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

This study has been completed.
Sponsor:
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
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: September 22, 2015
Last verified: July 2015
Results First Received: June 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infections
Cytomegalovirus Retinitis
Interventions: Drug: Foscarnet
Drug: Ganciclovir

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Foscarnet

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

Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day

Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours

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.

Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day

Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours


Participant Flow:   Overall Study
    Foscarnet     Ganciclovir  
STARTED     107     127  
COMPLETED     107     127  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Foscarnet

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

Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day

Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours

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.

Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day

Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours

Total Total of all reporting groups

Baseline Measures
    Foscarnet     Ganciclovir     Total  
Number of Participants  
[units: participants]
  107     127     234  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     107     127     234  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     9     11     20  
Male     98     116     214  
Region of Enrollment  
[units: participants]
     
United States     107     127     234  



  Outcome Measures

1.  Primary:   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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Curtis Meinert, PhD
Organization: The Johns Hopkins University
phone: 410-955-8198
e-mail: cmeinert@jhsph.edu


Publications:


Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00000136     History of Changes
Other Study ID Numbers: NEI-35
U10EY008057 ( US NIH Grant/Contract Award Number )
Study First Received: September 23, 1999
Results First Received: June 22, 2015
Last Updated: September 22, 2015
Health Authority: United States: Federal Government