HIV Infections Clinical Trial
Official title:
Foscarnet-Ganciclovir CMV Retinitis Trial
To evaluate the relative safety and efficacy of ganciclovir and foscarnet as initial treatment of patients with cytomegalovirus (CMV) retinitis.
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.
The first two drugs approved by the United States Food and Drug Administration (FDA) for the
treatment of CMV retinitis were ganciclovir (Cytovene) and foscarnet (Foscavir). At the time
of this trial, both ganciclovir and foscarnet were available only as intravenous
formulations. Both drugs were given in a similar two-step fashion: an initial 2-week course
of high-dose therapy (induction) to control the infection followed by long-term lower dose
therapy to prevent relapse (maintenance). The FGCRT compared foscarnet and ganciclovir as
initial therapy for CMV retinitis.
The FGCRT was a multicenter, randomized, controlled clinical trial comparing foscarnet and
ganciclovir as initial therapy for CMV retinitis. Patients with previously untreated CMV
retinitis were randomized to therapy with either intravenous ganciclovir or intravenous
foscarnet. The outcome measures of this trial were survival, retinitis progression, loss of
visual function (visual acuity and visual field), and morbidity.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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