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A PROSPECTIVE OBSERVATIONAL STUDY OF SOLID ORGAN TRANSPLANTATION UTILIZING HIV-POSITIVE DONORS IN HIV-POSITIVE RECIPIENTS

This is a prospective, observational study designed to evaluate the safety of solid organ transplantation using HIV-positive deceased donors (liver, kidney) and HIV-positive living donors (liver) in HIV-positive recipients.

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)
• Participant is able to understand and provide informed consent.
• Participant meets standard listing criteria for transplant.
• Documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV ab IFA, or documented history of detectable HIV-1 RNA).
• Participant is ≥ 18 years old.
• No evidence of active opportunistic complications of HIV infection.
• 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.
• 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.
• Concurrence by the study team that based on medical history and ART, viral suppression can be achieved in the recipient post-transplant.
• No history of primary CNS lymphoma or progressive PML.
• 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)
• 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)
• Must meet all clinical criteria for HIV-uninfected organ donors.
• No evidence of invasive opportunistic complications of HIV infection.
• 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.
• 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.
• 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)
• Donor meets all clinical criteria to be a living liver donor other than being HIV positive.
• 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.
• No evidence of invasive opportunistic complications of HIV infection
• Donor CD4+ T-cell count is >/= 500/µL in the 26 weeks prior to donation.
• The most recent HIV-1 RNA has been below 50 copies RNA/ml in the 26 weeks prior to donation.
• On a stable antiretroviral regimen.
• 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.
• 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.
• 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
HIV, Kidney Transplant, Liver Transplant, Transplant, HOPE Act, Clinics and Surgery Center (CSC)
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Role of exogenous and endogenous sex hormones on tenofovir and emtricitabine disposition in female genital tract

This study aims to determine the role of menopause and exogenous hormone use in regulating antiretroviral disposition in the female genital tract.

Melanie Nicol
Female
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03218085
1610M98383
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Inclusion Criteria:

• Female, or transgender female with a cervix, age 18 years or older
• HIV-positive
• Stable on antiretroviral regimen containing tenofovir or emtricitabine for at least 2 weeks at time of enrollment.
• Virally suppressed (HIV-RNA copies <50 copies/mL) for at least 6 months at time of enrollment.
• Willing to refrain from vaginal intercourse and use of vaginal devices such as douches and sex toys within 72 hours of the biopsy visit.
• Willing and able to give signed informed consent.
Drug: Tenofovir, Drug: Emtricitabine
HIV/AIDS, Menopause, Inflammation Vagina
tenofovir, prevention, microbiome, cervicovaginal, biopsy, swab, cytokines, inflammation, pharmacology
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SHP620-302: A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients

Drug study - Maribavir in HSCT patients with CMV infections

Jo-Anne Young, MD
All
16 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT02927067
1703M11501
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Inclusion Criteria:

• Be able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures. As applicable, a parent/both parents or legally authorized representative (LAR) must provide signature of informed consent and there must be documentation of assent by the participants before completing any study-related procedures. During the COVID-19 public health emergency, informed consent from a potential or current trial participant may, if permitted by local laws and regulations, be obtained via electronic informed consent (eIC) capabilities or an electronic face-to-face consent interview when these individuals are unable to travel to the site (FDA COVID-19 Guidance, 27 January 2021, Q11).
• Be greater than or equal to (>=) 16 years of age at the time of consent.
• Be a recipient of hematopoietic stem cell transplant.
• Have a documented asymptomatic CMV infection, with a screening value of CMV DNA >=1365 International Units per millilitre (IU/mL) to less than or equal to (<=) 273000 IU/mL in whole blood or >=455 IU/mL to <=91000 IU/mL in plasma in 2 consecutive assessments, separated by at least 1 day, as determined by local or central specialty laboratory quantitative polymerase chain reaction (qPCR) or comparable quantitative CMV DNA results. Both samples should be taken within 14 days prior to randomization with second sample obtained within 5 days prior to randomization. Same laboratory and same sample type (whole blood or plasma) should be used for these assessments. Asymptomatic CMV infection is defined as an infection that does not present with tissue invasive CMV disease, as assessed by the investigator. Participants with CMV DNA less than (<) 910 and >=455 IU/mL in plasma or <2730 and >=1365 IU/mL in whole blood will also need to meet at least 1 of the following criteria for high-risk CMV infection to be eligible:
• Human leukocyte antigen (HLA)-related (sibling) donor with at least 1 mismatch at 1 of the following 3 HLA-gene loci: HLA-A, -B or -DR,
• Haploidentical donor
• Unrelated donor with at least 1 mismatch at 1 of the following 4 HLA -gene loci: HLA-A, -B, -C and -DRB1,
• Use of umbilical cord blood as stem cell source,
• Use of ex vivo T-cell-depleted grafts,
• Grade 2 or greater graft-versus-host-disease (GVHD), requiring the use of systemic corticosteroids (defined as the use of >=1 milligram per kilogram per day (mg/kg/day) of prednisone or equivalent dose of another corticosteroid).
• Have the current CMV infection as the first episode of CMV viremia after HSCT, either primary or reactivation, which in the investigator's opinion requires treatment.
• Per investigator's judgment, be eligible for treatment with valganciclovir.
• Have all of the following results as part of screening laboratory assessments (results from either the central laboratory or a local laboratory can be used for qualification):
• Absolute neutrophil count to >=1000 per cubic millimeter (/mm^3) [1.0*10^9/L].
• Platelet count >=25,000/mm^3 [25*10^9/L].
• Hemoglobin >=8 grams per deciliter (g/dL).
• Estimated creatinine clearance >=30 milliliters per minute (mL/min).
• Have a negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy test at screening, if a female of child bearing potential. Urine pregnancy tests may be done per institutional requirements; however they are not sufficient for eligibility determination. Sexually active females of child bearing potential must agree to comply with any applicable contraceptive requirements of the protocol. If male, must agree to use an acceptable method of birth control, as defined in the protocol, during the study treatment administration period and for 90 days afterward the last dose of study treatment.
• Be able to swallow tablets.
• Have life expectancy of >=8 weeks.
• Weigh >=40 kilograms (kg).
• Be willing and have an understanding and ability to fully comply with study procedures and restrictions defined in the protocol.
Exclusion Criteria:

