Combination foscarnet and ganciclovir therapy vs monotherapy for the treatment of relapsed cytomegalovirus retinitis in patients with AIDS. The Cytomegalovirus Retreatment Trial. The Studies of Ocular Complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group
OBJECTIVES: To determine the best therapeutic regimen, using currently
approved drugs, for treatment of relapsed cytomegalovirus (CMV) retinitis.
DESIGN: Multicenter, randomized, controlled clinical trial. SETTING:
Ophthalmology, and acquired immunodeficiency syndrome (AIDS) services at
tertiary care medical centers. PATIENTS: Two hundred seventy-nine patients
with AIDS and either persistently active or relapsed CMV retinitis.
INTERVENTION: Patients were randomized to one of three therapeutic
regimens: induction with foscarnet sodium at 90 mg/kg intravenously every
12 hours for 2 weeks, followed by maintenance at a dosage of 120 mg/kg per
day (foscarnet group); induction with ganciclovir sodium at 5 mg/kg
intravenously every 12 hours for 2 weeks followed by maintenance at 10
mg/kg per day (ganciclovir group); or continuation of previous maintenance
therapy plus induction with the other drug (either ganciclovir or
foscarnet) for 2 weeks followed by maintenance therapy with both drugs,
ganciclovir sodium at 5 mg/kg per day and foscarnet sodium at 90 mg/kg per
day (combination therapy group). OUTCOMES: Mortality, retinitis
progression, visual acuity, visual fields, and morbidity. RESULTS: The
mortality rate was similar among the three groups. Median survival times
were as follows: foscarnet group, 8.4 months; ganciclovir group, 9.0
months; and combination therapy group, 8.6 months (P=.89). Comparison of
retinitis progression, as evaluated in a masked fashion by the centralized
Fundus Photograph Reading Center (FPRC), revealed that combination therapy
was the most effective regimen for controlling the retinitis. The median
times to retinitis progression were as follows: foscarnet group, 1.3
months; ganciclovir group, 2.0 months; and combination therapy group, 4.3
months (P<.001). Although no difference could be detected in visual
acuity outcomes, visual field loss and retinal area involvement on fundus
photographs both paralleled the progression results, with the most
favorable results in the combination therapy group. The rates of visual
field loss were as follows: foscarnet group, 28 degrees per month;
ganciclovir group, 18 degrees per month; combination therapy group, 16
degrees per month (P=.009); and the rates of increase of retinal area
involved by CMV were as follows: foscarnet group, 2.47% per month;
ganciclovir group, 1.40% per month; and combination therapy group, 1.19%
per month (P=.04). While side effects were similar among the three
treatment groups, combination therapy was associated with the greatest
negative impact of treatment on quality-of-life measures. CONCLUSION: For
patients with AIDS and CMV retinitis whose retinitis has relapsed and who
can tolerate both drugs, combination therapy appears to be the most
effective therapy for controlling CMV retinitis.
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