Human Immunodeficiency VirusNCT05159466
Tulane Abdominal Transplant Institute (TATI) of Solid Organ Transplantation of HIV-Positive Recipients From HIV-Positive Donors
An observational study of Human Immunodeficiency Virus and End Stage Renal Disease, run by Tulane University at 1 site in United States.
Trial summary
The U.S. Department of Health and Human Services (HHS), through the National Institutes of Health (NIH), published Final Human Immunodeficiency Virus (HIV) Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for Transplantation of Organs Infected With HIV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus, End Stage Renal Disease
- What is being tested?
- Kidney transplant
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited at the Tulane Abdominal Transplant Institute site where they are evaluated and followed for organ transplantation as part of standard of care. HIV-positive adult candidates on the wait list or referred for organ transplantation evaluation willing to accept an HIV positive organ will be recruited.
Who may be able to join
- 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
Who cannot join
- 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.
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- Participants who are unable or unwilling to provide informed consent.
- Donor Criteria Deceased Donor Criteria
- 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(s) to be prescribed for the recipient and justify its conclusion that the regimen will be safe, tolerable and effective.
- Pre-implant donor organ biopsy to be stored, at a minimum, for the duration of the study (or at least 5 years).
- 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.
- 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.
- 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
- Greater than or equal to 18 years of age
- Donor meets all clinical criteria to be a living donor other than being HIV positive.
- Donor has consented to participate as a HIV-Positive Donor under the separate Addendum protocol.
- Documented HIV infection using an FDA-licensed, approved, or cleared test device.
- Well-controlled HIV infection, as evidenced by:
- CD4+ T-cell count ≥500/mL for the 6-month period preceding donation.
- Fewer than 50 copies/mL of HIV- 1 RNA detectable by ultrasensitive or real-time polymerase chain reaction (PCR) assay.
- No evidence of invasive opportunistic complications of HIV infection
- 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.
- A complete history of ART regimens and ART resistance.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
East Jefferson General Hospital
Metairie, Louisiana, 70006
Alfred Luk, MD, 504-988-7316, aluk@tulane.edu
Delainna Bartholomew, BS, 504-988-6902, dbartho@tulane.edu
About this study
Official title: Tulane Abdominal Transplant Institute (TATI) of Solid Organ Transplantation of HIV-Positive Recipients From HIV-Positive Donors (TATI HOPE Act)
The U.S. Department of Health and Human Services (HHS), through the National Institutes of Health (NIH), published Final Human Immunodeficiency Virus (HIV) Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for Transplantation of Organs Infected With HIV. All such transplants must occur under an institutional review board (IRB) approved research protocol that is compliant with federal regulations governing human subjects research. This is an investigator-initiated, observational prospective study of solid organ transplantation utilizing HIV-positive donors in HIV positive recipients. Stable HIV-infected adults in need of a solid organ transplant (kidney) who meet standard and study specified HIV criteria for organ transplantation will be offered enrollment in the study. Deceased donors (kidney) and living donors (kidney) will be utilized in this protocol.
The goal of this research is to increase knowledge about the safety, efficacy, and effectiveness of solid organ transplantation (SOT) utilizing HIV-positive donors in HIV-positive recipients.
Read the detailed description
This is an observational prospective study of solid organ transplantation utilizing HIV-positive donors in HIV-positive recipients. Stable HIV-infected adults in need of a solid organ transplant (kidney) who meet standard and study specified HIV criteria for organ transplantation will be offered enrollment in the study. Deceased donors (kidney) and living donors (kidney) will be utilized in this protocol. 25 stable HIV-infected adults in need of a solid organ transplant (kidney) who meet standard and study specified HIV criteria for organ transplantation and 5 living donors (kidney) will be offered enrollment in the study. Living donors will be followed under a separate addendum protocol.
Each HIV-positive recipient and prospective HIV-positive recipient will be provided an independent advocate who is responsible for protecting and promoting the rights and interests of the HIV-positive recipient (or prospective recipient). The purpose of the independent advocate for the HIV-positive recipient is to:
- Promote and protect the interests of the HIV-positive prospective recipient (including with respect to having access to a suitable HIV-negative organ if it becomes available).
- Take steps to ensure that the HIV-positive recipient's decision is informed and free from coercion.
- Review whether the potential HIV-positive prospective recipient has received information regarding the results of Solid Organ Transplantation in general and transplantation in HIV positive recipients in particular and the unknown risks associated with HIV-positive to HIV-positive transplant.
