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Proof of Principle Study of Pulse Dosing of IL-15 to Deplete the Reservoir in HIV Infected People (ALT-803)

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT02191098
First received: July 8, 2014
Last updated: April 19, 2017
Last verified: April 2017
  Purpose
To assess the safety and tolerability of ALT-803, as well as, the potential efficacy of ALT-803 in HIV

Condition Intervention Phase
HIV Stable ART Drug: ALT-803 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proof of Principle Study of Pulse Dosing of IL-15 to Deplete the Reservoir in HIV Infected People on Optimized ART With Undetectable Plasma HIV RNA

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Assess the safety and tolerability of ALT-803 in HIV-infected subjects [ Time Frame: 4 weeks ]
    Safety and tolerability is determined by the incidence of adverse events, size of the inducible reservoir as estimated using the TILDA assay


Secondary Outcome Measures:
  • Assess the impact of ALT-803 on the size of the inducible reservoir, [ Time Frame: 4 weeks ]
    Assess the impact of ALT-803 on the size of the inducible reservoir, as estimated using the TILDA assay, in total CD4+ T cells and memory subsets


Estimated Enrollment: 10
Study Start Date: June 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALT-803
ALT-803
Drug: ALT-803
Interleukin 15 (IL-15) is a common γ-chain cytokine that is related to interleukin-2 (IL-2) and is a critical factor for the development, proliferation, and activation of effector natural killer (NK) and CD8+ memory T cells

Detailed Description:
This is an open-label, single-arm intra-patient dose escalating pilot study of ALT-803, a recombinant human super agonist interleukin-15 (IL-15) complex with an expansion cohort at the maximum tolerated dose (MTD). The primary aim is to investigate the safety and tolerability of ALT-803 in HIV-infected people receiving potent and optimized antiretroviral therapy. All infusions will occur on a Monday. Subjects will be monitored for 24 hours after the first infusion and then for 6 hours after each subsequent infusion, provided no unacceptable toxicity.
  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HIV-1 infected adults aged 18 years or over.
  2. Stable ART for at least 36 months
  3. Screening plasma HIV RNA levels below level of quantification (<40 to <50 copies RNA/mL depending on the assay) ≥ 2 years (a single measurement above the level of detection but < 100-200 copies/ml will be allowed)
  4. Screening CD4 count ≥500 cells/mm3
  5. Laboratory tests performed within 14 days of study enrollment:

    1. WBC ≥ 3000/mm3
    2. Platelets ≥ 50,000/mm3 [Patients may be transfused to meet this requirement]
    3. Hemoglobin ≥ 8 g/dL (>80g/L) [Patients may be transfused to meet this requirement]
    4. Calculated glomerular filtration rate (GFR) >45 mL/min/1.73m2
    5. Total bilirubin ≤ 2.0 X upper limit of institutional normal (ULN)
    6. AST, ALT, ALP ≤ 2.0 X ULN
  6. Adequate pulmonary function without any clinical sign of severe pulmonary dysfunction. PFTs > 50% of predicted if symptomatic or prior known impairment.
  7. Ability to be off prednisone and other immunosuppressive drugs for at least 14 days before first dose of study drug
  8. Women of child bearing potential and men with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy
  9. Voluntary written consent

Exclusion Criteria:

  1. Active infection other than HIV currently requiring systemic antimicrobial therapy
  2. Previously treated on this study or received previous ALT-803
  3. Latent TB infection or active TB disease prior to completing a standard regimen of anti-TB therapy
  4. Active fungal infection requiring systemic antifungal therapy
  5. Active or recurrent herpes or varicella-zoster virus infection requiring treatment (or chronic suppression)
  6. Chronic hepatitis B or C
  7. Planning or current pregnancy or breastfeeding
  8. Intended modification of antiretroviral therapy in the next 24 weeks
  9. NYHA (New York Heart Association) Class III or IV heart failure, uncontrollable supraventricular arrhythmias, any history of a ventricular arrhythmia, or other clinical signs of severe cardiac dysfunction
  10. Symptomatic congestive heart failure, unstable angina pectoris, or Myocardial infarction within 6 months prior to screening
  11. Marked baseline prolongation of QT/QTc interval (e.g. demonstration of a QTc interval greater than 500 milliseconds)
  12. History or evidence of uncontrollable CNS disease
  13. Prior organ allograft or allogeneic transplantation
  14. On-going chronic systemic or regular inhaled corticosteroid use or other immunosuppressive therapy (a history of mild asthma not requiring therapy is eligible)
  15. Psychiatric illness/social situations that would limit compliance with study requirements
  16. Other illness that in the opinion of the investigator would exclude the patient from participating in this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02191098

Contacts
Contact: Anne Thorkelson, RN 612-625-7472 segu0017@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Principal Investigator: Tim Schacker, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Tim Schacker, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02191098     History of Changes
Other Study ID Numbers: ALT-803
Study First Received: July 8, 2014
Last Updated: April 19, 2017

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
HIV
ART

ClinicalTrials.gov processed this record on September 25, 2017