search
Back to results

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

Primary Purpose

Cytomegalovirus Retinitis, HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ganciclovir implant and oral ganciclovir
Cidofovir intravenous
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cytomegalovirus Retinitis

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Arm Label

Ganciclovir implant and oral ganciclovir

Cidofovir IV (Intravenous)

Arm Description

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

Outcomes

Primary Outcome Measures

Survival

Secondary Outcome Measures

Full Information

First Posted
September 23, 1999
Last Updated
February 18, 2016
Sponsor
Johns Hopkins Bloomberg School of Public Health
search

1. Study Identification

Unique Protocol Identification Number
NCT00000143
Brief Title
Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)
Acronym
GCCRT
Official Title
Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
May 1997 (undefined)
Primary Completion Date
June 2000 (Actual)
Study Completion Date
June 2000 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Cytomegalovirus (CMV) is among the most frequently encountered opportunistic infections in patients with AIDS. In the era of prophylaxis for pneumocystic pneumonia, CMV disease is estimated to affect 45 percent of patients with AIDS sometime between the diagnosis of AIDS and death. Retinitis has been estimated to account for up to 85 percent of CMV disease in these patients, making CMV retinitis the most common ocular infection encountered. CMV retinitis is a relatively late-stage manifestation, associated with cluster of differentiation 4 (CD4) + T-cell counts < 100 cells/µL and often < 50 cells/µL. All currently available treatments for CMV suppress viral replication but do not eliminate the virus from the body. Discontinuation of therapy is associated with a prompt relapse of the retinitis. Despite the use of chronic suppressive therapy, relapse of the retinitis generally occurs, at least with systemically administered anti-CMV drugs. The first two treatments approved for CMV retinitis were intravenous ganciclovir and intravenous foscarnet. Both are given by daily intravenous infusions and therefore require central venous catheters. The development of newer treatments has focused not only on efficacious treatments, but also on treatments that do not require central venous catheters. Available treatments now include oral ganciclovir, the ganciclovir intraocular device, and intravenous cidofovir. In vitro data suggest that combination therapies are synergistic in inhibiting viral replication; these therapies include a foscarnet-ganciclovir combination and a cidofovir-ganciclovir combination. In the SOCA--CMV Retinitis Retreatment Trial, the combination of intravenous ganciclovir and foscarnet was more effective than either drug alone for the treatment of relapsed retinitis. Therefore, the combination of intermittent intravenous cidofovir and daily oral ganciclovir may be an attractive therapy for relapsed disease because it may provide synergy for controlling both ocular and visceral disease while not necessitating either a central venous catheter or an intraocular surgical procedure. The Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT) is a randomized, multicenter clinical trial. Patients will be assigned to receive one of two regimens: (1) ganciclovir intraocular device plus oral ganciclovir or (2) intravenous cidofovir. The intraocular device will be surgically implanted at baseline and again every 6 to 8 months in eyes with CMV retinitis. Oral ganciclovir is taken at a dose of 1 gram three times daily. Cidofovir will be administered intravenously at 5 mg/kg once weekly for 2 consecutive weeks and once every 2 weeks thereafter. If disease progression occurs in patients receiving cidofovir, patients will be given reinduction therapy, and oral ganciclovir at a dose of 1 gram three times per day will be added to the treatment. If patients assigned to cidofovir are unable to tolerate that regimen, an alternative systemic regimen will be recommended. Study outcome variables include a decrease of three or more lines from baseline in best corrected visual acuity and rate of visual field loss. The study will also assess other variables including mortality, blood CMV and HIV load, quality of life, and medical costs. Treatment assignment will not be masked to either patients or clinicians; however, reading of fundus photographs to determine both change in retinal involvement and progression will be masked.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Retinitis, HIV Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ganciclovir implant and oral ganciclovir
Arm Type
Experimental
Arm Description
Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily
Arm Title
Cidofovir IV (Intravenous)
Arm Type
Experimental
Arm Description
cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week
Intervention Type
Device
Intervention Name(s)
Ganciclovir implant and oral ganciclovir
Other Intervention Name(s)
Vitraset
Intervention Description
oral ganciclovir, 1 gm three times daily
Intervention Type
Drug
Intervention Name(s)
Cidofovir intravenous
Other Intervention Name(s)
Vistide
Intervention Description
intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week
Primary Outcome Measure Information:
Title
Survival
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Jabs, MD
Organizational Affiliation
SOCA Chairman's Office
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Ophthalmology, University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697-4375
Country
United States
Facility Name
Shiley Eye Center Center, 0946, University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0946
Country
United States
Facility Name
LAC/USC Medical Center, 5P21 Rand Schrader Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Jules Stein Eye Institute, University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-7003
Country
United States
Facility Name
Beckman Vision Center, University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Bascom Palmer Eye Institute, University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of South Florida, MDC Box 21
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-4799
Country
United States
Facility Name
The Emory Clinic, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Department of Ophthalmology, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Division of Infectious Diseases, Indiana University, Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-2879
Country
United States
Facility Name
LSU Eye Center, Louisiana State University Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
The Wilmer Ophthalmological Institute, The Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-9217
Country
United States
Facility Name
Harvard/BCH AIDS Clinical Trials Unit, Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
UMDNJ-New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103-2499
Country
United States
Facility Name
Department of Ophthalmology, New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Department of Ophthalmology, New York Hospital-Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Department of Ophthalmology, Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7030
Country
United States
Facility Name
Cullen Eye Institute, Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
11292409
Citation
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.
Results Reference
background
PubMed Identifier
15076943
Citation
Dunn 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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs