Combination Foscarnet and Ganciclovir Therapy vs Monotherapy for the Treatment of Relapsed Cytomegalovirus Retinitis in Patients With AIDS: The Cytomegalovirus Retreatment Trial

doi:10.1001/archopht.1996.01100130021004

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Vol. 114 No. 1, January 1996

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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

Arch Ophthalmol. 1996;114(1):23-33.

Abstract

Objective
To determine the best therapeutic regimen, using currently approveddrugs, 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 persistentlyactive or relapsed CMV retinitis.

Intervention
Patients were randomized to one of three therapeutic regimens:induction with foscarnet sodium at 90 mg/kg intravenously every12 hours for 2 weeks, followed by maintenance at a dosage of120 mg/kg per day (foscarnet group); induction with ganciclovirsodium at 5 mg/kg intravenously every 12 hours for 2 weeks followedby maintenance at 10mg/kg per day (ganciclovir group); or continuationof previous maintenance therapy plus induction with the otherdrug (either ganciclovir or foscarnet) for 2 weeks followedby maintenance therapy with both drugs, ganciclovir sodium at5 mg/kg per day and foscarnet sodium at 90 mg/kg per day (combinationtherapy group).

Outcomes
Mortality, retinitis progression, visual acuity, visual fields,and morbidity.

Results
The mortality rate was similar among the three groups. Mediansurvival 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, asevaluated in a masked fashion by the centralized Fundus PhotographReading Center (FPRC), revealed that combination therapy wasthe most effective regimen for controlling the retinitis. Themedian times to retinitis progression were as follows: foscarnetgroup, 1.3 months; ganciclovir group, 2.0 months; and combinationtherapy group, 4.3 months (P<.001). Although no differencecould be detected in visual acuity outcomes, visual field lossand retinal area involvement on fundus photographs both paralleledthe progression results, with the most favorable results inthe combination therapy group. The rates of visual field losswere as follows: foscarnet group, 28° per month; ganciclovirgroup, 18° per month; combination therapy group, 16°per month (P=.009); and the rates of increase of retinal areainvolved by CMV were as follows: foscarnet group, 2.47% permonth; ganciclovir group, 1.40% per month; and combination therapygroup, 1.19% per month (P=.04). While side effects were similaramong the three treatment groups, combination therapy was associatedwith the greatest negative impact of treatment on quality-of-lifemeasures.

Conclusions
For patients with AIDS and CMV retinitis whose retinitis hasrelapsed and who can tolerate both drugs, combination therapyappears to be the most effective therapy for controlling CMVretinitis.

Author Affiliations

Financial disclosure statements for study investigators are on file with the Study Coordinating Center, The Johns Hopkins School of Hygiene and Public Health, Baltimore.

Footnotes

All individuals participating in the conduct of this study arelisted on page 33.

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