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Study matches: 5

Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.


Adoptive Transfer of Haploidentical Natural Killer Cells and IL-2

Ann Thorkelson, MN -segu0017@umn.edu
Ann Thorkelson, RN BSN -segu0017@umn.edu
All
18 Years to 65 Years old
Phase 2
This study is NOT accepting healthy volunteers
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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
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NCT03346499
Biological: NK cells and IL-2
HIV
HIV
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Proof of Principle Study of Pulse Dosing of IL-15 to Deplete the Reservoir in HIV Infected People (ALT-803)

Ann Thorkelson -segu0017@umn.edu
All
18 Years to 99 Years old
Phase 1
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
1. HIV-1 infected adults aged 18 years or over. 2. Stable ART for at least 36 months 3. 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) 4. Screening CD4 count ¿500 cells/mm3 5. Laboratory tests performed within 14 days of study enrollment: 1. WBC ¿ 3000/mm3 2. Platelets ¿ 50,000/mm3 [Patients may be transfused to meet this requirement] 3. Hemoglobin ¿ 8 g/dL (>80g/L) [Patients may be transfused to meet this requirement] 4. Calculated glomerular filtration rate (GFR) >45 mL/min/1.73m2 5. Total bilirubin ¿ 2.0 X upper limit of institutional normal (ULN) 6. AST, ALT, ALP ¿ 2.0 X ULN 6. Adequate pulmonary function without any clinical sign of severe pulmonary dysfunction. PFTs > 50% of predicted if symptomatic or prior known impairment. 7. Ability to be off prednisone and other immunosuppressive drugs for at least 14 days before first dose of study drug 8. 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 9. Voluntary written consent
Exclusion Criteria:
1. Active infection other than HIV currently requiring systemic antimicrobial therapy 2. Previously treated on this study or received previous ALT-803 3. Latent TB infection or active TB disease prior to completing a standard regimen of anti-TB therapy 4. Active fungal infection requiring systemic antifungal therapy 5. Active or recurrent herpes or varicella-zoster virus infection requiring treatment (or chronic suppression) 6. Chronic hepatitis B or C 7. Planning or current pregnancy or breastfeeding 8. Intended modification of antiretroviral therapy in the next 24 weeks 9. 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 10. Symptomatic congestive heart failure, unstable angina pectoris, or Myocardial infarction within 6 months prior to screening 11. Marked baseline prolongation of QT/QTc interval (e.g. demonstration of a QTc interval greater than 500 milliseconds) 12. History or evidence of uncontrollable CNS disease 13. Prior organ allograft or allogeneic transplantation 14. On-going chronic systemic or regular inhaled corticosteroid use or other immunosuppressive therapy (a history of mild asthma not requiring therapy is eligible) 15. Psychiatric illness/social situations that would limit compliance with study requirements 16. Other illness that in the opinion of the investigator would exclude the patient from participating in this study
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NCT02191098
Drug: ALT-803
HIV; ART
HIV; Stable ART
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Observational Study of Solid Organ Transplantation Utilizing HIV-Positive Donors in HIV-Positive Recipients

Timothy L Pruett, MD -tlpruett@umn.edu
Varvara Kirchner, MD -kirc0079@umn.edu
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
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RECIPIENT ELIGIBILITY CRITERIA HIV-Positive Recipient Inclusion Criteria (liver, kidney) 1. Participant is able to understand and provide informed consent. 2. Participant meets standard listing criteria for transplant. 3. Documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV ab IFA, or documented history of detectable HIV-1 RNA). 4. Participant is ¿ 18 years old. 5. No evidence of active opportunistic complications of HIV infection. 6. Participant CD4+ T-cell count is >/= 200/µL within 16 weeks prior to transplant for kidney transplant recipients. For liver transplant recipient, CD4+ T-cell counts need to be >/= 100/ul (or >/= 200/µL if history of opportunistic infection) within 16 weeks prior to transplant. 7. Participant most recent HIV-1 RNA < 50 copies/mL (by any FDA-approved assay performed in CLIA-approved laboratory), in the 26 weeks prior to transplant. Participants unable to tolerate ART due to organ failure or who have only recently started ART may have detectable viral load and still be considered eligible if the study team is confident there will be a safe, tolerable, and effective antiretroviral regimen once organ function is restored after transplantation. 8. Concurrence by the study team that based on medical history and ART, viral suppression can be achieved in the recipient post-transplant. 9. No history of primary CNS lymphoma or progressive PML. 10. On a stable antiretroviral regimen. Participants unable to tolerate ART due to organ failure may still be considered eligible if the study team is confident there will be a safe, tolerable, and effective antiretroviral regimen once organ function is restored after transplantation. HIV-Positive Recipient Exclusion Criteria (liver, kidney) 1. Participant has concomitant conditions that, in the judgment of the investigators, would preclude transplantation or immunosuppression. DONOR ELIGIBILITY CRITERIA HIV-Positive Deceased Donor (liver, kidney) 1. Must meet all clinical criteria for HIV-uninfected organ donors. 2. No evidence of invasive opportunistic complications of HIV infection. 3. Pre-implant donor organ biopsy showing no disease process that would put the recipient at increased risk of rapid progression to end-stage organ failure, to be stored for the duration of the study. 4. Donor has documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV ab IFA, or history of detectable HIV-1 RNA) from a CLIA-approved laboratory. 5. If known history of HIV infection and prior antiretroviral therapy, the study team must describe the anticipated post-transplant antiretroviral regimen to be prescribed for the recipient and justify its conclusion that the regimen will be safe, tolerable and effective. HIV-Positive Living Donor (liver) 1. Donor meets all clinical criteria to be a living liver donor other than being HIV positive. 2. Donor has documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV ab IFA, or history of detectable HIV-1 RNA) from a CLIA-approved laboratory. 3. No evidence of invasive opportunistic complications of HIV infection 4. Donor CD4+ T-cell count is >/= 500/µL in the 26 weeks prior to donation. 5. The most recent HIV-1 RNA has been below 50 copies RNA/ml in the 26 weeks prior to donation. 6. On a stable antiretroviral regimen. 7. Must be evaluated by the HIV/Transplant Infectious Diseases team to verify resistance history and current ART regimens. The potential for transmission of resistant strain of HIV will be assessed. 8. Pre-implant donor liver biopsy to be stored for the duration of the study showing no evidence of a disease process that would put the donor at increased risk of progressing to end-stage organ failure after donation, or that would present a risk of poor graft function to the recipient. 9. Must be evaluated by an independent HIV study living donor advocate separate from the transplant service in addition to the living donor advocate seen by all living donors.
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NCT03170414
HIV; Kidney Transplant; Liver Transplant; Transplant; HOPE Act
HIV; Awaiting Organ Transplant
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Role of Exogenous and Endogenous Sex Hormones on Tenofovir and Emtricitabine Disposition in Female Genital Tract

