FAQ

General

What is the purpose of this site?

This site provides resources and updates for thoracic transplant centers that are either initiating pilot HOPE studies or are interested in participating in future work.

Lung transplant

Has a HOPE (HIV D+/R+) lung transplant been performed to date?

To date, no center worldwide has performed an HIV D+/R+ lung transplant.

Is there a national trial of HIV D+/R+ lung transplant planned?

While individual centers have developed or are developing their own protocols, there is currently no national trial ongoing or in the works. Any national funded trial is likely years away.

How have centers developed their independent lung protocols?

Individual transplant centers develop their protocols to be compatible with criteria established by the Department of Health and Human Services.

What are the requirements to develop an HIV D+/R+ transplant program?

Centers must attest to the presence of the teamwork necessary to perform such transplants in such areas as transplant medicine, thoracic surgery, infectious diseases, HIV, and pharmacy.

Is there a specific experience or volume requirement?

Volume requirements have now been eliminated in favor of the teamwork requirement.

What role does HOPE Thoracic play in current heart pilot protocols?

HOPE Thoracic aims to reduce the barrier for centers to initiate their protocols by providing guidance and resources. Center are free to use materials or to develop their own, as they see fit.

Heart transplant

Has a HOPE (HIV D+/R+) heart transplant been performed to date?

Yes. Several centers in the United States have performed HIV D+/R+ heart transplants, and others are evaluating patients under open research protocols.

What is the current status of funding for a national trial of HIV D+/R+ heart transplant?

At present, there is no funded national trial. However, an application has been submitted to the United States National Institutes of Health for future funding.

How have centers developed their heart protocols?

Individual transplant centers develop their protocols to be compatible with criteria established by the Department of Health and Human Services.

What role does HOPE Thoracic play in current heart pilot protocols?

HOPE Thoracic aims to reduce the barrier for centers to initiate their protocols by providing guidance and resources.

Donor evaluation

How are potential donors evaluated under HOPE protocols?

As with donors without HIV, the evaluation process is initiated by organ procurement organizations (OPOs) and shared via DonorNet. OPOs are encouraged to contact the HOPE-in-Action team, which can help obtain information specific to the donor’s HIV status and prior/current treatment. This information is typically shared via the active HOPE listserv.

Who makes the ultimate decision about accepting a donor for transplant?

As with all solid organ transplants, the decision rests with each individual transplant center and the patient (potential recipient). The HOPE-in-Action team serves as a resource for information and coordination but does not make the final decision.

Are there specific CD4+ lymphocyte count or viral load thresholds that determine donor eligibility?

No. There are no mandated thresholds. Kidney and liver transplant teams in the United States have successfully transplanted organs from donors with low CD4 counts or high viral loads, provided that opportunistic infection and malignancy are excluded through careful vetting.

Recipient evaluation

How are potential recipients evaluated under HOPE protocols?

HOPE itself does not mandate a specific evaluation process. Centers typically require that a physician experienced with transplant and with HIV evaluate the potential recipient to ensure that the recipient has been optimized for transplant. Antiretroviral regimens that contain medications which interact with post-transplant immunosuppression should be changed to those that do not. Prophylaxis strategies may need to be adjusted based on prior opportunistic infection history. Finally, a careful evaluation for opportunistic infection for which there is no prophylaxis and which may be exacerbated by post-transplant immunosuppression should be undertaken. See, for example, this reference for further details.

Sample and data collection for pilot study

Should we collect lymph nodes from donors for the pilot study?

If possible, yes. Some centers have incorporated lymph node collection into their protocols.

What data should be collected for the pilot study?

Data should be collected consistent with requirements set out by the Department of Health and Human Services. Each center is responsible for its own data collection instrument. However, REDCAP and Qualtrics do allow for sharing of instruments without data via the use of appropriate XML or JSON files. In the future, sites may be able to use pre-developed instruments to modify as they see fit.

Will data from multiple sites be collected in the future?

We antitipate future collection of preliminary from sites that have performed HOPE transplants.