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

Launched by JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH · Sep 23, 1999

Keywords

ClinConnect 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: ...

Gender

ALL

Eligibility criteria

• 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 Officials