• Have CMV tissue invasive disease as assessed by the investigator at the time of screening and randomization at Visit 2/Day 0.
• Have a CMV infection that is known to be genotypically resistant to ganciclovir, valganciclovir, foscarnet, or cidofovir based on documented evidence.
• Be presenting with recurrent CMV infection (defined as a new detection of CMV infection in a participants who had at least one previously documented episode of CMV infection post-transplant, and who has had at least 2 weeks of undetectable CMV DNA between the episodes during active surveillance, based on same local laboratory and same sample type). The Participants must also have been off any anti-CMV treatment between the current and prior infection. Otherwise, the current infection may be considered continuation of the prior infection.
• Require ganciclovir, valganciclovir, foscarnet, or cidofovir administration for conditions other than CMV when study treatment is initiated (example: herpes simplex virus [HSV] co-infection requiring use of any of these agents after the randomization) or would need a co-administration with maribavir for CMV infection.
• Be receiving leflunomide, letermovir, or artesunate when study treatment is initiated. Note: Participants who may be receiving leflunomide must discontinue the use at least 14 days prior to randomization at Visit 2/Day 0 and the first dose of study treatment. Participants receiving letermovir must discontinue use 3 days prior to first dose of study treatment. Participants receiving artesunate must discontinue the use prior to the first dose of study treatment.
• Be on treatment with anti-CMV agents (ganciclovir, valganciclovir, foscarnet or letermovir) for the current CMV infection for longer than 72 hours.
• Have known hypersensitivity to the active substance or to an excipient of the study treatments.
• Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the first dose of study treatment that would preclude administration of oral medication.
• Require mechanical ventilation or vasopressors for hemodynamic support at the time of randomization.
• Be female and pregnant or nursing.
• Have previously completed, discontinued, or have been withdrawn from this study.
• Have received any investigational agent with known anti-CMV activity within 30 days before initiation of study treatment or CMV vaccine at any time.
• Have received any unapproved agent or device within 30 days before initiation of study treatment.
• Have any clinically significant medical or surgical condition that, in the investigator's opinion, could interfere with interpretation of study results, contraindicate the administration of the assigned study treatment, or compromise the safety or well-being of the participant.
• Have previously received maribavir.
• Have serum aspartate aminotransferase (AST) greater than (>) 5 times upper limit of normal (ULN) at screening, or serum alanine aminotransferase (ALT) >5 times ULN at screening, or total bilirubin >= 3.0*ULN at screening (except for documented Gilbert's syndrome), as analyzed by local or central laboratory.
• Have known (previously documented) positive results for human immunodeficiency virus (HIV). Participants must have a confirmed negative HIV test result within 3 months of study entry or, if unavailable, be tested by a local laboratory during the screening period.
• Have active malignancy with the exception of nonmelanoma skin cancer, as determined by the investigator. Participants who experience relapse or progression of their underlying malignancy (for which HSCT was performed), as determined by the investigator, are not to be enrolled.
• Be undergoing treatment for acute or chronic hepatitis C
Drug: Maribavir, Drug: Valganciclovir, Other: Placebo
Cytomegalovirus (CMV)
Clinics and Surgery Center (CSC)
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The effect of inflammation and damage to lymph node structures on durable protective immunity following vaccination

Are you planning to receive the yellow fever vaccine for upcoming travel? This study may be for you! How well a vaccine works sometimes varies by geography, with good protection in one part of the world and poor protection in others. In this research study, the research team is investigating if this is due to different infections in communities, which could affect parts of the immune system that are needed for a good response to a vaccine. Healthy participants who receive the yellow fever vaccine in Uganda and Minnesota will have their levels of infections (from viruses, bacteria, fungi, parasites, and helminths [a type of parasitic worm]) compared. This will help us learn more about relationships between these infections, how they affect immune systems, and how that affects the body’s response to a vaccine.

