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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
Enrollment 267
Recruitment Details 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  
Arm/Group Title No IL-2 IL-2 Without ART IL-2 With Pericycle HAART
Hide Arm/Group Description Participants will receive no aldesleukin or HAART during the main study or extension 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. 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.
Period Title: Main Study
Started 91 89 87
Completed 83 78 74
Not Completed 8 11 13
Reason Not Completed
Death             0             0             2
Withdrawal by Subject             0             0             1
Lost to Follow-up             8             11             10
Period Title: Extended Follow-up
Started 80 69 73
Completed 78 65 69
Not Completed 2 4 4
Reason Not Completed
Death             1             0             3
Withdrawal by Subject             0             1             0
Lost to Follow-up             1             3             1
Arm/Group Title No IL-2 IL-2 Without ART IL-2 With Pericycle HAART Total
Hide Arm/Group Description Participants will receive no aldesleukin or 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. 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 of all reporting groups
Overall Number of Baseline Participants 91 89 87 267
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 89 participants 87 participants 267 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
91
 100.0%
89
 100.0%
85
  97.7%
265
  99.3%
>=65 years
0
   0.0%
0
   0.0%
2
   2.3%
2
   0.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 91 participants 89 participants 87 participants 267 participants
37.1  (7.7) 37.3  (9.6) 37.8  (11.0) 37.4  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 89 participants 87 participants 267 participants
Female
16
  17.6%
17
  19.1%
13
  14.9%
46
  17.2%
Male
75
  82.4%
72
  80.9%
74
  85.1%
221
  82.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 91 participants 89 participants 87 participants 267 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  
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3
Number Analyzed 91 participants 89 participants 87 participants 267 participants
432
(375 to 507)
398
(355 to 458)
425
(365 to 535)
418
(359 to 511)
1.Primary Outcome
Title Mean Change in CD4+ T Lymphocyte Count
Hide Description Change in CD4 count from baseline to week 32.
Time Frame Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
patients for whom the week-32 CD4+ cell count was measured
Arm/Group Title No IL-2 IL-2 Without ART IL-2 With Pericycle HAART
Hide Arm/Group Description:
Participants will receive no aldesleukin or 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.
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).
Overall Number of Participants Analyzed 83 78 74
Mean (Standard Deviation)
Unit of Measure: cell/mm^3
-21.8  (93.1) 113.7  (216.8) 110.4  (174.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No IL-2, IL-2 Without ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments Adjusted for 3 pairwise comparisons.
Method ANOVA
Comments stratified by geographic region and adjusted for baseline CD4.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 134
Confidence Interval (2-Sided) 95%
70 to 198
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection No IL-2, IL-2 With Pericycle HAART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments Adjusted for 3 pairwise comparisons.
Method ANOVA
Comments stratified by geographic region and adjusted for baseline CD4.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 133
Confidence Interval (2-Sided) 95%
68 to 199
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Discontinuation of IL-2
Hide Description Patients receiving fewer than 3 cycles of IL-2 by week 32
Time Frame week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
all patients randomized to a study arm containing IL-2
Arm/Group Title IL-2 Without ART IL-2 With Pericycle HAART
Hide Arm/Group Description:
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.
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).
Overall Number of Participants Analyzed 89 87
Measure Type: Number
Unit of Measure: participants
12 32
3.Secondary Outcome
Title Plasma HIV RNA
Hide Description change from baseline in HIV-RNA copies/ml (log10)
Time Frame At Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients for whom HIV-RNA was available at week 32
Arm/Group Title No IL-2 IL-2 Without ART IL-2 With Pericycle HAART
Hide Arm/Group Description:
Participants will receive no aldesleukin or 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.
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).
Overall Number of Participants Analyzed 82 79 72
Mean (Standard Deviation)
Unit of Measure: copies/ml (log 10)
-.39  (1.03) -.07  (.80) -.01  (.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No IL-2, IL-2 Without ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .01
Comments [Not Specified]
Method ANOVA
Comments stratified by region and adjusted for baseline HIV-RNA.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value .31
Confidence Interval (2-Sided) 95%
.08 to .54
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection No IL-2, IL-2 With Pericycle HAART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .003
Comments [Not Specified]
Method ANOVA
Comments stratified by region and adjusted for baseline HIV-RNA.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value .36
Confidence Interval (2-Sided) 95%
.12 to .60
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in CD4 T Lymphocyte Count
Hide Description change from baseline to month 12 in CD4 T lymphocyte count
Time Frame At Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
patients for whom the month 12 CD4 count was available
Arm/Group Title No IL-2 IL-2 Without ART IL-2 With Pericycle HAART
Hide Arm/Group Description:
Participants will receive no aldesleukin or 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.
