- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02750397
HIV-to-HIV Transplant at MGH
Prospective Study of HIV+ Deceased Donor Transplant for HIV+ Recipients
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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HIV D+/R+
HIV+ recipients who receive an organ transplant from an HIV+ donor
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HIV D-/R+
HIV+ recipients who receive an organ transplant from an HIV- donor
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient Survival
Time Frame: One Year
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One Year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of bacterial, fungal, viral and other opportunistic infections
Time Frame: Through study completion, up to three years
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Through study completion, up to three years
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Incidence of other transplant complications (surgical and vascular)
Time Frame: Through study completion, up to three years
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Through study completion, up to three years
|
Graft Survival
Time Frame: One, Two, Three Years
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One, Two, Three Years
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Graft Rejection
Time Frame: One, Two, Three Years
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One, Two, Three Years
|
HIV Disease Progression
Time Frame: One, Two, Three Years
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One, Two, Three Years
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Development of antiretroviral resistance and X4 tropic virus
Time Frame: Through study completion, up to three years
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Through study completion, up to three years
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Analysis of recurrent HIV associated nephropathy
Time Frame: Through study completion, up to three years
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Through study completion, up to three years
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Incidence of post-transplant malignancies
Time Frame: Through study completion, up to three years
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Through study completion, up to three years
|
Incidence of systemic HIV-superinfection
Time Frame: Through study completion, up to three years
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Through study completion, up to three years
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Changes in HIV latent viral reservoir
Time Frame: Through study completion, up to three years
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Through study completion, up to three years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2016P000355
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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