Timothy Schacker
All
18 Years to 60 Years old
Phase 1/Phase 2
This study is also accepting healthy volunteers
NCT04269265
STUDY00004946
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Inclusion Criteria:

• No contraindication to Yellow Fever vaccine (immunosuppressed for any reason or on an immunosuppressive drug where a live virus vaccine is contraindicated).
• If female of childbearing age must agree to contraception for one month following administration of the vaccination.
Exclusion Criteria:

• History of yellow fever or previous vaccination for yellow fever
• Known bleeding disorder
• Prior surgery complicated by clotting abnormality
• Psychiatric or behavioral disorder that, in the opinion of the investigator, will make it difficult for the participant to complete the study
• History of acute hypersensitivity reaction to any component of the vaccine (including gelatin, eggs, egg products, or chicken protein).
• Thymus disorder associated with abnormal immune function
• Immunosuppression from any of the following: HIV infection or AIDS, malignant neoplasms, primary immunodeficiencies, transplantation, transplantation, immunosuppressive or immunomodulatory therapy (corticosteroids, alkylating agents, antimetabolites, TNF inhibitors, IL-1 blocking agents, monoclonal antibodies targeting immune cells), previous radiation therapy.
• Pregnant or breastfeeding at the time of vaccination.
• Planning to conceive within 28 days of enrollment and vaccination with the yellow fever vaccine.
Biological: Yellow Fever Vaccine
Yellow Fever
Clinics and Surgery Center (CSC)

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care / (POPS): NICHD-2019-POP02 (including COVID-19 drugs) (POPS or POP02)

The majority of drugs administered to children are used off label, and PK studies to define appropriate dosing are lacking across pediatric age groups and special populations of children. Challenges associated with clinical trials in children limit the ability to conduct PK and dosing trials in this population. Studies capitalizing on standard-of-care procedures have proven successful in characterizing the PK of drugs used in children. The purpose of this study is to characterize the PK of understudied drugs administered to children per SOC as prescribed by their treating provider. This study will serve as a tool to better understand drug exposure in children receiving drugs per SOC. The data collected through this initiative will provide valuable PK and dosing information for drugs in different pediatric age groups as well as special populations of children, such as premature infants, critically ill children receiving ECMO or CRRT, children with Down syndrome and children with obesity, for which dosing may vary due to altered PK. In addition, the data collected in this study will serve as preliminary data to design and plan the best and most efficacious BPCA trials, proof-of-concept studies associated with biomarkers, and data to support applications for extramural funding. All of the drugs studied in this protocol are used as standard of care in children and are approved in adults. There will be multiple INDs held by the core study Principal Investigator: Danny Benjamin, MD, PhD (IND Sponsor) Kiser-Arena Distinguished Professor of Pediatrics, Duke University Faculty Associate Director, Duke Clinical Research Institute PO Box 17969 Durham NC 27715 Phone: 919-668-8295 Fax: 919-681-9457 danny.benjamin@duke.edu The Funding Sponsor is The National Institute of Child Health and Human Development (NICHD) NOTE: We will be participating in the COVID 19 arm of this study, which includes 6 drugs of interest (DOI). All other arms are on hold currently; and focus has been placed on the COVID 19 arm. However, in the future we may be interested in participating in other DOIs. The details of this arm of the study will be provided at the end of this document. (See Appendix P, pages 82-86 of main protocol)

Catherine Bendel
All
up to 20 Years old
NA
This study is NOT accepting healthy volunteers
NCT04278404
STUDY00009884
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Inclusion Criteria:

• Participant is < 21 years of age
• Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA:
• (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment
Exclusion Criteria:

• Participant has a known pregnancy Below exclusion criteria apply only to participants receiving one or more of the study drugs of interest at the time of enrollment,
• Has had intermittent dialysis within previous 24 hours
• Has had a kidney transplant within previous 30 days
• Has had a liver transplant within previous 1 year
• Has had a stem cell transplant within previous 1 year
• Has had therapeutic hypothermia within previous 24 hours
• Has had plasmapheresis within the previous 24 hours
• Has a Ventricular Assist Device
• Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Drug: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension, Urinary Tract Infections in Children, Hypertension, Pain, Hyperphosphatemia, Primary Hyperaldosteronism, Edema, Hypokalemia, Heart Failure, Hemophilia, Menorrhagia, Insomnia, Pneumonia, Skin Infection, Arrythmia, Asthma in Children, Bronchopulmonary Dysplasia, Adrenal Insufficiency, Fibrinolysis, Hemorrhage, Attention Deficit Hyperactivity Disorder, Multisystem Inflammatory Syndrome in Children (MIS-C), Kawasaki Disease, Coagulation Disorder, Down Syndrome
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An Open-label, Single-arm Study of Letermovir (LTV) for Prevention of Recurrent CMV Infection in High-risk Hematopoietic Cell Transplant (HCT) Recipients

This is an open-label single arm trial of letermovir (LTV, Prevymis) for prevention of recurrent CMV infection in allogeneic hematopoietic cell transplantation (HCT) recipients with history of CMV infection. The study is being conducted at MSKCC and at the University of Minnesota. Thirty-six HCT recipients who are ≥12 years of age, had clinically significant CMV infection treated with CMV antivirals and are at high risk for recurrent CMV infection, defined as receiving a transplant from an HLA mismatched donor (including cord blood), acute or chronic graft versus host disease (GVHD) requiring either topical and/or systemic steroid treatment within 14 days prior to enrollment, or T cell-depleted (CD34+-selected) allograft, will be eligible to participate in the study.

