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An International Study to Evaluate Recombinant Interleukin-2 in HIV Positive Patients Taking Anti-retroviral Therapy (ESPRIT)

This study has been completed.
Sponsor:
Collaborator:
Chiron Corporation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00004978
First received: March 10, 2000
Last updated: May 1, 2013
Last verified: October 2012
Results First Received: January 20, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: Drug: Recombinant interleukin-2 (rIL-2)

  Participant Flow
  Hide Participant Flow

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   2090 [1]   2060 [1] 
COMPLETED   1846   1790 
NOT COMPLETED   244   270 
Death                107                116 
Lost to Follow-up                101                108 
Withdrawal by Subject                17                26 
site closure - not in analysis cohort                19                20 
[1] includes patients participating in Vanguard studies from the sites which participated in ESPRIT



  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
rIL-2 Subcutaneous recombinant interleukin-2 (rIL-2) therapy
No rIL-2 Control group - no study-assigned medication
Total Total of all reporting groups

Baseline Measures
   rIL-2   No rIL-2   Total 
Overall Participants Analyzed 
[Units: Participants]
 2090   2060   4150 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   2071   2032   4103 
>=65 years   19   28   47 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.8  (8.8)   40.9  (9.1)   40.8  (9.0) 
Gender 
[Units: Participants]
     
Female   388   381   769 
Male   1702   1679   3381 
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   511   477   988 
CD4+ cell count 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
 465 
 (374 to 592) 
 451 
 (370 to 578) 
 458 
 (373 to 586) 


  Outcome Measures
  Show All Outcome Measures

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 ]

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 ]

3.  Secondary:   Number of Participants Who Died From Any Cause   [ Time Frame: from randomization through study end - median of 7.6 years follow-up ]

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 ]

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

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

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 ]

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

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

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


  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
No text entered.


  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.


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:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 ( U.S. NIH Grant/Contract )
00 I-0071
3U01AI046957-05S2 ( U.S. NIH Grant/Contract )
3U01AI046957-05S3 ( U.S. NIH Grant/Contract )
10118 ( Registry Identifier: DAIDS ES Registry Number )
Study First Received: March 10, 2000
Results First Received: January 20, 2011
Last Updated: May 1, 2013