Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)
Information source: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Acquired Immunodeficiency Syndrome; Cytomegalovirus Retinitis
Intervention: Ganciclovir (Drug); Foscarnet (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Johns Hopkins Bloomberg School of Public Health
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.
Clinical Details
Official title: Cytomegalovirus Retinitis Retreatment Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Compare the safety and efficacy of three therapeutic regimens in patients with AIDS related CMV retinitis previously treated with foscarnet or ganciclovir whose retinitis progresses or recurs
Secondary outcome: Compare the safety and efficacy of continuing to treat patients with the same anti-CMV drug versus switching to the alternative drug
Detailed 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. Outcome measures in this trial were survival, retinitis
progression, loss of visual function (acuity and field), and morbidity.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
inclusion criteria: Males and females eligible for the CRRT must have been age 18 years
or older and have had AIDS and CMV retinitis. They must have had active CMV despite a
minimum of 28 days of previous treatment with an anti-CMV drug. Furthermore, they must
have had an absolute neutrophil count greater than or equal to 500 cells/µL, platelet
count greater than or equal to 20,000 cells/µL, and a serum creatinine < 2. 5 mg/dL in
order to tolerate the drug regimens.
exclusion criteria: history of intolerance to ganciclovir or foscarnet, history of
therapy involving the combination of foscarnet and ganciclovir, unwillingness to practice
appropriate birth control, active drug or alcohol abuse, media opacity, retinal detachment
not scheduled for surgical repair
Locations and Contacts
Additional Information
NEI Press Release-Two Drug Treatment Is Effective Against Recurrent Eye Infection In AIDS Patients
Related publications: Combination foscarnet and ganciclovir therapy vs monotherapy for the treatment of relapsed cytomegalovirus retinitis in patients with AIDS. The Cytomegalovirus Retreatment Trial. The Studies of Ocular Complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group. Arch Ophthalmol. 1996 Jan;114(1):23-33. Martin BK, Kaplan Gilpin AM, Jabs DA, Wu AW; Studies of Ocular Complications of AIDS Research Group. Reliability, validity, and responsiveness of general and disease-specific quality of life measures in a clinical trial for cytomegalovirus retinitis. J Clin Epidemiol. 2001 Apr;54(4):376-86.
Starting date: December 1992
Last updated: April 10, 2015
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