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

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

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)

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 ]

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.