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Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT) (GCCRT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000143
First Posted: September 24, 1999
Last Update Posted: March 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
Results First Submitted: July 1, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Cytomegalovirus Retinitis
HIV Infections
Interventions: Device: Ganciclovir implant and oral ganciclovir
Drug: Cidofovir intravenous

  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
June 1997

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
Ganciclovir Implant and Oral Ganciclovir

Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily

Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily

Cidofovir IV (Intravenous)

cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week

Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week


Participant Flow:   Overall Study
    Ganciclovir Implant and Oral Ganciclovir   Cidofovir IV (Intravenous)
STARTED   31   30 
COMPLETED   31   30 
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.
No text entered.

Reporting Groups
  Description
Ganciclovir Implant and Oral Ganciclovir

Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily

Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily

Cidofovir IV (Intravenous)

cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week

Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week

Total Total of all reporting groups

Baseline Measures
   Ganciclovir Implant and Oral Ganciclovir   Cidofovir IV (Intravenous)   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   30   61 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   31   30   61 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   7   5   12 
Male   24   25   49 
Region of Enrollment 
[Units: Participants]
     
United States   31   30   61 


  Outcome Measures

1.  Primary:   Survival   [ Time Frame: 3 years ]


  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 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: Johns Hopkins School of Public Health
phone: 410-955-8198
e-mail: cmeinert@jhsph.edu


Publications:

Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00000143     History of Changes
Other Study ID Numbers: NEI-42
First Submitted: September 23, 1999
First Posted: September 24, 1999
Results First Submitted: July 1, 2015
Results First Posted: March 14, 2016
Last Update Posted: March 14, 2016