Overview

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