Studies of the Ocular Complications of AIDS (SOCA)--Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT)

This study has been completed.
Sponsor:
Collaborators:
Johns Hopkins University
University of Wisconsin, Madison
Baylor College of Medicine
Louisiana State University Health Sciences Center in New Orleans
New York Presbyterian Hospital
Mount Sinai School of Medicine
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: April 17, 2015
Last verified: April 2015
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Foscarnet-Ganciclovir CMV Retinitis Trial

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • survival, retinitis progression, loss of visual function (visual acuity and visual field), and morbidity [ 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. ] [ Designated as safety issue: Yes ]

Enrollment: 240
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
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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.

No Contacts or Locations Provided
  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
Study First Received: September 23, 1999
Last Updated: April 17, 2015
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cytomegalovirus Retinitis
Retinitis
Cytomegalovirus Infections
DNA Virus Infections
Eye Diseases
Eye Infections
Eye Infections, Viral
Herpesviridae Infections
Retinal Diseases
Virus Diseases
Foscarnet
Ganciclovir
Phosphonoacetic Acid
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on May 20, 2015