All potential participants who provide informed consent will be enrolled into the pre-transplant phase of the study. In the pre-transplant phase of the study, standard and HIV-specific eligibility will be confirmed. Enrolled participants will consent to the collection of retrospective medical record data including but not limited to clinic notes, laboratory data, diagnostic procedures and reports for all prior HIV therapies.
As per Health Resource Services Administration (HRSA) and Organ Procurement and Transplantation Network (OPTN)/Policy 15.6, at the time of transplant listing "willing to accept an HIV-positive organ" status will be indicated in the secure database used by both transplant hospitals and organ procurement organizations to coordinate organ recovery and waitlist candidate matching. HIV-positive matches will be run for study participants who have indicated an interest in HIV+ organs. If an HIV+ organ becomes available for a participant, the participant will have an opportunity to accept or defer the organ offer. Participants who accept an HIV+ or HIV suspected false positive organ offer will enter the Post-Transplant Follow-up Phase for HIV D+/R+ participants and participants who accept an HIV- (D) organ offer will enter the Post -Transplant Follow-up Phase for HIV D-/R+ participants.
Participants will then be followed prospectively for up to 5 years. Demographic and clinical data on the donors and recipients (and outcomes) will be extracted from the United Network for organ Sharing (UNOS) and Scientific Registry of Transplant Recipient (SRTR) databases. During this prospective follow-up, all medical record data includes but is not limited to records of hospitalization, laboratory reports, clinic notes, medication lists, biopsy results, and documentations of current therapies.
- Being tested
- Kidney transplant
- Keywords
- Organ donor, Organ recipient, Kidney Transplant, HOPE Act, HIV
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney transplantProcedure or surgery
Also called Nephrectomy
Participants will be recruited at the Tulane Abdominal Transplant Institute site where they are evaluated and followed for organ transplantation as part of standard of care. HIV-positive adult candidates on the wait list or referred for organ transplantation evaluation willing to accept an HIV positive organ will be recruited.
| Study group | Role | What they receive |
|---|---|---|
| Kidney transplant recipients | Up to 25 HIV-positive participants requiring kidney organ transplantation Receives: Procedure: Kidney transplant | |
| Kidney living donors | Up to 5 HIV-positive living donors will be enrolled. Receives: Procedure: Kidney transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient mortality rate after kidney transplant
Patient will be followed after kidney transplant and the mortality rate will be measured by patient survival post op.
Measured: 1 Year
Secondary outcomes (2)
Graft survival in transplant recipients
The graft survival will be measured in transplant recipients by:
- Proportion of participants with Estimated Glomerular Filtration Rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) < 60 mL/min/1.73 m2 .
- Proportion of participants with defined Chronic Kidney Disease (CKD) stage 4 or 5.
- Mean calculated eGFR by CKD-EPI.
Measured: 3, 6, 9, 12, 24, 36, 48, 60 Months
Incidence and severity of graft rejection for transplant recipients
The incidence and severity of graft rejection in transplant recipients will be measured by:
- Incidence of clinically suspected and biopsy proven acute rejection within the study period as defined as histologic evidence of rejection and graft dysfunction on biopsy.
- The severity of first and highest grade of acute cellular rejection within the study period.
- The incidence of antibody mediated rejection.
- The type of treatment for rejection. (The graft biopsy or kidney transplant recipients of HIV+ donor at month 6 and year 1 and for all transplant recipients at any point the clinical team feels is indicated).
Measured: 6, 9, 12, 24, 36, 48, 60 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start15 Nov 2021
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alfred Luk, MD, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159466
- Sponsor's protocol ID
- 2021-407
- Status last verified
- Sep 2025
- First submitted
- 1 Dec 2021
- Last updated
- 2 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tulane Abdominal Transplant Institute (TATI) of Solid Organ Transplantation of HIV-Positive Recipients From HIV-Positive Donors (TATI HOPE Act)
- ClinicalTrials.gov ID
- NCT05159466
- Acronym / sponsor ID
- 2021-407
- Keywords
- Organ donor, Organ recipient, Kidney Transplant, HOPE Act, HIV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The U.S. Department of Health and Human Services (HHS), through the National Institutes of Health (NIH), published Final Human Immunodeficiency Virus (HIV) Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for Transplantation of Organs Infected With HIV. All such transplants must occur under an institutional review board (IRB) approved research protocol that is compliant with federal regulations governing human subjects research. This is an investigator-initiated, observational prospective study of solid organ transplantation utilizing HIV-positive donors in HIV positive recipients. Stable HIV-infected adults in need of a solid organ transplant (kidney) who meet standard and study specified HIV criteria for organ transplantation will be offered enrollment in the study. Deceased donors (kidney) and living donors (kidney) will be utilized in this protocol.
