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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
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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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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 ]
  Hide Outcome Measure 3

Measure Type Secondary
Measure Title New or Recurrent Disease Progression Events
Measure Description

Number of participants with fatal or non-fatal AIDS-related opportunistic disease.

AIDS-related opportunistic disease includes CDC Category C 1993 definition plus the following diseases: Aspergillosis, invasive; Bartonellosis; Chagas disease of the CNS; Herpes zoster, multidermal; Leishmaniasis, visceral; Lymphoma, Hodgkin's; Microsporidiosis (> 1 month's duration); Nocardiosis; Penicillium marneffti, disseminated; Pneumocystis carinii, extrapulmonary; Rhodococcus equi disease.

Time Frame From randomization to date last known to be alive or November 15, 2008, whichever is earlier  
Safety Issue No  

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
Proleukin Plus Antiretroviral Therapy No text entered.
Antiretroviral Therapy Only No text entered.

Measured Values
   Proleukin Plus Antiretroviral Therapy   Antiretroviral Therapy Only 
Participants Analyzed 
[Units: Participants]
 849   846 
New or Recurrent Disease Progression Events 
[Units: Participants]
 49   66 


Statistical Analysis 1 for New or Recurrent Disease Progression Events
Groups [1] All groups
Method [2] Regression, Cox
P Value [3] 0.10
Hazard Ratio (HR) [4] 0.73
95% Confidence Interval 0.51 to 1.06
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Stratification by CD4+ stratum and country of randomization.
[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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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