3rd Conf Retro and Opportun Infect. 1996 Jan 28-Feb 1;:164. Unique
Purpose: In order to determine the best therapeutic regimen for
treatment of cytomegalovirus (CMV) retinitis which has relapsed, 279
patients with the acquired immune deficiency syndrome (AIDS) and either
persistently active or relapsed CMV retinitis were enrolled in a
multicenter, randomized, controlled, clinical trial. Patients were
randomized to one of 3 regimens: induction with foscarnet at 90 mg/kg
intravenously (IV) every 12 hours for 2 weeks, followed by maintenance
at 120 mg/kg/day (Fos); induction with ganciclovir at 5 mg/kg IV every
12 hours for 2 weeks followed by maintenance at 10 mg/kg/day (Gcv);
continuation of previous maintenance therapy plus induction with the
other drug (either or ganciclovir or foscarnet) for 2 weeks followed by
maintenance with both drugs, ganciclovir at 5 mg/kg/day and foscarnet at
90 mg/kg/day (Cmb). Results: Mortality was similar among the 3 groups;
median survivals were: Fos, 8.4 months; Gcv, 9.0 months; Cmb, 8.6
months(p=0.894). Analysis of retinitis progression, as evaluated in a
masked fashion by a centralized Fundus Photograph Reading Center,
revealed that Cmb was the most effective regimen for controlling the
retinitis. Median times to progression were: Fos, 1.3 months; Gcv, 2.0
months; Cmb, 4.3 months (p=0.000008). Switching from one monotherapy to
another was no more effective than remaining on the same drug (adjusted
relative risk for progression=1.00, p=0.983). Although no difference
could be detected in visual acuity outcomes, visual field loss and
retinal area involvement both paralleled the progression results with
the most favorable results in the Cmb group. Rates of visual field loss
were: Fos, 28%/month; Gcv, 18%/month; Cmb, 16%/month (p=0.009); and
rates of increase of retinal area involved by CMV were: Fos,
2.47%/month; Gcv,1.40%/month; Cmb, 1.19%/month (p=0.041). Although 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. Conclusions: For patients with AIDS and
relapsed CMV retinitis who can tolerate both drugs, combination therapy
appeared to be the most effective therapy for controlling CMV retinitis.
Acquired Immunodeficiency Syndrome/*COMPLICATIONS Antiviral
Agents/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Cytomegalovirus
Retinitis/COMPLICATIONS/*DRUG THERAPY Drug Therapy, Combination
Foscarnet/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE
Ganciclovir/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Quality of Life
Recurrence Treatment Outcome ABSTRACT