Ganciclovir treatment of cytomegalovirus colitis in AIDS: a randomized, double-blind, placebo-controlled multicenter study.
The efficacy and safety of ganciclovir therapy for cytomegalovirus (CMV) colitis in patients with AIDS was examined in a double-blind, placebo-controlled study. Sixty-two patients at four university medical centers were enrolled. All had biopsy-proven CMV colitis with diarrhea, fever, and weight loss. Other pathogens were excluded. Ganciclovir (5 mg/kg) or placebo was administered every 12 h for 14 days. A significant reduction in CMV-positive colonic and urine cultures was seen with ganciclovir (P = .034 and P < .001, respectively) compared with placebo. Colonoscopy scores were improved significantly more with ganciclovir than with placebo (P = .042). New extracolonic CMV disease developed in 7 (23%) of 30 placebo patients and in 3 (9%) of 32 ganciclovir patients in only 14 days (P = .026). Ganciclovir-treated patients maintained body weight, while placebo patients had a mean loss of 1.5 kg. Overall, ganciclovir appears of some benefit in treating CMV colitis in patients with AIDS.
Dieterich
D T
DT
New York University Medical Center, New York.
Kotler
D P
DP
Busch
D F
DF
Crumpacker
C
C
Du Mond
C
C
Dearmand
B
B
Buhles
W
W
D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D001706:Biopsy; D003092:Colitis / Q000150:complications / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D003113:Colonoscopy; D003586:Cytomegalovirus Infections / Q000188:drug therapy* / Q000473:pathology; D003967:Diarrhea / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D015774:Ganciclovir / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D016896:Treatment Outcome
D015774:Ganciclovir