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Studies of the Ocular Complications of AIDS (SOCA)--Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT) (FGCRT)
This study has been completed.
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborators:
National Eye Institute (NEI)
Johns Hopkins University
University of Wisconsin, Madison
Baylor College of Medicine
Louisiana State University Health Sciences Center in New Orleans
New York Presbyterian Hospital
Icahn School of Medicine at Mount Sinai
New York University School of Medicine
Northwestern University
University of California, Los Angeles
University of California, San Diego
University of California, San Francisco
University of Miami
University of Massachusetts, Worcester
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00000136
First received: September 23, 1999
Last updated: September 22, 2015
Last verified: July 2015
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Purpose
To evaluate the relative safety and efficacy of ganciclovir and foscarnet as initial treatment of patients with cytomegalovirus (CMV) retinitis.
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infections Cytomegalovirus Retinitis | Drug: Foscarnet Drug: Ganciclovir | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Foscarnet-Ganciclovir CMV Retinitis Trial |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Cytomegalovirus Retinitis
Cytomegalic Inclusion Disease
U.S. FDA Resources
Further study details as provided by Johns Hopkins Bloomberg School of Public Health:
Primary Outcome Measures:
- Mortality [ Time Frame: All patients enrolled will be followed until a common study closing date, which was chosen to provide a minimum of 1 year of follow-up for all patients enrolled in the trial. ]
| Enrollment: | 234 |
| Study Start Date: | March 1990 |
| Study Completion Date: | October 1991 |
| Primary Completion Date: | October 1991 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Foscarnet
The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day
|
Drug: Foscarnet
60 mg/kg every 8 hours, 90 mg/kg/day
Other Name: Foscavir
Drug: Ganciclovir
5 mg/kg every 12 hours, 5 mg/kg every 24 hours
Other Name: Vitraset
|
|
Experimental: Ganciclovir
The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.
|
Drug: Foscarnet
60 mg/kg every 8 hours, 90 mg/kg/day
Other Name: Foscavir
Drug: Ganciclovir
5 mg/kg every 12 hours, 5 mg/kg every 24 hours
Other Name: Vitraset
|
Detailed Description:
CMV retinitis is the most common intraocular infection in patients with AIDS and is estimated to affect 35 to 40 percent of patients with AIDS. Untreated CMV retinitis is a progressive disorder, the end result of which is total retinal destruction and blindness. The first two drugs approved by the United States Food and Drug Administration (FDA) for the treatment of CMV retinitis were ganciclovir (Cytovene) and foscarnet (Foscavir). At the time of this trial, both ganciclovir and foscarnet were available only as intravenous formulations. Both drugs were given in a similar two-step fashion: an initial 2-week course of high-dose therapy (induction) to control the infection followed by long-term lower dose therapy to prevent relapse (maintenance). The FGCRT compared foscarnet and ganciclovir as initial therapy for CMV retinitis.
The FGCRT was a multicenter, randomized, controlled clinical trial comparing foscarnet and ganciclovir as initial therapy for CMV retinitis. Patients with previously untreated CMV retinitis were randomized to therapy with either intravenous ganciclovir or intravenous foscarnet. The outcome measures of this trial were survival, retinitis progression, loss of visual function (visual acuity and visual field), and morbidity.
Eligibility| Ages Eligible for Study: | 13 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- CMV retinitis in one or both eyes
- At least 1/4 disk are of one CMV lesion photographable
- Diagnosis of AIDS as defined by Center for Disease Control criteria or documented HIV infection
- Age 13 and greater
- Visual acuity ≥ 3/200 in at least one eye diagnosed with CMV retinitis
- Absolute neutrophil count ≥ 1,000 cells/µl
- Platelet ≥ 25,000 cells/µl
- Serum creatinine ≥ 2.0 mg/dl
- Karnofsky score ≥ 60
- Informed consent
Exclusion criteria:
- Previous treatment of CMV retinitis
- Treatment with anti-CMV therapy for an extra-ocular CMV infection currently or in the past 28 days
- Known or suspected allergy to study drugs
- Pregnant or Lactating
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000136
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000136
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
National Eye Institute (NEI)
Johns Hopkins University
University of Wisconsin, Madison
Baylor College of Medicine
Louisiana State University Health Sciences Center in New Orleans
New York Presbyterian Hospital
Icahn School of Medicine at Mount Sinai
New York University School of Medicine
Northwestern University
University of California, Los Angeles
University of California, San Diego
University of California, San Francisco
University of Miami
University of Massachusetts, Worcester
Memorial Sloan Kettering Cancer Center
Investigators
| Principal Investigator: | Curtis Meinert, PhD | Johns Hopkins University |
More Information
Additional Information:
Publications:
| Responsible Party: | Johns Hopkins Bloomberg School of Public Health |
| ClinicalTrials.gov Identifier: | NCT00000136 History of Changes |
| Other Study ID Numbers: |
NEI-35 U10EY008057 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | September 23, 1999 |
| Results First Received: | June 22, 2015 |
| Last Updated: | September 22, 2015 |
Additional relevant MeSH terms:
|
HIV Infections Retinitis Cytomegalovirus Retinitis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Retinal Diseases Eye Diseases Cytomegalovirus Infections Herpesviridae Infections |
DNA Virus Infections Eye Infections, Viral Eye Infections Ganciclovir Foscarnet Phosphonoacetic Acid Ganciclovir triphosphate Antiviral Agents Anti-Infective Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Anti-Retroviral Agents |
ClinicalTrials.gov processed this record on June 27, 2017