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Interleukin-2 Plus Antiretroviral Therapy for HIV-Infected Patients With Low CD4+ Counts (SILCAAT Study) (SILCAAT)

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: NCT00013611
Recruitment Status : Completed
First Posted : March 26, 2001
Results First Posted : December 13, 2010
Last Update Posted : August 8, 2011
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
University of Minnesota

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infection
Intervention Drug: Proleukin
Enrollment 1695
Recruitment Details 1971 participants were randomized at 139 sites in 11 countries. The first randomization was on 30 April 1999 and the last randomization was on 28 September 2002. Sites who re-consented 2/3 or more of their participants to Version 3 of the protocol were included in the analysis cohort. There are 1695 participants in the analysis cohort.
Pre-assignment Details  
Arm/Group Title Proleukin Plus Antiretroviral Therapy Antiretroviral Therapy Only
Hide Arm/Group Description Patients receive an initial dose of 4.5 MIU of proleukin twice daily for 5 consecutive days every 8 weeks during the first year (6 cycles total). After the first year, additional cycles are given to either achieve or maintain the patient's CD4+ count goal. CD4+ goal is defined as an increase of 125 cells/cubic mm for participants in the 50-199 CD4+ count stratum, and an increase of 175 cells/cubic mm for participants in the 200-299 CD4+ stratum. In addition, all patients must be prescribed combination antiretroviral drug treatment. The choice of combination therapy is left to the discretion of the treating clinician. Investigators will use their national guidelines for determining when antiretroviral therapy should be changed and for when determining when therapy should be used. All patients must take antiretroviral therapy during each 5-consecutive-day treatment cycle. All patients must be prescribed combination antiretroviral drug treatment. The choice of combination therapy is left to the discretion of the treating clinician. Investigators will use their national guidelines for determining when antiretroviral therapy should be changed and for when determining when therapy should be used.
Period Title: Overall Study
Started 849 [1] 846 [1]
Completed 758 746
Not Completed 91 100
Reason Not Completed
Lost to Follow-up             91             100
[1]
138 were excluded from sites that did not re-consent 2/3 of patients to the amended protocol in 2003
Arm/Group Title Proleukin Plus Antiretroviral Therapy Antiretroviral Therapy Only Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 849 846 1695
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 849 participants 846 participants 1695 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
841
  99.1%
838
  99.1%
1679
  99.1%
>=65 years
8
   0.9%
8
   0.9%
16
   0.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 849 participants 846 participants 1695 participants
41.8  (8.7) 42.0  (8.8) 41.9  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 849 participants 846 participants 1695 participants
Female
137
  16.1%
143
  16.9%
280
  16.5%
Male
712
  83.9%
703
  83.1%
1415
  83.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 849 participants 846 participants 1695 participants
Belgium 16 13 29
Germany 50 46 96
Spain 139 131 270
France 47 50 97
Italy 131 142 273
Netherlands 11 12 23
Argentina 85 85 170
Australia 62 64 126
United States 203 203 406
Canada 68 62 130
Brazil 37 38 75
1.Primary Outcome
Title New or Recurrent Disease Progression Events, as Defined, or Death.
Hide Description

Number of participants with fatal or non-fatal AIDS-related opportunistic disease or death from any cause.

AIDS-related opportunistic disease includes CDC Category C 1993 definition plus the following diseases: Aspergillosis, invasive; Bartonellosis; Chagas disease of the CNS; Herpes zoster, multidermal; Leishmaniasis, visceral; Lymphoma, Hodgkin's; Microsporidiosis (> 1 month's duration); Nocardiosis; Penicillium marneffti, disseminated; Pneumocystis carinii, extrapulmonary; Rhodococcus equi disease.

Time Frame From randomization to date last known to be alive or November 15, 2008, whichever is earlier
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proleukin Plus Antiretroviral Therapy Antiretroviral Therapy Only
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 849 846
Measure Type: Number
Unit of Measure: Participants
110 119
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Proleukin Plus Antiretroviral Therapy, Antiretroviral Therapy Only
Comments Null hypothesis was that event rates in two groups are equal. Study was designed with 80%, two-sided alpha=.05, assuming a 28% reduction in the hazard of opportunistic disease or death.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments [Not Specified]
Method Regression, Cox
Comments Stratification by CD4+ count stratum (50-199 or 200-299) and country of randomization.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.70 to 1.18
Estimation Comments [Not Specified]
2.Secondary Outcome
Title All-cause Mortality
Hide Description Number of participants who died.
Time Frame From randomization to date last known to be alive or November 15, 2008, whichever is earlier
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proleukin Plus Antiretroviral Therapy Antiretroviral Therapy Only
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 849 846
Measure Type: Number
Unit of Measure: Participants
81 77
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Proleukin Plus Antiretroviral Therapy, Antiretroviral Therapy Only
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method Regression, Cox
Comments Stratification by CD4+ stratum and country of randomization.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.77 to 1.44
Estimation Comments [Not Specified]
3.Secondary Outcome
Title New or Recurrent Disease Progression Events
Hide Description

Number of participants with fatal or non-fatal AIDS-related opportunistic disease.

