Clinical Trial: Studies of the Ocular Complications of AIDS (SOCA)--Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Foscarnet-Ganciclovir CMV Retinitis Trial
Brief Summary: To evaluate the relative safety and efficacy of ganciclovir and foscarnet as initial treatment of patients with cytomegalovirus (CMV) retinitis.
Detailed Summary:
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.
Sponsor: Johns Hopkins Bloomberg School of Public Health
Current Primary Outcome: Mortality [ Time Frame: All patients enrolled will be followed until a common study closing date, which was chosen to provide a minimum of 1 year of follow-up for all patients enrolled in the trial. ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Johns Hopkins Bloomberg School of Public Health
Dates:
Date Received: September 23, 1999
Date Started: March 1990
Date Completion:
Last Updated: September 22, 2015
Last Verified: July 2015