Jo-Anne Young, MD
All
12 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT04017962
STUDY00011646
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Inclusion Criteria:

• Age >/= 12 years (any weight)
• Have received allogenic HCT
• Have received preemptive therapy for clinically significant CMV infection post-HCT and have completed preemptive therapy no longer than 7 days prior to enrollment. Preemptive treatment includes ganciclovir, valganciclovir, foscarnet or cidofovir. Clinically significant CMV infection is defined as CMV viremia requiring preemptive therapy or CMV EOD. Patients who have received LTV prophylaxis prior to onset of clinically significant CMV infection prior to enrollment (see also exclusion criteria below).
• Have one or more risk factors for recurrent CMV infection:
• Human leukocyte antigen (HLA) mismatch
• HLA-related (sibling) donor with at least one mismatch at the HLA-A, -B or -DR gene loci
• Haploidentical donor
• Unrelated donor with at least one mismatch at the HLA-A, -B, -C or -DRC1gene loci, or
• Cord blood as stem cell source
• Acute or chronic GVHD requiring either topical steroids for gastrointestinal GVHD and/or systemic steroid treatment (>/= 1mg/kg/day of prednisone or equivalent dose of another corticosteroid) within 14 days prior to enrollment
• T-cell-depleted allograft ex-vivo or in-vivo T-cell depleting agents including but not limited to ATG, alemtuzimab and post HCT cyclophosphamide.
• For adult patients, able to provide written consent and complete the informed consent. For patients under 18 years, the patient's parent(s) or legal guardian(s) must provide informed consent and the patient must provide written assent to participation in the study.
• Willing and able to comply with trial instructions and requirements
• Male and female patients of childbearing potential must be willing to use a highly effective method of contraception for the course of the study. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient. Subject eligibility criteria for the observational cohort:
• Age 18 years or older
• First allogenic peripheral blood or marrow HCT
• LTV prophylaxis starting <30 days post HCT and given for at least 6 weeks
• T-cell count >/=100 at day +100
Exclusion Criteria:

• Clinically significant CMV infection present at enrollment
• Breakthrough CMV infection while on primary LTV prophylaxis (unless patient non-adherent or unable to adequately absorb letermovir or documented resistance to LTV.
• Glomerular filtration rate (GFR) • Severe hepatic impairment
• Routine use of high-dose acyclovir (doses of > 800 mg twice daily), valacyclovir (doses of > 500mg twice daily), or famciclovir (doses > 500mg/day) for varicella zoster virus (VZV)/herpes simplex virus prophylaxis; limited treatment courses at higher doses for VZV infections are permissible if treatment duration dose not exceed 14 days total. Short courses of IV cidofovir for adeno virus (ADV) are permissible
• Suspected or known hypersensitivity to active or inactive ingredients of LTV formulations
• Patients treated with a medication whose administration with LTV is ontraindicated and whose discontinuation is not possible. Contraindicated medications include pimozide, ergot alkaloids and pitavastatin or simvastatin when co-administered with cyclosporine.
• Imminent demise (expected survival <6 weeks)
• Documented positive result for human immunodeficiency virus antibody (HIV-Ab) or for hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA, or hepatitis B surface antigen (HBsAg) at any time prior to HCT
• Need for mechanical ventilation and/or vasopressor support at the time of enrollment
• Pregnancy or breastfeeding
• Plans to conceive or father children within the projected duration of the trial
• History of current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or would place the subject at undue risk as judged by the investigator, such that it is not in the best interest of the subject to participate in this study.
• The following antivirals are allowed up to the listed dose limits:
• Acyclovir up to 800 mg twice daily
• Valacyclovir up to 500 mg twice daily
• Famciclovir up to 500 mg/day for VZV/HSV prophylaxis; limited treatment courses at higher doses for VZV infections are permissible if treatment duration does not exceed 14 days total.
• Short courses of IV cidofovir for ADV (up to two doses) Exclusion criteria for observational cohort:
• Clinically significant CMV infection during the 100 days following HCT. Clinically significant CMV infection defined as either CMV viremia requiring preemptive therapy with CMV antivirals or CMV end organ disease (EOD)
• Grade 3-4 GVHD
• Cord blood as cell source for HCT
• Treatment with systemic steroids (>0.5mg/kg for 2 weeks or longer) within 3 weeks prior to enrollment
Drug: Letermovir Pill, Other: blood draw
CMV, CMV Infection, Hematopoietic Cell Transplant
HCT, CMV infection, Letermovir, LTV, Memorial Sloan Kettering Cancer Center, 19-174, Clinics and Surgery Center (CSC)
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MET-COVID Trial METformin for Prevention and outpatient treatment of COVID-19: Does Metformin prevent severe COVID-19 disease?

