HIV-to-HIV Transplant at MGH

• ClinicalTrials.gov Identifier: NCT02750397
• Recruitment Status: Active, not recruiting
• First Posted: April 25, 2016
• Last Update Posted: January 31, 2020
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Nahel Elias, M.D., Massachusetts General Hospital

Study Description

Brief 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. HIV+ individuals who receive a solid organ transplant from HIV-uninfected donors will also be followed.

Condition or disease
HIV; Awaiting Organ Transplant

Detailed Description:

This is an observational study designed to evaluate safety and outcomes of solid organ transplantation in HIV+ recipients of HIV+ deceased donors. 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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 10 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Study of HIV+ Deceased Donor Transplant for HIV+ Recipients
• Study Start Date: August 2016
• Estimated Primary Completion Date: May 2020
• Estimated Study Completion Date: December 2022

Groups and Cohorts

Group/Cohort
HIV D+/R+; HIV+ recipients who receive an organ transplant from an HIV+ donor
HIV D-/R+; HIV+ recipients who receive an organ transplant from an HIV- donor

Outcome Measures

Primary Outcome Measures :

1. Patient Survival [ Time Frame: One Year ]

Secondary Outcome Measures :

1. Graft Survival [ Time Frame: One, Two, Three Years ]
2. Graft Rejection [ Time Frame: One, Two, Three Years ]
3. HIV Disease Progression [ Time Frame: One, Two, Three Years ]
4. Development of antiretroviral resistance and X4 tropic virus [ Time Frame: Through study completion, up to three years ]
5. Incidence of bacterial, fungal, viral and other opportunistic infections [ Time Frame: Through study completion, up to three years ]
6. Incidence of other transplant complications (surgical and vascular) [ Time Frame: Through study completion, up to three years ]
7. Analysis of recurrent HIV associated nephropathy [ Time Frame: Through study completion, up to three years ]
8. Incidence of post-transplant malignancies [ Time Frame: Through study completion, up to three years ]
9. Incidence of systemic HIV-superinfection [ Time Frame: Through study completion, up to three years ]
10. Changes in HIV latent viral reservoir [ Time Frame: Through study completion, up to three years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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.

Criteria

Inclusion Criteria:

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 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 prior to renal transplant or for liver transplant is >/= 100/μL within 16 weeks prior to transplant and no history of opportunistic infection (OI); or ≥200 μL if history of OI is present.
7. Participant HIV-1 RNA < 50 copies/mL (by any FDA-approved assay performed in CLIA-approved laboratory), in the 26 weeks prior to transplant. Non-consecutive viral "blips" between 50-400 copies RNA/mL will be allowed.
8. Antiretroviral therapy: To avoid drug interactions, ritonavir or cobicistat-containing regimens are not recommended, unless in the opinion of the HIV/Transplant Infectious Disease team there is no alternative regimen expected to control HIV replication.
9. Participant is willing to use 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 CNS lymphoma.
3. Participant has a history of any neoplasm except for the following: resolved kaposi's sarcoma, in situ anogenital carcinoma, adequatelytreated 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.

Contacts and Locations

Locations

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

More Information

• Responsible Party: Nahel Elias, M.D., Surgical Director, Kidney Transplant, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02750397
• Other Study ID Numbers: 2016P000355
• First Posted: April 25, 2016
• Last Update Posted: January 31, 2020
• Last Verified: January 2020

Keywords provided by Nahel Elias, M.D., Massachusetts General Hospital:

HIV; Kidney Transplant; Liver Transplant; Transplant