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

July 5, 2023 updated by: Luis Montaner, The Wistar Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • 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, 19107
        • Jonathan Lax Clinic, Philadelphia FIGHT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Pegintron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Copies of HIV DNA Per CD4+ T Cell at Week 24
Time Frame: Week 3 and 24
Difference in copies of HIV DNA per CD4+ T cell between baseline and week 24, assessed by Alu-HIVgag polymerase chain reaction
Week 3 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Wistar Institute

Collaborators

University of Pennsylvania
Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Luis J Montaner, DPhil, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 7, 2013

Primary Completion (Actual)

March 25, 2015

Study Completion (Actual)

May 2, 2016

Study Registration Dates

First Submitted

August 27, 2013

First Submitted That Met QC Criteria

August 29, 2013

First Posted (Estimated)

September 4, 2013

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 5, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Merck-0575

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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