       Document 0142
 DOCN  M9640142
 TI    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.
 DT    9604
 SO    Arch Ophthalmol. 1996 Jan;114(1):23-33. Unique Identifier : AIDSLINE
       MED/96133209
 AB    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.
 DE    Adult  Antiviral Agents/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE
       AIDS-Related Opportunistic Infections/*DRUG THERAPY/MORTALITY/
       PHYSIOPATHOLOGY  Comparative Study  Cytomegalovirus Retinitis/*DRUG
       THERAPY/MORTALITY/PHYSIOPATHOLOGY  Drug Therapy, Combination  Female
       Foscarnet/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE  Fundus Oculi
       Ganciclovir/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE  Human  Infusions,
       Intravenous  Male  Morbidity  Quality of Life  Recurrence
       Retinitis/PHYSIOPATHOLOGY  Support, U.S. Gov't, P.H.S.  Survival Rate
       Visual Acuity  Visual Fields  CLINICAL TRIAL  JOURNAL ARTICLE
       MULTICENTER STUDY  RANDOMIZED CONTROLLED TRIAL

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).

