Status:
COMPLETED
Proof of Principle Study of Pulse Dosing of IL-15 to Deplete the Reservoir in HIV Infected People
Lead Sponsor:
University of Minnesota
Conditions:
HIV
Stable ART
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
To assess the safety and tolerability of ALT-803, as well as, the potential efficacy of ALT-803 in HIV
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 tolerat...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02191098
Start Date
June 1 2015
End Date
September 9 2019
Last Update
January 27 2020
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455