HIV-to-HIV Transplant at MGH

NCT02750397 | Completed

• 1 other identifier: 2016P000355
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Awaiting Organ Transplant

Keywords

HIV; Kidney Transplant; Liver Transplant; Transplant

Outcome Measures

Primary Outcomes (1)

• Patient Survival

  One Year

Secondary Outcomes (10)

• Graft Survival

  One, Two, Three Years

• Graft Rejection

  One, Two, Three Years

• HIV Disease Progression

  One, Two, Three Years

• Development of antiretroviral resistance and X4 tropic virus

  Through study completion, up to three years

• Incidence of bacterial, fungal, viral and other opportunistic infections

  Through study completion, up to three years

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Participant is able to understand and provide informed consent
• Participant meets standard listing criteria for transplant.
• Documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV ab IFA, or documented history of detectable HIV-1 RNA).
• Participant is ≥ 18 years old.
• 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.
• 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.
• 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.
• 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.
• Participant is willing to use PCP, herpes virus and fungal prophylaxis as indicated.

You may not qualify if:

• Participant has concomitant conditions that, in the judgment of the investigators, would preclude transplantation or immunosuppression.
• Opportunistic Complication History: Any 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, 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.
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical Director, Kidney Transplant

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: April 25, 2016
• Study Start: August 1, 2016
• Primary Completion: July 15, 2025
• Study Completion: July 16, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

US (1)