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An International Study to Evaluate Recombinant Interleukin-2 in HIV Positive Patients Taking Anti-retroviral Therapy (ESPRIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00004978
Recruitment Status : Completed
First Posted : August 31, 2001
Results First Posted : April 25, 2011
Last Update Posted : May 6, 2013
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: Recombinant interleukin-2 (rIL-2)
Enrollment 4150
Recruitment Details Patients were enrolled to ESPRIT between 2000 and 2003. As per the ESPRIT protocol, patients from previous Vanguard studies (in Thailand, Argentina, and the U.S., enrolled 1997-1999) were followed and included in the analysis cohort of this study if at least 90% of patients from that site consented to ESPRIT.
Pre-assignment Details  
Arm/Group Title rIL-2 No rIL-2
Hide Arm/Group Description Subcutaneous recombinant interleukin-2 (rIL-2) therapy Control group - no study-assigned medication
Period Title: Overall Study
Started 2090 [1] 2060 [1]
Completed 1846 1790
Not Completed 244 270
Reason Not Completed
Death             107             116
Lost to Follow-up             101             108
Withdrawal by Subject             17             26
site closure - not in analysis cohort             19             20
[1]
includes patients participating in Vanguard studies from the sites which participated in ESPRIT
Arm/Group Title rIL-2 No rIL-2 Total
Hide Arm/Group Description Subcutaneous recombinant interleukin-2 (rIL-2) therapy Control group - no study-assigned medication Total of all reporting groups
Overall Number of Baseline Participants 2090 2060 4150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2090 participants 2060 participants 4150 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2071
  99.1%
2032
  98.6%
4103
  98.9%
>=65 years
19
   0.9%
28
   1.4%
47
   1.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2090 participants 2060 participants 4150 participants
40.8  (8.8) 40.9  (9.1) 40.8  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2090 participants 2060 participants 4150 participants
Female
388
  18.6%
381
  18.5%
769
  18.5%
Male
1702
  81.4%
1679
  81.5%
3381
  81.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2090 participants 2060 participants 4150 participants
Argentina 276 278 554
Australia 107 98 205
Austria 16 18 34
Belgium 39 41 80
Brazil 48 50 98
Canada 74 67 141
Denmark 39 33 72
France 86 96 182
Germany 136 130 266
Ireland 3 1 4
Israel 31 33 64
Italy 50 54 104
Japan 14 11 25
Morocco 12 14 26
Netherlands 29 25 54
Norway 3 5 8
Poland 48 52 100
Portugal 51 56 107
Singapore 10 10 20
Spain 151 157 308
Sweden 4 3 7
Switzerland 5 5 10
Thailand 182 183 365
United Kingdom 165 163 328
United States 511 477 988
CD4+ cell count  
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3
Number Analyzed 2090 participants 2060 participants 4150 participants
465
(374 to 592)
451
(370 to 578)
458
(373 to 586)
1.Primary Outcome
Title New or Recurrent HIV Disease Progression Event Including Death
Hide Description Participants who die or experience at least one: any CDC Category C 1993 AIDS-defining events or one of the following: invasive aspergillosis, bartonellosis, Chagas disease, Herpes zoster, visceral Leishmaniasis, Hodgkin's lymphoma, non-Hodgkin's lymphoma (all cell types), microsporidiosis, nocardiosis, disseminated Penicillium marneffii, extrapulmonary Pneumocystis carinii, and Rhodococcus equi disease
Time Frame from randomization through study end - median of 7.6 years follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title rIL-2 No rIL-2
Hide Arm/Group Description:
Subcutaneous recombinant interleukin-2 (rIL-2) therapy
Control group - no study-assigned medication
Overall Number of Participants Analyzed 2071 2040
Measure Type: Number
Unit of Measure: participants
159 165
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rIL-2, No rIL-2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .55
Comments P-value is 2-sided using an alpha of .05.
