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An International Study to Evaluate Recombinant Interleukin-2 (rIL-2) in HIV Positive Patients Taking Anti-retroviral Therapy (ESPRIT)
This study has been completed.
Study NCT00004978   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

First Received on March 10, 2000.   Last Updated on February 3, 2012   History of Changes
Results First Received: January 20, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: Drug: Recombinant interleukin-2 (rIL-2)

  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
Patients were enrolled to ESPRIT between 2000 and 2003. As per the ESPRIT protocol, patients from previous Vanguard studies (in Thailand, Argentina, and the U.S., enrolled 1997-1999) were followed and included in the analysis cohort of this study if at least 90% of patients from that site consented to ESPRIT.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
rIL-2 Subcutaneous recombinant interleukin-2 (rIL-2) therapy
No rIL-2 Control group - no study-assigned medication

Participant Flow:   Overall Study
    rIL-2     No rIL-2  
STARTED     2135 [1]   2106 [1]
Analysis Cohort     2071 [2]   2040 [2]
COMPLETED     1846     1790  
NOT COMPLETED     289     316  
Death                 107                 116  
Lost to Follow-up                 101                 108  
Withdrawal by Subject                 17                 26  
site closure                 19                 20  
Vanguard site not in main study                 45                 46  
[1] includes patients participating in Vanguard studies
[2] excludes patients from sites which did not continue from the Vanguard studies through the study end



  Baseline Characteristics
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Reporting Groups
  Description
rIL-2 Subcutaneous recombinant interleukin-2 (rIL-2) therapy
No rIL-2 Control group - no study-assigned medication

Baseline Measures
    rIL-2     No rIL-2     Total  
Number of Participants  
[units: participants]
 		  2071     2040     4111  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     2052     2012     4064  
>=65 years     19     28     47  
Age  
[units: years]
Mean ± Standard Deviation 		  40.8  ± 8.8     40.9  ± 9.1     40.9  ± 9.0  
Gender  
[units: participants]
 		     
Female     385     381     766  
Male     1686     1659     3345  
Region of Enrollment  
[units: participants]
 		     
Argentina     276     278     554  
Australia     107     98     205  
Austria     16     18     34  
Belgium     39     41     80  
Brazil     48     50     98  
Canada     74     67     141  
Denmark     39     33     72  
France     86     96     182  
Germany     136     130     266  
Ireland     3     1     4  
Israel     31     33     64  
Italy     50     54     104  
Japan     14     11     25  
Morocco     12     14     26  
Netherlands     29     25     54  
Norway     3     5     8  
Poland     48     52     100  
Portugal     51     56     107  
Singapore     10     10     20  
Spain     151     157     308  
Sweden     4     3     7  
Switzerland     5     5     10  
Thailand     182     183     365  
United Kingdom     165     163     328  
United States     492     457     949  
CD4+ cell count  
[units: cells/mm^3]
Median ( Inter-Quartile Range ) 		  464  
  ( 373 to 590 )   		  450  
  ( 370 to 576 )   		  457  
  ( 372 to 584 )  



  Outcome Measures
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1.  Primary:   New or Recurrent HIV Disease Progression Event Including Death   [ Time Frame: from randomization through study end - median of 7.6 years follow-up ]
  Show Outcome Measure 1

2.  Secondary:   New or Recurrent Serious HIV Disease Progression Event Including Death   [ Time Frame: from randomization through study end - median of 7.6 years follow-up ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants Who Died From Any Cause   [ Time Frame: from randomization through study end - median of 7.6 years follow-up ]
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4.  Secondary:   Participants With a New Disease Progression Event or Death   [ Time Frame: from randomization through 15 November 2008 - median of 7.6 years follow-up ]
  Show Outcome Measure 4

5.  Secondary:   Absolute CD4 Cell Counts Averaged Throughout Followup   [ Time Frame: from randomization through study end - median of 7.6 years follow-up ]
  Show Outcome Measure 5

6.  Secondary:   Plasma HIV RNA Levels   [ Time Frame: From randomization through study end - median of 7.6 years follow-up ]
  Show Outcome Measure 6

