Last updated on April 2019

Adoptive Transfer of Haploidentical Natural Killer Cells and IL-2


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: HIV positive | AIDS Vaccines | HIV | HIV infection
  • Age: Between 18 - 65 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Age-18-65
  • Stable ART for at least 12 months.
  • Screening plasma HIV RNA levels below level of quantification (<40 to <50 copies RNA/mL depending on the assay) for 6 months (a total of 3 measurements above the level of detection but < 500 copies/ml will be allowed if each detectable measure is separated by at least 1 year)
  • Screening CD4 count 500 cells/l
  • Laboratory tests (CBCD, CMP, Mg, Phosphorus, PT/PTT, TSH/T4,) performed within 14 days of study enrollment. All laboratory results (unless otherwise specified) must be Grade 1 or normal based on the DAIDS Adverse Event Grading Scale (Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events v2.0)
  • Adequate kidney function defined by estimated GFR (CrCl) > 60 ml/min or ml/min/1.73 m2 ( grade 2 per DAIDS) and creatinine 1.5 x ULN
  • Adequate pulmonary function without any clinical signs or symptoms of severe pulmonary dysfunction. PFT testing must show FEV1 and DLCOcorr > 50% of predicted if subjects have symptomatic or prior known impairment.
  • Transthoracic echocardiogram with PA pressures in the range of 18-26 mmHg
  • Ability to be off prednisone and other immunosuppressive drugs for at least 14 days before infusion of cells
  • 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 provided by the subject

Exclusion Criteria:

  • Any condition that precludes lymph node biopsy or colonoscopy with biopsy
  • Active infection other than HIV currently requiring systemic antimicrobial therapy
  • History of deep vein thrombosis
  • Active significant, tissue invasive fungal infection requiring systemic antifungal therapy (dermatologic conditions requiring only topical therapy are allowed).
  • Chronic active hepatitis B or C (defined as antibody positive and DNA+ or HepBsAG+).
  • 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)
  • On-going chronic systemic corticosteroid use or other immunosuppressive therapy (a history of mild asthma not requiring therapy is eligible and inhaled corticosteroids is allowed. Topical steroids are allowed.)
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • Previous diagnosis of an autoimmune disease (e.g. rheumatoid arthritis, lupus, inflammatory bowel disease, multiple sclerosis, vasculitis)
  • Use of any anticoagulants within the previous 4 weeks.
  • Other illness that in the opinion of the investigator would exclude the patient from participating in this study

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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