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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00000134
First received: September 23, 1999
Last updated: August 11, 2015
Last verified: August 2015
Results First Received: June 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: HIV Infections
Acquired Immunodeficiency Syndrome
Cytomegalovirus Retinitis
Interventions: Drug: Ganciclovir
Drug: Foscarnet

  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
December 1992

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Intravenous Foscarnet

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

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

Intravenous Ganciclovir

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

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

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.

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

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


Participant Flow:   Overall Study
    Intravenous Foscarnet     Intravenous Ganciclovir     Combination Therapy  
STARTED     89     94     96  
COMPLETED     89     94     96  
NOT COMPLETED     0     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.
No text entered.

Reporting Groups
  Description
Intravenous Foscarnet

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

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

Intravenous Ganciclovir

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

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

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.

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

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

Total Total of all reporting groups

Baseline Measures
    Intravenous Foscarnet     Intravenous Ganciclovir     Combination Therapy     Total  
Number of Participants  
[units: participants]
  89     94     96     279  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     89     94     96     279  
>=65 years     0     0     0     0  
Gender  
[units: participants]
       
Female     7     6     10     23  
Male     82     88     86     256  
Region of Enrollment  
[units: participants]
       
United States     89     94     96     279  



  Outcome Measures

1.  Primary:   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 ]


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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


Publications:

Responsible Party: Curtis Meinert, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00000134     History of Changes
Other Study ID Numbers: NEI-33
U10EY008057 ( US NIH Grant/Contract Award Number )
U01AI027668 ( US NIH Grant/Contract Award Number )
Study First Received: September 23, 1999
Results First Received: June 15, 2015
Last Updated: August 11, 2015
Health Authority: United States: Federal Government