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

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
History of Changes
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
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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
1971 participants were randomized at 139 sites in 11 countries. The first randomization was on 30 April 1999 and the last randomization was on 28 September 2002. Sites who re-consented 2/3 or more of their participants to Version 3 of the protocol were included in the analysis cohort. There are 1695 participants in the analysis cohort.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Proleukin Plus Antiretroviral Therapy Patients receive an initial dose of 4.5 MIU of proleukin twice daily for 5 consecutive days every 8 weeks during the first year (6 cycles total). After the first year, additional cycles are given to either achieve or maintain the patient's CD4+ count goal. CD4+ goal is defined as an increase of 125 cells/cubic mm for participants in the 50-199 CD4+ count stratum, and an increase of 175 cells/cubic mm for participants in the 200-299 CD4+ stratum. In addition, all patients must be prescribed combination antiretroviral drug treatment. The choice of combination therapy is left to the discretion of the treating clinician. Investigators will use their national guidelines for determining when antiretroviral therapy should be changed and for when determining when therapy should be used. All patients must take antiretroviral therapy during each 5-consecutive-day treatment cycle.
Antiretroviral Therapy Only All patients must be prescribed combination antiretroviral drug treatment. The choice of combination therapy is left to the discretion of the treating clinician. Investigators will use their national guidelines for determining when antiretroviral therapy should be changed and for when determining when therapy should be used.

Participant Flow:   Overall Study
    Proleukin Plus Antiretroviral Therapy     Antiretroviral Therapy Only  
STARTED     849 [1]   846 [1]
COMPLETED     758     746  
NOT COMPLETED     91     100  
Lost to Follow-up                 91                 100  
[1] 138 were excluded from sites that did not re-consent 2/3 of patients to the amended protocol in 2003



  Baseline Characteristics
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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 ]
  Show Outcome Measure 1

2.  Secondary:   All-cause Mortality   [ Time Frame: From randomization to date last known to be alive or November 15, 2008, whichever is earlier ]
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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 ]
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4.  Secondary:   Grade 4 Clinical Events   [ Time Frame: From randomization to date last known to be alive or November 15, 2008, whichever is earlier ]
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Measure Type Secondary
Measure Title Grade 4 Clinical Events
Measure Description Grade 4 clinical events were defined as potentially life-threatening events (excluding opportunistic disease) requiring medical intervention.
Time Frame From randomization to date last known to be alive or November 15, 2008, whichever is earlier  
Safety Issue Yes  

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.
The outcome is the number of participants experiencing at least one grade 4 event.

Reporting Groups
  Description
Proleukin Plus Antiretroviral Therapy No text entered.
Antiretroviral Therapy Only No text entered.

Measured Values
    Proleukin Plus Antiretroviral Therapy     Antiretroviral Therapy Only  
Number of Participants Analyzed  
[units: participants]
 		  849     846  
Grade 4 Clinical Events  
[units: Participants]
 		  203     186  


Statistical Analysis 1 for Grade 4 Clinical Events
Groups [1] All groups
Method [2] Regression, Cox
P Value [3] 0.35
Hazard Ratio (HR) [4] 1.10
95% Confidence Interval ( 0.90 to 1.34 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
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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 . ]
  Show Outcome Measure 5

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 ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
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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:


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