<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/NCT01701895</url>
  </required_header>
  <id_info>
    <org_study_id>CID 1213 - IRB 12-1550</org_study_id>
    <nct_id>NCT01701895</nct_id>
  </id_info>
  <brief_title>Assessing Short and Long Term Compliance With Caloric Intake in HIV Positive Women Taking Complera</brief_title>
  <official_title>CID 1213 - Assessing Short and Long Term Compliance With Caloric Intake in HIV Positive Women After Switching to Fixed Dose Combination of Rilpivirine, Emtricitabine and Tenofovir DF</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prema Menezes, PhD, PA-C</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to evaluate how easy it is for female HIV- positive&#xD;
      subjects taking Complera to comply with the dietary requirement using a food diary in the&#xD;
      short term (4 weeks) and long term (24 weeks and 48 weeks) and to determine association&#xD;
      between calorie intake and virologic suppression. A secondary goal of the study is to&#xD;
      evaluate subjects' attitudes towards contraception.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Compliance with meal instruction</measure>
    <time_frame>once per month over 48 weeks</time_frame>
    <description>Compliance will be assessed monthly by a subject-completed food diary and phone assessments.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of subjects' attitudes toward contraception</measure>
    <time_frame>up to 48 weeks</time_frame>
    <description>Subjects are questioned about their contraceptive choices.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between caloric intake and virologic suppression</measure>
    <time_frame>up to 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of medication adherence</measure>
    <time_frame>up to 48 weeks</time_frame>
    <description>Subjects will self-report adherence on a visual analog scale.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Measurement of change in fasting lipids</measure>
    <time_frame>Week 48</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Measurement of change in fasting lipids</measure>
    <time_frame>Baseline</time_frame>
  </other_outcome>
  <enrollment type="Actual">33</enrollment>
  <condition>HIV-1 Infection</condition>
  <eligibility>
    <study_pop>
      <textblock>
        HIV positive females ≥ 18 years of age who are currently on Complera with suppressed viral&#xD;
        load (VL) defined as having VL &lt;50 copies/ml in the 6 months prior to study entry and no&#xD;
        known resistance to FTC, TDF, or rilpivirine. Subjects may or may not be of child bearing&#xD;
        potential.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. HIV-1 infection documented by HIV serology or detectable viral load at any point prior&#xD;
             to study entry or other documentation confirming HIV infection. If no documentation is&#xD;
             available to confirm HIV infection, a rapid test may be performed to document HIV&#xD;
             infection.&#xD;
&#xD;
          2. HIV+ female ≥18 years old and obtaining care at UNC Health Care Infectious Diseases&#xD;
             Clinic, Wake County Human Services Clinic, or Durham County Early Intervention Clinic.&#xD;
             Patients receiving care at other clinics may be entered with approval of the study&#xD;
             team.&#xD;
&#xD;
          3. HIV viral load (VL) &lt; 50 copies/ml as measured by any FDA-approved test for&#xD;
             quantifying HIV-1 RNA during the six months prior to study entry (PSE). The timing of&#xD;
             the viral load may be longer than 6 months depending on the schedule of the last&#xD;
             clinic visit attended by the subject. The intent of the protocol was to assess viral&#xD;
             load status at the previous clinic visit which may occur at an interval longer than&#xD;
             six months due to the scheduling constraints of the UNC Infectious Diseases clinic.&#xD;
             Viral loads drawn &gt; than 6 months (but not &gt; 8 months) prior to the study entry visit&#xD;
             are acceptable. A single &quot;blip&quot; of &gt; 50 and &lt; 200 copies/ml is permissible provided&#xD;
             the most recent VL is &lt;50 copies/ml.&#xD;
&#xD;
          4. No documented resistance to FTC, TDF or rilpivirine. Note: genotyping will not be&#xD;
