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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)

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ClinicalTrials.gov Identifier: NCT00071890
Recruitment Status : Completed
First Posted : November 4, 2003
Results First Posted : October 5, 2010
Last Update Posted : October 5, 2010
Sponsor:
Collaborator:
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)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Interleukin 2
Drug: HAART
Drug: Treatment interruption
Enrollment 148
Recruitment Details 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 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)
Arm/Group Title Interleukin-2 Group Control Group
Hide Arm/Group Description HAART and tree cycles of IL-2 HAART alone (without Interleukin-2)
Period Title: Overall Study
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

Arm/Group Title Interleukin-2 Group Control Group Total
Hide Arm/Group Description HAART and tree cycles of IL-2 HAART alone (without Interleukin-2) Total of all reporting groups
Overall Number of Baseline Participants 81 67 148
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 67 participants 148 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
81
 100.0%
66
  98.5%
147
  99.3%
>=65 years
0
   0.0%
1
   1.5%
1
   0.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants 67 participants 148 participants
42  (8) 44  (9) 43  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 67 participants 148 participants
Female
15
  18.5%
13
  19.4%
28
  18.9%
Male
66
  81.5%
54
  80.6%
120
  81.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 81 participants 67 participants 148 participants
France 77 63 140
United States 4 4 8
CD4 at inclusion  
Median (Inter-Quartile Range)
Unit of measure:  Cells per mm3
Number Analyzed 81 participants 67 participants 148 participants
770
(646 to 876)
735
(625 to 834)
747
(637 to 851)
CD4 nadir  
Median (Inter-Quartile Range)
Unit of measure:  Cells per mm3
Number Analyzed 81 participants 67 participants 148 participants
326
(264 to 438)
328
(259 to 355)
326
(263 to 411)
1.Primary Outcome
Title Proportion of Patients Without Failure of Strategy From Week 0 to Week 72
Hide Description

A failure of strategy is defined on the first occurrence of one of the following events:

  • CD4 T-lymphocyte count becomes < 350 cells/mm3 between Wk0 and Wk72 (count confirmed by a 2nd measurement after 2-4 weeks
  • Planned interruption of therapy at Wk24 cannot be done for any reason;
  • Anti-retroviral treatment is restarted between Wk24 and Wk72 for any reason
  • Subject experiences clinical progression of HIV infection to a stage C AIDS diagnosis (appendix I)
  • Subject expires between Wk0 and Wk72 (whatever the cause of death)
  • Subject is lost to follow up
Time Frame week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis, missing = failure.
Arm/Group Title Interleukin-2 Group Control Group
Hide Arm/Group Description:
HAART and tree cycles of IL-2
HAART alone (without Interleukin-2)
Overall Number of Participants Analyzed 81 67
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Pourcentage
73
(63 to 83)
55
(43 to 67)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interleukin-2 Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Changes in CD4 Counts at Week 72
Hide Description [Not Specified]
Time Frame week 72
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interleukin-2 Group Control Group
Hide Arm/Group Description:
HAART and tree cycles of IL-2
HAART alone (without Interleukin-2)
Overall Number of Participants Analyzed 81 67
Median (Inter-Quartile Range)
Unit of Measure: cells per mm3
541
(398 to 702)
453
(379 to 580)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interleukin-2 Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.069
Comments Biphasic decline of CD4 after week 24 : first slope before W32 and weaker decline until W168.Slopes significantly different (all p values ≤0.0001) between the 2 groups, more pronounced in the IL-2 groups
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title AIDS Events
Hide Description AIDS defined events according to CDC classification
Time Frame Overall study
Hide Outcome Measure Data
Hide Analysis Population Description
  • IL-2 arm : Oesophageal candidasis at W196
  • Control arm :Ocular B-cell lymphoma at W43,Oesophageal candidasis at W82, B-cell lymphoma at W104
Arm/Group Title Interleukin-2 Group Control Group
Hide Arm/Group Description:
HAART and tree cycles of IL-2
HAART alone (without Interleukin-2)
Overall Number of Participants Analyzed 81 67
Measure Type: Number
Unit of Measure: event
1 3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Interleukin-2 Group Control Group
Hide Arm/Group Description HAART and tree cycles of IL-2 HAART alone (without Interleukin-2)
All-Cause Mortality
Interleukin-2 Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Interleukin-2 Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Interleukin-2 Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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 sponsor can review results communications prior to public release and can embargo communications regarding trial results with no delay specified
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pr G. Chene
Organization: INSERM U897 Bordeaux FRANCE
Phone: 557571392 ext +33
EMail: genevieve.chene@isped.u-bordeaux2.fr
Layout table for additonal information
Responsible Party: Irini Sereti, M.D./National Institute of Allergy and Infectious Diseases, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00071890    
Other Study ID Numbers: 040018
04-I-0018 ( Other Identifier: NIAID )
ANRS 118 ILIADE ( Other Identifier: ANRS )
First Submitted: November 3, 2003
First Posted: November 4, 2003
Results First Submitted: September 13, 2010
Results First Posted: October 5, 2010
Last Update Posted: October 5, 2010