Effect of Intermittent Aldesleukin Treatment With or With... | NCT00110812

ID	Type	Description	Link
10053	Registry Identifier	DAIDS ES Registry Number

Status Module

Name	Class
Chiron Corporation	INDUSTRY

Description Module

Detailed Description

Highly active antiretroviral therapy (HAART) has dramatically improved prognosis and lowered morbidity and mortality rates for HIV infected patients. However, significant drug toxicities, difficulties with patient compliance to HAART regimens, and development of drug resistance highlight the need for less toxic, immune-based strategies. Aldesleukin is a synthetic protein that can increase CD4 counts; it is currently approved by the Food and Drug Administration (FDA) for use in patients with metastatic melanoma and renal cell carcinoma. Previous studies of aldesleukin in HIV infected patients indicated that increased CD4 counts can persist for years after aldesleukin administration, and aldesleukin given with HAART may also lead to significant lowering of viral load. This study will examine the immunologic effects of intermittent cycles of aldesleukin administered with and without HAART as compared to no therapy in HIV infected patients.

This study will last approximately 31 months. Participants will be randomly assigned to one of three groups at study entry. Group A will receive no aldesleukin or HAART. Group B 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. Group C 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; Group C participants 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). HAART will not be provided by the study. Some Group B and C participants may take part in additional cycles of aldesleukin if they meet certain study criteria.

All participants in this study will have at least 8 study visits; these visits will occur at study entry and Weeks 4, 8, 12, 16, 20, 24, and 32. Blood collection will occur at all visits and will include tests for CD4 count and viral load. Groups B and C will have additional blood collection within 4 days prior to the start of each aldesleukin cycle. On the last day of each aldesleukin cycle, Groups B and C will be assessed for toxicities, adverse events, and adherence to the aldesleukin daily injections; they will also have another blood collection. Group C participants will have an additional blood collection for HIV genotyping after they have completed their third aldesleukin cycle. Extended follow-up visits will occur approximately every 4 months for an additional two years. Blood collection will occur at these visits and will include tests for CD4 count, viral load, and other laboratory tests.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No IL-2	No Intervention	Participants will receive no aldesleukin or HAART
IL-2 without ART	Experimental	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. Some Group 2 participants may take part in additional cycles of aldesleukin if they meet certain study criteria.	Drug: IL-2
IL-2 with pericycle HAART	Experimental	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; Group 3 participants 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). Some Group 3 participants may take part in additional cycles of aldesleukin if they meet certain study criteria. HAART is not supplied by the study, and choice of drugs is left to the participant and physician. The HAART regimen should include at least one protease inhibitor and at least 2 nucleoside/nucleotide reverse transcriptase inhibitors.	Drug: IL-2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IL-2	Drug	7.5 MIU injected intramuscularly; one arm uses Proleukin together with HAART of choice (protease inhibitor and at least 2 nucleoside/nucleotide reverse transcriptase inhibitors)

Measure	Description	Time Frame
Mean Change in CD4+ T Lymphocyte Count	Change in CD4 count from baseline to week 32.	Week 32

Measure	Description	Time Frame
Discontinuation of IL-2	Patients receiving fewer than 3 cycles of IL-2 by week 32	week 32
Plasma HIV RNA	change from baseline in HIV-RNA copies/ml (log10)

Eligibility Module

Name	Affiliation	Role
Jorge Tavel, MD	National Institute for Allergy and Infectious Diseases, National Institutes of Health	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
VA Greater Los Angeles Healthcare System, Infectious Diseases Section CRS		Los Angeles	California	90073	United States

PubMed Identifier	Type	Citation	Retractions
15767224	Background	Anaya JP, Sias JJ. The use of interleukin-2 in human immunodeficiency virus infection. Pharmacotherapy. 2005 Jan;25(1):86-95. doi: 10.1592/phco.25.1.86.55629.
12706405	Background	de Boer AW, Markowitz N, Lane HC, Saravolatz LD, Koletar SL, Donabedian H, Yoshizawa C, Duliege AM, Fyfe G, Mitsuyasu RT. A randomized controlled trial evaluating the efficacy and safety of intermittent 3-, 4-, and 5-day cycles of intravenous recombinant human interleukin-2 combined with antiretroviral therapy (ART) versus ART alone in HIV-seropositive patients with 100-300 CD4+ T cells. Clin Immunol. 2003 Mar;106(3):188-96. doi: 10.1016/s1521-6616(02)00038-4.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	No IL-2	Participants will receive no aldesleukin or HAART during the main study or extension
FG001	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	No IL-2	Participants will receive no aldesleukin or HAART
BG001	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.
BG002	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).
BG003	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Change in CD4+ T Lymphocyte Count

Change in CD4 count from baseline to week 32.

patients for whom the week-32 CD4+ cell count was measured

Posted

Mean

Standard Deviation

cell/mm^3

Week 32

ID	Title	Description
OG000	No IL-2	Participants will receive no aldesleukin or HAART
OG001	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.
OG002	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).

