<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/NCT01680536</url>
  </required_header>
  <id_info>
    <org_study_id>SSAT 046</org_study_id>
    <nct_id>NCT01680536</nct_id>
  </id_info>
  <brief_title>A Study to Assess Cerebrospinal Fluid INflammatory Markers After Addition of Maraviroc to MONotherapy Darunavir/Ritonavir - The CINAMMON Study</brief_title>
  <acronym>CINAMMON</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>St Stephens Aids Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St Stephens Aids Trust</source>
  <brief_summary>
    <textblock>
      The purpose of the study is to investigate the possible benefits of giving the anti-HIV drug&#xD;
      maraviroc to people who are taking darunavir/ritonavir alone for their HIV treatment. Many&#xD;
      people successfully take only darunavir/ritonavir treatment for their HIV. However, there are&#xD;
      some concerns that this treatment may not reach some areas of the body, such as the brain and&#xD;
      spinal cord (central nervous system or CNS), as effectively as it does the bloodstream.&#xD;
&#xD;
      There is already a large clinical study looking at any differences between 'conventional' HIV&#xD;
      treatment with 3 drugs and single drug treatment with a protease inhibitor, also called PI&#xD;
      monotherapy, such as darunavir/ritonavir. This includes differences in the effects on the&#xD;
      CNS. However, this study will only be finished in 2013.&#xD;
&#xD;
      The investigators know that maraviroc can reach the CNS very effectively. The investigators&#xD;
      in this study will investigate the effect of adding maraviroc to darunavir/ritonavir&#xD;
      monotherapy by looking at levels of inflammation within the fluid that surrounds the CNS,&#xD;
      called cerebrospinal fluid or CSF.&#xD;
&#xD;
      Maraviroc is a licensed drug for the treatment of HIV treatment.. It showed good results in 2&#xD;
      clinical studies when it was taken by people whose HIV virus had developed resistance to&#xD;
      previous HIV treatments.&#xD;
&#xD;
      This study will also investigate safety as well as monitor effectiveness when patients take&#xD;
      maraviroc is taken on top of normal treatment of darunavir/ritonavir monotherapy.&#xD;
&#xD;
      Maraviroc has been shown to be present in the fluid that surrounds the brain in people taking&#xD;
      Maraviroc. It is not known if whether the presence of Maraviroc has any impact on brain&#xD;
      function. Therefore this study will also investigate brain (neurocognitive) functioning with&#xD;
      a computer test and some written tests.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in inflammatory markers in CSF week 12 to week 36</measure>
    <time_frame>36 weeks</time_frame>
    <description>To investigate changes from week 12 to week 36 in inflammatory markers in CSF when maraviroc (150mg qd) is added to stable darunavir/ritonavir (800/100mg qd) monotherapy for 24 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CSF inflammatory markers from baseline to week 12 on darunavir/ritonavir monotherapy (control phase)</measure>
    <time_frame>12 weeks</time_frame>
    <description>To investigate changes in CSF inflammatory markers from baseline to week 12 on darunavir/ritonavir monotherapy (control phase)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Maraviroc, darunavir, ritonavir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single-arm,assessing cerebrospinal fluid inflammatory markers after addition of maraviroc to patients stable on monotherapy darunavir/ritonavir</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>maraviroc</intervention_name>
    <arm_group_label>Maraviroc, darunavir, ritonavir</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patient volunteers who meet all of the following criteria are eligible for this trial:&#xD;
&#xD;
          1. male or female aged between 18 and 65 years&#xD;
&#xD;
          2. has a documented HIV-1 infection&#xD;
&#xD;
          3. has signed the Informed Consent Form voluntarily&#xD;
&#xD;
          4. is willing to comply with the protocol requirements&#xD;
&#xD;
          5. has an HIV-plasma viral load at screening &lt;40 copies/mL (one off retesting for blips&#xD;
             &lt;200 copies/ml is allowed)&#xD;
&#xD;
          6. has a CD4 cell count at Screening &gt;200 cells/mm3&#xD;
&#xD;
          7. has been on a stable darunavir/ritonavir regimen 800/100 once daily alone for at least&#xD;
             12 weeks at Screening, and willing to remain on this;&#xD;
&#xD;
          8. estimated glomerular filtration rate (by MDRD or CG methods) &gt;60 ml/min at screening&#xD;
&#xD;
          9. CCR5 tropic by geno2pheno assay performed at screening&#xD;
&#xD;
         10. if female and of childbearing potential, she is using effective birth control methods&#xD;
             (as agreed by the investigator) and is willing to continue practising these birth&#xD;
             control methods during the trial and for at least 30 days after the end of the trial&#xD;
             (or after last intake of investigational ARVs); Note: Women who are postmenopausal for&#xD;
             least 2 years, women with total hysterectomy, and women who have a tubal ligation are&#xD;
             considered of non-childbearing potential&#xD;
&#xD;
         11. if a heterosexually active male, he is using effective birth control methods and is&#xD;
             willing to continue practising these birth control methods during the trial and until&#xD;
             follow-up visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients meeting 1 or more of the following criteria cannot be selected:&#xD;
&#xD;
          1. is infected with HIV-2&#xD;
&#xD;
          2. is using any concomitant therapy disallowed as per SPC for the study drugs (section&#xD;
             5.2)&#xD;
&#xD;
          3. has a currently active AIDS defining illness (Category C conditions according to the&#xD;
             CDC Classification System for HIV Infection 1993) with the following exceptions (must&#xD;
             be discussed with the Investigator prior to enrolment):Stable cutaneous Kaposi's&#xD;
             Sarcoma (no pulmonary or gastrointestinal involvement other than oral lesions)&#xD;
             unlikely to require systemic therapy during the trial period Note: Primary and&#xD;
             secondary prophylaxis for an AIDS defining illness is allowed&#xD;
&#xD;
          4. has acute viral hepatitis including, but not limited to, A, B, or C&#xD;
&#xD;
          5. has chronic hepatitis B and/or C&#xD;
&#xD;
          6. has received any investigational drug within 30 days prior to the trial drug&#xD;
             administration&#xD;
&#xD;
          7. Clinically significant allergy or hypersensitivity to any trial medication excipients&#xD;
&#xD;
          8. If female, she is pregnant or breastfeeding&#xD;
&#xD;
          9. Screening blood results with any grade 3/4 toxicity according to Division of AIDS&#xD;
             (DAIDS) grading scale, except: asymptomatic grade 3 glucose, amylase or lipid&#xD;
             elevation or asymptomatic grade 4 triglyceride elevation (re-test allowed).&#xD;
&#xD;
         10. Clinical or laboratory evidence of significantly decreased hepatic function or&#xD;
             decompensation: INR &gt; 1.5 or albumin &lt; 30g/L or bilirubin &gt; 2.5 x ULN.&#xD;
&#xD;
         11. Platelets of &lt; 50 based on lumbar puncture examination at baseline.&#xD;
&#xD;
         12. Any condition (including drug/alcohol abuse) or laboratory results which, in the&#xD;
             investigator's opinion, interfere with assessments or completion of the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>St Stephen's AIDS Trust</name>
      <address>
        <city>London</city>
        <zip>SW10 9TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>February 26, 2016</last_update_submitted>
  <last_update_submitted_qc>February 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 29, 2016</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>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/NCT01680536
org study id: SSAT 046
nct id: NCT01680536
lead sponsor: 
The purpose of the study is to investigate the possible benefits of giving the anti-HIV drug
      maraviroc to people who are taking darunavir/ritonavir alone for their HIV treatment. Many
      people successfully take only darunavir/ritonavir treatment for their HIV. However, there are
      some concerns that this treatment may not reach some areas of the body, such as the brain and
      spinal cord (central nervous system or CNS), as effectively as it does the bloodstream.

