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. 2024 Jan 1;17(1):10.1111/cts.13696. doi: 10.1111/cts.13696

TABLE 1.

Completed key clinical trials investigating the efficacy and safety of maribavir in the treatment of cytomegalovirus infection in adults and adolescents.

Study Trial design Treatment duration/follow‐up period Dose(s) Study population Number of subjects
NCT01611974 21 (Study 202) Phase II, randomized, double‐blind, multicenter, dose‐ranging Treatment up to 24 weeks Maribavir 400, 800, or 1200 mg b.i.d. HSCT/SOT recipients, ≥12 years of age a with R/R CMV infection and plasma CMV DNA ≥1000 copies/mL
N = 120 randomized; 47 HCT and 73 SOT
  • Maribavir 400 mg, n = 40
  • Maribavir 800 mg, n = 40
  • Maribavir 1200 mg, n = 40
EUDRACT 2010–024247‐32 22 (Study 203) Phase II, randomized, open‐label, dose‐ranging, dose‐blind, multicenter, active‐controlled Treatment up to 12 weeks and post‐treatment follow‐up of 12 weeks

Maribavir 400, 800, or 1200 mg b.i.d.

Valganciclovir 900 mg b.i.d. weeks 1–3 and q.d. after 3 weeks

 HSCT/SOT recipients, ≥18 years of age, with CMV reactivation and plasma CMV DNA 1000–100,000 copies/mL

N = 161 randomized

N = 159 received treatment; 82 HCT and 77 SOT
  • Maribavir 400 mg, n = 40
  • Maribavir 800 mg, n = 40
  • Maribavir 1200 mg, n = 39
  • Valganciclovir 900 mg, n = 40
NCT02931539 26 (SOLSTICE) Phase III, randomized, open‐label, multicenter, active‐controlled 8‐weeks treatment and post‐treatment follow‐up of 12 weeks

Maribavir: 400 mg b.i.d.

IAT (foscarnet, ganciclovir, valganciclovir, cidofovir, foscarnet/valganciclovir, foscarnet/ganciclovir)

 HSCT and SOT recipients, aged ≥12 years a with refractory CMV infection with or without resistance and plasma CMV DNA at screening of ≥910 IU/mL
N = 352 randomized; 141 HCT and 211 SOT
  • Maribavir, n = 235
  • IAT, n = 117
    • ⚬
      Foscarnet, n = 47
    • ⚬
      Ganciclovir, n = 28
    • ⚬
      Valganciclovir, n = 28
    • ⚬
      Cidofovir, n = 6
    • ⚬
      Foscarnet/valganciclovir, n = 4
    • ⚬
      Foscarnet/ganciclovir, n = 3

NCT02927067 27

(AURORA)

 Phase III, randomized, double‐blind, double‐dummy, multicenter, active‐controlled 8‐weeks treatment and post‐treatment follow‐up of 12 weeks

Maribavir 400 mg b.i.d.

Valganciclovir 900 mg b.i.d.

Placebo matched to either maribavir or valganciclovir b.i.d.

 HSCT recipients aged ≥16 years with first post‐transplant CMV infection with plasma CMV DNA at screening of ≥455 IU/mL to ≤91,000 IU/mL N = 533 recipients randomized

  • Maribavir, n = 276

  • Valganciclovir, n = 277

Abbreviations: b.i.d., twice daily; CMV, cytomegalovirus; HSCT, hematopoietic stem cell transplant; IAT, investigator‐assigned treatment; q.d., once daily; R/R, refractory/resistant; SOT, solid organ transplant.

a

Although entry criteria permitted enrollment of children (≥12 years of age), only adults (≥18 years of age) were enrolled into these studies.