1) Determine whether metformin can prevent ED utilization for Covid-19 disease in persons with SARS-CoV-2 infection; 2) Determine whether metformin is effective post-exposure prophylaxis of SARS-CoV-2 infection in persons with close contact to someone with SARS-CoV-2 infection

Carolyn Bramante
All
30 Years to 85 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04510194
STUDY00011393
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Inclusion Criteria:

• Positive laboratory test for active SARS-CoV-2 viral infection based on local laboratory standard (i.e. +PCR) within 3 days of randomization.
• No known history of confirmed SARS-CoV-2 infection
• BMI >= 25kg/m2 by self-report height/weight or >= 23kg/m2 in patients who self-identify in South Asian or Latinx background.
• Willing and able to comply with study procedures (i.e. swallow pills)
• Has an address and electronic device for communication
• GFR>45ml/min within 2 weeks for patients >75 years old, or with history of heart, kidney, or liver failure.
Exclusion Criteria:

• Hospitalized, for COVID-19 or other reasons.
• Symptom onset greater than 7 days before randomization (symptoms not required for inclusion).
• Immune compromised state (solid organ transplant, bone marrow transplant, AIDS, on high dose steroids)
• Hepatic impairment (Child-Pugh B and C) or other condition that, in the opinion of the investigator, would affect safety
• Inability to obtain informed consent
• Enrollment in another blinded Randomized Controlled Trial for COVID-19
• Already received an effective (FDA approved/EUA*) therapy for COVID-19 (currently monoclonal antibody treatment)
• Alcohol use disorder
• Other unstable medical condition or combination of home medications that in the view of the PI make it unsafe for the individual to participate
• History of severe kidney disease i.e.:
• Stage 4 or 5 CKD, or Estimated Glomerular Filtration Rate (eGFR) of < 45ml/min/1.73 m2
• Other kidney disease that in the opinion of the investigator would affect clearance
• Unstable heart failure (Stage 3 or 4 heart failure)
• Allergic reaction to metformin, fluvoxamine, or ivermectin in the past
• Bipolar disease: individuals who report they have bipolar disorder or are taking medication for bipolar disorder (lithium, valproate, high-dose antipsychotic), unless the investigator concludes that the risk for mania is unlikely
• Current loa loa or onchocerciasis infection
• Typhoid, BCG, or cholera vaccination within the 14-days or 3 days after Medication Exclusions:
• Cimetidine, hydroxychloroquine, insulin, sulfonylurea, dolutegravir, patiromer, ranolazine, tafenoquine.
• Rasagiline, selegiline, or monoamine oxidase inhibitors, linezolid, methadone
• Duloxetine, methylene blue
• Tizanidine, ramelteon, sodium picosulfate
• Alosetron, agomelatine, bromopride, dapoxetine, tamsimelteon, thioridazine, urokinase, pimozide The following medications may not need to be excluded when dose for that individual is considered alongside the low dose of fluvoxamine being used and other medications being used. The PI or site PI may review and decide if the patient should be excluded from the fluvoxamine arms:
• Taking SSRIs, SNRIs, or tricyclic antidepressants, unless these are at a low dose such that a study investigator concludes that a clinically significant interaction with fluvoxamine (ie either serotonin syndrome or TCA overdose) is unlikely (examples: participant takes escitalopram but only at 10mg daily; that dose plus 100mg fluvoxamine would be insufficient to cause serotonin syndrome; or, participant takes amitriptyline but only at 25mg nightly; even if fluvoxamine inhibits its metabolism, it would be an insufficient dose to cause QTc prolongation or problematic side effects). Risk Class C, monitor therapy.
• Individuals who take alprazolam or diazepam and are unwilling to cut the medication by 20% (rationale: fluvoxamine modestly inhibits the metabolism of these drugs). Risk Class C, monitor therapy
• Participants taking theophylline, clozapine, or olanzapine (drugs with a narrow therapeutic index that are primarily metabolized by CYP 1A2, which is inhibited by fluvoxamine) will be reviewed with a study investigator and excluded unless the investigator concludes that the risk to the participant is low (this would be unlikely; example: participant takes clozapine only as needed and is willing to avoid it for the 14 days of the study).
• Patients will be advised that there is a small risk that the following substances will be affected by fluvoxamine, but that significant effects are not likely at the low dose being used: caffeine, nicotine, melatonin. Risk Class C, monitor therapy
• Taking warfarin-also known as Coumadin, NSAIDs, and Aspirin (rationale: increased risk of bleeding), phenytoin (rationale: fluvoxamine inhibits its metabolism), clopidogrel (rationale: fluvoxamine inhibits its metabolism from pro-drug to active drug which raises risk of cardiovascular events), and St John's wort (rationale: fluvoxamine + St John's wort are considered contraindicated because of the risk of serotonin syndrome) Risk C, monitor therapy.
• Additional COVID-19 treatments to exclude will be decided by a panel of at least 3 Co-Investigators on this study. The additional treatments to exclude will be documented and submitted to the IRB but may be implemented before formal IRB approval is complete. We take this approach because of the rapidly changing treatment landscape of COVID-19. Participation in the study does not prevent them from receiving such treatments after enrollment.
Drug: Metformin, Drug: Placebo, Drug: Fluvoxamine, Drug: Ivermectin
COVID-19, Infectious Diseases, Respiratory System, Covid19, SARS-CoV Infection
Covid
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Effect of N-803 on B Cell Follicles in Antiretroviral Treated HIV Disease

