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

September 23, 1999
April 17, 2015
March 1990
October 1991   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00000136 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Studies of the Ocular Complications of AIDS (SOCA)--Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT)
Foscarnet-Ganciclovir CMV Retinitis Trial

To evaluate the relative safety and efficacy of ganciclovir and foscarnet as initial treatment of patients with cytomegalovirus (CMV) retinitis.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • HIV Infections
  • Cytomegalovirus Retinitis
  • 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: Foscarnet
    The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day
    Interventions:
    • Drug: Foscarnet
    • Drug: Ganciclovir
  • 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.
    Interventions:
    • Drug: Foscarnet
    • Drug: Ganciclovir

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
October 1991
October 1991   (final data collection date for primary outcome measure)

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
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00000136
NEI-35, U10EY008057
Yes
Johns Hopkins Bloomberg School of Public Health
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
  • 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
Not Provided
Johns Hopkins Bloomberg School of Public Health
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP