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

• Status: Completed
• Trial end date: 1991-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: Baylor College of Medicine; Icahn School of Medicine at Mount Sinai; Johns Hopkins University; Louisiana State University Health Sciences Center in New Orleans; Memorial Sloan Kettering Cancer Center; National Eye Institute (NEI); New York Presbyterian Hospital; New York University School of Medicine; Northwestern University; NYU Langone Health; University of California, Los Angeles; University of California, San Diego; University of California, San Francisco; University of Massachusetts, Worcester; University of Miami; University of Wisconsin, Madison
• Treatments: Foscarnet; Ganciclovir; Ganciclovir triphosphate; Phosphonoacetic Acid

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