Units	Counts
Participants	OG00083 OG00178 OG00274

Title

Denominators

Categories

Title	Measurements
	OG000-21.8± 93.1 OG001113.7± 216.8 OG002110.4± 174.7

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANOVA	stratified by geographic region and adjusted for baseline CD4.	<.001	Adjusted for 3 pairwise comparisons.	Mean Difference (Net)	134			2-Sided	95	70	198					Superiority or Other (legacy)
OG000 OG002

Secondary

Discontinuation of IL-2

Patients receiving fewer than 3 cycles of IL-2 by week 32

all patients randomized to a study arm containing IL-2

Posted

Number

participants

week 32

ID	Title	Description
OG000	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.
OG001	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).

Units	Counts
Participants	OG000

Secondary

Plasma HIV RNA

change from baseline in HIV-RNA copies/ml (log10)

Patients for whom HIV-RNA was available at week 32

Posted

Mean

Standard Deviation

copies/ml (log 10)

At Week 32

ID	Title	Description
OG000	No IL-2	Participants will receive no aldesleukin or HAART
OG001	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.
OG002	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).

Units

Secondary

Change in CD4 T Lymphocyte Count

change from baseline to month 12 in CD4 T lymphocyte count

patients for whom the month 12 CD4 count was available

Posted

Mean

Standard Deviation

cell/mm^3

At Month 12

ID	Title	Description
OG000	No IL-2	Participants will receive no aldesleukin or HAART
OG001	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.
OG002	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).

Secondary

HIV-1 Genotype Changes

Patients who developed mutations associated with antiretroviral drugs.

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.

Posted

Number

participants

after 3rd cycle of IL-2

ID	Title	Description
OG000	IL-2 With Pericycle HAART

Units	Counts
Participants	OG00047

Secondary

Fasting Lipid Profile

total fasting cholesterol

all patients with laboratory data at week 32 who reported fasting

Posted

Mean

Standard Deviation

mg/dl

week 32

ID	Title	Description
OG000	No IL-2	Participants will receive no aldesleukin or HAART
OG001	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.
OG002	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).

Units

Secondary

Disease Progression or Death

occurrence of an opportunistic event (AIDS-defining infection or malignancy) or death

all randomized patients

Posted

Number

participants

throughout study, through Feb 28 2009 (median followup of 19 months)

ID	Title	Description
OG000	No IL-2	Participants will receive no aldesleukin or HAART
OG001	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.
OG002	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).

Secondary

Initiation of Continuous ART

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.

all patients randomized

Posted

Number

participants

from randomization through February 28, 2009

ID	Title	Description
OG000	No IL-2	Participants will receive no aldesleukin or HAART
OG001	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.
OG002	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).

Secondary

Change in HIV-RNA Copies/ml (log10) From Baseline to Month 12

patients for whom HIV-RNA measurement was available at baseline and month 12.

Posted

Mean

Standard Deviation

copies/ml (log 10)

month 12

ID	Title	Description
OG000	No IL-2	Participants will receive no aldesleukin or HAART
OG001	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.
OG002	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).

Units	Counts

Secondary

Thyroid Stimulating Hormone

Number of participants with thyroid stimulating hormone greater than the upper limit of normal

all patients with TSH measured at 32 weeks

Posted

Number

participants

week 32

ID	Title	Description
OG000	No IL-2	Participants will receive no aldesleukin or HAART
OG001	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.
OG002	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).

Secondary

SGOT

Number of participants with aspartate aminotransferase (SGOT) greater than 5 times the upper limit of normal

all patients with SGOT measured at week 32

Posted

Number

participants

week 32

ID	Title	Description
OG000	No IL-2	Participants will receive no aldesleukin or HAART
OG001	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.
OG002	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).

Post-Hoc

Opportunistic Disease or Death During the Trial Extension Phase

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.

