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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
1608M93841
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.
• 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.
Clinics and Surgery Center (CSC)
Investigation of Persistent HIV Immune Stimulation in Lymphoid Tissues During Therapy as a Cause of Sustained Immune Activation
Even when HIV levels are suppressed in the blood, HIV infection continues to cause immune system activation that can lead to other health problems in people living with HIV. In this study, we want to see if there is a relationship between the levels of HIV medications within cells, how many cells in the body are still producing HIV, and how the immune system continues to be activated. Participants will be asked to provide blood and stool samples, have a colonoscopy with biopsy samples from their gut, and a lymph node biopsy. There are three study visits including a short visit for a COVID-19 nasal swab. Blood will be collected at the first and third visit. Colon and lymph node biopsies will also be collected at the third visit.
Timothy Schacker
STUDY00009216
Inclusion Criteria:
• At least 18 years of age
• HIV infection
• Receiving an ART regimen
• Able to provide written voluntary consent before performance of any study related procedure.
Exclusion Criteria:
• BMI greater or equal to 30
• Currently taking anticoagulant blood thinners such as warfarin, enoxaparin, heparin
• Pregnant or breastfeeding
• Adults lacking capacity to consent and/or adults with diminished capacity to consent, including, but not limited to, those with acute medical conditions, psychiatric disorders, neurologic disorders, developmental disorders, and behavioral disorders.
• More than 3 pervious lymph node biopsies for the main study. No more than 2 lymph nodes for the sub-study.
Infectious Diseases
HIV, immune activation, immune response
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
1610M98383
Inclusion Criteria:
• at least 18 years old
• female, or transgender female with a cervix
• HIV- positive
• on a stable antiretroviral regimen containing tenofovir or emtricitabine for at least 2 weeks before starting the study
Exclusion Criteria:
• currently pregnant, or previous pregnancy in the past 3 months, or breast feeding
• vaginal infection within 2 weeks before starting the study
• abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior starting the study
• use of oral and/or vaginal preparations of antibiotic or antifungal medications within 30 days prior to starting the study
Women's Health
HIV/AIDS, Inflammation Vagina, Menopause