AIDS-related opportunistic disease includes CDC Category C 1993 definition plus the following diseases: Aspergillosis, invasive; Bartonellosis; Chagas disease of the CNS; Herpes zoster, multidermal; Leishmaniasis, visceral; Lymphoma, Hodgkin's; Microsporidiosis (> 1 month's duration); Nocardiosis; Penicillium marneffti, disseminated; Pneumocystis carinii, extrapulmonary; Rhodococcus equi disease.

Time Frame From randomization to date last known to be alive or November 15, 2008, whichever is earlier
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proleukin Plus Antiretroviral Therapy Antiretroviral Therapy Only
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 849 846
Measure Type: Number
Unit of Measure: Participants
49 66
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Proleukin Plus Antiretroviral Therapy, Antiretroviral Therapy Only
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Regression, Cox
Comments Stratification by CD4+ stratum and country of randomization.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.51 to 1.06
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Grade 4 Clinical Events
Hide Description Grade 4 clinical events were defined as potentially life-threatening events (excluding opportunistic disease) requiring medical intervention.
Time Frame From randomization to date last known to be alive or November 15, 2008, whichever is earlier
Hide Outcome Measure Data
Hide Analysis Population Description
The outcome is the number of participants experiencing at least one grade 4 event.
Arm/Group Title Proleukin Plus Antiretroviral Therapy Antiretroviral Therapy Only
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 849 846
Measure Type: Number
Unit of Measure: Participants
203 186
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Proleukin Plus Antiretroviral Therapy, Antiretroviral Therapy Only
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.90 to 1.34
Estimation Comments [Not Specified]
5.Secondary Outcome
Title CD4+ Cell Count
Hide Description Mean CD4+ cell count (cells per cubic mm) averaged over follow-up
Time Frame Every 4 months from randomization through date last known to be alive or November 15, 2008, whichever was earliest .
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proleukin Plus Antiretroviral Therapy Antiretroviral Therapy Only
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 849 846
Mean (Standard Error)
Unit of Measure: cells per cubic mm
345.1  (5.1) 292.1  (4.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Proleukin Plus Antiretroviral Therapy, Antiretroviral Therapy Only
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 53.0
Confidence Interval (2-Sided) 95%
40.3 to 65.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.5
Estimation Comments [Not Specified]
6.Secondary Outcome
Title New or Recurrent Serious Disease Progression Events or Death
Hide Description

Number of participants with fatal or non-fatal serious AIDS-related opportunistic disease.

A serious disease progression event is one of the following: progressive multifocal leukoencephalopathy (PML), lymphoma, Kaposi's sarcoma (visceral), AIDS dementia complex (ADC) stage II or higher, toxoplasmosis, histoplasmosis (systemic), cryptococcosis (systemic), disseminated Mycobacterium avium complex (MAC) disease, wasting syndrome, and cytomegalovirus (CMV) disease.

Time Frame From randomization to date last known to be alive or November 15, 2008, whichever is earlier
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proleukin Plus Antiretroviral Therapy Antiretroviral Therapy Only
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 849 846
Measure Type: Number
Unit of Measure: Participants
19 28
Time Frame From randomization to date last known to be alive or November 15, 2008, whichever is earlier
Adverse Event Reporting Description

Adverse events are defined as Grade 4 events not due to progression of HIV disease.

Serious and/or other [non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.

