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

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ClinicalTrials.gov Identifier: NCT00110812
Recruitment Status : Completed
First Posted : May 16, 2005
Results First Posted : May 12, 2014
Last Update Posted : May 12, 2014
Sponsor:
Collaborator:
Chiron Corporation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: Drug: IL-2

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

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

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

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

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

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

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

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

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

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

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

11.  Secondary:   SGOT   [ Time Frame: week 32 ]
  Show Outcome Measure 11

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

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

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

Measure Type Post-Hoc
Measure Title Undetectable HIV-RNA
Measure Description Patients with undetectable HIV-RNA levels measured at 24 months after the close of the main study, at the end of the extension phase.
Time Frame 24 months post-trial  

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 patients for whom an HIV-RNA measurement was available during the extension phase. 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 
Participants Analyzed   141   80 
Undetectable HIV-RNA 
[Units: Participants]
 		 97   60 

No statistical analysis provided for Undetectable HIV-RNA



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


  Serious Adverse Events


  Other Adverse Events


  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
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

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 by ClinicalTrials.gov Identifier (NCT Number):


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 ( Registry Identifier: DAIDS ES Registry Number )
First Submitted: May 13, 2005
First Posted: May 16, 2005
Results First Submitted: December 12, 2012
Results First Posted: May 12, 2014
Last Update Posted: May 12, 2014