             performed on study. Subjects with no historical genotype will be considered to have no&#xD;
             documented resistance.&#xD;
&#xD;
          5. Able and willing to provide informed consent.&#xD;
&#xD;
          6. In the opinion of the investigator, able to comply with study medication and&#xD;
             procedures, including ability to complete food diary.&#xD;
&#xD;
          7. Willing to receive monthly phone calls.&#xD;
&#xD;
          8. Agreement between ID clinic provider and study team that clinical monitoring and care&#xD;
             of patient will reside with the ID clinic provider. The study responsibility is&#xD;
             limited to providing 48 weeks of Complera.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any condition which, in the opinion of the investigator, would be likely to interfere&#xD;
             with ability to take the study medications appropriately and comply with the study&#xD;
             protocol.&#xD;
&#xD;
          2. Current active illness requiring systemic treatment and/or hospitalization until the&#xD;
             individual completes therapy or, in the opinion of the investigator, is clinically&#xD;
             stable on therapy for at least 7 days prior to study entry.&#xD;
&#xD;
          3. Acute viral hepatitis.&#xD;
&#xD;
          4. Known allergy/hypersensitivity to components of the study drugs or their formulations.&#xD;
&#xD;
          5. Current or expected use of medication on the prohibited medication list.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Prema Menezes, PhD, PA-C</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599-7215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.sf-36.org/tools/sf36.shtml</url>
    <description>SF-36® Health Survey Update by John E. Ware, Jr., Ph.D.</description>
  </link>
  <reference>
    <citation>Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. January 10, 2011; 1-166. Available at http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed 20Jun2011</citation>
  </reference>
  <reference>
    <citation>Bartlett JA, Fath MJ, Demasi R, Hermes A, Quinn J, Mondou E, Rousseau F. An updated systematic overview of triple combination therapy in antiretroviral-naive HIV-infected adults. AIDS. 2006 Oct 24;20(16):2051-64. doi: 10.1097/01.aids.0000247578.08449.ff.</citation>
    <PMID>17053351</PMID>
  </reference>
  <reference>
    <citation>El-Ibiary SY, Cocohoba JM. Effects of HIV antiretrovirals on the pharmacokinetics of hormonal contraceptives. Eur J Contracept Reprod Health Care. 2008 Jun;13(2):123-32. doi: 10.1080/13625180701829952.</citation>
    <PMID>18465473</PMID>
  </reference>
  <reference>
    <citation>Sekar V, Ryan R, Schaible D, et al Pharmacokinetic profile of darunavir co-administered with low-dose ritonavir in treatment-experienced women and men with HIV infection: 4-week analysis in a substudy of the GRACE (Gender, Race, And Clinical Experience) study. 9th International Workshop on Clinical Pharmacology of HIV Therapy. April 7-9, 2008. New Orleans. Abstract O16</citation>
  </reference>
  <reference>
    <citation>Umeh O, Currier J, Park JG et al. Sex differences in lopinavir/ritonavir soft gel capsule pharmacokinetics among HIV infected females and males. Conference on Retroviruses and Opportunistic Infections. February 3-6,2008, Boston, Massachusetts Abstract 786</citation>
  </reference>
  <reference>
    <citation>Ford N, Lee J, Andrieux-Meyer I, Calmy A. Safety, efficacy, and pharmacokinetics of rilpivirine: systematic review with an emphasis on resource-limited settings. HIV AIDS (Auckl). 2011;3:35-44. doi: 10.2147/HIV.S14559. Epub 2011 Apr 28.</citation>
    <PMID>22096405</PMID>
  </reference>
  <reference>
    <citation>Cohen C, Molina JM, Cahn P et al, Pooled 48 week efficacy and safety results from ECHO and THRIVE, two double blind randomized Phase III trials comparing TMC 278 vs. efavirenz in treatment naïve HIV-1 infected patients. HIV DART 2010 Abstract 45</citation>
  </reference>
  <reference>
    <citation>Hodder SL, Mounzer K, Dejesus E, Ebrahimi R, Grimm K, Esker S, Ecker J, Farajallah A, Flaherty JF; AI266073 Study Group. Patient-reported outcomes in virologically suppressed, HIV-1-Infected subjects after switching to a simplified, single-tablet regimen of efavirenz, emtricitabine, and tenofovir DF. AIDS Patient Care STDS. 2010 Feb;24(2):87-96. doi: 10.1089/apc.2009.0259.</citation>
