HIV Clinical Trial
Official title:
Adoptive Transfer of Haploidentical Natural Killer Cells and IL-2 in Human Immunodeficiency Virus (HIV)
Verified date | November 2019 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a pilot study of the infusion of haploidentical NK cells with IL-2 in 5 HIV+ individuals who are on stable ART with full HIV suppression.
Status | Completed |
Enrollment | 4 |
Est. completion date | November 13, 2018 |
Est. primary completion date | November 13, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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/µl - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota Medical Center | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of administration of haploidentical NK cells in HIV infected individuals - Adverse Events | Subjects will receive haploidentical NK and all adverse events will be collected | Baseline, 100 days | |
Primary | Tolerability of administration of haploidentical NK cells in HIV infected individuals- Side effects | Side effects from all subjects will be collected | Baseline, 100 days |
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