Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)

Completed · Phase 3

Conditions studied: Cytomegalovirus Retinitis, HIV Infections

In brief

To compare the newest CMV retinitis drug, cidofovir, with a regimen of the ganciclovir intraocular device plus oral ganciclovir with respect to efficacy in preventing vision loss. To compare a treatment regimen that incorporates highly active local therapy (ganciclovir device) with a treatment regimen that does not.

Key facts

Study ID

NCT00000143

Run by

Johns Hopkins Bloomberg School of Public Health

People needed

61

Starts

1997-05-01

Expected to finish

2000-06-01

Last updated by the study team

2016-03-14

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 13 years or older
• Diagnosis of AIDS according to current Centers for Disease Control and Prevention (CDC) definition
• Diagnosis of active CMV retinitis by a SOCA-certified ophthalmologist (involvement of any zone or amount of retina is allowed)
• Best corrected visual acuity of 20/100 or better in at least one eye
• At least one lesion 750 cells/µL or greater
• Platelet count 50,000 cells/µL or greater
• Willingness and ability, with the assistance of a caregiver if necessary to comply with treatment and follow up procedures
• Willingness of all men and women of childbearing potential to practice adequate birth control to prevent pregnancies during the study and for 3 months afterwards
• Collection of all baseline data within 5 days prior to randomization
• Signed consent statement

You may not qualify if…

• Media opacities that preclude visualization of the fundus of all otherwise eligible eyes
• Treatment for CMV retinitis with the ganciclovir intraocular implant within 9 months of study entry
• Medical problems or drug or alcohol abuse sufficient to hinder adherence to treatment or follow up procedures
• Unwillingness to refrain from breast-feeding during the study and for 3 months afterwards

Where it is running

• Department of Ophthalmology, University of California, Irvine — Irvine, California, United States
• Shiley Eye Center Center, 0946, University of California, San Diego — La Jolla, California, United States
• LAC/USC Medical Center, 5P21 Rand Schrader Clinic — Los Angeles, California, United States
• Jules Stein Eye Institute, University of California, Los Angeles — Los Angeles, California, United States
• Beckman Vision Center, University of California, San Francisco — San Francisco, California, United States
• Bascom Palmer Eye Institute, University of Miami — Miami, Florida, United States
• University of South Florida, MDC Box 21 — Tampa, Florida, United States
• The Emory Clinic, Emory University — Atlanta, Georgia, United States
• Department of Ophthalmology, Northwestern University — Chicago, Illinois, United States
• Division of Infectious Diseases, Indiana University, Indianapolis — Indianapolis, Indiana, United States
• LSU Eye Center, Louisiana State University Medical Center — New Orleans, Louisiana, United States
• The Wilmer Ophthalmological Institute, The Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Harvard/BCH AIDS Clinical Trials Unit, Massachusetts General Hospital — Boston, Massachusetts, United States
• UMDNJ-New Jersey Medical School — Newark, New Jersey, United States
• Department of Ophthalmology, New York University Medical Center — New York, New York, United States
• Department of Ophthalmology, New York Hospital-Cornell Medical Center — New York, New York, United States
• Department of Ophthalmology, Mount Sinai School of Medicine — New York, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Cullen Eye Institute, Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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