The primary objectives of this study are: -To determine the impact of N-803 on the frequency and function of CD8+ T cells in B cell follicles. -To determine the safety of N-803 HIV+ ART suppressed individuals by assessment of adverse events experienced by participants during the conduct of the trial.

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:
• Condoms (male or female) with or without a spermicidal agent
• Diaphragm or cervical cap with spermicide
• Intrauterine device (IUD) with published data showing that expected failure rate is < 1% per year
• Tubal ligation
• 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:
• Platelet counts (≥ 150,000/mm3)
• 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.
• 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:
• acute myocardial infarction
• acute coronary syndromes
• stable or unstable angina
• coronary or other arterial revascularization
• stroke
• transient ischemic attack (TIA)
• 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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Standardized Patients to Measure and Address Intersectional Stigma

All
18 Years to 99 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04896216
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Inclusion Criteria:

• Eligible facilities will be those with:
• formal government accreditation as a medical center (a basic tenet of all public hospitals in China); and
• possession of an accredited on-site laboratory with capacity to provide enzyme-linked immunosorbent assay testing for HIV, treponemal (e.g. Treponema pallidum particle agglutination) and non-treponemal tests (e.g. rapid plasma regain) for syphilis.
• Within eligible and consenting facilities, eligible providers will be those who are licensed at the time of the study to practice dermatovenereology in China.
Exclusion Criteria:

• none
Behavioral: Stigma Reduction Intervention
Hiv, HIV Infections, AIDS
stigma
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014 / ACTIV-3: A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients with COVID-19 (TICO)

Mahsa Abassi
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04501978
STUDY00011184
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Inclusion Criteria:

• Signed informed consent.
• Positive test for COVID-19 and progressive disease suggestive of ongoing COVID-19 infection.
• Symptoms of COVID-19 for ≤ 12 days.
• Require admission to hospital for acute medical care (not for purely public health or quarantine purposes).
Exclusion Criteria:

• Patients who have received plasma from a person who recovered from COVID-19 or who have received neutralizing monoclonal antibodies at any time prior to hospitalization.
• Patients not willing to abstain from participation in other COVID-19 treatment trials until after Day 5 of the study. Co-enrollment in certain trials that compare recommended Standard of Care treatments may be allowed, based on the opinion of the study leadership team.
• Any condition which, in the opinion of the responsible investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments.
• Patients considered unable to participate in study procedures.
• Women of child-bearing potential who are not already pregnant at study entry and who are unwilling to acknowledge strong advice to abstain from sexual intercourse with men or practice appropriate contraception through 18 months of the study.
• Women of child-bearing potential who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with men or practice appropriate contraception through 5 weeks of the study (PF-07304814 investigational agent).
• Pregnant women (PF-07304814 investigational agents).
• Nursing mothers (PF-07304814 investigational agents).
• Men who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through 18 months of the study.
• Men who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through 5 weeks of the study (PF-07304814 investigational agent).
• Presence at study enrollment of any of the following:
• stroke
• meningitis
• encephalitis
• myelitis
• myocardial ischemia
• myocarditis
• pericarditis
• symptomatic congestive heart failure
• arterial or deep venous thrombosis or pulmonary embolism
• Current or imminent requirement for any of the following:
• invasive mechanical ventilation
• ECMO (extracorporeal membrane oxygenation)
• Mechanical circulatory support
• vasopressor therapy
• commencement of renal replacement therapy at this admission (i.e. not patients on chronic renal replacement therapy).
• Participants with moderate to severe hepatic impairment (i.e. Child-Pugh class B or C) or acute liver failure (PF-07304814 investigational agent).
• Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450 (CYP) 3A4 (PF-07304814 investigational agent).
• Patients will be excluded if taking drugs which have a narrow therapeutic window that are substrates of CYP3A4, including but not limited to: astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, pimozide, quinidine, sirolimus, tacrolimus, and terfenadine (PF-07304814 investigational agent).
• Patients with a history of deep vein thrombosis or pulmonary thrombotic embolism (Prior to initial futility assessment of PF-07304814 investigational agent).
Biological: LY3819253, Drug: Placebo, Biological: Remdesivir, Biological: VIR-7831, Biological: BRII-196/BRII-198, Biological: AZD7442, Drug: MP0420, Drug: PF-07304814
Covid19
COVID-19, COVID 19, Coronaviridae Infections, Coronavirus Infections, RNA Virus Infections, Virus Diseases, Nidovirales Infections, SARS-CoV-2, SARS Coronavirus, ACTIV-3, ACTIV3
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A Phase 2/3, Two-Part, Open-Label, Dose Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 months to < 12 Years of Age (mRNA-1273-P204) - COVID-19

The Sponsor of this study, ModernaTX, is studying the mRNA-1273 vaccine for the prevention of COVID-19 in children. This study is being conducted to learn about the safety, any side effects, and how your child’s body responds to the study vaccine (the “immune response”).

