HIV Infections Clinical Trial
Official title:
Cytomegalovirus Retinitis Retreatment Trial
To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV
retinitis who have been previously treated but whose retinitis either is nonresponsive or
has relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose
ganciclovir, and (3) combination foscarnet and ganciclovir.
To compare two treatment strategies in patients with relapsed or nonresponsive CMV
retinitis: (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.
CMV retinitis is the most common intraocular infection in patients with AIDS and is
estimated to affect 35 to 40 percent of patients with AIDS. Untreated CMV retinitis is a
progressive disorder, the end result of which is total retinal destruction and blindness. At
the time of this trial, drugs approved by the United States Food and Drug Administration
(FDA) for the treatment of CMV retinitis were ganciclovir (Cytovene) and foscarnet
(Foscavir). Although most retinitis responds well to initial therapy with systemically
administered drugs, given enough time, nearly all patients will suffer a relapse of the
retinitis. Relapsed retinitis generally responds to reinduction and maintenance therapy, but
the interval between successive relapses progressively shortens. The CRRT addressed the
issue of the management of relapsed CMV retinitis.
The CRRT was a multicenter, randomized, controlled clinical trial comparing three regimens
in patients with relapsed retinitis. Patients with AIDS and CMV retinitis that had relapsed
or was nonresponsive to initial therapy were randomized to one of three regimens: (1)
intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by
maintenance therapy at 120 mg/kg/day; (2) intravenous ganciclovir reinduction at 5 mg/kg
twice daily for 2 weeks followed by maintenance at 10 mg/kg/day; and (3) combination
therapy, wherein patients continued their previous therapy and were reinduced with the
second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and
ganciclovir at 5 mg/kg/day.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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