The purpose of this study is to compare the safety and effectiveness of 2 treatments to
prevent invasive fungal infections (IFI), which are infections caused by yeasts and molds
that are common in patients with weak immune systems or transplant patients. AmBisome, a new
treatment, will be compared to fluconazole, the traditional treatment for fungal infections
caused by the yeast Candida. Treatment will only be given to liver transplant patients who
are found to be at high risk for IFI. Liver transplant patients who are at low risk for IFI
will be monitored but will receive no study medication.
IFIs are found mainly in a high risk group of liver transplant patients, and are not common
in those with low risk. If IFI preventive therapy is focused on the high risk group, there
may be a lesser chance of Candida becoming resistant (able to grow despite the presence of
drugs used to kill it). Treating only the high risk group will also save money.
If you are in the high risk group you will be assigned randomly (like tossing a coin) to
receive either AmBisome or fluconazole. If you are in the low risk group, you will not
receive any treatment. Both groups will be monitored for IFIs. The study will last for 100
days following your liver transplant.
You may be eligible for this study if you:
- Have had a liver transplant within 5 days of enrollment and agree to receive
You will not be eligible for this study if you:
- Are HIV-positive.
- Have a history of invasive fungal infection.
- Have received antifungal agents within 14 days prior to your liver transplant.
- Are allergic to azoles, amphotericin B, or tacrolimus.