Observational Study of HIV+ Deceased Donor Transplant for HIV+ Recipients

HIV Infection Clinical Trial

Official title:

Observational Study of HIV+ Deceased Donor Solid Organ Transplant for HIV+ Recipients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02602262
• Other study ID #: IRB00085148
• Secondary ID: JHUHIVDD1U01AI13
• Status: Recruiting
• Start date: November 2015
• Est. completion date: July 1, 2026

Study information

• Verified date: December 2023
• Source: Johns Hopkins University
• Contact: Christine Durand, MD
• Phone: 410-955-5684
• Email: cdurand2[@]jhmi.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

HIV-infected (HIV+) individuals who agree to accept and receive a solid organ transplant from an HIV+ deceased donor will be followed to determine the safety and efficacy of this practice. Some HIV+ individuals who receive a solid organ transplant from HIV-uninfected (HIV-) donors will also be followed.

Description:

This is an observational study designed to evaluate safety and outcomes of solid organ transplantation in HIV+ recipients of HIV+ deceased donor organs. This study will evaluate overall survival and graft survival compared to transplantation with an HIV- organ.

In addition the study will assess potential complications of organ transplant using HIV+ deceased donors - including but not limited to - HIV superinfection, incidence and severity of graft rejection, recurrence of HIV-associated nephropathy, incidence of bacterial infections, and opportunistic infections.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: July 1, 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All individuals with end-stage organ disease and HIV infection who meet standard clinical criteria for transplantation and the study inclusion and exclusion criteria will be eligible for participation in the study.

1. Participant is able to understand and provide informed consent

2. Participant meets standard listing criteria for transplant.

3. Documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV Ab Immunofluorescence Assay (IFA), or documented history of detectable HIV-1 RNA).

4. Participant is > 18 years old.

5. Opportunistic Complications: None or previous history of protocol allowed opportunistic infections or neoplasms with appropriate acute and maintenance therapy and no evidence of active disease.

6. Participant CD4+ T-cell count is >/= 200/µL in the 16 weeks prior to transplant.

7. Participant most recent HIV-1 RNA < 50 copies/mL (by any FDA-approved assay performed in Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory) and on a stable antiretroviral regimen. Non-consecutive viral "blips" between 50-400 copies RNA/mL will be allowed. The Federal Register HIV Organ Policy Equity (HOPE) Act Final Safeguards and Research criteria does not specify a required frequency of HIV-1 RNA monitoring to determine recipient eligibility. The most recent HIV Viral Load (VL) should be < 50 copies, but this result can be documented outside the 16 week window according to the judgement of the local clinical team and site investigator. Organ recipients who are unable to tolerate Antiretroviral Therapy (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 to be used by the recipient once organ function is restored after transplantation.

8. Participant is willing to use Pneumocystis Carinii Pneumonia (PCP), herpes virus and fungal prophylaxis as indicated.

Exclusion Criteria:

1. Participant has concomitant conditions that, in the judgment of the investigators, would preclude transplantation or immunosuppression.

2. Opportunistic Complication History: Any history of progressive multifocal leukoencephalopathy (PML), chronic intestinal cryptosporidiosis of > 1 month duration, or primary Central Nervous System (CNS) lymphoma.

3. 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.

4. 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 clinical practice. Women that become pregnant should not breastfeed.

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

Other:
• HIV-infected deceased donor organ
HIV-infected deceased donor organ transplant

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Colorado Denver	Aurora	Colorado
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Maryland, Institute of Human Virology	Baltimore	Maryland
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Methodist Health System	Dallas	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	New York University School of Medicine	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (19)

Lead Sponsor

Collaborator

Johns Hopkins University

Columbia University, Emory University, Georgetown University, Icahn School of Medicine at Mount Sinai, Indiana University, Methodist Health System, National Institute of Allergy and Infectious Diseases (NIAID), Northwestern University, NYU Langone Health, Rush University Medical Center, University of Colorado, Denver, University of Illinois at Chicago, University of Maryland, University of Pittsburgh Medical Center, University of Virginia, Washington University School of Medicine, Weill Medical College of Cornell University, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Patient survival at one year	One year
Secondary	Graft survival	Transplanted organ function	one year, two years, 3 years, 4 years
Secondary	Graft rejection	Incidence and severity of organ rejection	One year
Secondary	HIV disease progression	Incidence of virologic breakthrough or failure	through study completion, up to 4 years
Secondary	Antiretroviral resistance and X4 tropic virus	incidence of new antiretroviral drug resistance and/or X4 tropic virus	through study completion, up to 4 years
Secondary	Incidence of bacterial, fungal, viral, and other opportunistic infection	incidence of bacterial, fungal, viral, and other opportunistic infections	through study completion, up to 4 years
Secondary	Surgical complications	incidence of surgical and vascular transplant complications	within the first 3 months
Secondary	Recurrent HIV-associated nephropathy	incidence of recurrent HIV-associated nephropathy in kidney recipients	through study completion, up to 4 years
Secondary	Incidence of post-transplant Malignancy	incidence of post-transplant malignancies	through study completion, up to 4 years
Secondary	Incidence of HIV superinfection in blood and/or tissue	Incidence of HIV superinfection in blood and/or tissue	measured at 3 months, 6 months, year 1, year 2, year 3, year 4
Secondary	HIV latent reservoir	Frequency of infected CD4 T cells in blood	measured at 3 months, 6 months, year 1, year 2, year 3, year 4
Secondary	Immune activation	Cytokine levels	measured at 3 months, 6 months, year 1, year 2, year 3, year 4