Valganciclovir to Prevent Cytomegalovirus Infection in Patients Following Donor Stem Cell Transplantation

Summary

RATIONALE: Antivirals such as valganciclovir act against viruses and may be effective in preventing cytomegalovirus. It is not yet known if valganciclovir is effective in preventing cytomegalovirus. PURPOSE: This randomized phase III trial is studying valganciclovir to see how well it works in preventing cytomegalovirus in patients who have undergone donor stem cell transplantation.

Timeline

Start

2001-01

Primary completion

—

Completion

2007-09

Outcome

Missed primary endpoint

paper Valganciclovir prophylaxis was not superior in reducing the composite end point of CMV disease, invasive bacterial or fungal disease, or death PMID 25560711 ↗

paper treatment difference, -0.01 [95% CI, -0.13 to 0.10]; P = 0.86 PMID 25560711 ↗

Publications

• Boeckh M, Nichols WG, Chemaly RF, Papanicolaou GA, Wingard JR, Xie H, Syrjala KL, Flowers ME, Stevens-Ayers T, Jerome KR, Leisenring W. Valganciclovir for the prevention of complications of late cytomegalovirus infection after allogeneic hematopoietic cell transplantation: a randomized trial. Ann Intern Med. 2015 Jan 6;162(1):1-10. doi: 10.7326/M13-2729.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Valganciclovir	Small molecule	900 mg	Oral
Background	Ganciclovir	Small molecule	5 mg/kg	Intravenous

Indications