Method Regression, Cox
Comments Hazard ratio is from unadjusted proportional hazards regression model.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.75 to 1.16
Estimation Comments HR is for rIL-2 vs control.
2.Secondary Outcome
Title New or Recurrent Serious HIV Disease Progression Event Including Death
Hide Description Patients with at least one: progressive multifocal leukoencephalopathy, lymphoma, visceral Kaposi's sarcoma, AIDS dementia complex, toxoplasmosis, histoplasmosis, cryptococcosis, Mycobacterium avium complex, wasting syndrome, and cytomegalovirus disease.
Time Frame from randomization through study end - median of 7.6 years follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title rIL-2 No rIL-2
Hide Arm/Group Description:
Subcutaneous recombinant interleukin-2 (rIL-2) therapy
Control group - no study-assigned medication
Overall Number of Participants Analyzed 2071 2040
Measure Type: Number
Unit of Measure: participants
126 130
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rIL-2, No rIL-2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .62
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.74 to 1.20
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants Who Died From Any Cause
Hide Description [Not Specified]
Time Frame from randomization through study end - median of 7.6 years follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rIL-2 No rIL-2
Hide Arm/Group Description:
Subcutaneous recombinant interleukin-2 (rIL-2) therapy
Control group - no study-assigned medication
Overall Number of Participants Analyzed 2071 2040
Measure Type: Number
Unit of Measure: participants
107 116
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rIL-2, No rIL-2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .42
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.69 to 1.17
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Participants With a New Disease Progression Event or Death
Hide Description Includes first new episode of: CDC Category C 1993 AIDS-defining events plus invasive aspergillosis, bartonellosis, Chagas disease, Herpes zoster, visceral Leishmaniasis, Hodgkin's lymphoma, non-Hodgkin's lymphoma (all cell types), microsporidiosis, nocardiosis, disseminated Penicillium marneffii, extrapulmonary Pneumocystis carinii, and Rhodococcus equi disease
Time Frame from randomization through 15 November 2008 - median of 7.6 years follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rIL-2 No rIL-2
Hide Arm/Group Description:
Subcutaneous recombinant interleukin-2 (rIL-2) therapy
Control group - no study-assigned medication
Overall Number of Participants Analyzed 2071 2040
Measure Type: Number
Unit of Measure: participants
154 164
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rIL-2, No rIL-2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .41
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.73 to 1.14
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Absolute CD4 Cell Counts Averaged Throughout Followup
Hide Description Average of all available CD4+ cell counts measured at follow-up visits
Time Frame from randomization through study end - median of 7.6 years follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
CD4+ cell counts averaged over all participants with at least one CD4+ measurement recorded during follow-up.
Arm/Group Title rIL-2 No rIL-2
Hide Arm/Group Description:
Subcutaneous recombinant interleukin-2 (rIL-2) therapy
Control group - no study-assigned medication
Overall Number of Participants Analyzed 2053 2024
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
715.4  (273.1) 556.3  (193.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rIL-2, No rIL-2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 159
Confidence Interval (2-Sided) 95%
145 to 174
Estimation Comments treatment difference (rIL2 - no rIL2) estimated from a longitudinal model that considers CD4+ measured at followup visits
6.Secondary Outcome
Title Plasma HIV RNA Levels
Hide Description log10 HIV-RNA averaged throughout follow-up
Time Frame From randomization through study end - median of 7.6 years follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
HIV-RNA measurement averaged over followup visits for all participants with at least one follow-up measurement.
Arm/Group Title rIL-2 No rIL-2
Hide Arm/Group Description:
Subcutaneous recombinant interleukin-2 (rIL-2) therapy
Control group - no study-assigned medication
Overall Number of Participants Analyzed 2065 2036
Mean (Standard Deviation)
Unit of Measure: log10 HIV-RNA
2.20  (0.65) 2.17  (0.61)
7.Secondary Outcome
Title Number of Participants With Changes in Anti-retroviral Treatment (ART)
Hide Description Number of participants who changed ART at least once during the study period.
