Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
NCT ID:
NCT05159466
Eligibility Criteria:
Recipient Criteria
Inclusion Criteria:
* Participant meets standard listing criteria for transplant.
* Greater than or equal to 18 years of age.
* Participant has documented HIV infection using an FDA-licensed, approved, or cleared test device(s).
* CD4+ T-cell count ≥200/μL within 16 weeks prior to transplant; any patient with history of Opportunistic Infections must have a CD4 positive T-cell count ≥200/uL.
* HIV RNA less than 50 copies/mL and on a stable antiretroviral regimen.
* No evidence of active opportunistic complications of HIV infection.
* 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.
* No history of primary CNS lymphoma or progressive PML
Exclusion Criteria:
* Participant has concomitant conditions that, in the judgment of the investigators, would preclude transplantation or immunosuppression.
* Less than 18 years of age.
* Requires multi-organ transplantation.
* Participant is pregnant or breastfeeding.
* Participant has a history of progressive multifocal leukoencephalopathy (PML), chronic intestinal cryptosporidiosis of \> 1 month duration, or primary CNS lymphoma.
* Participant has a history of any neoplasm except for the following: resolved Kaposi's sarcoma, in situ anogenital carcinoma, adequately treated basal or squamous cell carcinoma of the skin, solid tumors (except primary CNS lymphoma) treated with curative therapy and disease free for more than 5 years. History of renal cell carcinoma requires disease-free state for 2 years. History of leukemia and disease free duration will be per site policy.
* Participants who are unable or unwilling to provide informed consent.
Donor Criteria Deceased Donor Criteria
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(s) to be prescribed for the recipient and justify its conclusion that the regimen will be safe, tolerable and effective.
6. Pre-implant donor organ biopsy to be stored, at a minimum, for the duration of the study (or at least 5 years).
7. For donors with newly diagnosed/discovered HIV-1 infection, any HIV-1 RNA viral load is allowed assuming the donor meets other criteria and the HIV/Transplant Infectious Diseases team is able to predict a tolerable and effective ART regimen for the recipient.
8. If there is any history of documented antiretroviral resistance in the donor by medical chart review, the HIV/Transplant Infectious Diseases team is able to predict a tolerable and effective ART regimen for the recipient.
9. Donors with documented chronic hepatitis C virus (HCV+) co-infection (detectable HCV nucleic acid using any licensed assay in a CLIA certified lab) can be used only for HCV+ participants.
Living Donor Criteria
1. Greater than or equal to 18 years of age
2. Donor meets all clinical criteria to be a living donor other than being HIV positive.
3. Donor has consented to participate as a HIV-Positive Donor under the separate Addendum protocol.
4. Documented HIV infection using an FDA-licensed, approved, or cleared test device.
5. Well-controlled HIV infection, as evidenced by:
1. CD4+ T-cell count ≥500/mL for the 6-month period preceding donation.
2. Fewer than 50 copies/mL of HIV- 1 RNA detectable by ultrasensitive or real-time polymerase chain reaction (PCR) assay.
6. No evidence of invasive opportunistic complications of HIV infection
7. A kidney biopsy 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.
8. A complete history of ART regimens and ART resistance.
9. The study team must be able to predict a safe, tolerable, and effective regimen to be prescribed for the recipient based on the donor's current ART regimen as well as the donor's history of ART resistance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05159466
Study Brief:
Protocol Section:
NCT05159466