<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/NCT02227277</url>
  </required_header>
  <id_info>
    <org_study_id>ES11990</org_study_id>
    <secondary_id>1U01AI110434</secondary_id>
    <nct_id>NCT02227277</nct_id>
  </id_info>
  <brief_title>Reducing Proviral HIV DNA With Interferon-a</brief_title>
  <acronym>BEAT-HIV</acronym>
  <official_title>Towards Eradication: Reducing Proviral HIV DNA With Interferon-a Immunotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Wistar Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <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>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The Wistar Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if treatment with pegylated interferon alpha 2b&#xD;
      (peg-IFN-α2b) will reduce the amount of integrated HIV DNA in peripheral blood cells and&#xD;
      tissues of individuals with chronic HIV infection receiving antiretroviral treatment (ART).&#xD;
&#xD;
      A reduction and/or clearance of the latent viral reservoir (i.e.: virus that remains dormant&#xD;
      in HIV-infected subjects receiving suppressive treatment ) is considered essential for HIV&#xD;
      eradication.&#xD;
&#xD;
      By measuring the changes in integrated proviral HIV DNA, which is considered a surrogate&#xD;
      measure of the latent reservoir, the investigators will establish if peg-IFN-α2b treatment&#xD;
      should be considered as a component of future viral eradication strategies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our long-term goal is to evaluate the effect of pegylated interferon (peg-IFN) α as an&#xD;
      anti-HIV reservoir immunotherapy that could potentiate eradication strategies against HIV.&#xD;
&#xD;
      The present study is a 3-arm randomized clinical trial (RCT). The aim of this study is to&#xD;
      determine whether a 20-week treatment course with 1μg/kg/week of pegylated interferon alpha 2&#xD;
      b (peg-IFN-α2b) will reduce the levels of HIV-1 proviral DNA levels in circulating PBMC and&#xD;
      mucosa-associated lymphoid tissue (MALT) in HIV-infected individuals receiving long-term ART.&#xD;
&#xD;
      In addition, we will study if a 4-week interruption of ART is necessary to observe any change&#xD;
      in proviral DNA levels.&#xD;
&#xD;
      In our previous study (NCT00594880) with a different form of Interferon alpha (peg-IFN-α2a),&#xD;
      we observed a reduction in proviral DNA in peripheral blood cells in 50% of the patients.&#xD;
      However, we did not measure the levels in MALT, and we could not determine whether or not an&#xD;
      interruption of ART was necessary. The present study will address these questions.&#xD;
&#xD;
      We will also seek to determine the biological mechanisms (such as an increase in Natural&#xD;
      Killer cell cytotoxicity) that mediate the antiviral effects of peg-IFN-α.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 11, 2015</start_date>
  <completion_date type="Anticipated">July 24, 2018</completion_date>
  <primary_completion_date type="Actual">February 7, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Integrated HIV proviral DNA</measure>
    <time_frame>24 weeks</time_frame>
    <description>The study endpoint is the change in the number of copies of integrated HIV DNA/10^6 CD4+ T cells (as assessed by Alu-HIV gag PCR) between baseline and 20 weeks of peg-IFNα-2b administration (study week 24).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Integrated proviral DNA in tissue</measure>
    <time_frame>24 weeks</time_frame>
    <description>Copies of HIV DNA per tissue derived 2x106 isolated lymphocytes (GALT biopsy)-recovered lymphocyte (week 0 vs. week 24)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CD4 count</measure>
    <time_frame>24 weeks</time_frame>
    <description>compare the frequency of occurrence of CD4 count &lt; 350 (trigger to resume ART during ART interruption in arm 1) between study arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral load</measure>
    <time_frame>24 weeks</time_frame>
    <description>compare the frequency of occurrence of VL &gt; 50 copies/ml (trigger for resuming ART during ART interruption in arm 1) between arms</description>