Time Frame From randomization through study end - median of 7.6 years follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rIL-2 No rIL-2
Hide Arm/Group Description:
Subcutaneous recombinant interleukin-2 (rIL-2) therapy
Control group - no study-assigned medication
Overall Number of Participants Analyzed 2071 2040
Measure Type: Number
Unit of Measure: participants
1760 1751
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rIL-2, No rIL-2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .07
Comments [Not Specified]
Method Regression, Cox
Comments Hazard ratio (rIL-2 vs. no rIL-2) for first change in antiretroviral treatment.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.88 to 1.00
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Grade 4 Signs and Symptoms
Hide Description Participants with at least one grade 4 sign or symptom (except those limited to a laboratory measurement), other than AIDS-defining conditions. Events were graded according to a standardized toxicity table. Events not specifically contained in the toxicity table were considered Grade 4 if they resulted in extreme limitation in activity or required significant medical intervention/therapy, hospitalization or hospice care. Grade 4 events by type are given under the adverse events section.
Time Frame From randomization through study end - median of 7.6 years follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rIL-2 No rIL-2
Hide Arm/Group Description:
Subcutaneous recombinant interleukin-2 (rIL-2) therapy
Control group - no study-assigned medication
Overall Number of Participants Analyzed 2071 2040
Measure Type: Number
Unit of Measure: Participants
466 383
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rIL-2, No rIL-2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .003
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
1.07 to 1.41
Estimation Comments HR (IL-2 vs control) for first grade 4 event, ITT analysis.
9.Secondary Outcome
Title Pattern of Use of Prophylaxis for Opportunistic Infections
Hide Description Number of participants using pneumocystis pneumonia (PCP) prophylaxis at the last attended followup visit.
Time Frame last followup visit - median of 7.6 years follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) - Medication use recorded on the last followup visit attended among all participants attending at least one followup visit.
Arm/Group Title rIL-2 No rIL-2
Hide Arm/Group Description:
Subcutaneous recombinant interleukin-2 (rIL-2) therapy
Control group - no study-assigned medication
Overall Number of Participants Analyzed 2028 2005
Measure Type: Number
Unit of Measure: participants
54 53
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rIL-2, No rIL-2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .97
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
10.Secondary Outcome
Title Hepatic, Metabolic, and Cardiac Conditions
Hide Description Number of participants experiencing a "serious non-AIDS" event defined as first serious cardiovascular, renal, or hepatic event, or non-AIDS malignancy.
Time Frame From randomization through study end - median of 7.6 years follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rIL-2 No rIL-2
Hide Arm/Group Description:
Subcutaneous recombinant interleukin-2 (rIL-2) therapy
Control group - no study-assigned medication
Overall Number of Participants Analyzed 2071 2040
Measure Type: Number
Unit of Measure: participants
134 136
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rIL-2, No rIL-2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .74
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.76 to 1.22
Estimation Comments [Not Specified]
Time Frame Grade 4 events were reportable from randomization through study end (15 November 2008), irrespective of whether patient was taking a study treatment.
Adverse Event Reporting Description Adverse events are grade 4 events (excluding AIDS-defining events and events limited to abnormal laboratory values), reportable in both treatment arms. All grade 4 events are included under "serious adverse events", categorized according to MedDRA HLGT. Common adverse events of any grade are reported under "other adverse events" by MedDRA PT.