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).
Overall Number of Participants Analyzed 78 77 72
Mean (Standard Deviation)
Unit of Measure: cell/mm^3
-8.4  (129.1) 59.0  (176.0) 49.8  (155.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No IL-2, IL-2 Without ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .009
Comments [Not Specified]
Method ANOVA
Comments ANOVA with stratification by region and adjustment for baseline CD4
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 65.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection No IL-2, IL-2 With Pericycle HAART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .02
Comments [Not Specified]
Method ANOVA
Comments stratified by region and adjusted for baseline CD4
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 58.2
Estimation Comments [Not Specified]
5.Secondary Outcome
Title HIV-1 Genotype Changes
Hide Description Patients who developed mutations associated with antiretroviral drugs.
Time Frame after 3rd cycle of IL-2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol, the analysis of genotypic changes associated with antiretroviral resistance was restricted patients in one arm, namely, patients assigned to take pericycle HAART who completed 3 cycles of IL-2 and who had successful genotypes.
Arm/Group Title IL-2 With Pericycle HAART
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
2
6.Secondary Outcome
Title Fasting Lipid Profile
Hide Description total fasting cholesterol
Time Frame week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
all patients with laboratory data at week 32 who reported fasting
Arm/Group Title No IL-2 IL-2 Without ART IL-2 With Pericycle HAART
Hide Arm/Group Description:
Participants will receive no aldesleukin or 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.
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).
Overall Number of Participants Analyzed 65 66 58
Mean (Standard Deviation)
Unit of Measure: mg/dl
173.4  (33.7) 167.0  (32.7) 164.6  (40.8)
7.Secondary Outcome
Title Disease Progression or Death
Hide Description occurrence of an opportunistic event (AIDS-defining infection or malignancy) or death
Time Frame throughout study, through Feb 28 2009 (median followup of 19 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
all randomized patients
Arm/Group Title No IL-2 IL-2 Without ART IL-2 With Pericycle HAART
Hide Arm/Group Description:
Participants will receive no aldesleukin or 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.
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).
Overall Number of Participants Analyzed 91 89 87
Measure Type: Number
Unit of Measure: participants
1 5 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No IL-2, IL-2 Without ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .14
Comments [Not Specified]
Method Regression, Cox
Comments Unadjusted, stratified by region.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 5.08
Confidence Interval (2-Sided) 95%
0.59 to 43.6
Estimation Comments Patients taking IL-2 alone compared to patients not taking IL-2.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection No IL-2, IL-2 With Pericycle HAART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .08
Comments [Not Specified]
Method Regression, Cox
Comments Unadjusted, stratified by region.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 6.56
Confidence Interval (2-Sided) 95%
0.80 to 53.6
Estimation Comments Patients taking IL-2 plus pericycle HAART compared to patients not receiving IL-2
8.Secondary Outcome
Title Initiation of Continuous ART
Hide Description While patients were not taking ART at baseline or while undergoing IL-2 cycles (other than use of pericycle ART in one of the three groups), some chose to start an ART regimen during the study.
Time Frame from randomization through February 28, 2009
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
all patients randomized
Arm/Group Title No IL-2 IL-2 Without ART IL-2 With Pericycle HAART
Hide Arm/Group Description:
Participants will receive no aldesleukin or 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.
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).
Overall Number of Participants Analyzed 91 89 87
Measure Type: Number
Unit of Measure: participants
34 23 14
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No IL-2, IL-2 Without ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .048
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value .58
Confidence Interval (2-Sided) 95%
.34 to .99
Estimation Comments IL-2 without ART vs control group
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection No IL-2, IL-2 With Pericycle HAART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value .32
Confidence Interval (2-Sided) 95%
.17 to .62
Estimation Comments IL-2 with pericycle HAART compared to control
9.Secondary Outcome
Title Change in HIV-RNA Copies/ml (log10) From Baseline to Month 12
Hide Description [Not Specified]
Time Frame month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
patients for whom HIV-RNA measurement was available at baseline and month 12.
Arm/Group Title No IL-2 IL-2 Without ART IL-2 With Pericycle HAART
Hide Arm/Group Description:
Participants will receive no aldesleukin or 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.
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).
