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Interleukin-2 Plus Antiretroviral Therapy for HIV-Infected Patients With Low CD4+ Counts (SILCAAT Study) (SILCAAT)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00013611
First received: March 24, 2001
Last updated: August 2, 2011
Last verified: August 2011
Results First Received: November 8, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infection
Intervention: Drug: Proleukin

  Participant Flow


  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
Proleukin Plus Antiretroviral Therapy No text entered.
Antiretroviral Therapy Only No text entered.
Total Total of all reporting groups

Baseline Measures
    Proleukin Plus Antiretroviral Therapy   Antiretroviral Therapy Only   Total
Overall Participants Analyzed 
[Units: Participants]
 849   846   1695 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   841   838   1679 
>=65 years   8   8   16 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.8  (8.7)   42.0  (8.8)   41.9  (8.7) 
Gender 
[Units: Participants]
     
Female   137   143   280 
Male   712   703   1415 
Region of Enrollment 
[Units: Participants]
     
Belgium   16   13   29 
Germany   50   46   96 
Spain   139   131   270 
France   47   50   97 
Italy   131   142   273 
Netherlands   11   12   23 
Argentina   85   85   170 
Australia   62   64   126 
United States   203   203   406 
Canada   68   62   130 
Brazil   37   38   75 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   New or Recurrent Disease Progression Events, as Defined, or Death.   [ Time Frame: From randomization to date last known to be alive or November 15, 2008, whichever is earlier ]

2.  Secondary:   All-cause Mortality   [ Time Frame: From randomization to date last known to be alive or November 15, 2008, whichever is earlier ]

3.  Secondary:   New or Recurrent Disease Progression Events   [ Time Frame: From randomization to date last known to be alive or November 15, 2008, whichever is earlier ]

4.  Secondary:   Grade 4 Clinical Events   [ Time Frame: From randomization to date last known to be alive or November 15, 2008, whichever is earlier ]

5.  Secondary:   CD4+ Cell Count   [ Time Frame: Every 4 months from randomization through date last known to be alive or November 15, 2008, whichever was earliest . ]

6.  Secondary:   New or Recurrent Serious Disease Progression Events or Death   [ Time Frame: From randomization to date last known to be alive or November 15, 2008, whichever is earlier ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Gary Collins, M.S.
Organization: University of Minnesota
phone: 612-626-9006
e-mail: gary-c@ccbr.umn.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: DAIDS, NIAID
ClinicalTrials.gov Identifier: NCT00013611     History of Changes
Obsolete Identifiers: NCT00002421
Other Study ID Numbers: 0303M44961
01-I-0126 ( Other Identifier: NIAID )
Study First Received: March 24, 2001
Results First Received: November 8, 2010
Last Updated: August 2, 2011
Health Authority: United States: Federal Government