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Studies of the Ocular Complications of AIDS (SOCA)--HPMPC Peripheral CMV Retinitis Trial (HPCRT) (HPCRT)

This study has been completed.
Sponsor:
Collaborators:
Baylor College of Medicine
Johns Hopkins University
Louisiana State University Health Sciences Center in New Orleans
Icahn School of Medicine at Mount Sinai
New Jersey Medical School
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 North Carolina, Chapel Hill
University of South Florida
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00000142
First received: September 23, 1999
Last updated: October 14, 2015
Last verified: July 2015
Results First Received: June 2, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV Infections
CMV Cytomegalovirus Retinitis
Intervention: Drug: Cidofovir

  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
April 1994

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
Treatment Deferral

IV (in the vein) treatment deferred until retinitis progressed, either:

5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or

5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.

Cidofovir: Three groups:

  1. the deferral group, treatment deferred until retinitis progressed
  2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
  3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir (Low Dose)

5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks

Cidofovir: Three groups:

  1. the deferral group, treatment deferred until retinitis progressed
  2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
  3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir (High Dose)

5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.

Cidofovir: Three groups:

  1. the deferral group, treatment deferred until retinitis progressed
  2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
  3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.

Participant Flow:   Overall Study
    Treatment Deferral   Cidofovir (Low Dose)   Cidofovir (High Dose)
STARTED   26   26   12 
COMPLETED   26   26   12 
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
Treatment Deferral

IV (in the vein) treatment deferred until retinitis progressed, either:

5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or

5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.

Cidofovir: Three groups:

  1. the deferral group, treatment deferred until retinitis progressed
  2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
  3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir (Low Dose)

5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks

Cidofovir: Three groups:

  1. the deferral group, treatment deferred until retinitis progressed
  2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
  3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir (High Dose)

5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.

Cidofovir: Three groups:

  1. the deferral group, treatment deferred until retinitis progressed
  2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
  3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Total Total of all reporting groups

Baseline Measures
   Treatment Deferral   Cidofovir (Low Dose)   Cidofovir (High Dose)   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   26   12   64 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   26   26   12   64 
>=65 years   0   0   0   0 
Gender 
[Units: Participants]
       
Female   2   2   1   5 
Male   24   24   11   59 


  Outcome Measures

1.  Primary:   Survival   [ Time Frame: All patients enrolled will be followed until a common study closing date ]


  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 more than 60 days but less than or equal to 180 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: Dr. Curtis Meinert
Organization: Johns Hopkins Bloomberg School of Public Health
phone: 410-955-8175
e-mail: cmeinert@jhsph.edu


Publications:

Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00000142     History of Changes
Other Study ID Numbers: NEI-41
Study First Received: September 23, 1999
Results First Received: June 2, 2015
Last Updated: October 14, 2015
Health Authority: United States: Federal Government