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.

Posted

Number

participants

two years following close of main study

ID	Title	Description
OG000	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.
OG001	Control	Consenting patients who were in the control group during the main phase of the trial.

Units	Counts
Participants

Post-Hoc

CD4+ Cell Count 2 Years Post-study

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.

Posted

Mean

Standard Deviation

cell/mm^3

two years following close of main study

ID	Title	Description
OG000	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.
OG001	Control	Consenting patients who were in the control group during the main phase of the trial.

Units	Counts
Participants	OG000

Post-Hoc

Undetectable HIV-RNA

Patients with undetectable HIV-RNA levels measured at 24 months after the close of the main study, at the end of the extension phase.

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.

Posted

Number

participants

24 months post-trial

ID	Title	Description
OG000	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.
OG001	Control	Consenting patients who were in the control group during the main phase of the trial.

Units	Counts
Participants	OG000

Post-Hoc

Commencement of Continuous Antiretroviral Treatment

Number of patients commencing continuous antiretroviral treatment.

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.

Posted

Number

participants

from randomization through February 28, 2011, the end of the extension phase

ID	Title	Description
OG000	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.
OG001	Control	Consenting patients who were in the control group during the main phase of the trial.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemias NEC	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected89 at risk EG0021 events1 affected91 at risk
Bacterial infections NEC	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected87 at risk EG0012 events2 affected89 at risk EG0020 events0 affected91 at risk
Bladder and urethral symptoms	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected87 at risk EG0010 events0 affected89 at risk EG0020 events0 affected91 at risk
Bronchospasm and obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected87 at risk EG0011 events1 affected89 at risk EG0021 events1 affected91 at risk
Calcium metabolism disorders	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected87 at risk EG0011 events1 affected89 at risk EG0020 events0 affected91 at risk
Cholecystitis and cholelithiasis	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected89 at risk EG0021 events1 affected91 at risk
Diarrhoea (excl infective)	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected87 at risk EG0010 events0 affected89 at risk EG0020 events0 affected91 at risk
Ear infections	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected87 at risk EG0011 events1 affected89 at risk EG0020 events0 affected91 at risk
Febrile disorders	General disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected87 at risk EG0010 events0 affected89 at risk EG0020 events0 affected91 at risk
Gastrointestinal atonic and hypomotility disorders NEC	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected89 at risk EG0021 events1 affected91 at risk
Abdominal and gastrointestinal infections	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected89 at risk EG0022 events2 affected91 at risk
General nutritional disorders NEC	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected87 at risk EG0011 events1 affected89 at risk EG0020 events0 affected91 at risk
Hyperparathyroid disorders	Endocrine disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected87 at risk EG0011 events1 affected89 at risk EG0020 events0 affected91 at risk
Non-site specific injuries NEC	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected87 at risk EG0010 events0 affected89 at risk EG0020 events0 affected91 at risk
Renal failure and impairment	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected87 at risk EG0010 events0 affected89 at risk EG0021 events1 affected91 at risk
Male reproductive tract infections	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected87 at risk EG0011 events1 affected89 at risk EG0020 events0 affected91 at risk
Salivary gland disorders NEC	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected87 at risk EG0010 events0 affected89 at risk EG0020 events0 affected91 at risk
Central nervous sytem haemorrhages and cerebrovascular accidents	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected89 at risk EG0021 events1 affected91 at risk
Chemical injuries	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected89 at risk EG0021 events1 affected91 at risk
Coronary artery disorders NEC	Cardiac disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected87 at risk EG0010 events0 affected89 at risk EG0020 events0 affected91 at risk
Depressive disorders	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected89 at risk EG0022 events1 affected91 at risk
Epstein-Barr viral infections	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected87 at risk EG0011 events1 affected89 at risk EG0020 events0 affected91 at risk
Pulmonary thrombotic and embolic conditions	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected89 at risk EG0021 events1 affected91 at risk
Sepsis, bacteraemia, viraemia and fungaemia NEC	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected87 at risk EG0010 events0 affected89 at risk EG0021 events1 affected91 at risk

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
D007378	Interleukins
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D008222	Lymphokines
D011506	Proteins
D001685	Biological Factors

ID	Title	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	IL-2 With Pericylce HAART	6	87	7	87
EG001	IL-2 Without ART	6	89	3	89
EG002	No IL-2	3	91	3	91