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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by The Wistar Institute
Sponsor:
Collaborators:
University of Pennsylvania
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Luis Montaner, The Wistar Institute
ClinicalTrials.gov Identifier:
NCT01935089
First received: August 27, 2013
Last updated: August 26, 2014
Last verified: August 2014

August 27, 2013
August 26, 2014
November 2013
December 2015   (final data collection date for primary outcome measure)
Change from baseline in copies of HIV DNA per CD4+ T cell at Week 24 [ Time Frame: Week 0 and 24 ] [ Designated as safety issue: No ]
Assessed by Alu-HIVgag polymerase chain reaction
Same as current
Complete list of historical versions of study NCT01935089 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Pilot Peg-Interferon-a2b in Decreasing Viral DNA in HIV
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

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV-1 Infection
Drug: Pegylated Interferon alpha 2b
1µg/kg/week
Other Name: Pegintron
Experimental: Interferon alpha
pegylated Interferon alpha 2b (Pegintron) 1 µg/kg per week, 20 weeks
Intervention: Drug: Pegylated Interferon alpha 2b
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
July 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Luis J Montaner, DPhil 215-898-3934 montaner@wistar.org
Contact: Jay R Kostman, MD 215-662-8693 kostman@mail.med.upenn.edu
United States
 
NCT01935089
Merck-0575
Yes
Luis Montaner, The Wistar Institute
The Wistar Institute
  • University of Pennsylvania
  • Merck Sharp & Dohme Corp.
Principal Investigator: Luis J Montaner, DPhil University of Pennsylvania
The Wistar Institute
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP