Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients

Inclusion Criteria

1. Be ≥12 years of age.

2. Weigh ≥ 40 kg.

3. Be a recipient of stem cell or solid organ transplantation.

4. Have documented CMV infection in blood or plasma, with a screening value of ≥1,000
DNA copies/mL.

5. Have a current CMV infection that is resistant (known CMV genetic mutations) or
refractory (clinical failure to respond) to treatment with ganciclovir/valganciclovir
and/or foscarnet.

6. If female, be either postmenopausal, surgically sterile, or have a negative pregnancy
test prior to randomization.

7. Be able to swallow tablets.

8. If adult, provide written informed consent. If child (age <18 years), have a
parent/legal guardian who is willing and able to provide written informed consent
(with assent from the child when appropriate).

9. Be assessed by the investigator to determine whether prophylaxis for non-CMV
herpesvirus infections (e.g., herpes simplex virus [HSV type 1 and type 2] and
varicella zoster virus [VZV]) is appropriate according to institutional guidelines or
standard practices, keeping in mind that maribavir is not active in vitro against
these viruses.

Exclusion Criteria

1. Be receiving any other anti-CMV agent(s).

2. Have a current CMV infection that is considered resistant or refractory due to
inadequate adherence to prior oral anti-CMV treatment.

3. Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24
hours prior to the time of enrollment.

4. Have severe hepatic impairment.

5. Require mechanical ventilation or vasopressors for hemodynamic support at the time of
enrollment.

6. Have expected survival less than 6 weeks.

7. Be pregnant or breastfeeding.

8. Other clinically significant medical or surgical condition.