Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00000143
First received: September 23, 1999
Last updated: February 18, 2016
Last verified: July 2015
Results First Received: July 1, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Cytomegalovirus Retinitis
HIV Infections
Interventions: Device: Ganciclovir implant and oral ganciclovir
Drug: Cidofovir intravenous

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  Hide Limitations and Caveats

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
  Hide More Information

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
Study First Received: September 23, 1999
Results First Received: July 1, 2015
Last Updated: February 18, 2016
Health Authority: United States: Federal Government