Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
NCT ID:
NCT05159466
Brief Summary:
The U.S. Department of Health and Human Services (HHS), through the National Institutes of Health (NIH), published Final Human Immunodeficiency Virus (HIV) Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for Transplantation of Organs Infected With HIV. All such transplants must occur under an institutional review board (IRB) approved research protocol that is compliant with federal regulations governing human subjects research. This is an investigator-initiated, observational prospective study of solid organ transplantation utilizing HIV-positive donors in HIV positive recipients. Stable HIV-infected adults in need of a solid organ transplant (kidney) who meet standard and study specified HIV criteria for organ transplantation will be offered enrollment in the study. Deceased donors (kidney) and living donors (kidney) will be utilized in this protocol.
The goal of this research is to increase knowledge about the safety, efficacy, and effectiveness of solid organ transplantation (SOT) utilizing HIV-positive donors in HIV-positive recipients.
Detailed Description:
This is an observational prospective study of solid organ transplantation utilizing HIV-positive donors in HIV-positive recipients. Stable HIV-infected adults in need of a solid organ transplant (kidney) who meet standard and study specified HIV criteria for organ transplantation will be offered enrollment in the study. Deceased donors (kidney) and living donors (kidney) will be utilized in this protocol. 25 stable HIV-infected adults in need of a solid organ transplant (kidney) who meet standard and study specified HIV criteria for organ transplantation and 5 living donors (kidney) will be offered enrollment in the study. Living donors will be followed under a separate addendum protocol.
Each HIV-positive recipient and prospective HIV-positive recipient will be provided an independent advocate who is responsible for protecting and promoting the rights and interests of the HIV-positive recipient (or prospective recipient). The purpose of the independent advocate for the HIV-positive recipient is to:
1. Promote and protect the interests of the HIV-positive prospective recipient (including with respect to having access to a suitable HIV-negative organ if it becomes available).
2. Take steps to ensure that the HIV-positive recipient's decision is informed and free from coercion.
3. Review whether the potential HIV-positive prospective recipient has received information regarding the results of Solid Organ Transplantation in general and transplantation in HIV positive recipients in particular and the unknown risks associated with HIV-positive to HIV-positive transplant.
All potential participants who provide informed consent will be enrolled into the pre-transplant phase of the study. In the pre-transplant phase of the study, standard and HIV-specific eligibility will be confirmed. Enrolled participants will consent to the collection of retrospective medical record data including but not limited to clinic notes, laboratory data, diagnostic procedures and reports for all prior HIV therapies.
As per Health Resource Services Administration (HRSA) and Organ Procurement and Transplantation Network (OPTN)/Policy 15.6, at the time of transplant listing "willing to accept an HIV-positive organ" status will be indicated in the secure database used by both transplant hospitals and organ procurement organizations to coordinate organ recovery and waitlist candidate matching. HIV-positive matches will be run for study participants who have indicated an interest in HIV+ organs. If an HIV+ organ becomes available for a participant, the participant will have an opportunity to accept or defer the organ offer. Participants who accept an HIV+ or HIV suspected false positive organ offer will enter the Post-Transplant Follow-up Phase for HIV D+/R+ participants and participants who accept an HIV- (D) organ offer will enter the Post -Transplant Follow-up Phase for HIV D-/R+ participants.
Participants will then be followed prospectively for up to 5 years. Demographic and clinical data on the donors and recipients (and outcomes) will be extracted from the United Network for organ Sharing (UNOS) and Scientific Registry of Transplant Recipient (SRTR) databases. During this prospective follow-up, all medical record data includes but is not limited to records of hospitalization, laboratory reports, clinic notes, medication lists, biopsy results, and documentations of current therapies.
Study:
NCT05159466
Study Brief:
Protocol Section:
NCT05159466