7.  Secondary:   Number of Participants With Changes in Anti-retroviral Treatment (ART)   [ Time Frame: From randomization through study end - median of 7.6 years follow-up ]
  Show Outcome Measure 7

8.  Secondary:   Grade 4 Signs and Symptoms   [ Time Frame: From randomization through study end - median of 7.6 years follow-up ]
  Show Outcome Measure 8

9.  Secondary:   Pattern of Use of Prophylaxis for Opportunistic Infections   [ Time Frame: last followup visit - median of 7.6 years follow-up ]
  Show Outcome Measure 9

10.  Secondary:   Hepatic, Metabolic, and Cardiac Conditions   [ Time Frame: From randomization through study end - median of 7.6 years follow-up ]
  Show Outcome Measure 10


  Serious Adverse Events
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  Other Adverse Events
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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 NOT 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.


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
No text entered.  


Results Point of Contact:  
Name/Title: James Neaton, PhD
Organization: Division of Biostatistics, University of Minnesota
phone: 612-626-9040
e-mail: jim@ccbr.umn.edu


Publications of Results:
Arduino RC, Nannini EC, Rodriguez-Barradas M, Schrader S, Losso M, Ruxrungtham K, Allende MC, Emery S, Fosdick L, Neaton J, Tavel JA, Davey RT, Lane HC; Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT) Vanguard Group; ESPRIT Executive Committee. CD4 cell response to 3 doses of subcutaneous interleukin 2: meta-analysis of 3 Vanguard studies. Clin Infect Dis. 2004 Jul 1;39(1):115-22. Epub 2004 Jun 14.
INSIGHT-ESPRIT Study Group; SILCAAT Scientific Committee; Abrams D, Lévy Y, Losso MH, Babiker A, Collins G, Cooper DA, Darbyshire J, Emery S, Fox L, Gordin F, Lane HC, Lundgren JD, Mitsuyasu R, Neaton JD, Phillips A, Routy JP, Tambussi G, Wentworth D. Interleukin-2 therapy in patients with HIV infection. N Engl J Med. 2009 Oct 15;361(16):1548-59.

Other Publications:
Chun TW, Engel D, Mizell SB, Hallahan CW, Fischette M, Park S, Davey RT Jr, Dybul M, Kovacs JA, Metcalf JA, Mican JM, Berrey MM, Corey L, Lane HC, Fauci AS. Effect of interleukin-2 on the pool of latently infected, resting CD4+ T cells in HIV-1-infected patients receiving highly active anti-retroviral therapy. Nat Med. 1999 Jun;5(6):651-5.
Connors M, Kovacs JA, Krevat S, Gea-Banacloche JC, Sneller MC, Flanigan M, Metcalf JA, Walker RE, Falloon J, Baseler M, Feuerstein I, Masur H, Lane HC. HIV infection induces changes in CD4+ T-cell phenotype and depletions within the CD4+ T-cell repertoire that are not immediately restored by antiviral or immune-based therapies. Nat Med. 1997 May;3(5):533-40.
Emery S, Abrams DI, Cooper DA, Darbyshire JH, Lane HC, Lundgren JD, Neaton JD; ESPRIT Study Group. The evaluation of subcutaneous proleukin (interleukin-2) in a randomized international trial: rationale, design, and methods of ESPRIT. Control Clin Trials. 2002 Apr;23(2):198-220.

Publications automatically indexed to this study:
Pett SL, Carey C, Lin E, Wentworth D, Lazovski J, Miró JM, Gordin F, Angus B, Rodriguez-Barradas M, Rubio R, Tambussi G, Cooper DA, Emery S; INSIGHT-ESPRIT Study Group. Predictors of bacterial pneumonia in Evaluation of Subcutaneous Interleukin-2 in a Randomized International Trial (ESPRIT). HIV Med. 2011 Apr;12(4):219-27. Epub 2010 Aug 31.


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00004978     History of Changes
Obsolete Identifiers: NCT00004737
Other Study ID Numbers: ESPRIT 001, 5U01AI046957, 00 I-0071, 3U01AI046957-05S2, 3U01AI046957-05S3, 10118
Study First Received: March 10, 2000
Results First Received: January 20, 2011
Last Updated: February 3, 2012
Health Authority: United States: Food and Drug Administration





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