  </secondary_outcome>
  <other_outcome>
    <measure>SUSAR (serious unexpected suspected adverse reactions)</measure>
    <time_frame>24 weeks</time_frame>
    <description>compare occurrence of SUSAR between arms</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>HIV</condition>
  <condition>HIV/AIDS</condition>
  <arm_group>
    <arm_group_label>Conditional 12-week ART interruption</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>18 participants will receive peg-IFN-α2b (1 μg/kg/week) for 20 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuous ART</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>18 participants will receive peg-IFN-α2b (1 μg/kg/week) for 20 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control with continuous ART</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>18 participants will continue their current ART regimens and be observed for 20 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Peg-IFN-α2b</intervention_name>
    <description>Arm 1: At week 4 of the treatment, ART will be interrupted. Viral load will be monitored every 2 weeks. ART will be resumed at the earlier of a) a single measurement of VL &gt; 50 c/ml or b) 16 weeks of treatment, and subjects will be observed for the remaining 4 weeks (total of 20 weeks on treatment).&#xD;
Arm 2: In week 4, participants in arm 2 will add peg-IFN-α-2b to their ART regimen for a period of 20 weeks.</description>
    <arm_group_label>Conditional 12-week ART interruption</arm_group_label>
    <arm_group_label>Continuous ART</arm_group_label>
    <other_name>Pegintron</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  18-65 years of age&#xD;
&#xD;
          -  Body weight ≥ 125 and ≤ 300 lbs&#xD;
&#xD;
          -  Confirmed diagnosis of HIV-1 infection by western blot or by a documented HIV-1 viral&#xD;
             load at screening.&#xD;
&#xD;
          -  Currently receiving ART and on ART for ≥ 1 year&#xD;
&#xD;
          -  VL &lt; 50 copies/ml for ≥ 1 year, with at least 2 measurements in the previous year. 1&#xD;
             viral &quot;blip&quot; with VL&lt; 400 copies/ml allowed if 1 or more measurements of &lt; 50&#xD;
             copies/ml are available no more than 3 months before and 3 months after the &quot;blip&quot;&#xD;
             without change in ART&#xD;
&#xD;
          -  HIV viral load of &lt;50 copies/ml at screening.&#xD;
&#xD;
          -  CD4 &gt;450 cells/µL at screening.&#xD;
&#xD;
          -  a negative electrocardiogram (EKG, see section 7.4) for: a) men &gt;45 years or women &gt;&#xD;
             55 years of age b) younger subjects of either sex with two risk factors for coronary&#xD;
             artery disease [smoking, hypertension (BP &gt;140/90 or on antihypertensive medications),&#xD;
             low HDL (&lt;40 mg/dl), family history of premature CHD (&lt;55 yrs males/&lt;65 females, c)&#xD;
             subjects with a Framingham score &gt; 15% (men) or 10% (women)&#xD;
&#xD;
        Exclusion criteria Current or prior medications&#xD;
&#xD;
          -  Confirmed clinical history of developing resistance to ART regimens that resulted in&#xD;
             treatment changes&#xD;
&#xD;
          -  Receiving didanosine as part of the participant's ART regimen at the time of screening&#xD;
&#xD;
          -  Ongoing treatment with Isoniazid, Pyrazinamide, Rifabutin, Rifampicin, Ganciclovir,&#xD;
             Valgancyclovir, Oxymetholone, Thalidomide or Theophylline.&#xD;
&#xD;
          -  Ongoing treatment with anticoagulants&#xD;
&#xD;
          -  Use of any investigational drug within 30 days prior to screening&#xD;
&#xD;
          -  History or current use of immunomodulatory therapy for over 2 weeks during the 6&#xD;
             months prior to enrollment, including, but not limited to: IFN-α or γ (recombinant or&#xD;
             pegylated), systemic corticosteroids (inhaled steroids allowed at the discretion of&#xD;
             the Investigator); systemic cancer chemotherapy/irradiation; cyclosporin; tacrolimus&#xD;
             (FK-506); OKT-3; any Interleukin, including IL-2; cyclophosphamide; methotrexate; IVIG&#xD;
             (gamma globulin); G/M-CSF; hydroxyurea; thalidomide; pentoxifylline; thymopentin;&#xD;