Shane McAllister
Phase II/III
This study is also accepting healthy volunteers
NCT04796896
STUDY00012613
SARS-CoV-2
COVID-19, COVID-19 Vaccine, Coronavirus, Messenger RNA, Moderna, SARS-CoV-2, SARS-CoV-2 Vaccine, Virus Diseases, mRNA-1273, mRNA-1273 vaccine
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ACTIV-6: COVID-19 Study of Repurposed Medications

All
30 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04885530
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Inclusion Criteria:

• Completed Informed Consent
• Age ≥ 30 years old
• Confirmed SARS-CoV-2 infection by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days of screening
• Two or more current symptoms of acute infection for ≤7 days. Symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell
Exclusion Criteria:

• Prior diagnosis of COVID-19 infection (> 10 days from screening)
• Current or recent (within 10 days of screening) hospitalization
• Known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo
• Known contraindication(s) to study drug including prohibited concomitant medications
Drug: Ivermectin, Drug: Fluvoxamine, Drug: Fluticasone, Other: Placebo
Covid19
SARS-CoV-2, COVID-19, ivermectin, Placebo, Duke University Health System, Outcomes, Duke Clinical Research Institute, fluticasone, fluvoxamine, ACTIV 6, ACTIV
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Understanding the long term impact of COVID-19 on the brain by advanced MR imaging and spectroscopy

In this study, we want to learn more about what kinds of structural and chemical changes are happening in the nervous systems of people recovering from COVID-19 compared to people who have not been exposed to COVID-19.

Gulin Oz
18 Years and over
NA
This study is also accepting healthy volunteers
RAD-2021-29124
STUDY00012571
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Inclusion Criteria:

• Participants must be 18 years or older
• Participants must fall into one of the following groups: a) no known COVID-19 exposure (for controls), or b) laboratory confirmed COVID-19 who present with neurological symptoms in the months after infection and were either 1) non-hospitalized, or 2) hospitalized, but never underwent invasive (tube in throat) ventilation
• Participants must be English or Spanish speaking
• Participants must be able to provide written informed consent
• Participants must be clear of any contraindications for MRI (see exclusions) *Study not registered on Clinicaltrials.gov
Exclusion Criteria:

• Medical conditions likely to interfere with the study, including chronic neurologic conditions (such as Alzheimer disease, Parkinson's disease, ALS, HIV-Associated Neurocognitive Disorder, brain infections, or brain tumors), traumatic brain injury with loss of consciousness, end-stage kidney disease, end-stage liver disease, restless leg syndrome, chronic lung disease unrelated to COVID-19 needing oxygen, history of stroke unrelated to COVID-19, history of bipolar disorder or psychotic illness (such as schizophrenia or schizoaffective disorder)
• Individuals who had COVID-19 and required mechanical invasive ventilation
• Pregnant women
• Inability to undergo MRI scanning, including but not limited to claustrophobia, unable to remain still in an MRI scanner for more than 30 minutes, presence of metallic foreign bodies or pacemakers in body, weight over 350 lbs. *Study not registered on Clinicaltrials.gov
Brain & Nervous System, COVID-19
CMRR, COVID-19, Coronavirus, MRI, MRS, SARS-CoV-2, long COVID, long-term, neurological
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Study of Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant (Prevent)

All
1 Year and over
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT05305040
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Key
Inclusion Criteria:

• ≥1 year of age at the day of screening visit.
• No known or suspected clinically significant disease from AdV, BKV, CMV, EBV, HHV-6, and/or JCV
• Within 15 and 42 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment
• Meet one or more of the following criteria at the time of randomization:
• Related (sibling) donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B or -DR
• Haploidentical donor
• Matched or Mismatched unrelated donor
• Use of umbilical cord blood as stem cell source
• Ex vivo graft manipulation resulting in T cell depletion
• Received anti-thymocyte globulin or alemtuzumab (Campath-1H) Key
Exclusion Criteria:

• History of AdV, BKV, CMV, EBV, HHV-6, and/or JCV end-organ disease within 6 months prior to randomization
• Evidence of active Grade >2 acute GVHD
• Presence of non-minor uncontrolled or progressive bacterial, viral or fungal infections
• Known history or current (suspected) diagnosis of CRS requiring treatment associated with the administration of peptides, proteins, and/or antibodies
• Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >0.5 mg/kg/day) within 24 hours prior to dosing
• Relapse of primary malignancy other than minimal residual disease Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Biological: Posoleucel (ALVR105), Biological: Placebo
Adenovirus Infection, BK Virus Infection, Cytomegalovirus Infections, Epstein-Barr Virus Infections, Human Herpes Virus-6 Infection, JC Virus Infection
Allogeneic Hematopoietic Cell Transplant, ALVR105, Posoleucel, Viralym-M
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MT2021-33: Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial, with Cross-Over, of Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation

To compare the percent of participants who have clearance of AdV viremia at Day 29 in participants receiving posoleucel and standard of care to that in participants receiving placebo and standard of care.

