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Pilot Peg-Interferon-a2b in Decreasing Viral DNA in HIV

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ClinicalTrials.gov Identifier: NCT01935089
Recruitment Status : Unknown
Verified October 2016 by Luis Montaner, The Wistar Institute.
Recruitment status was:  Active, not recruiting
First Posted : September 4, 2013
Last Update Posted : November 2, 2016
Sponsor:
Collaborators:
University of Pennsylvania
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Luis Montaner, The Wistar Institute

Study Description
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Brief Summary:

We propose to test our primary hypothesis that treatment with Peg-IFN-α-2b will result in a decrease in integrated HIV DNA in peripheral blood and tissue in chronically HIV-infected immune-reconstituted individuals (see section 3.1) in a prospective, interventional, 1-arm, open label clinical trial. To this end, we propose to enroll 25 HIV-1-infected subjects (please refer to power calculations in section 10.1 below) currently stably suppressed (> 1y with VL < 50 copies/ml) on ART and with CD4 count > 450 cells/µl.

We hypothesize that 20 weeks of treatment with Peg-IFN-alpha-2b, in the presence of HIV reactivation (i.e.: ART interruption), will result in activation of intrinsic and/or immune-mediated anti-HIV mechanisms resulting in a decrease in the levels of viral reservoir in chronically HIV-infected, immune-reconstituted individuals.


Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: Pegylated Interferon alpha 2b Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study: Single Arm, Multi-site, Open-label Study to Assess the Effectiveness of Peg-IFN-a2b in Decreasing the Levels of Cell-associated Integrated Viral DNA in HIV Chronic Infection
Study Start Date : November 2013
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: Interferon alpha
pegylated Interferon alpha 2b (Pegintron) 1 µg/kg per week, 20 weeks
 Drug: Pegylated Interferon alpha 2b
1µg/kg/week
Other Name: Pegintron


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in copies of HIV DNA per CD4+ T cell at Week 24 [ Time Frame: Week 0 and 24 ]
    Assessed by Alu-HIVgag polymerase chain reaction


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-65 years of age
  • Body weight between 125 and 299 lbs
  • Confirmed diagnosis of HIV-1 infection by western blot or by a documented HIV-1 viral load
  • Currently receiving ART and on ART for > 1 year
  • VL < 50 copies/ml for ≥ 1 year, with at least 2 measurements in the previous year, 1 viral "blip" with VL< 400 copies/ml allowed
  • HIV viral load of <50 copies/ml at screening.
  • CD4 >450 cells/µL at screening.
  • A negative ECG if >45yrs men/>55yrs women years of age or if below these years of age but with two added risk factors for coronary artery disease [smoking, hypertension (BP >140/90 or on antihypertensive medications), low HDL (<40 mg/dL), family history of premature CHD (<55 yrs males/<65 females)] or a Framingham score > 15% (men) or 10% (women))

Exclusion Criteria:

  • Confirmed clinical history of developing resistance to ART regimens that resulted in treatment changes
  • Receiving didanosine as part of the participant's ART regimen at the time of screening
  • Ongoing treatment with Isoniazide, pyrazinamide, Rifabutin, Rifampicin, Diadenosine Ganciclovir, Valgancyclovir, Oxymetholone, Thalidomide or Theophylline.
  • Use of any investigational drug within 30 days prior to screening
  • History or current use of immunomodulatory therapy for over 2 weeks during the 6 months prior to enrollment, including, but not limited to: IFN-alpha or gamma (recombinant or pegylated), systemic corticosteroids (nasal or pulmonary steroids will be allowed; systemic cancer chemotherapy/irradiation; cyclosporin; tacrolimus (FK-506); OKT-3; any Interleukin, including IL-2; cyclophosphamide; methotrexate; IVIG (gamma globulin); G/M-CSF; hydroxyurea; thalidomide; pentoxifylline; thymopentin; thymosin; dithiocarbonate; polyribonucleotide.
  • History of adverse or allergic reactions to any type-1 interferon (e.g. IFN-alpha2a, IFN-α2b, IFN-beta)
  • History of severe depression, or ongoing moderate depression determined by PHQ-9 at screening
  • Type I diabetes mellitus, or type II diabetes mellitus that is not controlled with oral agents and/or insulin.
  • Prior diagnosis of multiple sclerosis or other neurodegenerative disorders

  • Significant co-existing lab abnormalities including:

    1. Anemia (Hgb <9.1 mg/dl men, <8.9 mg/dl women)
    2. WBC <2000 cells/µl
    3. Absolute neutrophil count (ANC) <1200 cells/ µl
    4. Platelet count <60,000 cells/ µl
    5. Liver disease (AST/ALT > 2.5x, Total Bilirubin > 1.5x upper limits of norm (ULN), or Total Bilirubin >3x ULN if receiving indinavir OR Atazanavir)
    6. Renal disease (creatinine > 2x upper normal limits or creatinine clearance <60mg/dl (by Crockoff-Gault)
  • Chronic HCV infection (HCV viremia), or HBV Ag positive and/ or HBV viremia (Notice: subjects with prior HCV infection with a documented sustained virologic response with treatment finishing >1 year prior to screening are eligible for enrollment).
  • Liver cirrhosis or hepatic decompensation with Child Pugh score > 6
  • History of major organ transplantation with an existing functional graft.
  • Evidence of OI or other active infectious diseases or active malignancies
  • Active Autoimmune diseases, including autoimmune hepatitis
  • History of retinopathy or clinically significant ophthalmologic disease on eye exam performed within 6 months prior to initiation of IFN
  • Pregnancy, actively attempting to become pregnant, or breastfeeding
  • Body weight under 125 lbs or over 300 lbs
  • Other conditions, such as active drug/alcohol abuse or dependence which would interfere with study compliance
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01935089


Locations
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United States, Pennsylvania
AIDS Clinical Trials Unit (ACTU), and Department of Medicine, University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, United States, 19104
Presbyterian Hospital, Department of Medicine, University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, United States, 19104
Jonathan Lax Clinic, Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
The Wistar Institute
University of Pennsylvania
Merck Sharp & Dohme LLC
Investigators
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Principal Investigator: Luis J Montaner, DPhil University of Pennsylvania
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Luis Montaner, Professor, The Wistar Institute
ClinicalTrials.gov Identifier: NCT01935089    
Other Study ID Numbers: Merck-0575
First Posted: September 4, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: October 2016
Keywords provided by Luis Montaner, The Wistar Institute:
HIV-1
Interferon alpha
Integrated DNA
Latent reservoir
Additional relevant MeSH terms:
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Infections
Interferons
Interferon-alpha
Interferon alpha-2
Peginterferon alfa-2b
 Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs