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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;   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     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  
Number of Participants  
[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:

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: May 1, 2013
Health Authority: United States: Food and Drug Administration