Transplanting organs from HIV-positive donors to HIV-positive recipients

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

This study tests whether using organs from HIV-positive donors for HIV-positive recipients is safe and effective compared to using organs from HIV-negative donors.

Quick facts

• Study type: Observational
• Enrollment: 125 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Johns Hopkins University (other)
• Locations: 18 sites (Aurora, Colorado and 17 other locations)
• Trial ID: NCT02602262 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the safety and efficacy of solid organ transplants from HIV-positive deceased donors to HIV-positive recipients. Participants will be monitored for overall survival and graft survival, comparing outcomes with those receiving organs from HIV-negative donors. The study will also assess potential complications such as HIV superinfection, graft rejection, and opportunistic infections. The goal is to better understand the implications of using HIV-positive organs in transplantation.

Who should consider this trial

Good fit: Ideal candidates include HIV-positive individuals with end-stage organ disease who meet standard clinical criteria for transplantation.

Not a fit: Patients who are HIV-negative or those with active opportunistic infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could expand organ transplant options for HIV-positive individuals, improving their health outcomes.

How similar studies have performed: Other studies have explored organ transplantation in HIV-positive patients, but this specific approach of using HIV-positive donors is relatively novel.

Eligibility criteria

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.

Where this trial is running

Aurora, Colorado and 17 other locations

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

Study contacts

• Principal investigator: Christine Durand, MD — Johns Hopkins University
• Study coordinator: Christine Durand, MD

Conditions: HIV Infection