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

Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.