Overview

Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)

Status:
Completed

Trial end date:
1995-03-01

Target enrollment:
0

Participant gender:
All

Summary

To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV retinitis who have been previously treated but whose retinitis either is nonresponsive or has relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and (3) combination foscarnet and ganciclovir. To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis: (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.

Phase:

Phase 3

Accepts Healthy Volunteers?

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
Memorial Sloan Kettering Cancer Center
National Eye Institute (NEI)
National Institute of Allergy and Infectious Diseases (NIAID)
New York Presbyterian Hospital
New York University
Northwestern University
Tulane University School of Medicine
University of California, Los Angeles
University of California, San Diego
University of California, San Francisco
University of Miami
University of North Carolina, Chapel Hill
University of Wisconsin, Madison

Treatments:

Foscarnet
Ganciclovir
Ganciclovir triphosphate
Phosphonoacetic Acid

Criteria

inclusion criteria: Males and females eligible for the CRRT must have been age 18 years or
older and have had AIDS and CMV retinitis. They must have had active CMV despite a minimum
of 28 days of previous treatment with an anti-CMV drug. Furthermore, they must have had an
absolute neutrophil count greater than or equal to 500 cells/µL, platelet count greater
than or equal to 20,000 cells/µL, and a serum creatinine < 2.5 mg/dL in order to tolerate
the drug regimens.

exclusion criteria: history of intolerance to ganciclovir or foscarnet, history of therapy
involving the combination of foscarnet and ganciclovir, unwillingness to practice
appropriate birth control, active drug or alcohol abuse, media opacity, retinal detachment
not scheduled for surgical repair