Trial Outcomes & Findings for Effect of Intermittent Aldesleukin Treatment With or Without Anti-HIV Drugs in HIV Infected People (NCT NCT00110812)
NCT ID: NCT00110812
Last Updated: 2021-11-04
Results Overview
Change in CD4 count from baseline to week 32.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
267 participants
Primary outcome timeframe
Week 32
Results posted on
2021-11-04
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Main Study
STARTED
|
91
|
89
|
87
|
|
Main Study
COMPLETED
|
83
|
78
|
74
|
|
Main Study
NOT COMPLETED
|
8
|
11
|
13
|
|
Extended Follow-up
STARTED
|
80
|
69
|
73
|
|
Extended Follow-up
COMPLETED
|
78
|
65
|
69
|
|
Extended Follow-up
NOT COMPLETED
|
2
|
4
|
4
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|
|
Main Study
Death
|
0
|
0
|
2
|
|
Main Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Main Study
Lost to Follow-up
|
8
|
11
|
10
|
|
Extended Follow-up
Death
|
1
|
0
|
3
|
|
Extended Follow-up
Withdrawal by Subject
|
0
|
1
|
0
|
|
Extended Follow-up
Lost to Follow-up
|
1
|
3
|
1
|
Baseline Characteristics
Effect of Intermittent Aldesleukin Treatment With or Without Anti-HIV Drugs in HIV Infected People
Baseline characteristics by cohort
| Measure |
No IL-2
n=91 Participants
Participants will receive no aldesleukin or HAART
|
IL-2 Without ART
n=89 Participants
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
n=87 Participants
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
n=267 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
91 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
265 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Continuous
|
37.1 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
37.3 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
37.8 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
37.4 years
STANDARD_DEVIATION 9.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
221 Participants
n=4 Participants
|
|
Region of Enrollment
Portugal
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Region of Enrollment
Morocco
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
Argentina
|
25 participants
n=5 Participants
|
24 participants
n=7 Participants
|
21 participants
n=5 Participants
|
70 participants
n=4 Participants
|
|
Region of Enrollment
Thailand
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
22 participants
n=5 Participants
|
64 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Region of Enrollment
Chile
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
10 participants
n=5 Participants
|
27 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
5 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
CD4 cell count
|
432 cells/mm^3
n=5 Participants
|
398 cells/mm^3
n=7 Participants
|
425 cells/mm^3
n=5 Participants
|
418 cells/mm^3
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 32Population: patients for whom the week-32 CD4+ cell count was measured
Change in CD4 count from baseline to week 32.
Outcome measures
| Measure |
No IL-2
n=83 Participants
Participants will receive no aldesleukin or HAART
|
IL-2 Without ART
n=78 Participants
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
n=74 Participants
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).
|
|---|---|---|---|
|
Mean Change in CD4+ T Lymphocyte Count
|
-21.8 cell/mm^3
Standard Deviation 93.1
|
113.7 cell/mm^3
Standard Deviation 216.8
|
110.4 cell/mm^3
Standard Deviation 174.7
|
SECONDARY outcome
Timeframe: week 32Population: all patients randomized to a study arm containing IL-2
Patients receiving fewer than 3 cycles of IL-2 by week 32
Outcome measures
| Measure |
No IL-2
n=89 Participants
Participants will receive no aldesleukin or HAART
|
IL-2 Without ART
n=87 Participants
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).
|
|---|---|---|---|
|
Discontinuation of IL-2
|
12 participants
|
32 participants
|
—
|
SECONDARY outcome
Timeframe: At Week 32Population: Patients for whom HIV-RNA was available at week 32
change from baseline in HIV-RNA copies/ml (log10)
Outcome measures
| Measure |
No IL-2
n=82 Participants
Participants will receive no aldesleukin or HAART
|
IL-2 Without ART
n=79 Participants
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
n=72 Participants
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).
|
|---|---|---|---|
|
Plasma HIV RNA
|
-.39 copies/ml (log 10)
Standard Deviation 1.03
|
-.07 copies/ml (log 10)
Standard Deviation .80
|
-.01 copies/ml (log 10)
Standard Deviation .40
|
SECONDARY outcome
Timeframe: At Month 12Population: patients for whom the month 12 CD4 count was available
change from baseline to month 12 in CD4 T lymphocyte count
Outcome measures
| Measure |
No IL-2
n=78 Participants
Participants will receive no aldesleukin or HAART
|
IL-2 Without ART
n=77 Participants
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
n=72 Participants
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).
|
|---|---|---|---|
|
Change in CD4 T Lymphocyte Count
|
-8.4 cell/mm^3
Standard Deviation 129.1 • Interval 356.0 to 472.0
|
59.0 cell/mm^3
Standard Deviation 176.0 • Interval 357.0 to 589.0
|
49.8 cell/mm^3
Standard Deviation 155.6 • Interval 359.0 to 605.0
|
SECONDARY outcome
Timeframe: after 3rd cycle of IL-2Population: 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.
