Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)

Last updated: August 11, 2015
Sponsor: Johns Hopkins Bloomberg School of Public Health
Overall Status: Completed

Phase

3

Condition

Aids And Aids Related Infections

Cytomegalovirus Infections

Hiv Infections

Treatment

N/A

Clinical Study ID

NCT00000134
NEI-33
U10EY008057
U01AI027668
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

inclusion criteria: Males and females eligible for the CRRT must have been age 18 years orolder and have had AIDS and CMV retinitis. They must have had active CMV despite a minimumof 28 days of previous treatment with an anti-CMV drug. Furthermore, they must have had anabsolute neutrophil count greater than or equal to 500 cells/µL, platelet count greaterthan or equal to 20,000 cells/µL, and a serum creatinine < 2.5 mg/dL in order to toleratethe drug regimens.

Exclusion

exclusion criteria: history of intolerance to ganciclovir or foscarnet, history of therapyinvolving the combination of foscarnet and ganciclovir, unwillingness to practiceappropriate birth control, active drug or alcohol abuse, media opacity, retinal detachmentnot scheduled for surgical repair

Study Design

Total Participants: 279
Study Start date:
December 01, 1992
Estimated Completion Date:
March 31, 1995

Study Description

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.