    <PMID>20156091</PMID>
  </reference>
  <reference>
    <citation>Walsh JC, Mandalia S, Gazzard BG. Responses to a 1 month self-report on adherence to antiretroviral therapy are consistent with electronic data and virological treatment outcome. AIDS. 2002 Jan 25;16(2):269-77. doi: 10.1097/00002030-200201250-00017.</citation>
    <PMID>11807312</PMID>
  </reference>
  <reference>
    <citation>Giordano TP, Guzman D, Clark R, Charlebois ED, Bangsberg DR. Measuring adherence to antiretroviral therapy in a diverse population using a visual analogue scale. HIV Clin Trials. 2004 Mar-Apr;5(2):74-9. doi: 10.1310/JFXH-G3X2-EYM6-D6UG.</citation>
    <PMID>15116282</PMID>
  </reference>
  <reference>
    <citation>Prins M, Meyer L, Hessol NA. Sex and the course of HIV infection in the pre- and highly active antiretroviral therapy eras. AIDS. 2005 Mar 4;19(4):357-70. doi: 10.1097/01.aids.0000161765.75663.27.</citation>
    <PMID>15750389</PMID>
  </reference>
  <reference>
    <citation>Justice AC, Holmes W, Gifford AL, Rabeneck L, Zackin R, Sinclair G, Weissman S, Neidig J, Marcus C, Chesney M, Cohn SE, Wu AW; Adult AIDS Clinical Trials Unit Outcomes Committee. Development and validation of a self-completed HIV symptom index. J Clin Epidemiol. 2001 Dec;54 Suppl 1:S77-90. doi: 10.1016/s0895-4356(01)00449-8.</citation>
    <PMID>11750213</PMID>
  </reference>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>November 30, 2015</last_update_submitted>
  <last_update_submitted_qc>November 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of North Carolina, Chapel Hill</investigator_affiliation>
    <investigator_full_name>Prema Menezes, PhD, PA-C</investigator_full_name>
    <investigator_title>Clinical Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Complera</keyword>
  <keyword>short-term</keyword>
  <keyword>long-term</keyword>
  <keyword>compliance</keyword>
  <keyword>caloric</keyword>
  <keyword>intake</keyword>
  <keyword>HIV</keyword>
  <keyword>positive</keyword>
  <keyword>women</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Seropositivity</mesh_term>
  </condition_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/NCT01701895
org study id: CID 1213 - IRB 12-1550
nct id: NCT01701895
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this research study is to evaluate how easy it is for female HIV- positive
      subjects taking Complera to comply with the dietary requirement using a food diary in the
      short term (4 weeks) and long term (24 weeks and 48 weeks) and to determine association
      between calorie intake and virologic suppression. A secondary goal of the study is to
      evaluate subjects' attitudes towards contraception.
observational model: Case-Only
time perspective: Prospective
measure: Compliance with meal instruction
time frame: once per month over 48 weeks
description: Compliance will be assessed monthly by a subject-completed food diary and phone assessments.
measure: Evaluation of subjects' attitudes toward contraception
time frame: up to 48 weeks
description: Subjects are questioned about their contraceptive choices.
measure: Association between caloric intake and virologic suppression
time frame: up to 48 weeks
measure: Assessment of medication adherence
time frame: up to 48 weeks
description: Subjects will self-report adherence on a visual analog scale.
measure: Measurement of change in fasting lipids
time frame: Week 48
measure: Measurement of change in fasting lipids
time frame: Baseline
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Prema Menezes, PhD, PA-C
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
url: http://www.sf-36.org/tools/sf36.shtml
description: SF-36® Health Survey Update by John E. Ware, Jr., Ph.D.
citation: Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. January 10, 2011; 1-166. Available at http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed 20Jun2011
citation: Bartlett JA, Fath MJ, Demasi R, Hermes A, Quinn J, Mondou E, Rousseau F. An updated systematic overview of triple combination therapy in antiretroviral-naive HIV-infected adults. AIDS. 2006 Oct 24;20(16):2051-64. doi: 10.1097/01.aids.0000247578.08449.ff.
