PrEP showed fewer HIV infections among study participants receiving the study drugs
      compared to those receiving placebo. Although the results are promising, concerns about
      adherence, pharmacokinetics, and toxicity still needs further exploration so new and more
      effective preventive pharmacological approaches should be evaluated. This trial will evaluate
      the safety, pharmacokinetics and efficacy of ex vivo HIV infection of rectal mucosa by the
      CCR5 antagonist drug maraviroc (Selzentry) administered to healthy volunteers. This trial
      will last approximately one year. Twenty-one volunteers will receive MVC 300 mg orally in a
      single dose. Study visits will occur at enrollment and at days 0, 7, 9, 14 and 16. All study
      visits will include a physical examination, blood collection and storage and in the basal
      visit and a day 7 or 9 the participants will undergo a colonoscopy. Ex vivo HIV infectivity
      in rectal mucosa biopsies and plasma/mucosa MVC levels will be evaluated.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Infectivity of HIV: p24 production
time frame: Baseline
description: HIV replication will be measured by the determination of HIV p24 production in culture supernatant after 12 days of culture. The HIV production in ex vivo cultures from the basal and after drug administration will be compared and the results will be expressed as a measure of Maraviroc efficacy.
measure: Infectivity of HIV: p24 production
time frame: Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9)
description: HIV replication will be measured by the determination of HIV p24 production in culture supernatant after 12 days of culture. The HIV production in ex vivo cultures from the basal and after drug administration will be compared and the results will be expressed as a measure of Maraviroc efficacy.
measure: Maraviroc plasmatic levels
time frame: Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9)
measure: Maraviroc levels in rectal mucosa
time frame: Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9)
measure: Truvada plasmatic levels
time frame: Visit 1 (day 7)
measure: Truvada levels in rectal mucosa
time frame: Visit 1 (day 7)
arm group label: MVC 300 mg
arm group type: Experimental
description: MVC 300 mg in unique dose
arm group label: TVD 300/200 QD
arm group type: Active Comparator
description: TVD 300/200 QD during 7 days.
arm group label: Maraviroc 600mg
arm group type: Experimental
description: MVC 600mg in unique dose
intervention type: Drug
intervention name: Maraviroc
description: Unique dose of Maraviroc 300mg
arm group label: MVC 300 mg
intervention type: Drug
intervention name: TVD 300/200 QD
description: TVD 300/200 QD during 7 days
arm group label: TVD 300/200 QD
intervention type: Drug
intervention name: Maraviroc
description: Unique dose of Maraviroc 600mg
arm group label: Maraviroc 600mg
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Infections
mesh term: HIV Infections
mesh term: Maraviroc