Phase II/III Study Evaluating the Effect of IL-2 on Preservation of the CD4 T-Lymphocytes After Interruption of Antiretroviral Treatment in HIV-Infected Patients With CD4 T-Lymphocyte Count Greater Than 500 Cells/mm3 Who Received Antiretroviral Tx (ILIADE)

This study has been completed.
Sponsor:
Collaborators:
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00071890
First received: November 3, 2003
Last updated: September 13, 2010
Last verified: September 2010
Results First Received: September 13, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Interleukin 2
Drug: HAART
Drug: Treatment interruption

  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
From November 2003 to July 2006, 148 patients were randomized (81 in the IL-2 arm and 67 in the control arm in one centre of the NIH (USA) and 21 centres of the ANRS network (France).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
31 patients were not included because : CD4 below 500 (n=8), patient decision (n=6), HIV RNA < 50 copies/ml (n=5), neutropenia or high bilirubin(n=3), CD4 nadir below 200 (n=2),other diseases (n=2), AIDS (n=1), other reason (n=4)

Reporting Groups
  Description
Interleukin-2 Group HAART and tree cycles of IL-2
Control Group HAART alone (without Interleukin-2)

Participant Flow:   Overall Study
    Interleukin-2 Group     Control Group  
STARTED     81 [1]   67 [2]
COMPLETED     81 [3]   67 [4]
NOT COMPLETED     0     0  
[1] 3 patients did not received Interleukin-2
[2] 1 patients stopped HAART at week 0
[3]

1 withdrawal

1 death 81 patients analysed

[4]

1 withdrawal

1 lost of follow-up

1 death 67 patients analysed




  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
Interleukin-2 Group HAART and tree cycles of IL-2
Control Group HAART alone (without Interleukin-2)
Total Total of all reporting groups

Baseline Measures
    Interleukin-2 Group     Control Group     Total  
Number of Participants  
[units: participants]
  81     67     148  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     81     66     147  
>=65 years     0     1     1  
Age  
[units: years]
Mean ± Standard Deviation
  42  ± 8     44  ± 9     43  ± 8  
Gender  
[units: participants]
     
Female     15     13     28  
Male     66     54     120  
Region of Enrollment  
[units: participants]
     
France     77     63     140  
United States     4     4     8  
CD4 at inclusion  
[units: cells per mm3]
Median ( Inter-Quartile Range )
  770  
  ( 646 to 876 )  
  735  
  ( 625 to 834 )  
  747  
  ( 637 to 851 )  
CD4 nadir  
[units: cells per mm3]
Median ( Inter-Quartile Range )
  326  
  ( 264 to 438 )  
  328  
  ( 259 to 355 )  
  326  
  ( 263 to 411 )  



  Outcome Measures
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1.  Primary:   Proportion of Patients Without Failure of Strategy From Week 0 to Week 72   [ Time Frame: week 72 ]

2.  Secondary:   Changes in CD4 Counts at Week 72   [ Time Frame: week 72 ]

3.  Secondary:   AIDS Events   [ Time Frame: Overall study ]


  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:  
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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Pr G. Chene
Organization: INSERM U897 Bordeaux FRANCE
phone: 557571392 ext +33
e-mail: genevieve.chene@isped.u-bordeaux2.fr


Publications:

Responsible Party: Irini Sereti, M.D./National Institute of Allergy and Infectious Diseases, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00071890     History of Changes
Other Study ID Numbers: 040018, 04-I-0018, ANRS 118 ILIADE
Study First Received: November 3, 2003
Results First Received: September 13, 2010
Last Updated: September 13, 2010
Health Authority: United States: Federal Government
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)