Ganciclovir for the treatment of cytomegalovirus gastroenteritis in bone marrow transplant patients. A randomized, placebo-controlled trial.
OBJECTIVE
To determine the efficacy of ganciclovir for the treatment of cytomegalovirus enteritis after bone marrow transplant.


METHODS
A randomized, double-blind, placebo-controlled trial.


METHODS
Inpatient units of a cancer center.


METHODS
Consecutive patients with biopsy-documented cytomegalovirus infection of the gastrointestinal tract. Cytomegalovirus was identified by culture or by immunohistologic or standard histologic analysis.


METHODS
Ganciclovir, 2.5 mg/kg body weight every 8 hours for 14 days, or placebo, with dosage adjusted for decreases in renal function. Therapy was discontinued if the neutrophil count or creatinine clearance fell below preset criteria.


RESULTS
Virus cultures of throat, urine, and blood specimens were done before, 3 times weekly during, and weekly for 3 weeks after therapy. Endoscopy was repeated after treatment. Patients were examined, and blood counts, electrolytes, and renal and hepatic function were monitored during therapy. Ganciclovir recipients had cessation of oropharyngeal (P = 0.001) and urinary (P = 0.004) cytomegalovirus excretion and negative cultures of repeat esophageal specimens (P = 0.002) more often than placebo recipients. No difference existed in either clinical symptoms or endoscopic appearance between the groups after treatment. Cytomegalovirus pneumonia occurred in four patients who received ganciclovir and in six who received placebo. One ganciclovir recipient and four placebo recipients were withdrawn from treatment because of neutropenia, but there was no overall difference in the proportional decrease in leukocyte counts between groups.


CONCLUSIONS
Although ganciclovir suppressed cytomegalovirus replication, 2 weeks of treatment was not associated with clinical or endoscopic improvement when compared with supportive care.
Reed
E C
EC
Fred Hutchinson Cancer Research, Seattle, Washington.
Wolford
J L
JL
Kopecky
K J
KJ
Lilleby
K E
KE
Dandliker
P S
PS
Todaro
J L
JL
McDonald
G B
GB
Meyers
J D
JD
D000293:Adolescent; D000328:Adult; D016026:Bone Marrow Transplantation / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D003587:Cytomegalovirus / Q000187:drug effects / Q000302:isolation & purification; D003586:Cytomegalovirus Infections / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D004724:Endoscopy; D002149:Energy Intake; D005260:Female; D015774:Ganciclovir / Q000009:adverse effects / Q000627:therapeutic use*; D005759:Gastroenteritis / Q000188:drug therapy* / Q000209:etiology / Q000382:microbiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D009894:Opportunistic Infections / Q000188:drug therapy*; D011024:Pneumonia, Viral / Q000209:etiology; D016032:Randomized Controlled Trials as Topic
D015774:Ganciclovir