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

Primary Purpose

HIV Infections, Cytomegalovirus Retinitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Foscarnet
Ganciclovir
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 HIV Infections

Eligibility Criteria

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

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Foscarnet

    Ganciclovir

    Arm Description

    The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day

    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.

    Outcomes

    Primary Outcome Measures

    Mortality

    Secondary Outcome Measures

    Full Information

    First Posted
    September 23, 1999
    Last Updated
    September 22, 2015
    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, NYU Langone Health, 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
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000136
    Brief Title
    Studies of the Ocular Complications of AIDS (SOCA)--Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT)
    Acronym
    FGCRT
    Official Title
    Foscarnet-Ganciclovir CMV Retinitis Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1990 (undefined)
    Primary Completion Date
    October 1991 (Actual)
    Study Completion Date
    October 1991 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the 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, NYU Langone Health, 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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    234 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Foscarnet
    Arm Type
    Experimental
    Arm Description
    The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day
    Arm Title
    Ganciclovir
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Foscarnet
    Other Intervention Name(s)
    Foscavir
    Intervention Description
    60 mg/kg every 8 hours, 90 mg/kg/day
    Intervention Type
    Drug
    Intervention Name(s)
    Ganciclovir
    Other Intervention Name(s)
    Vitraset
    Intervention Description
    5 mg/kg every 12 hours, 5 mg/kg every 24 hours
    Primary Outcome Measure Information:
    Title
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Curtis Meinert, PhD
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    1315661
    Citation
    Studies of ocular complications of AIDS Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial: 1. Rationale, design, and methods. AIDS Clinical Trials Group (ACTG). Control Clin Trials. 1992 Feb;13(1):22-39. doi: 10.1016/0197-2456(92)90027-w.
    Results Reference
    background
    PubMed Identifier
    8660161
    Citation
    Assessment of cytomegalovirus retinitis. Clinical evaluation vs centralized grading of fundus photographs. Studies of Ocular Complications of AIDS Research Group, AIDS Clinical Trials Group. Arch Ophthalmol. 1996 Jul;114(7):791-805.
    Results Reference
    background
    PubMed Identifier
    8660169
    Citation
    Clinical vs photographic assessment of treatment of cytomegalovirus retinitis. Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial Report 8. Studies of Ocular Complications of AIDS Research Group, AIDS Clinical Trials Group. Arch Ophthalmol. 1996 Jul;114(7):848-55.
    Results Reference
    background
    PubMed Identifier
    8660168
    Citation
    Wu AW, Coleson LC, Holbrook J, Jabs DA. Measuring visual function and quality of life in patients with cytomegalovirus retinitis. Development of a questionnaire. Studies of Ocular Complication of AIDS Research Group. Arch Ophthalmol. 1996 Jul;114(7):841-7. doi: 10.1001/archopht.1996.01100140055008.
    Results Reference
    background
    PubMed Identifier
    9207349
    Citation
    Cytomegalovirus (CMV) culture results, drug resistance, and clinical outcome in patients with AIDS and CMV retinitis treated with foscarnet or ganciclovir. Studies of Ocular Complications of AIDS (SOCA) in collaboration with the AIDS Clinical Trial Group. J Infect Dis. 1997 Jul;176(1):50-8. doi: 10.1086/514039.
    Results Reference
    background
    PubMed Identifier
    9262538
    Citation
    Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial: 5. Clinical features of cytomegalovirus retinitis at diagnosis. Studies of ocular complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group. Am J Ophthalmol. 1997 Aug;124(2):141-57.
    Results Reference
    background
    PubMed Identifier
    9222234
    Citation
    Rhegmatogenous retinal detachment in patients with cytomegalovirus retinitis: the Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial. The Studies of Ocular Complications of AIDS (SOCA) Research Group in Collaboration with the AIDS Clinical Trials Group (ACTG). Am J Ophthalmol. 1997 Jul;124(1):61-70.
    Results Reference
    background
    PubMed Identifier
    1345799
    Citation
    Studies of Ocular Complications of AIDS Research Group; AIDS Clinical Trials Group. Mortality in patients with the acquired immunodeficiency syndrome treated with either foscarnet or ganciclovir for cytomegalovirus retinitis. N Engl J Med. 1992 Jan 23;326(4):213-20. doi: 10.1056/NEJM199201233260401. Erratum In: N Engl J Med 1992 Apr 23;326(17):1172.
    Results Reference
    background
    PubMed Identifier
    8035989
    Citation
    Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial. 4. Visual outcomes. Studies of Ocular Complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group. Ophthalmology. 1994 Jul;101(7):1250-61.
    Results Reference
    background
    PubMed Identifier
    7658051
    Citation
    Antiviral effects of foscarnet and ganciclovir therapy on human immunodeficiency virus p24 antigen in patients with AIDS and cytomegalovirus retinitis. Studies of Ocular Complications of AIDS Research Group in collaboration with AIDS Clinical Trials Group. J Infect Dis. 1995 Sep;172(3):613-21. doi: 10.1093/infdis/172.3.613.
    Results Reference
    background
    PubMed Identifier
    7802522
    Citation
    Morbidity and toxic effects associated with ganciclovir or foscarnet therapy in a randomized cytomegalovirus retinitis trial. Studies of ocular complications of AIDS Research Group, in collaboration with the AIDS Clinical Trials Group. Arch Intern Med. 1995 Jan 9;155(1):65-74.
    Results Reference
    background
    PubMed Identifier
    9330549
    Citation
    Wu AW, Revicki DA, Jacobson D, Malitz FE. Evidence for reliability, validity and usefulness of the Medical Outcomes Study HIV Health Survey (MOS-HIV). Qual Life Res. 1997 Aug;6(6):481-93. doi: 10.1023/a:1018451930750.
    Results Reference
    background
    PubMed Identifier
    10980764
    Citation
    Holbrook JT, Davis MD, Hubbard LD, Martin BK, Holland GN, Jabs DA, Gilpin AK, Meinert C, Reshef DS. Risk factors for advancement of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome. Studies of Ocular Complications of AIDS Research Group. Arch Ophthalmol. 2000 Sep;118(9):1196-204. doi: 10.1001/archopht.118.9.1196.
    Results Reference
    background
    Links:
    URL
    http://www.nei.nih.gov/news/pressreleases/fgcrtpressrelease.asp
    Description
    http://www.nei.nih.gov/news/pressreleases/fgcrtpressrelease.asp

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

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