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Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT) (CRRT)

Primary Purpose

HIV Infections, Acquired Immunodeficiency Syndrome, Cytomegalovirus Retinitis

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

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

inclusion criteria: Males and females eligible for the CRRT must have been age 18 years or older and have had AIDS and CMV retinitis. They must have had active CMV despite a minimum of 28 days of previous treatment with an anti-CMV drug. Furthermore, they must have had an absolute neutrophil count greater than or equal to 500 cells/µL, platelet count greater than or equal to 20,000 cells/µL, and a serum creatinine < 2.5 mg/dL in order to tolerate the drug regimens. exclusion criteria: history of intolerance to ganciclovir or foscarnet, history of therapy involving the combination of foscarnet and ganciclovir, unwillingness to practice appropriate birth control, active drug or alcohol abuse, media opacity, retinal detachment not scheduled for surgical repair

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    intravenous foscarnet

    intravenous ganciclovir

    combination therapy

    Arm Description

    intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day

    intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day

    combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.

    Outcomes

    Primary Outcome Measures

    Morbidity
    To determine the best therapeutic regimen, using currently approved drugs, for treatment of relapsed cytomegalovirus (CMV) retinitis.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 23, 1999
    Last Updated
    August 11, 2015
    Sponsor
    Johns Hopkins Bloomberg School of Public Health
    Collaborators
    National Eye Institute (NEI), National Institute of Allergy and Infectious Diseases (NIAID), Johns Hopkins University, University of Wisconsin, Madison, Baylor College of Medicine, Tulane University School of Medicine, Icahn School of Medicine at Mount Sinai, New York Presbyterian Hospital, New York University, Northwestern University, University of California, Los Angeles, University of California, San Francisco, University of California, San Diego, University of Miami, University of North Carolina, Chapel Hill, Memorial Sloan Kettering Cancer Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000134
    Brief Title
    Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)
    Acronym
    CRRT
    Official Title
    Cytomegalovirus Retinitis Retreatment Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1992 (undefined)
    Primary Completion Date
    March 1995 (Actual)
    Study Completion Date
    March 1995 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Johns Hopkins Bloomberg School of Public Health
    Collaborators
    National Eye Institute (NEI), National Institute of Allergy and Infectious Diseases (NIAID), Johns Hopkins University, University of Wisconsin, Madison, Baylor College of Medicine, Tulane University School of Medicine, Icahn School of Medicine at Mount Sinai, New York Presbyterian Hospital, New York University, Northwestern University, University of California, Los Angeles, University of California, San Francisco, University of California, San Diego, University of Miami, University of North Carolina, Chapel Hill, Memorial Sloan Kettering Cancer Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV retinitis who have been previously treated but whose retinitis either is nonresponsive or has relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and (3) combination foscarnet and ganciclovir. To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis: (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.
    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. At the time of this trial, drugs approved by the United States Food and Drug Administration (FDA) for the treatment of CMV retinitis were ganciclovir (Cytovene) and foscarnet (Foscavir). Although most retinitis responds well to initial therapy with systemically administered drugs, given enough time, nearly all patients will suffer a relapse of the retinitis. Relapsed retinitis generally responds to reinduction and maintenance therapy, but the interval between successive relapses progressively shortens. The CRRT addressed the issue of the management of relapsed CMV retinitis. The CRRT was a multicenter, randomized, controlled clinical trial comparing three regimens in patients with relapsed retinitis. Patients with AIDS and CMV retinitis that had relapsed or was nonresponsive to initial therapy were randomized to one of three regimens: (1) intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day; (2) intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day; and (3) combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    279 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    intravenous foscarnet
    Arm Type
    Experimental
    Arm Description
    intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day
    Arm Title
    intravenous ganciclovir
    Arm Type
    Active Comparator
    Arm Description
    intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
    Arm Title
    combination therapy
    Arm Type
    Active Comparator
    Arm Description
    combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.
    Intervention Type
    Drug
    Intervention Name(s)
    Ganciclovir
    Other Intervention Name(s)
    cytovene
    Intervention Description
    intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
    Intervention Type
    Drug
    Intervention Name(s)
    Foscarnet
    Other Intervention Name(s)
    foscavir
    Intervention Description
    intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day
    Primary Outcome Measure Information:
    Title
    Morbidity
    Description
    To determine the best therapeutic regimen, using currently approved drugs, for treatment of relapsed cytomegalovirus (CMV) retinitis.
    Time Frame
    Patients will be seen at baseline, monthly for six months, and then every three months until death or termination of the trial

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    inclusion criteria: Males and females eligible for the CRRT must have been age 18 years or older and have had AIDS and CMV retinitis. They must have had active CMV despite a minimum of 28 days of previous treatment with an anti-CMV drug. Furthermore, they must have had an absolute neutrophil count greater than or equal to 500 cells/µL, platelet count greater than or equal to 20,000 cells/µL, and a serum creatinine < 2.5 mg/dL in order to tolerate the drug regimens. exclusion criteria: history of intolerance to ganciclovir or foscarnet, history of therapy involving the combination of foscarnet and ganciclovir, unwillingness to practice appropriate birth control, active drug or alcohol abuse, media opacity, retinal detachment not scheduled for surgical repair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    8540847
    Citation
    Combination foscarnet and ganciclovir therapy vs monotherapy for the treatment of relapsed cytomegalovirus retinitis in patients with AIDS. The Cytomegalovirus Retreatment Trial. The Studies of Ocular Complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group. Arch Ophthalmol. 1996 Jan;114(1):23-33. doi: 10.1001/archopht.1996.01100130021004.
    Results Reference
    background
    PubMed Identifier
    11305288
    Citation
    Martin BK, Kaplan Gilpin AM, Jabs DA, Wu AW; Studies of Ocular Complications of AIDS Research Group. Reliability, validity, and responsiveness of general and disease-specific quality of life measures in a clinical trial for cytomegalovirus retinitis. J Clin Epidemiol. 2001 Apr;54(4):376-86. doi: 10.1016/s0895-4356(00)00294-8.
    Results Reference
    background
    Links:
    URL
    http://www.nei.nih.gov/news/pressreleases/crrtpressrelease.asp
    Description
    NEI Press Release-Two Drug Treatment Is Effective Against Recurrent Eye Infection In AIDS Patients

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    Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)

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