 
Arm/Group Title rIL-2 No rIL-2
Hide Arm/Group Description Subcutaneous recombinant interleukin-2 (rIL-2) therapy Control group - no study-assigned medication
All-Cause Mortality
rIL-2 No rIL-2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
rIL-2 No rIL-2
Affected / at Risk (%) Affected / at Risk (%)
Total   466/2071 (22.50%)   383/2040 (18.77%) 
Blood and lymphatic system disorders     
Anaemias nonhaemolytic and marrow depression  1  7/2071 (0.34%)  9/2040 (0.44%) 
Platelet disorders  1  1/2071 (0.05%)  3/2040 (0.15%) 
Spleen, lymphatic, and reticuloendothelial system disorders  1  3/2071 (0.14%)  1/2040 (0.05%) 
White blood cell disorders  1  0/2071 (0.00%)  5/2040 (0.25%) 
Cardiac disorders     
cardiac arrhythmias  1  6/2071 (0.29%)  4/2040 (0.20%) 
cardiac valve disorders  1  3/2071 (0.14%)  0/2040 (0.00%) 
Coronary artery disorders  1  41/2071 (1.98%)  46/2040 (2.25%) 
Heart failures  1  6/2071 (0.29%)  0/2040 (0.00%) 
Myocardial disorders  1  0/2071 (0.00%)  2/2040 (0.10%) 
Pericardial disorders  1  2/2071 (0.10%)  1/2040 (0.05%) 
Congenital, familial and genetic disorders     
Muscuoloskeletal and connective tissue disorders congenital  1  1/2071 (0.05%)  0/2040 (0.00%) 
Ear and labyrinth disorders     
Inner ear and VIIIth cranial nerve disorders  1  2/2071 (0.10%)  0/2040 (0.00%) 
Middle ear disorders (excl congenital)  1  1/2071 (0.05%)  0/2040 (0.00%) 
Endocrine disorders     
Adrenal gland disorders  1  1/2071 (0.05%)  0/2040 (0.00%) 
Thyroid gland disorders  1  5/2071 (0.24%)  2/2040 (0.10%) 
Eye disorders     
Ocular infections, irritations and inflammations  1  2/2071 (0.10%)  0/2040 (0.00%) 
Ocular neuromuscular disorders  1  0/2071 (0.00%)  1/2040 (0.05%) 
Ocular structural change, deposit and degeneration NEC  1  1/2071 (0.05%)  2/2040 (0.10%) 
Vision disorders  1  1/2071 (0.05%)  0/2040 (0.00%) 
Gastrointestinal disorders     
Abdominal hernias and other abdominal wall conditions  1  3/2071 (0.14%)  6/2040 (0.29%) 
Anal and rectal conditions NEC  1  1/2071 (0.05%)  5/2040 (0.25%) 
Benign neoplasms gastrointestinal  1  1/2071 (0.05%)  0/2040 (0.00%) 
Diverticular disorders  1  1/2071 (0.05%)  1/2040 (0.05%) 
Exocrine pancreas conditions  1  8/2071 (0.39%)  11/2040 (0.54%) 
Gastrointestinal conditions NEC  1  0/2071 (0.00%)  2/2040 (0.10%) 
Gastrointestinal haemorrhages NEC  1  8/2071 (0.39%)  9/2040 (0.44%) 
Gastrointestinal inflammatory conditions  1  1/2071 (0.05%)  3/2040 (0.15%) 
Gastrointestinal motility and defaecation conditions  1  11/2071 (0.53%)  9/2040 (0.44%) 
Gastrointestinal signs and symptoms  1  15/2071 (0.72%)  13/2040 (0.64%) 
Gastrointestinal stenosis and obstruction  1  2/2071 (0.10%)  2/2040 (0.10%) 
Gastrointestinal ulceration and perforation  1  5/2071 (0.24%)  1/2040 (0.05%) 
Gastrointestinal vascular conditions  1  2/2071 (0.10%)  2/2040 (0.10%) 
