Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)
GCCRT
1 other identifier
interventional
61
1 country
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 1997
Typical duration for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 1997
CompletedFirst Submitted
Initial submission to the registry
September 23, 1999
CompletedFirst Posted
Study publicly available on registry
September 24, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2000
CompletedResults Posted
Study results publicly available
March 14, 2016
CompletedMarch 14, 2016
July 1, 2015
3.1 years
September 23, 1999
July 1, 2015
February 18, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Survival
3 years
Study Arms (2)
Ganciclovir implant and oral ganciclovir
EXPERIMENTALGanciclovir device and oral dose of Ganciclovir 1 gm three times daily
Cidofovir IV (Intravenous)
EXPERIMENTALcidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week
Interventions
oral ganciclovir, 1 gm three times daily
intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Department of Ophthalmology, University of California, Irvine
Irvine, California, 92697-4375, United States
Shiley Eye Center Center, 0946, University of California, San Diego
La Jolla, California, 92093-0946, United States
LAC/USC Medical Center, 5P21 Rand Schrader Clinic
Los Angeles, California, 90033, United States
Jules Stein Eye Institute, University of California, Los Angeles
Los Angeles, California, 90095-7003, United States
Beckman Vision Center, University of California, San Francisco
San Francisco, California, 94143, United States
Bascom Palmer Eye Institute, University of Miami
Miami, Florida, 33136, United States
University of South Florida, MDC Box 21
Tampa, Florida, 33612-4799, United States
The Emory Clinic, Emory University
Atlanta, Georgia, 30322, United States
Department of Ophthalmology, Northwestern University
Chicago, Illinois, 60611, United States
Division of Infectious Diseases, Indiana University, Indianapolis
Indianapolis, Indiana, 46202-2879, United States
LSU Eye Center, Louisiana State University Medical Center
New Orleans, Louisiana, 70112, United States
The Wilmer Ophthalmological Institute, The Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287-9217, United States
Harvard/BCH AIDS Clinical Trials Unit, Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
UMDNJ-New Jersey Medical School
Newark, New Jersey, 07103-2499, United States
Department of Ophthalmology, New York University Medical Center
New York, New York, 10016, United States
Department of Ophthalmology, New York Hospital-Cornell Medical Center
New York, New York, 10021, United States
Department of Ophthalmology, Mount Sinai School of Medicine
New York, New York, 10029-6574, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7030, United States
Cullen Eye Institute, Baylor College of Medicine
Houston, Texas, 77030, United States
Related Publications (2)
Studies of Ocular Complications of AIDS Research Group. The AIDS Clinical Trials Group.. The ganciclovir implant plus oral ganciclovir versus parenteral cidofovir for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome: The Ganciclovir Cidofovir Cytomegalovirus Retinitis Trial. Am J Ophthalmol. 2001 Apr;131(4):457-67. doi: 10.1016/s0002-9394(01)00840-6.
PMID: 11292409BACKGROUNDDunn JP, Van Natta M, Foster G, Kuppermann BD, Martin DF, Zong A, Jabs DA; Studies of Ocular Complications of AIDS Research Group. Complications of ganciclovir implant surgery in patients with cytomegalovirus retinitis: the Ganciclovir Cidofovir Cytomegalovirus Retinitis Trial. Retina. 2004 Feb;24(1):41-50. doi: 10.1097/00006982-200402000-00007.
PMID: 15076943BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Curtis Meinert, PhD
- Organization
- Johns Hopkins School of Public Health
Study Officials
- STUDY CHAIR
Douglas Jabs, MD
SOCA Chairman's Office
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 1999
First Posted
September 24, 1999
Study Start
May 1, 1997
Primary Completion
June 1, 2000
Study Completion
June 1, 2000
Last Updated
March 14, 2016
Results First Posted
March 14, 2016
Record last verified: 2015-07
Data Sharing
- IPD Sharing
- Will share