             thymosin; dithiocarbonate; polyribonucloside.&#xD;
&#xD;
          -  History of adverse or allergic reactions to any type-1 interferon (e.g. IFN-α2a,&#xD;
             IFN-α2b, IFN-β)&#xD;
&#xD;
        Current or prior clinical conditions&#xD;
&#xD;
          -  History of severe depression, including history of suicidal ideation or attempt, or&#xD;
             ongoing moderate depression determined by PHQ-9 at screening&#xD;
&#xD;
          -  Type I diabetes mellitus, or type II diabetes mellitus that is not controlled with&#xD;
             oral agents and/or insulin (i.e.: subjects with a history of diabetes mellitus and&#xD;
             HA1C of &gt; 9 in the last 3 months or at screening).&#xD;
&#xD;
          -  Prior diagnosis of multiple sclerosis or other neurodegenerative disorders&#xD;
&#xD;
          -  Significant co-existing lab abnormalities including: a) Anemia (Hgb &lt;9.1 mg/dl men,&#xD;
             &lt;8.9 mg/dl women); b) Ongoing coagulopathy/clotting disorder; c) WBC &lt;2000 cells/µl;&#xD;
             d) Absolute neutrophil count (ANC) &lt;1200 cells/ µl; e) Platelet count &lt;60,000 cells/&#xD;
             µl; f) Liver disease (AST/ALT &gt; 2.5x OR total bilirubin &gt; 1.5x upper limits of norm&#xD;
             (ULN), (if not receiving atazanavir) or direct bilirubin &gt; 0.6 (if receiving&#xD;
             atazanavir); g) Pancreatic disease (amylase : &gt; 1.5 ULN, lipase &gt; 1.5 ULN,&#xD;
             triglycerides &gt; 750 mg/dl); h Renal disease (creatinine &gt; 2x ULN or creatinine&#xD;
             clearance &lt;60mg/dl (by Crockoff-Gault)&#xD;
&#xD;
          -  Chronic HCV infection (HCV viremia), or HBV Ag positive and/ or HBV viremia (Notice:&#xD;
             subjects with prior HCV infection with a documented sustained virologic response with&#xD;
             treatment finishing &gt;1 year prior to screening are eligible for enrollment).&#xD;
&#xD;
          -  Liver cirrhosis or hepatic decompensation with Child Pugh score &gt; 6&#xD;
&#xD;
          -  History of major organ transplantation with an existing functional graft.&#xD;
&#xD;
          -  Evidence of OI or other active infectious diseases or active malignancies&#xD;
&#xD;
          -  Active Autoimmune diseases, including autoimmune hepatitis&#xD;
&#xD;
          -  History of retinopathy or clinically significant ophthalmologic disease on eye exam&#xD;
             performed within 60 days prior to initiation of IFN&#xD;
&#xD;
          -  Significant EKG abnormalities (see section 7.4)&#xD;
&#xD;
        Other conditions&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  A planned pregnancy during study participation&#xD;
&#xD;
          -  Lack of one of three strategies for birth control during study participation: a)&#xD;
             Barrier contraceptives (male or female condoms with or without a spermicidal agent,&#xD;
             diaphragm or cervical cap with spermicidal); b) Non-hormonal Intrauterine Devices&#xD;
             (IUDs); c) Hormonal-based, including hormonal IUDs, in combination with barrier&#xD;
             contraceptives.&#xD;
&#xD;
          -  Body weight &lt; 125 lbs or &gt; 300 lbs&#xD;
&#xD;
          -  Other conditions, such as active drug/alcohol abuse or dependence,that in the opinion&#xD;
             of the Investigator would interfere with study compliance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luis J. Montaner, DVM, DPhil</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Wistar Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn-Presbyterian Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jonathan Lax Center at Philadelphia FIGHT</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.wistar.org/our-science/scientists/luis-montaner-dvm-dphil</url>
    <description>Montaner Lab at the Wistar Institute</description>
  </link>
  <link>
    <url>http://www.pennmedicine.org/infectious/presby/</url>
    <description>Infectious Disease Services at Penn-Presby</description>
  </link>
  <link>
    <url>https://fight.org</url>
    <description>Philadelphia FIGHT</description>
  </link>
  <reference>