Peritoneal and retroperitoneal conditions  1  0/2071 (0.00%)  3/2040 (0.15%) 
General disorders     
Administration site reactions  1  0/2071 (0.00%)  1/2040 (0.05%) 
Body temperature conditions  1  15/2071 (0.72%)  4/2040 (0.20%) 
General system disorders NEC  1  17/2071 (0.82%)  6/2040 (0.29%) 
Therapeutic and nontherapeutic effects (excl toxicity)  1  1/2071 (0.05%)  0/2040 (0.00%) 
Tissue disorders NEC  1  2/2071 (0.10%)  0/2040 (0.00%) 
Hepatobiliary disorders     
Bile duct disorders  1  3/2071 (0.14%)  1/2040 (0.05%) 
Gallbladder disorders  1  10/2071 (0.48%)  10/2040 (0.49%) 
Hepatic and hepatobiliary disorders  1  13/2071 (0.63%)  8/2040 (0.39%) 
Immune system disorders     
Allergic conditions  1  3/2071 (0.14%)  2/2040 (0.10%) 
Immune disorders NEC  1  1/2071 (0.05%)  1/2040 (0.05%) 
Infections and infestations     
Bacterial infectious disorders  1  20/2071 (0.97%)  17/2040 (0.83%) 
Fungal infectious disorders  1  3/2071 (0.14%)  0/2040 (0.00%) 
Infections - pathogen unspecified  1  47/2071 (2.27%)  42/2040 (2.06%) 
Mycobacterial infectious disorders  1  1/2071 (0.05%)  1/2040 (0.05%) 
Protozoal infectious disorders  1  0/2071 (0.00%)  1/2040 (0.05%) 
Viral infectious disorders  1  19/2071 (0.92%)  18/2040 (0.88%) 
Injury, poisoning and procedural complications     
Bone and joint injuries  1  15/2071 (0.72%)  8/2040 (0.39%) 
Chemical injury and poisoning  1  4/2071 (0.19%)  4/2040 (0.20%) 
Injuries NEC  1  9/2071 (0.43%)  13/2040 (0.64%) 
Medication errors  1  5/2071 (0.24%)  1/2040 (0.05%) 
Procedural and device related injuries and complications NEC  1  1/2071 (0.05%)  1/2040 (0.05%) 
Investigations     
Enzyme investigations NEC  1  1/2071 (0.05%)  0/2040 (0.00%) 
Gastrointestinal investigations  1  1/2071 (0.05%)  0/2040 (0.00%) 
Haematology investigations (incl blood groups)  1  1/2071 (0.05%)  3/2040 (0.15%) 
Hepatobiliary investigations  1  6/2071 (0.29%)  1/2040 (0.05%) 
Lipid analyses  1  1/2071 (0.05%)  0/2040 (0.00%) 
Metabolic, nutritional and blood gas investigations  1  1/2071 (0.05%)  0/2040 (0.00%) 
Physical examination topics  1  2/2071 (0.10%)  0/2040 (0.00%) 
Renal and urinary tract investigations and urinalyses  1  1/2071 (0.05%)  0/2040 (0.00%) 
Metabolism and nutrition disorders     
Acid-base disorders  1  3/2071 (0.14%)  3/2040 (0.15%) 
Electrolyte and fluid balance conditions  1  2/2071 (0.10%)  4/2040 (0.20%) 
Glucose metabolism disorders (incl diabetes mellitus)  1  6/2071 (0.29%)  5/2040 (0.25%) 
Lipid metabolism disorders  1  2/2071 (0.10%)  0/2040 (0.00%) 
Diabetic complications  1  1/2071 (0.05%)  0/2040 (0.00%) 
Musculoskeletal and connective tissue disorders     
Bone disorders (excl congenital and fractures)  1  3/2071 (0.14%)  5/2040 (0.25%) 
Connective tissue disorders (excl congenital)  1  1/2071 (0.05%)  0/2040 (0.00%) 
Fractures  1  3/2071 (0.14%)  0/2040 (0.00%) 
