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

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ClinicalTrials.gov Identifier: NCT00000134
Recruitment Status : Completed
First Posted : September 24, 1999
Results First Posted : September 14, 2015
Last Update Posted : September 14, 2015
Sponsor:
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
Information provided by (Responsible Party):
Curtis Meinert, Johns Hopkins Bloomberg School of Public Health

Tracking Information
First Submitted Date  ICMJE September 23, 1999
First Posted Date  ICMJE September 24, 1999
Results First Submitted Date  ICMJE June 15, 2015
Results First Posted Date  ICMJE September 14, 2015
Last Update Posted Date September 14, 2015
Study Start Date  ICMJE December 1992
Actual Primary Completion Date March 1995   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2015)
Morbidity [ Time Frame: Patients will be seen at baseline, monthly for six months, and then every three months until death or termination of the trial ]
To determine the best therapeutic regimen, using currently approved drugs, for treatment of relapsed cytomegalovirus (CMV) retinitis.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)
Official Title  ICMJE Cytomegalovirus Retinitis Retreatment Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Cytomegalovirus Retinitis
Intervention  ICMJE
  • Drug: Ganciclovir
    intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
    Other Name: cytovene
  • Drug: Foscarnet
    intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day
    Other Name: foscavir
Study Arms  ICMJE
  • Experimental: intravenous foscarnet
    intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day
    Intervention: Drug: Foscarnet
  • Active Comparator: intravenous ganciclovir
    intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
    Intervention: Drug: Ganciclovir
  • Active Comparator: combination therapy
    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.
    Interventions:
    • Drug: Ganciclovir
    • Drug: Foscarnet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2015)
279
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 1995
Actual Primary Completion Date March 1995   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000134
Other Study ID Numbers  ICMJE NEI-33
U10EY008057 ( U.S. NIH Grant/Contract )
U01AI027668 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Curtis Meinert, Johns Hopkins Bloomberg School of Public Health
Study Sponsor  ICMJE Johns Hopkins Bloomberg School of Public Health
Collaborators  ICMJE
  • 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
Investigators  ICMJE Not Provided
PRS Account Johns Hopkins Bloomberg School of Public Health
Verification Date August 2015

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