Overall Number of Participants Analyzed 77 74 71
Mean (Standard Deviation)
Unit of Measure: copies/ml (log 10)
-0.64  (1.24) -0.28  (0.95) -0.09  (0.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No IL-2, IL-2 Without ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .03
Comments [Not Specified]
Method ANOVA
Comments Stratified by region and adjusted for baseline HIV-RNA
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
0.03 to 0.64
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection No IL-2, IL-2 With Pericycle HAART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method ANOVA
Comments Stratified by region and adjusted for baseline HIV-RNA
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.54
Confidence Interval (2-Sided) 95%
0.24 to 0.85
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Thyroid Stimulating Hormone
Hide Description Number of participants with thyroid stimulating hormone greater than the upper limit of normal
Time Frame week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
all patients with TSH measured at 32 weeks
Arm/Group Title No IL-2 IL-2 Without ART IL-2 With Pericycle HAART
Hide Arm/Group Description:
Participants will receive no aldesleukin or 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.
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).
Overall Number of Participants Analyzed 79 75 71
Measure Type: Number
Unit of Measure: participants
3 2 7
11.Secondary Outcome
Title SGOT
Hide Description Number of participants with aspartate aminotransferase (SGOT) greater than 5 times the upper limit of normal
Time Frame week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
all patients with SGOT measured at week 32
Arm/Group Title No IL-2 IL-2 Without ART IL-2 With Pericycle HAART
Hide Arm/Group Description:
Participants will receive no aldesleukin or 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.
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).
Overall Number of Participants Analyzed 83 79 74
Measure Type: Number
Unit of Measure: participants
1 0 0
12.Post-Hoc Outcome
Title Opportunistic Disease or Death During the Trial Extension Phase
Hide Description Incidence of an opportunistic event (AIDS-defining infection or malignancy) or death between February 28, 2009, when the main study ended, and February 28, 2011, when the extended phase was completed.
Time Frame two years following close of main study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who were alive at the end of the main study and who consented to be followed for an additional 2 years in 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.
Arm/Group Title IL-2 Control
Hide Arm/Group Description:
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.
Consenting patients who were in the control group during the main phase of the trial.
Overall Number of Participants Analyzed 142 80
Measure Type: Number
Unit of Measure: participants
8 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IL-2, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .59
Comments [Not Specified]
Method Regression, Cox
Comments Stratification by region.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.45
Confidence Interval (2-Sided) 95%
0.38 to 5.45
Estimation Comments IL-2 group compared to control group
13.Post-Hoc Outcome
Title CD4+ Cell Count 2 Years Post-study
Hide Description [Not Specified]
Time Frame two years following close of main study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients for whom a CD4 count 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.
Arm/Group Title IL-2 Control
Hide Arm/Group Description:
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.
Consenting patients who were in the control group during the main phase of the trial.
Overall Number of Participants Analyzed 141 80
Mean (Standard Deviation)
Unit of Measure: cell/mm^3
499.9  (191.4) 557.2  (225.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IL-2, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .05
Comments [Not Specified]
Method ANOVA
Comments Last measured CD4 is imputed if month 24 CD4 count is missing. Analysis is adjusted for baseline CD4.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -55.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 28.4
Estimation Comments IL-2 group minus control group CD4.
14.Post-Hoc Outcome
Title Undetectable HIV-RNA
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title IL-2 Control
Hide Arm/Group Description:
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.
Consenting patients who were in the control group during the main phase of the trial.
Overall Number of Participants Analyzed 141 80
Measure Type: Number
Unit of Measure: participants
97 60
15.Post-Hoc Outcome
Title Commencement of Continuous Antiretroviral Treatment
Hide Description Number of patients commencing continuous antiretroviral treatment.
Time Frame from randomization through February 28, 2011, the end of the extension phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title IL-2 Control
Hide Arm/Group Description:
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.
Consenting patients who were in the control group during the main phase of the trial.
Overall Number of Participants Analyzed 176 91
Measure Type: Number
Unit of Measure: participants
108 66
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IL-2, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .03
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value .71
Confidence Interval (2-Sided) 95%
.52 to .97
Estimation Comments IL-2 groups vs. control
Time Frame From randomization through Feb 28 2011, end of extended followup.