Patients who developed mutations associated with antiretroviral drugs.
Outcome measures
| Measure |
No IL-2
n=47 Participants
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).
|
|---|---|---|---|
|
HIV-1 Genotype Changes
|
2 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: week 32Population: all patients with laboratory data at week 32 who reported fasting
total fasting cholesterol
Outcome measures
| Measure |
No IL-2
n=65 Participants
Participants will receive no aldesleukin or HAART
|
IL-2 Without ART
n=66 Participants
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
n=58 Participants
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).
|
|---|---|---|---|
|
Fasting Lipid Profile
|
173.4 mg/dl
Standard Deviation 33.7
|
167.0 mg/dl
Standard Deviation 32.7
|
164.6 mg/dl
Standard Deviation 40.8
|
SECONDARY outcome
Timeframe: throughout study, through Feb 28 2009 (median followup of 19 months)Population: all randomized patients
occurrence of an opportunistic event (AIDS-defining infection or malignancy) or death
Outcome measures
| Measure |
No IL-2
n=91 Participants
Participants will receive no aldesleukin or HAART
|
IL-2 Without ART
n=89 Participants
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
n=87 Participants
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).
|
|---|---|---|---|
|
Disease Progression or Death
|
1 participants
|
5 participants
|
7 participants
|
SECONDARY outcome
Timeframe: from randomization through February 28, 2009Population: all patients randomized
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.
Outcome measures
| Measure |
No IL-2
n=91 Participants
Participants will receive no aldesleukin or HAART
|
IL-2 Without ART
n=89 Participants
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
n=87 Participants
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).
|
|---|---|---|---|
|
Initiation of Continuous ART
|
34 participants
|
23 participants
|
14 participants
|
SECONDARY outcome
Timeframe: month 12Population: patients for whom HIV-RNA measurement was available at baseline and month 12.
Outcome measures
| Measure |
No IL-2
n=77 Participants
Participants will receive no aldesleukin or HAART
|
IL-2 Without ART
n=74 Participants
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
n=71 Participants
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).
|
|---|---|---|---|
|
Change in HIV-RNA Copies/ml (log10) From Baseline to Month 12
|
-0.64 copies/ml (log 10)
Standard Deviation 1.24 • Interval 1740.0 to 25771.0
|
-0.28 copies/ml (log 10)
Standard Deviation 0.95 • Interval 1794.0 to 69953.0
|
-0.09 copies/ml (log 10)
Standard Deviation 0.84 • Interval 7790.0 to 49183.0
|
SECONDARY outcome
Timeframe: week 32Population: all patients with TSH measured at 32 weeks
Number of participants with thyroid stimulating hormone greater than the upper limit of normal
Outcome measures
| Measure |
No IL-2
n=79 Participants
Participants will receive no aldesleukin or HAART
|
IL-2 Without ART
n=75 Participants
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
n=71 Participants
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).
|
|---|---|---|---|
|
Thyroid Stimulating Hormone
|
3 participants
|
2 participants
|
7 participants
|
SECONDARY outcome
Timeframe: week 32Population: all patients with SGOT measured at week 32
Number of participants with aspartate aminotransferase (SGOT) greater than 5 times the upper limit of normal
Outcome measures
| Measure |
No IL-2
n=83 Participants
Participants will receive no aldesleukin or HAART
|
IL-2 Without ART
n=79 Participants
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
n=74 Participants
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).
|
|---|---|---|---|
|
SGOT
|
1 participants
|
0 participants
|
0 participants
|
POST_HOC outcome
Timeframe: two years following close of main studyPopulation: 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.
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.
Outcome measures
| Measure |
No IL-2
n=142 Participants
Participants will receive no aldesleukin or HAART
|
IL-2 Without ART
n=80 Participants
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).
|
|---|---|---|---|
|
Opportunistic Disease or Death During the Trial Extension Phase
|
8 participants
|
3 participants
|
—
|
POST_HOC outcome
Timeframe: two years following close of main studyPopulation: 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.
Outcome measures
| Measure |
No IL-2
n=141 Participants
Participants will receive no aldesleukin or HAART
|
IL-2 Without ART
n=80 Participants
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).
|
|---|---|---|---|
|
CD4+ Cell Count 2 Years Post-study
|
499.9 cell/mm^3
Standard Deviation 191.4
|
557.2 cell/mm^3
Standard Deviation 225.5
|
—
|
POST_HOC outcome
Timeframe: 24 months post-trialPopulation: 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.
Patients with undetectable HIV-RNA levels measured at 24 months after the close of the main study, at the end of the extension phase.
Outcome measures
| Measure |
No IL-2
n=141 Participants
Participants will receive no aldesleukin or HAART
|
IL-2 Without ART
n=80 Participants
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).
|
|---|---|---|---|
|
Undetectable HIV-RNA
|
97 participants
|
60 participants
|
—
|
POST_HOC outcome
Timeframe: from randomization through February 28, 2011, the end of the extension phasePopulation: 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.