Melanie Nicol, PharmD, PhD -mrnicol@umn.edu
Female
18 Years and over
N/A
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
1. Female, or transgender female with a cervix, age 18 years or older 2. HIV-positive 3. Stable on antiretroviral regimen containing tenofovir or emtricitabine for at least 2 weeks at time of enrollment. 4. Virally suppressed (HIV-RNA copies <50 copies/mL) for at least 6 months at time of enrollment. 5. Willing to refrain from vaginal intercourse and use of vaginal devices such as douches and sex toys within 72 hours of the biopsy visit. 6. Willing and able to give signed informed consent.
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NCT03218085
Drug: Tenofovir; Drug: Emtricitabine
tenofovir; prevention; microbiome; cervicovaginal; biopsy; swab; cytokines; inflammation; pharmacology
HIV/AIDS; Menopause; Inflammation Vagina
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Autologous Peripheral Stem Cell Transplant in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma

This study is seeking individuals up to the age of 75 with lymphoma. The study aims to determine the effectiveness of high dose chemotherapy followed by autologous hematopoetic cell transplantion.
sfinder@umn.edu
All
up to 75 Years old
Phase 2
This study is NOT accepting healthy volunteers
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Inclusion Criteria:

• Karnofsky performance status: >80% (>60% if poor performance status is related to lymphoma)
• No evidence of serious organ dysfunction that is not attributable to tumor
• Central nervous system: Patients with a history of CNS involvement by lymphoma or with relapsed primary lymphoma will be eligible.
• Infection: Patients with serious uncontrolled infections at the time of transplant will be excluded.
• Hepatitis B: Patients who are carriers of Hepatitis B will be included in this study. These patients are not eligible to receive rituximab as a component of their chemotherapy mobilization.
• HIV disease. Patients with HIV disease are eligible for this study provided that:
• Patients will be seen in the infectious disease (ID)/HIV clinic prior to enrollment on study for the purpose of determining eligibility and for local coordination of HIV care during the peri-transplant period.
• Must be on a maximally active anti-HIV regimen
• CD4+ ¿ 50/¿L
• HIV RNA viral load ¿ 100,000 copies per mL on each of samples 4 weeks apart. The most recent level must be within one month of enrollment.
• Non-Hodgkin's lymphoma (NHL). Patients with chemo-sensitive histologically confirmed NHL.
• Precursor B-cell or Precursor T-cell NHL
• Lymphoblastic lymphoma
• All patients will be eligible in second or greater complete remission (CR) or first or subsequent partial remission (PR)
• Mature B-cell Lymphomas:
• Small lymphocytic lymphoma (SLL) or Chronic Lymphocytic Leukemia (CLL)
• Follicular Lymphoma
• Diffuse Large B-cell Lymphoma
• Mantle Cell Lymphoma
• Burkitt's/Burkitt's like
• Mature T-cell lymphoma
• Hodgkin's lymphoma (HL)
• patients with histologically proven HL will be eligible for transplantation after failing prior therapy.
Exclusion Criteria:

• Patients eligible for any higher priority transplant protocols
• Women who are pregnant or breast feeding
• Patients with chemotherapy resistant disease
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NCT00345865
Drug: carmustine; Drug: cyclophosphamide; Drug: etoposide; Procedure: peripheral blood stem cell transplantation; Radiation: irradiation therapy; Biological: G-CSF; Drug: Cytarabine
Hodgkin lymphoma; non-Hodgkin lymphoma; HIV-associated lymphoma
Lymphoma
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