Studies of the Ocular Complications of AIDS (SOCA)--Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT)

Study Overview
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Brief Summary
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To evaluate the relative safety and efficacy of ganciclovir and foscarnet as initial treatment of patients with cytomegalovirus (CMV) retinitis.

Detailed Description
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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.

Official Title
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Foscarnet-Ganciclovir CMV Retinitis Trial

Conditions
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HIV Infections, Cytomegalovirus Retinitis

Intervention / Treatment
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* Drug: Foscarnet
* Drug: Ganciclovir


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: CMV retinitis in one or both eyes At least 1/4 disk are of one CMV lesion photographable Diagnosis of AIDS as defined by Center for Disease Control criteria or documented HIV infection Age 13 and greater Visual acuity ≥ 3/200 in at least one eye diagnosed with CMV retinitis Absolute neutrophil count ≥ 1,000 cells/µl Platelet ≥ 25,000 cells/µl Serum creatinine ≥ 2.0 mg/dl Karnofsky score ≥ 60 Informed consent Exclusion criteria: Previous treatment of CMV retinitis Treatment with anti-CMV therapy for an extra-ocular CMV infection currently or in the past 28 days Known or suspected allergy to study drugs Pregnant or Lactating

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Foscarnet<br>The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day | Drug: Foscarnet<br>* 60 mg/kg every 8 hours, 90 mg/kg/day<br>* Other names: Foscavir;Drug: Ganciclovir<br>* 5 mg/kg every 12 hours, 5 mg/kg every 24 hours<br>* Other names: Vitraset;|
| Experimental: Ganciclovir<br>The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week. | Drug: Foscarnet<br>* 60 mg/kg every 8 hours, 90 mg/kg/day<br>* Other names: Foscavir;Drug: Ganciclovir<br>* 5 mg/kg every 12 hours, 5 mg/kg every 24 hours<br>* Other names: Vitraset;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 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. |