 
Arm/Group Title Proleukin Plus Antiretroviral Therapy Antiretroviral Therapy Only
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Proleukin Plus Antiretroviral Therapy Antiretroviral Therapy Only
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Proleukin Plus Antiretroviral Therapy Antiretroviral Therapy Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   203/849 (23.91%)      186/846 (21.99%)    
Blood and lymphatic system disorders     
Aneamias nonhaemolytic and marrow depression  3/849 (0.35%)  5 6/846 (0.71%)  6
Haemolyses and related conditions  1/849 (0.12%)  1 0/846 (0.00%)  0
Platelet disorders  2/849 (0.24%)  2 0/846 (0.00%)  0
Spleen, lymphatic and reticuloendothelial system disorders  1/849 (0.12%)  1 0/846 (0.00%)  0
White blood cell disorders  0/849 (0.00%)  0 1/846 (0.12%)  1
Cardiac disorders     
Cardiac arrythmias  4/849 (0.47%)  5 4/846 (0.47%)  5
Cardiac disorder signs and symptoms  0/849 (0.00%)  0 1/846 (0.12%)  1
Cornoary artery disorders  20/849 (2.36%)  29 20/846 (2.36%)  24
Heart failures  3/849 (0.35%)  3 6/846 (0.71%)  13
Myocardial disorders  1/849 (0.12%)  1 2/846 (0.24%)  2
Pericardial disorders  2/849 (0.24%)  2 1/846 (0.12%)  1
Cardiac valve disorders  2/849 (0.24%)  2 1/846 (0.12%)  2
Congenital, familial and genetic disorders     
Renal and urinary tract disoerders congenital  1/849 (0.12%)  1 0/846 (0.00%)  0
Endocrine disorders     
Endocrine disorders of gonadal function  0/849 (0.00%)  0 1/846 (0.12%)  1
Thyroid gland disorders  0/849 (0.00%)  0 2/846 (0.24%)  3
Eye disorders     
Ocular neuromuscular disorders  0/849 (0.00%)  0 1/846 (0.12%)  1
Gastrointestinal disorders     
Abdominal hernias and other adominal wall conditions  5/849 (0.59%)  5 0/846 (0.00%)  0
Diverticular disorders  1/849 (0.12%)  1 2/846 (0.24%)  2
Exocrine pancreas conditions  6/849 (0.71%)  13 6/846 (0.71%)  7
Gastrointestinal condictions NEC  2/849 (0.24%)  2 1/846 (0.12%)  1
Gastrointestinal haemorrhages NEC  13/849 (1.53%)  15 5/846 (0.59%)  10
Gastrointestinal inflammatory conditions  4/849 (0.47%)  4 3/846 (0.35%)  5
Gastrointestinal motility and defaecation conditions  6/849 (0.71%)  8 5/846 (0.59%)  9
Gastrointestinal stenosis and obstructions  5/849 (0.59%)  9 3/846 (0.35%)  3
Gastrointestinal signs and symptoms  4/849 (0.47%)  4 2/846 (0.24%)  2
Gastrointestinal ulceration and perforation  5/849 (0.59%)  5 3/846 (0.35%)  3
Gastrointestinal vascular conditions  7/849 (0.82%)  9 2/846 (0.24%)  3
Peritoneal and retrooperationael conditions  2/849 (0.24%)  2 4/846 (0.47%)  4
General disorders     
Body temperature conditions  3/849 (0.35%)  4 2/846 (0.24%)  2
General system disorders NEC  6/849 (0.71%)  6 3/846 (0.35%)  4
Fatal outcomes  1/849 (0.12%)  1 0/846 (0.00%)  0
Therapeutic and nontherapeutic effects (excl toxicity)  1/849 (0.12%)  1 0/846 (0.00%)  0
Hepatobiliary disorders     
Bile duct disorders  0/849 (0.00%)  0 2/846 (0.24%)  3
Gallbladder disorders  4/849 (0.47%)  4 7/846 (0.83%)  7
Hepatic and hepatobiliary disorders  20/849 (2.36%)  26 10/846 (1.18%)  14
Immune system disorders     
Allergic conditions  1/849 (0.12%)  1 1/846 (0.12%)  1
Immune disorders NEC  0/849 (0.00%)  0 1/846 (0.12%)  1
Infections and infestations     
Bacterial infectious disorders  14/849 (1.65%)  19 18/846 (2.13%)  20
Fungal infectious disorders  1/849 (0.12%)  1 0/846 (0.00%)  0
Infections - pathogen unspecified  28/849 (3.30%)  31 27/846 (3.19%)  30
Mycobacterial infectious disorders  1/849 (0.12%)  1 0/846 (0.00%)  0
Viral infectious disorders  11/849 (1.30%)  11 11/846 (1.30%)  16
Injury, poisoning and procedural complications     
Bone and joint injuries  6/849 (0.71%)  6 3/846 (0.35%)  3