Number of patients commencing continuous antiretroviral treatment.
Outcome measures
| Measure |
No IL-2
n=176 Participants
Participants will receive no aldesleukin or HAART
|
IL-2 Without ART
n=91 Participants
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).
|
|---|---|---|---|
|
Commencement of Continuous Antiretroviral Treatment
|
108 participants
|
66 participants
|
—
|
Adverse Events
IL-2 With Pericylce HAART
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
IL-2 Without ART
Serious events: 6 serious events
Other events: 3 other events
Deaths: 0 deaths
No IL-2
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IL-2 With Pericylce HAART
n=87 participants at risk
|
IL-2 Without ART
n=89 participants at risk
|
No IL-2
n=91 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemias NEC
|
0.00%
0/87 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/89 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
1.1%
1/91 • Number of events 1 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
|
Infections and infestations
Bacterial infections NEC
|
0.00%
0/87 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
2.2%
2/89 • Number of events 2 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/91 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
|
Renal and urinary disorders
Bladder and urethral symptoms
|
1.1%
1/87 • Number of events 1 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/89 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/91 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm and obstruction
|
0.00%
0/87 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
1.1%
1/89 • Number of events 1 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
1.1%
1/91 • Number of events 1 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
|
Metabolism and nutrition disorders
Calcium metabolism disorders
|
0.00%
0/87 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
1.1%
1/89 • Number of events 1 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/91 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
|
Hepatobiliary disorders
Cholecystitis and cholelithiasis
|
0.00%
0/87 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/89 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
1.1%
1/91 • Number of events 1 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
|
Gastrointestinal disorders
Diarrhoea (excl infective)
|
1.1%
1/87 • Number of events 1 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/89 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/91 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
|
Infections and infestations
Ear infections
|
0.00%
0/87 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
1.1%
1/89 • Number of events 1 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/91 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
|
General disorders
Febrile disorders
|
1.1%
1/87 • Number of events 1 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/89 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/91 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
|
Gastrointestinal disorders
Gastrointestinal atonic and hypomotility disorders NEC
|
0.00%
0/87 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/89 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
1.1%
1/91 • Number of events 1 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
|
Infections and infestations
Abdominal and gastrointestinal infections
|
0.00%
0/87 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/89 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
2.2%
2/91 • Number of events 2 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
|
Metabolism and nutrition disorders
General nutritional disorders NEC
|
0.00%
0/87 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
1.1%
1/89 • Number of events 1 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/91 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
|
Endocrine disorders
Hyperparathyroid disorders
|
0.00%
0/87 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
1.1%
1/89 • Number of events 1 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/91 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
|
Injury, poisoning and procedural complications
Non-site specific injuries NEC
|
1.1%
1/87 • Number of events 1 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/89 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/91 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
|
Renal and urinary disorders
Renal failure and impairment
|
1.1%
1/87 • Number of events 1 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/89 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
1.1%
1/91 • Number of events 1 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
|
Infections and infestations
Male reproductive tract infections
|
0.00%
0/87 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
1.1%
1/89 • Number of events 1 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/91 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
|
Gastrointestinal disorders
Salivary gland disorders NEC
|
1.1%
1/87 • Number of events 1 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/89 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/91 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
|
Nervous system disorders
Central nervous sytem haemorrhages and cerebrovascular accidents
|
0.00%
0/87 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/89 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
1.1%
1/91 • Number of events 1 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
|
Injury, poisoning and procedural complications
Chemical injuries
|
0.00%
0/87 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/89 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
1.1%
1/91 • Number of events 1 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
|
Cardiac disorders
Coronary artery disorders NEC
|
1.1%
1/87 • Number of events 1 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/89 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/91 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
|
Psychiatric disorders
Depressive disorders
|
0.00%
0/87 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/89 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
1.1%
1/91 • Number of events 2 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
|
Infections and infestations
Epstein-Barr viral infections
|
0.00%
0/87 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
1.1%
1/89 • Number of events 1 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/91 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombotic and embolic conditions
|
0.00%
0/87 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/89 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
1.1%
1/91 • Number of events 1 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
|
Infections and infestations
Sepsis, bacteraemia, viraemia and fungaemia NEC
|
0.00%
0/87 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/89 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
1.1%
1/91 • Number of events 1 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
Other adverse events
| Measure |
IL-2 With Pericylce HAART
n=87 participants at risk
|
IL-2 Without ART
n=89 participants at risk
|
No IL-2
n=91 participants at risk
|
|---|---|---|---|
|
General disorders
Febrile disorders
|
8.0%
7/87 • Number of events 7 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
3.4%
3/89 • Number of events 3 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/91 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
|
Infections and infestations
Abdominal and gastrointestinal infections
|
0.00%
0/87 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
0.00%
0/89 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
3.3%
3/91 • Number of events 3 • From randomization through Feb 28 2011, end of extended followup.
Adverse events were recorded if grade 3 (moderate) or 4 (serious), according to DAIDS toxicity table.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place