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

This study has been completed.
Sponsor:
Collaborator:
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  
Number of Participants  
[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
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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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