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

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT00000134
First received: September 23, 1999
Last updated: April 10, 2015
Last verified: April 2015

September 23, 1999
April 10, 2015
December 1992
March 1995   (final data collection date for primary outcome measure)
Compare the safety and efficacy of three therapeutic regimens in patients with AIDS related CMV retinitis previously treated with foscarnet or ganciclovir whose retinitis progresses or recurs [ Time Frame: Patients will be seen at baseline, monthly for six months, and then every three months until death or termination of the trial ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00000134 on ClinicalTrials.gov Archive Site
Compare the safety and efficacy of continuing to treat patients with the same anti-CMV drug versus switching to the alternative drug [ Time Frame: Patients will be seen at baseline, monthly for six months, and then every three months until death or termination of the trial ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)
Cytomegalovirus Retinitis Retreatment Trial

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.

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. Outcome measures in this trial were survival, retinitis progression, loss of visual function (acuity and field), and morbidity.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Cytomegalovirus Retinitis
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
279
March 1995
March 1995   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00000134
NEI-33, U10EY008057, U01AI027668
Yes
Curtis Meinert, Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
  • 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
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