PMID: 17053351
citation: El-Ibiary SY, Cocohoba JM. Effects of HIV antiretrovirals on the pharmacokinetics of hormonal contraceptives. Eur J Contracept Reprod Health Care. 2008 Jun;13(2):123-32. doi: 10.1080/13625180701829952.
PMID: 18465473
citation: Sekar V, Ryan R, Schaible D, et al Pharmacokinetic profile of darunavir co-administered with low-dose ritonavir in treatment-experienced women and men with HIV infection: 4-week analysis in a substudy of the GRACE (Gender, Race, And Clinical Experience) study. 9th International Workshop on Clinical Pharmacology of HIV Therapy. April 7-9, 2008. New Orleans. Abstract O16
citation: Umeh O, Currier J, Park JG et al. Sex differences in lopinavir/ritonavir soft gel capsule pharmacokinetics among HIV infected females and males. Conference on Retroviruses and Opportunistic Infections. February 3-6,2008, Boston, Massachusetts Abstract 786
citation: Ford N, Lee J, Andrieux-Meyer I, Calmy A. Safety, efficacy, and pharmacokinetics of rilpivirine: systematic review with an emphasis on resource-limited settings. HIV AIDS (Auckl). 2011;3:35-44. doi: 10.2147/HIV.S14559. Epub 2011 Apr 28.
PMID: 22096405
citation: Cohen C, Molina JM, Cahn P et al, Pooled 48 week efficacy and safety results from ECHO and THRIVE, two double blind randomized Phase III trials comparing TMC 278 vs. efavirenz in treatment naïve HIV-1 infected patients. HIV DART 2010 Abstract 45
citation: Hodder SL, Mounzer K, Dejesus E, Ebrahimi R, Grimm K, Esker S, Ecker J, Farajallah A, Flaherty JF; AI266073 Study Group. Patient-reported outcomes in virologically suppressed, HIV-1-Infected subjects after switching to a simplified, single-tablet regimen of efavirenz, emtricitabine, and tenofovir DF. AIDS Patient Care STDS. 2010 Feb;24(2):87-96. doi: 10.1089/apc.2009.0259.
PMID: 20156091
citation: Walsh JC, Mandalia S, Gazzard BG. Responses to a 1 month self-report on adherence to antiretroviral therapy are consistent with electronic data and virological treatment outcome. AIDS. 2002 Jan 25;16(2):269-77. doi: 10.1097/00002030-200201250-00017.
PMID: 11807312
citation: Giordano TP, Guzman D, Clark R, Charlebois ED, Bangsberg DR. Measuring adherence to antiretroviral therapy in a diverse population using a visual analogue scale. HIV Clin Trials. 2004 Mar-Apr;5(2):74-9. doi: 10.1310/JFXH-G3X2-EYM6-D6UG.
PMID: 15116282
citation: Prins M, Meyer L, Hessol NA. Sex and the course of HIV infection in the pre- and highly active antiretroviral therapy eras. AIDS. 2005 Mar 4;19(4):357-70. doi: 10.1097/01.aids.0000161765.75663.27.
PMID: 15750389
citation: Justice AC, Holmes W, Gifford AL, Rabeneck L, Zackin R, Sinclair G, Weissman S, Neidig J, Marcus C, Chesney M, Cohn SE, Wu AW; Adult AIDS Clinical Trials Unit Outcomes Committee. Development and validation of a self-completed HIV symptom index. J Clin Epidemiol. 2001 Dec;54 Suppl 1:S77-90. doi: 10.1016/s0895-4356(01)00449-8.
PMID: 11750213
responsible party type: Sponsor-Investigator
investigator affiliation: University of North Carolina, Chapel Hill
investigator full name: Prema Menezes, PhD, PA-C
investigator title: Clinical Assistant Professor of Medicine
mesh term: HIV Seropositivity