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Effect of Intermittent Aldesleukin Treatment With or Without Anti-HIV Drugs in HIV Infected People (STALWART)

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:
NCT00110812
First received: May 13, 2005
Last updated: April 7, 2014
Last verified: April 2014
Results First Received: December 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: Drug: IL-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
Participants were enrolled by HIV care providers between December 2005 and June 2008. When the main study ended in February 2009, patients who consented to a study extension were followed another 2 years, during which study drug was not given.

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
No IL-2 Participants will receive no aldesleukin or HAART during the main study or extension
IL-2 Without ART During the main study, participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level. Patients did not receive aldesleukin during the extension phase.
IL-2 With Pericycle HAART During the main study, participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle). Patients did not receive aldesleukin during the extension phase.

Participant Flow for 2 periods

Period 1:   Main Study
    No IL-2     IL-2 Without ART     IL-2 With Pericycle HAART  
STARTED     91     89     87  
COMPLETED     83     78     74  
NOT COMPLETED     8     11     13  
Death                 0                 0                 2  
Withdrawal by Subject                 0                 0                 1  
Lost to Follow-up                 8                 11                 10  

Period 2:   Extended Follow-up
    No IL-2     IL-2 Without ART     IL-2 With Pericycle HAART  
STARTED     80     69     73  
COMPLETED     78     65     69  
NOT COMPLETED     2     4     4  
Death                 1                 0                 3  
Withdrawal by Subject                 0                 1                 0  
Lost to Follow-up                 1                 3                 1  



  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
No IL-2 Participants will receive no aldesleukin or HAART
IL-2 Without ART Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
IL-2 With Pericycle HAART Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
Total Total of all reporting groups

Baseline Measures
    No IL-2     IL-2 Without ART     IL-2 With Pericycle HAART     Total  
Number of Participants  
[units: participants]
  91     89     87     267  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     91     89     85     265  
>=65 years     0     0     2     2  
Age  
[units: years]
Mean ± Standard Deviation
  37.1  ± 7.7     37.3  ± 9.6     37.8  ± 11.0     37.4  ± 9.5  
Gender  
[units: participants]
       
Female     16     17     13     46  
Male     75     72     74     221  
Region of Enrollment  
[units: participants]
       
Portugal     3     3     4     10  
United States     8     9     9     26  
Morocco     1     0     0     1  
Argentina     25     24     21     70  
Thailand     21     21     22     64  
Spain     1     1     1     3  
Poland     3     2     3     8  
Australia     10     8     8     26  
Chile     2     5     4     11  
United Kingdom     8     9     10     27  
Italy     9     7     5     21  
CD4 cell count  
[units: cells/mm^3]
Median ( Inter-Quartile Range )
  432  
  ( 375 to 507 )  
  398  
  ( 355 to 458 )  
  425  
  ( 365 to 535 )  
  418  
  ( 359 to 511 )  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change in CD4+ T Lymphocyte Count   [ Time Frame: Week 32 ]

2.  Secondary:   Discontinuation of IL-2   [ Time Frame: week 32 ]

3.  Secondary:   Plasma HIV RNA   [ Time Frame: At Week 32 ]

4.  Secondary:   Change in CD4 T Lymphocyte Count   [ Time Frame: At Month 12 ]

5.  Secondary:   HIV-1 Genotype Changes   [ Time Frame: after 3rd cycle of IL-2 ]

6.  Secondary:   Fasting Lipid Profile   [ Time Frame: week 32 ]

7.  Secondary:   Disease Progression or Death   [ Time Frame: throughout study, through Feb 28 2009 (median followup of 19 months) ]

8.  Secondary:   Initiation of Continuous ART   [ Time Frame: from randomization through February 28, 2009 ]

9.  Secondary:   Change in HIV-RNA Copies/ml (log10) From Baseline to Month 12   [ Time Frame: month 12 ]

10.  Secondary:   Thyroid Stimulating Hormone   [ Time Frame: week 32 ]

11.  Secondary:   SGOT   [ Time Frame: week 32 ]

12.  Post-Hoc:   Opportunistic Disease or Death During the Trial Extension Phase   [ Time Frame: two years following close of main study ]

13.  Post-Hoc:   CD4+ Cell Count 2 Years Post-study   [ Time Frame: two years following close of main study ]

14.  Post-Hoc:   Undetectable HIV-RNA   [ Time Frame: 24 months post-trial ]

15.  Post-Hoc:   Commencement of Continuous Antiretroviral Treatment   [ Time Frame: from randomization through February 28, 2011, the end of the extension phase ]
  Hide Outcome Measure 15

Measure Type Post-Hoc
Measure Title Commencement of Continuous Antiretroviral Treatment
Measure Description Number of patients commencing continuous antiretroviral treatment.
Time Frame from randomization through February 28, 2011, the end of the extension phase  
Safety Issue Yes  

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.
All randomized patients are counted. Patients who did not consent to the extension phase are censored at the end of the main study (Feb 28, 2009). Because the focus of the extension was on the safety of patients exposed to IL-2, the outcomes were summarized for the two groups exposed to IL-2 vs. the group that did not take IL-2.

Reporting Groups
  Description
IL-2 Consenting patients who were assigned IL-2 during the main phase of the study, including patients who took IL-2 alone as well as patients who took IL-2 with ART.
Control Consenting patients who were in the control group during the main phase of the trial.

Measured Values
    IL-2     Control  
Number of Participants Analyzed  
[units: participants]
  176     91  
Commencement of Continuous Antiretroviral Treatment  
[units: participants]
  108     66  


Statistical Analysis 1 for Commencement of Continuous Antiretroviral Treatment
Groups [1] All groups
Method [2] Regression, Cox
P Value [3] .03
Hazard Ratio (HR) [4] .71
95% Confidence Interval ( .52 to .97 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  IL-2 groups vs. control




  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
All randomized patients were followed through 28 Feb 2009. A subset of 222 consenting patients were followed 2 additional years, through 28 Feb 2011.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Deborah Wentworth
Organization: University of Minnesota
phone: 612-726-9005
e-mail: wentw001@umn.edu


Publications:
Publications automatically indexed to this study:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00110812     History of Changes
Obsolete Identifiers: NCT00106730
Other Study ID Numbers: ESPRIT 002, 10053
Study First Received: May 13, 2005
Results First Received: December 12, 2012
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration