HIVNCT02750397
HIV-to-HIV Transplant at MGH
An observational study of HIV and Awaiting Organ Transplant, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Awaiting Organ Transplant
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 16 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Prospective Study of HIV+ Deceased Donor Transplant for HIV+ Recipients
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.
Read the 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.
- Conditions
- HIV, Awaiting Organ Transplant
- Keywords
- HIV, Kidney Transplant, Liver Transplant, Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Survival
Measured: One Year
Secondary outcomes (10)
Graft Survival
Measured: One, Two, Three Years
Graft Rejection
Measured: One, Two, Three Years
HIV Disease Progression
Measured: One, Two, Three Years
Development of antiretroviral resistance and X4 tropic virus
Measured: Through study completion, up to three years
Incidence of bacterial, fungal, viral and other opportunistic infections
Measured: Through study completion, up to three years
Incidence of other transplant complications (surgical and vascular)
Measured: Through study completion, up to three years
Analysis of recurrent HIV associated nephropathy
Measured: Through study completion, up to three years
Incidence of post-transplant malignancies
Measured: Through study completion, up to three years
Incidence of systemic HIV-superinfection
Measured: Through study completion, up to three years
Changes in HIV latent viral reservoir
Measured: Through study completion, up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startAug 2016
- Primary completion15 Jul 2025
- Study completion16 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahel Elias, M.D., Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750397
- Sponsor's protocol ID
- 2016P000355
- Status last verified
- Sep 2025
- First submitted
- 21 Apr 2016
- Last updated
- 25 Sep 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of HIV+ Deceased Donor Transplant for HIV+ Recipients
- ClinicalTrials.gov ID
- NCT02750397
- Acronym / sponsor ID
- 2016P000355
- Conditions
- HIV, Awaiting Organ Transplant
- Keywords
- HIV, Kidney Transplant, Liver Transplant, Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Survival
Time frame: One Year
10 secondary outcomes
Graft Survival
Time frame: One, Two, Three Years
Graft Rejection
Time frame: One, Two, Three Years
HIV Disease Progression
Time frame: One, Two, Three Years
Development of antiretroviral resistance and X4 tropic virus
Time frame: Through study completion, up to three years
Incidence of bacterial, fungal, viral and other opportunistic infections
Time frame: Through study completion, up to three years
Incidence of other transplant complications (surgical and vascular)
Time frame: Through study completion, up to three years
Analysis of recurrent HIV associated nephropathy
Time frame: Through study completion, up to three years
Incidence of post-transplant malignancies
Time frame: Through study completion, up to three years
Incidence of systemic HIV-superinfection
Time frame: Through study completion, up to three years
Changes in HIV latent viral reservoir
Time frame: Through study completion, up to three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Awaiting Organ Transplant, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Survival (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.