Paul Orchard
Phase III
This study is NOT accepting healthy volunteers
NCT05179057
STUDY00014640
Adenovirus Infection
ALVR105, Adenoviremia, Adenovirus, Allogeneic Hematopoietic Cell Transplant, Clinics and Surgery Center (CSC), Posoleucel, Stem cell transplant
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Evaluation of Point-of-Care (EPOC) for COVID-19 ((EPOC))

The overall objective of this protocol is to assess the feasibility of using POC antibody tests for patient management.

All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT05227404
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Inclusion Criteria:

• Age ≥ 18 years.
• Informed consent by the patient or the patient's legally authorized representative (LAR) for up to 4 fingersticks for POC testing and a blood draw for stored blood samples.
• SARS-CoV-2 infection, documented by a nucleic acid test (NAT) or equivalent testing within 3 days prior to consent OR documented by NAT or equivalent testing more than 3 days prior to consent AND progressive disease suggestive of ongoing SARS-CoV-2 infection per the responsible investigator. (For non-NAT tests, only those deemed with equivalent specificity to NAT by the protocol team will be allowed. A central list of allowed non-NAT tests is maintained for TICO and that list will also be used for this protocol.)
• Duration of symptoms attributable to COVID-19 ≤ 12 days per the responsible investigator.
• Requiring admission for inpatient hospital acute medical care for clinical manifestations of COVID-19, per the responsible investigator, and NOT for purely public health or quarantine purposes.
Exclusion Criteria:

• Prior receipt of SARS-CoV-2 hIVIG, convalescent plasma from a person who recovered from COVID-19, or SARS-CoV-2 nMAb within 6 months of the blood draws for testing as part of this protocol.
• Disease severity beyond that of stratum 1 in the TICO trial. This includes the following conditions:
• stroke
• meningitis
• encephalitis
• myelitis
• myocardial infarction
• myocarditis
• pericarditis
• symptomatic congestive heart failure (CHF; New York Heart Association [NYHA] class III-IV)
• arterial or deep venous thrombosis or pulmonary embolism
• Current requirement for any of the following:
• high-flow supplemental oxygen
• non-invasive ventilation
• invasive mechanical ventilation
• extracorporeal membrane oxygenation
• mechanical circulatory support
• vasopressor therapy
• commencement of renal replacement therapy at this admission (i.e., not patients on chronic renal replacement therapy).
• In the opinion of the responsible investigator, any condition for which, participation would not be in the best interest of the participant or that could limit protocol specified assessments.
Diagnostic Test: LumiraDX, Diagnostic Test: RightSign, Diagnostic Test: Case Control
COVID-19, SARS CoV 2 Infection
COVID-19, SARS COV 2, COVID19 testing
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HOPE in Action Trial of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients

All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03734393
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Inclusion Criteria:

• Participant meets the standard criteria for liver transplant at the local center.
• Participants being listed for a simultaneous liver kidney (SLK) are eligible if participants meet the standard criteria for both organs.
• Participant is able to understand and provide informed consent.
• Participant meets with an independent advocate per the HIV Organ Policy Equity (HOPE) Act Safeguards and Research Criteria.
• Documented HIV infection (by any licensed assay or documented history of detectable HIV-1 RNA).*
• Participant is ≥ 18 years old.
• Opportunistic complications: prior history of certain opportunistic infections is not an exclusion if the participant has received appropriate therapy and has no evidence of active disease. Medical record documentation should be provided whenever possible.
• CD4+ T-cell count: ≥ 100/µL within 16 weeks prior to transplant if no history of AIDS-defining infection; or ≥ 200 μL if history of opportunistic infection is present.
• HIV-1 RNA is below 50 RNA/mL.* Viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements > 200 copies/mL. *Organ recipients who are unable to tolerate anti-retroviral therapy (ART) due to organ. failure or recently started ART may be eligible despite a detectable viral load if safe and effective ART to be used by the recipient after transplantation is described.
• Participant must have or be willing to start seeing a primary medical care provider with expertise in HIV management.
• Participant is willing to comply with all medications related to participant's transplant and HIV management.
• For participants with a history of aspergillus colonization or disease, no current clinical evidence of active disease.
• Agreement to use contraception.
• Participant is not suffering from significant wasting (e.g. body mass index < 21) thought to be related to HIV disease.
Exclusion Criteria:

• Participant has a history of progressive multifocal leukoencephalopathy (PML), or primary central nervous system (CNS) lymphoma.*
• Participant is pregnant or breastfeeding. (Note: Participants who become pregnant post-transplant will continue to be followed in the study and will be managed per local site practice. Women that become pregnant should not breastfeed.)
• Past or current medical problems or findings from medical history, physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Other: HIVD+/R+
Hiv
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