Metairie, LANCT05159466Now EnrollingIRB Ready

Human Immunodeficiency Virus Clinical Trial in Metairie, LA

Access cutting-edge human immunodeficiency virus treatment through this clinical trial at a research site in Metairie. Study-provided care at no cost to qualified participants.

Sponsored by Tulane University

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Expert Care in Metairie

Access human immunodeficiency virus specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related human immunodeficiency virus treatment provided free

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Check if you qualify for this human immunodeficiency virus clinical trial in Metairie, LA

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Why Participate?

  • No-Cost Study Care

  • Local to Metairie

    Convenient for LA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Metairie site if eligible
  4. 4Begin participation

About This Human Immunodeficiency Virus Study in Metairie

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.

Sponsor: Tulane University

Who Can Participate

Inclusion Criteria

Participant meets standard listing criteria for transplant.
Greater than or equal to 18 years of age.
Participant has documented HIV infection using an FDA-licensed, approved, or cleared test device(s).
CD4+ T-cell count ≥200/μL within 16 weeks prior to transplant; any patient with history of Opportunistic Infections must have a CD4 positive T-cell count ≥200/uL.
HIV RNA less than 50 copies/mL and on a stable antiretroviral regimen.
No evidence of active opportunistic complications of HIV infection.
On a stable antiretroviral regimen. Participants unable to tolerate ART due to organ failure may still be considered eligible if the study team is confident there will be a safe, tolerable, and effective antiretroviral regimen once organ function is restored after transplantation.
No history of primary CNS lymphoma or progressive PML

Exclusion Criteria

Participant has concomitant conditions that, in the judgment of the investigators, would preclude transplantation or immunosuppression.
Less than 18 years of age.
Requires multi-organ transplantation.
Participant is pregnant or breastfeeding.
Participant has a 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, adequately treated 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.
Participants who are unable or unwilling to provide informed consent. Donor Criteria Deceased Donor Criteria
Must meet all clinical criteria for HIV-uninfected organ donors.
No evidence of invasive opportunistic complications of HIV infection.
Pre-implant donor organ biopsy showing no disease process that would put the recipient at increased risk of rapid progression to end-stage organ failure, to be stored for the duration of the study.
Donor has documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV ab IFA, or history of detectable HIV-1 RNA) from a CLIA approved laboratory.
If known history of HIV infection and prior antiretroviral therapy, the study team must describe the anticipated post-transplant antiretroviral regimen(s) to be prescribed for the recipient and justify its conclusion that the regimen will be safe, tolerable and effective.
Pre-implant donor organ biopsy to be stored, at a minimum, for the duration of the study (or at least 5 years).
For donors with newly diagnosed/discovered HIV-1 infection, any HIV-1 RNA viral load is allowed assuming the donor meets other criteria and the HIV/Transplant Infectious Diseases team is able to predict a tolerable and effective ART regimen for the recipient.
If there is any history of documented antiretroviral resistance in the donor by medical chart review, the HIV/Transplant Infectious Diseases team is able to predict a tolerable and effective ART regimen for the recipient.
Donors with documented chronic hepatitis C virus (HCV+) co-infection (detectable HCV nucleic acid using any licensed assay in a CLIA certified lab) can be used only for HCV+ participants. Living Donor Criteria
Greater than or equal to 18 years of age
Donor meets all clinical criteria to be a living donor other than being HIV positive.
Donor has consented to participate as a HIV-Positive Donor under the separate Addendum protocol.
Documented HIV infection using an FDA-licensed, approved, or cleared test device.
Well-controlled HIV infection, as evidenced by:
CD4+ T-cell count ≥500/mL for the 6-month period preceding donation.
Fewer than 50 copies/mL of HIV- 1 RNA detectable by ultrasensitive or real-time polymerase chain reaction (PCR) assay.
No evidence of invasive opportunistic complications of HIV infection
A kidney biopsy showing no evidence of a disease process that would put the donor at increased risk of progressing to end-stage organ failure after donation, or that would present a risk of poor graft function to the recipient.
A complete history of ART regimens and ART resistance.
The study team must be able to predict a safe, tolerable, and effective regimen to be prescribed for the recipient based on the donor's current ART regimen as well as the donor's history of ART resistance.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Metairie?

Yes, this clinical trial (NCT05159466) has an active research site in Metairie, LA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Human Immunodeficiency Virus Treatment Options in Metairie, LA

If you're searching for human immunodeficiency virus treatment options in Metairie, LA, this clinical trial (NCT05159466) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Metairie research site is actively enrolling participants for this clinical trial. You'll receive care from experienced human immunodeficiency virus specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all human immunodeficiency virus clinical trials near you to find additional studies recruiting in your area.

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