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

Completed · Phase 1

Conditions studied: HIV, Stable ART

In brief

To assess the safety and tolerability of ALT-803, as well as, the potential efficacy of ALT-803 in HIV

Key facts

Study ID

NCT02191098

Run by

University of Minnesota

People needed

10

Starts

2015-06-01

Expected to finish

2019-09-09

Last updated by the study team

2020-01-27

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV-1 infected adults aged 18 years or over.
• Stable ART for at least 36 months
• 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)
• Screening CD4 count ≥500 cells/mm3
• Laboratory tests performed within 14 days of study enrollment:
• WBC ≥ 3000/mm3
• Platelets ≥ 50,000/mm3 [Patients may be transfused to meet this requirement]
• Hemoglobin ≥ 8 g/dL (>80g/L) [Patients may be transfused to meet this requirement]
• Calculated glomerular filtration rate (GFR) >45 mL/min/1.73m2
• Total bilirubin ≤ 2.0 X upper limit of institutional normal (ULN)
• AST, ALT, ALP ≤ 2.0 X ULN
• Adequate pulmonary function without any clinical sign of severe pulmonary dysfunction. PFTs > 50% of predicted if symptomatic or prior known impairment.
• Ability to be off prednisone and other immunosuppressive drugs for at least 14 days before first dose of study drug
• 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
• Voluntary written consent

You may not qualify if…

• Active infection other than HIV currently requiring systemic antimicrobial therapy
• Previously treated on this study or received previous ALT-803
• Latent TB infection or active TB disease prior to completing a standard regimen of anti-TB therapy
• Active fungal infection requiring systemic antifungal therapy
• Active or recurrent herpes or varicella-zoster virus infection requiring treatment (or chronic suppression)
• Chronic hepatitis B or C
• Planning or current pregnancy or breastfeeding
• Intended modification of antiretroviral therapy in the next 24 weeks
• 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
• Symptomatic congestive heart failure, unstable angina pectoris, or Myocardial infarction within 6 months prior to screening
• Marked baseline prolongation of QT/QTc interval (e.g. demonstration of a QTc interval greater than 500 milliseconds)
• History or evidence of uncontrollable CNS disease
• Prior organ allograft or allogeneic transplantation
• On-going chronic systemic or regular inhaled corticosteroid use or other immunosuppressive therapy (a history of mild asthma not requiring therapy is eligible)
• Psychiatric illness/social situations that would limit compliance with study requirements
• Other illness that in the opinion of the investigator would exclude the patient from participating in this study

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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