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

Johns Hopkins Bloomberg School of Public Health

Status and phase: Completed; Phase 3

Conditions: Cytomegalovirus Retinitis; HIV Infections

Treatments: Drug: Ganciclovir; Drug: Foscarnet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00000136

NEI-35

U10EY008057 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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. 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.

Enrollment: 234 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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234 participants in 2 patient groups

Foscarnet

Experimental group

Description:

The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day

Treatment:

Drug: Ganciclovir

Drug: Foscarnet

Ganciclovir

Experimental group

Description:

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.

Treatment:

Drug: Ganciclovir

Drug: Foscarnet