Maraviroc for Primary Graft Dysfunction
(MARAVIROC Trial)

Recruiting in Palo Alto (17 mi)

Overseen byDaniel Calabrese, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of California, San Francisco

Prior Safety Data

Trial Summary

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.

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

I am 18 years or older and on the lung transplant waitlist.

My risk of lung transplant rejection is over 50%.

Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

+2 more

Exclusion Criteria

I am scheduled for a treatment that reduces my immune cells.

I am receiving an organ from a donor with HIV, HCV, or HBV.

Recipient listed for concurrent heart or other solid organ transplantation

+2 more

Participant Groups

The trial tests Maraviroc, an FDA-approved drug that may prevent lung injury after a transplant. It's compared to a placebo in a double-blind setup where neither doctors nor patients know who gets the real drug. Participants take their assigned treatment every 12 hours for three days post-surgery.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MaravirocExperimental Treatment1 Intervention

This arm is the Maraviroc drug which will be administered to patients.

Group II: PlaceboPlacebo Group1 Intervention

This arm is the placebo drug which will be matched in appearance and taste to the Maraviroc and is available in PO and liquid (PFT) formulations.