Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT) (GCCRT)
Cytomegalovirus Retinitis, HIV Infections
About this trial
This is an interventional treatment trial for Cytomegalovirus Retinitis
Eligibility Criteria
Inclusion criteria: 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 Exclusion criteria: 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
Sites / Locations
- Department of Ophthalmology, University of California, Irvine
- Shiley Eye Center Center, 0946, University of California, San Diego
- LAC/USC Medical Center, 5P21 Rand Schrader Clinic
- Jules Stein Eye Institute, University of California, Los Angeles
- Beckman Vision Center, University of California, San Francisco
- Bascom Palmer Eye Institute, University of Miami
- University of South Florida, MDC Box 21
- The Emory Clinic, Emory University
- Department of Ophthalmology, Northwestern University
- Division of Infectious Diseases, Indiana University, Indianapolis
- LSU Eye Center, Louisiana State University Medical Center
- The Wilmer Ophthalmological Institute, The Johns Hopkins University School of Medicine
- Harvard/BCH AIDS Clinical Trials Unit, Massachusetts General Hospital
- UMDNJ-New Jersey Medical School
- Department of Ophthalmology, New York University Medical Center
- Department of Ophthalmology, New York Hospital-Cornell Medical Center
- Department of Ophthalmology, Mount Sinai School of Medicine
- University of North Carolina at Chapel Hill
- Cullen Eye Institute, Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Ganciclovir implant and oral ganciclovir
Cidofovir IV (Intravenous)
Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily
cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week