Adverse Event Reporting Description Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
 
Arm/Group Title IL-2 With Pericylce HAART IL-2 Without ART No IL-2
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
IL-2 With Pericylce HAART IL-2 Without ART No IL-2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
IL-2 With Pericylce HAART IL-2 Without ART No IL-2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/87 (6.90%)      6/89 (6.74%)      3/91 (3.30%)    
Blood and lymphatic system disorders       
Anaemias NEC  1  0/87 (0.00%)  0 0/89 (0.00%)  0 1/91 (1.10%)  1
Cardiac disorders       
Coronary artery disorders NEC  1  1/87 (1.15%)  1 0/89 (0.00%)  0 0/91 (0.00%)  0
Endocrine disorders       
Hyperparathyroid disorders  1  0/87 (0.00%)  0 1/89 (1.12%)  1 0/91 (0.00%)  0
Gastrointestinal disorders       
Diarrhoea (excl infective)  1  1/87 (1.15%)  1 0/89 (0.00%)  0 0/91 (0.00%)  0
Gastrointestinal atonic and hypomotility disorders NEC  1  0/87 (0.00%)  0 0/89 (0.00%)  0 1/91 (1.10%)  1
Salivary gland disorders NEC  1  1/87 (1.15%)  1 0/89 (0.00%)  0 0/91 (0.00%)  0
General disorders       
Febrile disorders  1  1/87 (1.15%)  1 0/89 (0.00%)  0 0/91 (0.00%)  0
Hepatobiliary disorders       
Cholecystitis and cholelithiasis  1  0/87 (0.00%)  0 0/89 (0.00%)  0 1/91 (1.10%)  1
Infections and infestations       
Bacterial infections NEC  1  0/87 (0.00%)  0 2/89 (2.25%)  2 0/91 (0.00%)  0
Ear infections  1  0/87 (0.00%)  0 1/89 (1.12%)  1 0/91 (0.00%)  0
Abdominal and gastrointestinal infections  1  0/87 (0.00%)  0 0/89 (0.00%)  0 2/91 (2.20%)  2
Male reproductive tract infections  1  0/87 (0.00%)  0 1/89 (1.12%)  1 0/91 (0.00%)  0
Epstein-Barr viral infections  1  0/87 (0.00%)  0 1/89 (1.12%)  1 0/91 (0.00%)  0
Sepsis, bacteraemia, viraemia and fungaemia NEC  1  0/87 (0.00%)  0 0/89 (0.00%)  0 1/91 (1.10%)  1
Injury, poisoning and procedural complications       
Non-site specific injuries NEC  1  1/87 (1.15%)  1 0/89 (0.00%)  0 0/91 (0.00%)  0
Chemical injuries  1  0/87 (0.00%)  0 0/89 (0.00%)  0 1/91 (1.10%)  1
Metabolism and nutrition disorders       
Calcium metabolism disorders  1  0/87 (0.00%)  0 1/89 (1.12%)  1 0/91 (0.00%)  0
General nutritional disorders NEC  1  0/87 (0.00%)  0 1/89 (1.12%)  1 0/91 (0.00%)  0
Nervous system disorders       
Central nervous sytem haemorrhages and cerebrovascular accidents  1  0/87 (0.00%)  0 0/89 (0.00%)  0 1/91 (1.10%)  1
Psychiatric disorders       
Depressive disorders  1  0/87 (0.00%)  0 0/89 (0.00%)  0 1/91 (1.10%)  2
Renal and urinary disorders       
Bladder and urethral symptoms  1  1/87 (1.15%)  1 0/89 (0.00%)  0 0/91 (0.00%)  0
Renal failure and impairment  1  1/87 (1.15%)  1 0/89 (0.00%)  0 1/91 (1.10%)  1
Respiratory, thoracic and mediastinal disorders       
Bronchospasm and obstruction  1  0/87 (0.00%)  0 1/89 (1.12%)  1 1/91 (1.10%)  1
Pulmonary thrombotic and embolic conditions  1  0/87 (0.00%)  0 0/89 (0.00%)  0 1/91 (1.10%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
IL-2 With Pericylce HAART IL-2 Without ART No IL-2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/87 (8.05%)      3/89 (3.37%)      3/91 (3.30%)    
General disorders       
Febrile disorders  1  7/87 (8.05%)  7 3/89 (3.37%)  3 0/91 (0.00%)  0
Infections and infestations       
Abdominal and gastrointestinal infections  1  0/87 (0.00%)  0 0/89 (0.00%)  0 3/91 (3.30%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
All randomized patients were followed through 28 Feb 2009. A subset of 222 consenting patients were followed 2 additional years, through 28 Feb 2011.
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
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