Joint disorders  1  4/2071 (0.19%)  4/2040 (0.20%) 
Muscle disorders  1  1/2071 (0.05%)  4/2040 (0.20%) 
Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)  1  2/2071 (0.10%)  5/2040 (0.25%) 
Musculoskeletal and connective tissue disorders NEC  1  2/2071 (0.10%)  6/2040 (0.29%) 
Synovial and bursal disorders  1  0/2071 (0.00%)  1/2040 (0.05%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast neoplasms malignant and unspecified (incl nipple)  1  1/2071 (0.05%)  5/2040 (0.25%) 
Endocrine neoplasms benign  1  1/2071 (0.05%)  1/2040 (0.05%) 
Endocrine neoplasms malignant and unspecified  1  1/2071 (0.05%)  3/2040 (0.15%) 
Gastrointestinal neoplasms benign  1  1/2071 (0.05%)  0/2040 (0.00%) 
Gastrointestinal neoplasms malignant and unspecified  1  20/2071 (0.97%)  8/2040 (0.39%) 
Haematopoietic neoplasms (excl leukaemias and lymphomas)  1  2/2071 (0.10%)  1/2040 (0.05%) 
Hepatic and biliary neoplasms benign  1  1/2071 (0.05%)  0/2040 (0.00%) 
Hepatobiliary neoplasms malignant and unspecified  1  1/2071 (0.05%)  3/2040 (0.15%) 
Leukaemias  1  1/2071 (0.05%)  1/2040 (0.05%) 
Metastases  1  1/2071 (0.05%)  1/2040 (0.05%) 
Miscellaneous and site unspecified neoplasms benign  1  1/2071 (0.05%)  0/2040 (0.00%) 
Miscellaneous and site unspecified neoplasms malignant and unspecified  1  6/2071 (0.29%)  9/2040 (0.44%) 
Renal and urinary tract neoplasms malignant and unspecified  1  0/2071 (0.00%)  2/2040 (0.10%) 
Reproductive neoplasms female benign  1  4/2071 (0.19%)  5/2040 (0.25%) 
Reproductive neoplasms female malignant and unspecified  1  3/2071 (0.14%)  1/2040 (0.05%) 
Reproductive neoplasms male malignant and unspecified  1  1/2071 (0.05%)  4/2040 (0.20%) 
Respiratory and mediastinal neoplasms malignant and unspecified  1  8/2071 (0.39%)  8/2040 (0.39%) 
Skin neoplasms malignant and unspecified  1  9/2071 (0.43%)  4/2040 (0.20%) 
Soft tissue neoplasms benign  1  1/2071 (0.05%)  1/2040 (0.05%) 
Soft tissue sarcomas  1  0/2071 (0.00%)  1/2040 (0.05%) 
Nervous system disorders     
Central nervous system infections and inflammations  1  1/2071 (0.05%)  0/2040 (0.00%) 
Central nervous system vascular disorders  1  16/2071 (0.77%)  11/2040 (0.54%) 
Cranial nerve disorders (excl neoplasms)  1  2/2071 (0.10%)  0/2040 (0.00%) 
Demyelinating disorders  1  1/2071 (0.05%)  0/2040 (0.00%) 
Encephalopathies  1  1/2071 (0.05%)  2/2040 (0.10%) 
Headaches  1  5/2071 (0.24%)  6/2040 (0.29%) 
Increased intracranial pressure and hydrocephalus  1  1/2071 (0.05%)  0/2040 (0.00%) 
Movement disorders (incl parkinsonism)  1  3/2071 (0.14%)  0/2040 (0.00%) 
Neurological disorders NEC  1  9/2071 (0.43%)  12/2040 (0.59%) 
Neuromuscular disorders  1  2/2071 (0.10%)  0/2040 (0.00%) 
Peripheral neuropathies  1  2/2071 (0.10%)  4/2040 (0.20%) 
Seizures (incl subtypes)  1  8/2071 (0.39%)  4/2040 (0.20%) 
Spinal cord and nerve root disorders  1  1/2071 (0.05%)  0/2040 (0.00%) 