    <citation>Azzoni L, Foulkes AS, Papasavvas E, Mexas AM, Lynn KM, Mounzer K, Tebas P, Jacobson JM, Frank I, Busch MP, Deeks SG, Carrington M, O'Doherty U, Kostman J, Montaner LJ. Pegylated Interferon alfa-2a monotherapy results in suppression of HIV type 1 replication and decreased cell-associated HIV DNA integration. J Infect Dis. 2013 Jan 15;207(2):213-22. doi: 10.1093/infdis/jis663. Epub 2012 Oct 26.</citation>
    <PMID>23105144</PMID>
  </reference>
  <reference>
    <citation>Mexas AM, Graf EH, Pace MJ, Yu JJ, Papasavvas E, Azzoni L, Busch MP, Di Mascio M, Foulkes AS, Migueles SA, Montaner LJ, O'Doherty U. Concurrent measures of total and integrated HIV DNA monitor reservoirs and ongoing replication in eradication trials. AIDS. 2012 Nov 28;26(18):2295-306. doi: 10.1097/QAD.0b013e32835a5c2f.</citation>
    <PMID>23014521</PMID>
  </reference>
  <reference>
    <citation>Sun H, Buzon MJ, Shaw A, Berg RK, Yu XG, Ferrando-Martinez S, Leal M, Ruiz-Mateos E, Lichterfeld M. Hepatitis C therapy with interferon-alpha and ribavirin reduces CD4 T-cell-associated HIV-1 DNA in HIV-1/hepatitis C virus-coinfected patients. J Infect Dis. 2014 May 1;209(9):1315-20. doi: 10.1093/infdis/jit628. Epub 2013 Nov 25.</citation>
    <PMID>24277743</PMID>
  </reference>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>April 3, 2018</last_update_submitted>
  <last_update_submitted_qc>April 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Wistar Institute</investigator_affiliation>
    <investigator_full_name>Luis Montaner</investigator_full_name>
    <investigator_title>Professor, Immunology Program and Director, HIV-1 Immunopathogenesis Laboratory</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>HIV-1</keyword>
  <keyword>Pegintron</keyword>
  <keyword>Peg-IFN-α2b</keyword>
  <keyword>Viral suppression</keyword>
  <keyword>ART cessation</keyword>
  <keyword>Immune function</keyword>
  <keyword>Innate immunity</keyword>
  <keyword>Toxicity</keyword>
  <keyword>Immune-based therapy</keyword>
  <keyword>Treatment interruption</keyword>
  <keyword>HIV Cure</keyword>
  <keyword>HIV Eradication</keyword>
  <keyword>BEAT-HIV</keyword>
  <keyword>HIV Cure Trial</keyword>
  <keyword>Cure Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</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>Peginterferon alfa-2b</mesh_term>
    <mesh_term>Interferon alpha-2</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/NCT02227277
org study id: ES11990
secondary id: 1U01AI110434
nct id: NCT02227277
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine if treatment with pegylated interferon alpha 2b
      (peg-IFN-α2b) will reduce the amount of integrated HIV DNA in peripheral blood cells and
      tissues of individuals with chronic HIV infection receiving antiretroviral treatment (ART).

      A reduction and/or clearance of the latent viral reservoir (i.e.: virus that remains dormant
      in HIV-infected subjects receiving suppressive treatment ) is considered essential for HIV
      eradication.

      By measuring the changes in integrated proviral HIV DNA, which is considered a surrogate
      measure of the latent reservoir, the investigators will establish if peg-IFN-α2b treatment
      should be considered as a component of future viral eradication strategies.
Our long-term goal is to evaluate the effect of pegylated interferon (peg-IFN) α as an
      anti-HIV reservoir immunotherapy that could potentiate eradication strategies against HIV.

      The present study is a 3-arm randomized clinical trial (RCT). The aim of this study is to
      determine whether a 20-week treatment course with 1μg/kg/week of pegylated interferon alpha 2
      b (peg-IFN-α2b) will reduce the levels of HIV-1 proviral DNA levels in circulating PBMC and
      mucosa-associated lymphoid tissue (MALT) in HIV-infected individuals receiving long-term ART.

      In addition, we will study if a 4-week interruption of ART is necessary to observe any change
      in proviral DNA levels.

      In our previous study (NCT00594880) with a different form of Interferon alpha (peg-IFN-α2a),
      we observed a reduction in proviral DNA in peripheral blood cells in 50% of the patients.
      However, we did not measure the levels in MALT, and we could not determine whether or not an
      interruption of ART was necessary. The present study will address these questions.