The goal of this research is to increase knowledge about the safety, efficacy, and effectiveness of solid organ transplantation (SOT) utilizing HIV-positive donors in HIV-positive recipients.
Detailed description
This is an observational prospective study of solid organ transplantation utilizing HIV-positive donors in HIV-positive recipients. Stable HIV-infected adults in need of a solid organ transplant (kidney) who meet standard and study specified HIV criteria for organ transplantation will be offered enrollment in the study. Deceased donors (kidney) and living donors (kidney) will be utilized in this protocol. 25 stable HIV-infected adults in need of a solid organ transplant (kidney) who meet standard and study specified HIV criteria for organ transplantation and 5 living donors (kidney) will be offered enrollment in the study. Living donors will be followed under a separate addendum protocol.
Each HIV-positive recipient and prospective HIV-positive recipient will be provided an independent advocate who is responsible for protecting and promoting the rights and interests of the HIV-positive recipient (or prospective recipient). The purpose of the independent advocate for the HIV-positive recipient is to:
- Promote and protect the interests of the HIV-positive prospective recipient (including with respect to having access to a suitable HIV-negative organ if it becomes available).
- Take steps to ensure that the HIV-positive recipient's decision is informed and free from coercion.
- Review whether the potential HIV-positive prospective recipient has received information regarding the results of Solid Organ Transplantation in general and transplantation in HIV positive recipients in particular and the unknown risks associated with HIV-positive to HIV-positive transplant.
All potential participants who provide informed consent will be enrolled into the pre-transplant phase of the study. In the pre-transplant phase of the study, standard and HIV-specific eligibility will be confirmed. Enrolled participants will consent to the collection of retrospective medical record data including but not limited to clinic notes, laboratory data, diagnostic procedures and reports for all prior HIV therapies.
As per Health Resource Services Administration (HRSA) and Organ Procurement and Transplantation Network (OPTN)/Policy 15.6, at the time of transplant listing "willing to accept an HIV-positive organ" status will be indicated in the secure database used by both transplant hospitals and organ procurement organizations to coordinate organ recovery and waitlist candidate matching. HIV-positive matches will be run for study participants who have indicated an interest in HIV+ organs. If an HIV+ organ becomes available for a participant, the participant will have an opportunity to accept or defer the organ offer. Participants who accept an HIV+ or HIV suspected false positive organ offer will enter the Post-Transplant Follow-up Phase for HIV D+/R+ participants and participants who accept an HIV- (D) organ offer will enter the Post -Transplant Follow-up Phase for HIV D-/R+ participants.
Participants will then be followed prospectively for up to 5 years. Demographic and clinical data on the donors and recipients (and outcomes) will be extracted from the United Network for organ Sharing (UNOS) and Scientific Registry of Transplant Recipient (SRTR) databases. During this prospective follow-up, all medical record data includes but is not limited to records of hospitalization, laboratory reports, clinic notes, medication lists, biopsy results, and documentations of current therapies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kidney transplant recipients | – | Procedure: Kidney transplantUp to 25 HIV-positive participants requiring kidney organ transplantation |
| Kidney living donors | – | Procedure: Kidney transplantUp to 5 HIV-positive living donors will be enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited at the Tulane Abdominal Transplant Institute site where they are evaluated and followed for organ transplantation as part of standard of care. HIV-positive adult candidates on the wait list or referred for organ transplantation evaluation willing to accept an HIV positive organ will be recruited.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kidney transplantAlso: NephrectomyParticipants will be recruited at the Tulane Abdominal Transplant Institute site where they are evaluated and followed for organ transplantation as part of standard of care. HIV-positive adult candidates on the wait list or referred for organ transplantation evaluation willing to accept an HIV positive organ will be recruited. | Procedure or surgery | Kidney living donors, Kidney transplant recipients |
Primary outcome
Patient mortality rate after kidney transplant
Time frame: 1 Year
Patient will be followed after kidney transplant and the mortality rate will be measured by patient survival post op.
2 secondary outcomes
Graft survival in transplant recipients
Time frame: 3, 6, 9, 12, 24, 36, 48, 60 Months
Incidence and severity of graft rejection for transplant recipients
Time frame: 6, 9, 12, 24, 36, 48, 60 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alfred Luk, MD principal investigator
Tulane University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus and End Stage Renal Disease, run by Tulane University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alfred Luk, MD, ((504) 988-7316, aluk@tulane.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient mortality rate after kidney transplant (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.