Structural brain disorders  1  1/2071 (0.05%)  1/2040 (0.05%) 
Pregnancy, puerperium and perinatal conditions     
Abortions and stillbirth  1  3/2071 (0.14%)  1/2040 (0.05%) 
Foetal complications  1  0/2071 (0.00%)  1/2040 (0.05%) 
Maternal complications of pregnancy  1  1/2071 (0.05%)  1/2040 (0.05%) 
Postpartum and puerperal disorders  1  1/2071 (0.05%)  0/2040 (0.00%) 
Psychiatric disorders     
Anxiety disorders and symptoms  1  4/2071 (0.19%)  1/2040 (0.05%) 
Deliria (incl confusion)  1  0/2071 (0.00%)  1/2040 (0.05%) 
Depressed mood disorders and disturbances  1  13/2071 (0.63%)  9/2040 (0.44%) 
Disturbances in thinking and perception  1  1/2071 (0.05%)  0/2040 (0.00%) 
Eating disorders and disturbances  1  0/2071 (0.00%)  1/2040 (0.05%) 
Impulse control disorders NEC  1  0/2071 (0.00%)  1/2040 (0.05%) 
Manic and bipolar mood disorders and disturbances  1  2/2071 (0.10%)  0/2040 (0.00%) 
Mood disorders and disturbances NEC  1  1/2071 (0.05%)  1/2040 (0.05%) 
Personality disorders and disturbances in behaviour  1  0/2071 (0.00%)  1/2040 (0.05%) 
Psychiatric disorders NEC  1  3/2071 (0.14%)  5/2040 (0.25%) 
Schizophrenia and other psychotic disorders  1  4/2071 (0.19%)  3/2040 (0.15%) 
Suicidal and self-injurious behaviours NEC  1  18/2071 (0.87%)  10/2040 (0.49%) 
Renal and urinary disorders     
Bladder and bladder neck disorders (excl calculi)  1  1/2071 (0.05%)  0/2040 (0.00%) 
Nephropathies  1  1/2071 (0.05%)  1/2040 (0.05%) 
Renal disorders (excl nephropathies)  1  9/2071 (0.43%)  10/2040 (0.49%) 
Urethral disorders (excl calculi)  1  1/2071 (0.05%)  0/2040 (0.00%) 
Urinary tract signs and symptoms  1  6/2071 (0.29%)  4/2040 (0.20%) 
Urolithiases  1  3/2071 (0.14%)  5/2040 (0.25%) 
Reproductive system and breast disorders     
Breast disorders  1  0/2071 (0.00%)  1/2040 (0.05%) 
Cervix disorders (excl infections and inflammations)  1  2/2071 (0.10%)  3/2040 (0.15%) 
Menstrual cycle and uterine bleeding disorders  1  1/2071 (0.05%)  1/2040 (0.05%) 
Ovarian and fallopian tube disorders  1  1/2071 (0.05%)  0/2040 (0.00%) 
Prostatic disorders (excl infections and inflammations)  1  1/2071 (0.05%)  0/2040 (0.00%) 
Testicular and epididymal disorders  1  1/2071 (0.05%)  1/2040 (0.05%) 
Uterine, pelvic and broad ligament disorders  1  3/2071 (0.14%)  1/2040 (0.05%) 
Respiratory, thoracic and mediastinal disorders     
Bronchial disorders (excl neoplasms)  1  9/2071 (0.43%)  7/2040 (0.34%) 
Lower respiratory tract disorders (excl obstruction and infection)  1  0/2071 (0.00%)  4/2040 (0.20%) 
Pleural disorders  1  3/2071 (0.14%)  3/2040 (0.15%) 
Pulmonary vascular disorders  1  6/2071 (0.29%)  5/2040 (0.25%) 
Respiratory disorders NEC  1  8/2071 (0.39%)  6/2040 (0.29%) 
Skin and subcutaneous tissue disorders     
Angioedema and urticaria  1  1/2071 (0.05%)  0/2040 (0.00%) 