      We will also seek to determine the biological mechanisms (such as an increase in Natural
      Killer cell cytotoxicity) that mediate the antiviral effects of peg-IFN-α.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Integrated HIV proviral DNA
time frame: 24 weeks
description: The study endpoint is the change in the number of copies of integrated HIV DNA/10^6 CD4+ T cells (as assessed by Alu-HIV gag PCR) between baseline and 20 weeks of peg-IFNα-2b administration (study week 24).
measure: Integrated proviral DNA in tissue
time frame: 24 weeks
description: Copies of HIV DNA per tissue derived 2x106 isolated lymphocytes (GALT biopsy)-recovered lymphocyte (week 0 vs. week 24)
measure: CD4 count
time frame: 24 weeks
description: compare the frequency of occurrence of CD4 count < 350 (trigger to resume ART during ART interruption in arm 1) between study arms
measure: Viral load
time frame: 24 weeks
description: compare the frequency of occurrence of VL > 50 copies/ml (trigger for resuming ART during ART interruption in arm 1) between arms
measure: SUSAR (serious unexpected suspected adverse reactions)
time frame: 24 weeks
description: compare occurrence of SUSAR between arms
arm group label: Conditional 12-week ART interruption
arm group type: Experimental
description: 18 participants will receive peg-IFN-α2b (1 μg/kg/week) for 20 weeks.
arm group label: Continuous ART
arm group type: Experimental
description: 18 participants will receive peg-IFN-α2b (1 μg/kg/week) for 20 weeks.
arm group label: Control with continuous ART
arm group type: No Intervention
description: 18 participants will continue their current ART regimens and be observed for 20 weeks.
intervention type: Drug
intervention name: Peg-IFN-α2b
description: Arm 1: At week 4 of the treatment, ART will be interrupted. Viral load will be monitored every 2 weeks. ART will be resumed at the earlier of a) a single measurement of VL > 50 c/ml or b) 16 weeks of treatment, and subjects will be observed for the remaining 4 weeks (total of 20 weeks on treatment).
Arm 2: In week 4, participants in arm 2 will add peg-IFN-α-2b to their ART regimen for a period of 20 weeks.
arm group label: Conditional 12-week ART interruption
arm group label: Continuous ART
other name: Pegintron
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Luis J. Montaner, DVM, DPhil
role: Principal Investigator
affiliation: The Wistar Institute
facility: 
facility: 
facility: 
country: United States
url: http://www.wistar.org/our-science/scientists/luis-montaner-dvm-dphil
description: Montaner Lab at the Wistar Institute
url: http://www.pennmedicine.org/infectious/presby/
description: Infectious Disease Services at Penn-Presby
url: https://fight.org
description: Philadelphia FIGHT
citation: Azzoni L, Foulkes AS, Papasavvas E, Mexas AM, Lynn KM, Mounzer K, Tebas P, Jacobson JM, Frank I, Busch MP, Deeks SG, Carrington M, O'Doherty U, Kostman J, Montaner LJ. Pegylated Interferon alfa-2a monotherapy results in suppression of HIV type 1 replication and decreased cell-associated HIV DNA integration. J Infect Dis. 2013 Jan 15;207(2):213-22. doi: 10.1093/infdis/jis663. Epub 2012 Oct 26.
PMID: 23105144
citation: Mexas AM, Graf EH, Pace MJ, Yu JJ, Papasavvas E, Azzoni L, Busch MP, Di Mascio M, Foulkes AS, Migueles SA, Montaner LJ, O'Doherty U. Concurrent measures of total and integrated HIV DNA monitor reservoirs and ongoing replication in eradication trials. AIDS. 2012 Nov 28;26(18):2295-306. doi: 10.1097/QAD.0b013e32835a5c2f.
PMID: 23014521
citation: Sun H, Buzon MJ, Shaw A, Berg RK, Yu XG, Ferrando-Martinez S, Leal M, Ruiz-Mateos E, Lichterfeld M. Hepatitis C therapy with interferon-alpha and ribavirin reduces CD4 T-cell-associated HIV-1 DNA in HIV-1/hepatitis C virus-coinfected patients. J Infect Dis. 2014 May 1;209(9):1315-20. doi: 10.1093/infdis/jit628. Epub 2013 Nov 25.
PMID: 24277743
responsible party type: Principal Investigator
investigator affiliation: The Wistar Institute
investigator full name: Luis Montaner
investigator title: Professor, Immunology Program and Director, HIV-1 Immunopathogenesis Laboratory
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Peginterferon alfa-2b
mesh term: Interferon alpha-2