Maraviroc for Primary Graft Dysfunction
(MARAVIROC Trial)
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants will be on a routine maintenance immunosuppression regimen including tacrolimus, mycophenolate, and prednisone.
How is the drug Maraviroc unique for treating primary graft dysfunction?
Maraviroc is unique because it is primarily known as an HIV medication that blocks the CCR5 receptor, which is different from other treatments like levosimendan, a calcium sensitizer used for heart function. This novel mechanism may offer a new approach to managing primary graft dysfunction, which currently lacks a standard treatment.12345
What is the purpose of this trial?
Lung transplant recipient survival lags other solid organ recipients, with the main early cause of death being primary graft dysfunction (PGD). PGD occurs in up to 1/3 of all recipients, is driven by the body's innate immune response, and has no known medical therapies for treatment or prevention. Investigators have recently shown that Natural Killer (NK) cells, a key innate immune cell, are critical in causing PGD. Importantly, the investigators found that Maraviroc, an FDA-approved drug that works to inhibit these immune cells, prevented lung injury in mouse models of PGD.The goal of this clinical trial is to learn if Maraviroc works to treat PGD in Lung Transplant patients who are above the age of 18 and have a PGD risk score greater than 50%. The objectives the study hopes to address are:To address the safety and tolerability of Maraviroc. To test a strategy for PGD enrichment in a lung transplant population. To measure the efficacy and biological efficacy of using Maraviroc. To study the biochemical, physiologic, and molecular effects of the drug on the body.This will be a double blind study where patients will either get the Maraviroc drug or a placebo. Researchers will then compare the two groups to address the above objectives.Participants will:Take drug Maraviroc or a placebo every 12 hours for 3 days post surgery. Follow up will occur during the entire length of stay at UCSF, about 16 days, with a single 12 month follow up once released.
Research Team
Daniel Calabrese, MD
Principal Investigator
University of California, San Francisco
Eligibility Criteria
This trial is for lung transplant patients over 18 with a high risk of primary graft dysfunction (PGD). They must have a PGD risk score above 50%. The study excludes certain individuals, but specific exclusion criteria are not provided.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Maraviroc or placebo every 12 hours for 3 days post-surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment during their hospital stay and have a single follow-up visit 12 months post-discharge
Long-term Follow-up
Participants are monitored for mortality and other long-term outcomes
Treatment Details
Interventions
- Maraviroc
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator