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2 Study Matches

Effect of N-803 on B Cell Follicles in Antiretroviral Treated HIV Disease

Recruiting

Rodolfo Batres - rbatres@umn.edu

Timothy Schacker
All
18 Years to 65 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT04808908
STUDY00007810
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Inclusion Criteria:

• HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA viral load.
• On continuous antiretroviral therapy for over 24 months without any interruptions of greater than 14 consecutive days, without plans to modify ARTduring the study period.
• Screening plasma HIV RNA levels < 20 copies/mL and on at least 1 determination in past 12 months (isolated single values greater than or equal to 20 but < 200 copies/mL will be allowed if they were preceded and followed by undetectable viral load determinations)
• Screening CD4+ T cell count greater than or equal to 350 cells/mm3 and nadir CD4+ T cell count of >200 per participant report.
• Ability to be off prednisone and other immunosuppressive drugs for at least 14 days before screen. Inhaled, nasal spray, and topical steroids are acceptable.
• Acceptable blood pressure and heart rate parameters within normal limits (systolic = 88-140mmHg; diastolic = 50-<90mmHg; heart rate = 46-100 bpm). Treatment with antihypertensive medication is allowed. However, if someone is on a beta-blocker this must be switched to another class of medication as there is a theoretical risk for bradycardia if the participant were to experience cytokine release syndrome symptoms (which has not happened with this drug delivered SQ).
• Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use effective contraception during study participation and for 1 month following the final study visit (4 months after final dose of study drug). Acceptable birth control is defined as the following: (1) For female participants of childbearing potential, two of the following forms of contraception are required, one of which must be a barrier method: 1. Condoms (male or female) with or without a spermicidal agent 2. Diaphragm or cervical cap with spermicide 3. Intrauterine device (IUD) with published data showing that expected failure rate is < 1% per year 4. Tubal ligation 5. Hormone-based contraceptive such as oral birth control pills
• Laboratory tests performed within 14 days of study enrollment must be a grade 0 or 1 as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, with the following exceptions: 1. Platelet counts (≥ 150,000/mm3) 2. Hemoglobin > 12.5 g/dL for men and > 11.5 g/dL for women. It is not acceptable for patients to be transfused to meet this requirement. The use of Epogen is permitted. 3. Estimated Cr Cl (eGFR) > 50
Exclusion Criteria:

• Active or recent malignancy requiring systemic chemotherapy or surgery in the preceding 36 months or for whom such therapies are expected in the subsequent 12 months; minor surgical removal of localized skin cancers (squamous cell carcinoma, basal cell carcinoma) are not exclusionary
• Chronic liver disease defined as Class B and C on the Child-Pugh chronic liver disease scale.
• Active and poorly controlled atherosclerotic cardiovascular disease (ASCVD), as defined by 2013 ACC/AHA guidelines, including a previous diagnosis of any of the following: 1. acute myocardial infarction 2. acute coronary syndromes 3. stable or unstable angina 4. coronary or other arterial revascularization 5. stroke 6. transient ischemic attack (TIA) 7. peripheral arterial disease presumed to be of atherosclerotic origin.
• History of potential immune-mediated medical conditions requiring concomitant treatment with immunomodulatory drugs, and/or exposure to any immunomodulatory drug in the 30 days prior to screen (e.g. corticosteroid therapy equal to or exceeding a dose of 15 mg/day of prednisone for more than 10 days, IL-2, interferon, methotrexate, cancer chemotherapy). NOTE: use of inhaled, nasal steroid or topical steroid lotions and creams is not exclusionary. Prior exposure to N-803 is not exclusionary if prior exposure occurred at least 6 months before screen.
• Unable to undergo leukapheresis procedure
• Exposure to any experimental therapies within 90 days of study screen. Exposure to long acting injectable ART therapies is not exclusionary.
• Latent TB infection or active TB disease prior to completing a standard regimen of anti-TB therapy that is defined as meeting PPD criteria for TB exposure or a positive quantiferon gold test collected at screening.
• Active fungal infection requiring systemic antifungal therapy
• Active herpes outbreak or varicella-zoster virus infection requiring episodic treatment
• Chronic active hepatitis B or C. For Hepatitis B this will be defined as HBs antigen + and for Hepatitis C this will be defined as Hepatitis C antibody positive and Hepatitis C PCR+.
• History and/or presence of any clinically significant disease or disorder, such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal and psychiatric/mental disease/disorder, which, in the opinion of the site Principle Investigator may either put the subject at risk because of participation in the study, influence the results of the study or the subject's ability to participate in the study.
• Any degree of baseline QT/QTc interval prolongation (QTc interval > 450 msec in males and > 470 msec in females.)
• Any ischemic changes seen in the stress treadmill test administered per the discretion of the PI in order to assess any other EKG abnormalities outlined in study protocol
• History or evidence of uncontrollable CNS disease such as dementia, demyelinating disease, Parkinson's, or a CNS degenerative disease that, in the opinion of the site Principle Investigator, may either put the subject at risk because of participation in the study, influence the results of the study or the subject's ability to participate in the study.
• Prior organ allograft or allogeneic transplantation
• Planning or current pregnancy or breastfeeding
• Any clinically indicated vaccination (other than influenza) administered within 14 days of screen
Biological: N-803
Hiv, HIV Infections, AIDS
Clinics and Surgery Center (CSC)
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Observational Study of Solid Organ Transplantation Utilizing HIV-Positive Donors in HIV-Positive Recipients

Recruiting

Timothy Pruett - tlpruett@umn.edu

Timothy Pruett
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03170414
1608M93841
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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.
HIV, Awaiting Organ Transplant
Clinics and Surgery Center (CSC), HIV, Kidney Transplant, Liver Transplant, Transplant, HOPE Act
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