TABLE 7.

Randomized trials of preemptive therapy in solid-organ transplant recipients^d

Type of transplant	Reference	Type of study	No. of patients studied (no. of D+/R− patients)a	Prophylactic regimenb	Outcome(s)	CMV diseasec	Mortalityc
Kidney	447	Secondary prophylaxis, >6 days of prophylactic treatment posttransplant with ALG or OKT3 or treatment within first 2 weeks for acute rejection	16 (0)	Immunoglobulin (Sandoglobulin; Novartis Pharmaceuticals Corp., East Hanover, N.J.) 500 mg/kg i.v. on day 0 and wk 2 and 4; 250 mg/kg at wk 6 and 8	Reduction in severity of symptomatic CMV illness and incidence of CMV complications	13% vs. 39%	Not reported
				vs.
			18 (0)	untreated controls
	300	Primary and secondary prophylaxis of patients receiving ATG for rejection, double-blind, placebo controlled	19 (5)	CMV immunoglobulin (Cytogam; Medimmune Inc., Gaithersburg, Md.) 100 mg/kg/day on day of ATG therapy and days 7, 14, 35, 56, and 77 thereafter	Prevented fatal CMV disease; should be targeted to D+/R− group	37% vs. 30%	0% vs. 20%
				vs.
			20 (4)	placebo (albumin)
	197	Secondary prophylaxis of patients receiving OKT3 or ALG, non-placebo controlled, prospective	64 (0)	Ganciclovir 2.5 mg/kg i.v. twice a day till termination of antilymphocyte therapy	Ganciclovir reduced excessive occurrence of CMV disease	14% vs. 33%	2% vs. 4%
				vs.
			49 (0)	untreated controls
	76	Primary and secondary prophylaxis of patients on OKT3, prospective, non-placebo controlled	22 (0)	Ganciclovir 2.5 mg/kg i.v. on day that antilymphocyte antibody therapy was given	Reduction in CMV disease	0% vs. 17%	100% vs. 100%
				vs.
			18 (0)	no prophylaxis
Liver	453	Secondary prophylaxis of patients on antilymphocyte antibody preparations, prospective, non-placebo controlled	50 (14)	Immunoglobulin (Gammagard; Baxter Healthcare Corp., Glendale, Calif.) 0.5 g/kg i.v. on days 1, 3, 5, then each wk for 3 wk with acyclovir 400 mg p.o. 5 times a day for 3 months	No benefit	Not shown	10% vs. 22%
				vs.
			50 (3)	no prophylaxis
	423	Primary and secondary prophylaxis; stratified by donor and recipient CMV serostatus	24 (2)	Acyclovir 800 mg p.o. 4 times a day for 24 wk	Ganciclovir provided effective prophylaxis against CMV disease	29% vs. 4%	13% vs. 13%
				vs.
			23 (2)	ganciclovir 5 mg/kg i.v. twice a day for 7 days if surveillance cultures (buffy coat, urine) yield CMV

^aIf known, the number of CMV-negative patients given donor-positive organs (D⁺/R⁻) is shown in parentheses. 

^bALG, antilymphocyte globulin; ATG, antithymocyte globulin; i.v., intravenous; p.o., peroral. 

^cAmong patients given the drug, the percentage refers to the first versus the second listed regimen. 

^dModified from references 334a and 336a with permission of the publisher.