      There is already a large clinical study looking at any differences between 'conventional' HIV
      treatment with 3 drugs and single drug treatment with a protease inhibitor, also called PI
      monotherapy, such as darunavir/ritonavir. This includes differences in the effects on the
      CNS. However, this study will only be finished in 2013.

      The investigators know that maraviroc can reach the CNS very effectively. The investigators
      in this study will investigate the effect of adding maraviroc to darunavir/ritonavir
      monotherapy by looking at levels of inflammation within the fluid that surrounds the CNS,
      called cerebrospinal fluid or CSF.

      Maraviroc is a licensed drug for the treatment of HIV treatment.. It showed good results in 2
      clinical studies when it was taken by people whose HIV virus had developed resistance to
      previous HIV treatments.

      This study will also investigate safety as well as monitor effectiveness when patients take
      maraviroc is taken on top of normal treatment of darunavir/ritonavir monotherapy.

      Maraviroc has been shown to be present in the fluid that surrounds the brain in people taking
      Maraviroc. It is not known if whether the presence of Maraviroc has any impact on brain
      function. Therefore this study will also investigate brain (neurocognitive) functioning with
      a computer test and some written tests.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in inflammatory markers in CSF week 12 to week 36
time frame: 36 weeks
description: To investigate changes from week 12 to week 36 in inflammatory markers in CSF when maraviroc (150mg qd) is added to stable darunavir/ritonavir (800/100mg qd) monotherapy for 24 weeks
measure: CSF inflammatory markers from baseline to week 12 on darunavir/ritonavir monotherapy (control phase)
time frame: 12 weeks
description: To investigate changes in CSF inflammatory markers from baseline to week 12 on darunavir/ritonavir monotherapy (control phase)
arm group label: Maraviroc, darunavir, ritonavir
arm group type: Experimental
description: Single-arm,assessing cerebrospinal fluid inflammatory markers after addition of maraviroc to patients stable on monotherapy darunavir/ritonavir
intervention type: Drug
intervention name: maraviroc
arm group label: Maraviroc, darunavir, ritonavir
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Maraviroc