HIV-to-HIV Transplant at MGH

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02750397
• Other study ID #: 2016P000355
• Status: Active, not recruiting
• Start date: August 2016
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• 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. HIV+ individuals who receive a solid organ transplant from HIV-uninfected 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Awaiting Organ Transplant
• HIV

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Survival		One Year
Secondary	Graft Survival		One, Two, Three Years
Secondary	Graft Rejection		One, Two, Three Years
Secondary	HIV Disease Progression		One, Two, Three Years
Secondary	Development of antiretroviral resistance and X4 tropic virus		Through study completion, up to three years
Secondary	Incidence of bacterial, fungal, viral and other opportunistic infections		Through study completion, up to three years
Secondary	Incidence of other transplant complications (surgical and vascular)		Through study completion, up to three years
Secondary	Analysis of recurrent HIV associated nephropathy		Through study completion, up to three years
Secondary	Incidence of post-transplant malignancies		Through study completion, up to three years
Secondary	Incidence of systemic HIV-superinfection		Through study completion, up to three years
Secondary	Changes in HIV latent viral reservoir		Through study completion, up to three years