Epidermal and dermal conditions  1  6/2071 (0.29%)  3/2040 (0.15%) 
Skin and subcutaneous tissue disorders NEC  1  1/2071 (0.05%)  0/2040 (0.00%) 
Skin appendage conditions  1  0/2071 (0.00%)  1/2040 (0.05%) 
Social circumstances     
Skin vascular abnormalities  1  0/2071 (0.00%)  1/2040 (0.05%) 
Legal issues  1  0/2071 (0.00%)  1/2040 (0.05%) 
Surgical and medical procedures     
Hepatobiliary therapeutic procedures  1  0/2071 (0.00%)  1/2040 (0.05%) 
Obstetric and gynaecological therapeutic procedures  1  0/2071 (0.00%)  2/2040 (0.10%) 
Vascular disorders     
Aneurysms and artery dissections  1  1/2071 (0.05%)  1/2040 (0.05%) 
Arteriosclerosis, stenosis, vascular insufficiency and necrosis  1  6/2071 (0.29%)  2/2040 (0.10%) 
Decreased and nonspecific blood pressure disorders and shock  1  5/2071 (0.24%)  0/2040 (0.00%) 
Embolism and thrombosis  1  9/2071 (0.43%)  3/2040 (0.15%) 
Vascular disorders NEC  1  2/2071 (0.10%)  0/2040 (0.00%) 
Vascular haemorrhagic disorders  1  1/2071 (0.05%)  1/2040 (0.05%) 
Vascular hypertensive disorders  1  6/2071 (0.29%)  3/2040 (0.15%) 
Venous varices  1  0/2071 (0.00%)  1/2040 (0.05%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.5%
rIL-2 No rIL-2
Affected / at Risk (%) Affected / at Risk (%)
Total   133/2071 (6.42%)   92/2040 (4.51%) 
Blood and lymphatic system disorders     
Anaemia  1  9/2071 (0.43%)  10/2040 (0.49%) 
Cardiac disorders     
Acute myocardial infarction  1  16/2071 (0.77%)  15/2040 (0.74%) 
Coronary artery disease  1  12/2071 (0.58%)  9/2040 (0.44%) 
Myocardial infarction  1  14/2071 (0.68%)  18/2040 (0.88%) 
Gastrointestinal disorders     
Diarrhoea  1  16/2071 (0.77%)  10/2040 (0.49%) 
Vomiting  1  13/2071 (0.63%)  3/2040 (0.15%) 
General disorders     
Pyrexia  1  18/2071 (0.87%)  9/2040 (0.44%) 
Infections and infestations     
Appendicitis  1  10/2071 (0.48%)  8/2040 (0.39%) 
Nervous system disorders     
Cerebrovascular accident  1  12/2071 (0.58%)  4/2040 (0.20%) 
Psychiatric disorders     
Depression  1  14/2071 (0.68%)  7/2040 (0.34%) 
Suicide attempt  1  11/2071 (0.53%)  10/2040 (0.49%) 
Vascular disorders     
Deep vein thrombosis  1  10/2071 (0.48%)  2/2040 (0.10%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: James Neaton, PhD
Organization: Division of Biostatistics, University of Minnesota
Phone: 612-626-9040
EMail: jim@ccbr.umn.edu
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00004978    
Obsolete Identifiers: NCT00004737
Other Study ID Numbers: ESPRIT 001
5U01AI046957 ( U.S. NIH Grant/Contract )
00 I-0071
3U01AI046957-05S2 ( U.S. NIH Grant/Contract )
3U01AI046957-05S3 ( U.S. NIH Grant/Contract )
10118 ( Registry Identifier: DAIDS ES Registry Number )
First Submitted: March 10, 2000
First Posted: August 31, 2001
Results First Submitted: January 20, 2011
Results First Posted: April 25, 2011
Last Update Posted: May 6, 2013