Injuries NEC  2/849 (0.24%)  3 5/846 (0.59%)  5
Procedural and device related injuries and complications NEC  1/849 (0.12%)  1 5/846 (0.59%)  5
Medications errors  2/849 (0.24%)  2 3/846 (0.35%)  3
Chemical injury and poisoning  1/849 (0.12%)  1 2/846 (0.24%)  2
Investigations     
Gastrointestinal investigations  1/849 (0.12%)  1 0/846 (0.00%)  0
Hepatobiliary investigations  0/849 (0.00%)  0 1/846 (0.12%)  1
Lipid analyses  0/849 (0.00%)  0 1/846 (0.12%)  1
Metabolic, nutritional and blood gas investigations  0/849 (0.00%)  0 1/846 (0.12%)  1
Metabolism and nutrition disorders     
Acid-base disorders  0/849 (0.00%)  0 1/846 (0.12%)  1
Appetite and general nutritional disorders  0/849 (0.00%)  0 2/846 (0.24%)  2
Electrolyte and fluid balance conditions  1/849 (0.12%)  1 1/846 (0.12%)  1
Glucose metabolism disorders (incl diabetes mellitus)  4/849 (0.47%)  9 1/846 (0.12%)  1
Purine and pyrimidine metabolism disorders  1/849 (0.12%)  1 1/846 (0.12%)  1
Musculoskeletal and connective tissue disorders     
Bone disorders (excl congenital and fractuers)  6/849 (0.71%)  7 2/846 (0.24%)  2
Joint disorders  2/849 (0.24%)  2 6/846 (0.71%)  8
Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)  0/849 (0.00%)  0 2/846 (0.24%)  3
Musculoskeletal and connective tissue disorders NEC  1/849 (0.12%)  1 2/846 (0.24%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Endocrine neoplasms malignant and unspecified  2/849 (0.24%)  2 1/846 (0.12%)  2
Gastrointestinal neoplasms malignant and unspecified  7/849 (0.82%)  9 10/846 (1.18%)  11
Hepatic and biliary neoplasms benign  1/849 (0.12%)  1 0/846 (0.00%)  0
Hepatobiliary neoplasms malignant and unspecified  1/849 (0.12%)  1 1/846 (0.12%)  1
Leukaemias  1/849 (0.12%)  1 1/846 (0.12%)  1
Mesotheliomas  0/849 (0.00%)  0 1/846 (0.12%)  1
Metastases  0/849 (0.00%)  0 2/846 (0.24%)  2
Miscellaneuous and site unspecified neoplasms malignant and unspecified  5/849 (0.59%)  5 3/846 (0.35%)  3
Miscellaneous and site unspecified neoplasms benign  0/849 (0.00%)  0 1/846 (0.12%)  1
Nervous system neoplasms malignant and unspecified NEC  1/849 (0.12%)  1 0/846 (0.00%)  0
Renal and urinary tract neoplasms malignant and unspecified  3/849 (0.35%)  4 1/846 (0.12%)  1
Reproductive neoplasms female malignant and unspecified  1/849 (0.12%)  1 1/846 (0.12%)  1
Reproductive neoplasms male malignant and unspecified  5/849 (0.59%)  5 3/846 (0.35%)  3
Respiratory and mediastinal neoplams malignant and unspecified  12/849 (1.41%)  14 11/846 (1.30%)  13
Skin neoplasms malignant and unspecified  7/849 (0.82%)  9 4/846 (0.47%)  5
Oncologic complications and emergencies  1/849 (0.12%)  1 0/846 (0.00%)  0
Nervous system disorders     
Central nervous system vascular disorders  9/849 (1.06%)  9 8/846 (0.95%)  10
Cranial nerve disorders (excl neoplasms)  1/849 (0.12%)  1 3/846 (0.35%)  3
Encephalopathies  2/849 (0.24%)  2 2/846 (0.24%)  2
Headaches  2/849 (0.24%)  2 0/846 (0.00%)  0
Movement disorders (incl parkinsonism)  1/849 (0.12%)  1 0/846 (0.00%)  0
Neurological disorders NEC  0/849 (0.00%)  0 2/846 (0.24%)  2
Neuromuscular disorders  1/849 (0.12%)  1 0/846 (0.00%)  0
Seizures (incl subtypes)  3/849 (0.35%)  4 4/846 (0.47%)  4
Spinal cord and nreve root disorders  1/849 (0.12%)  1 1/846 (0.12%)  1
Structural brain disorders  1/849 (0.12%)  1 0/846 (0.00%)  0
Psychiatric disorders     
Anxiety disorders and symptoms  3/849 (0.35%)  3 0/846 (0.00%)  0
Cognitive and attention disorders and distrubances  1/849 (0.12%)  1 0/846 (0.00%)  0
Deliria (incl confusion)  1/849 (0.12%)  1 1/846 (0.12%)  1
Depressed mood disorders and disturbances  7/849 (0.82%)  8 4/846 (0.47%)  4
Manic and bipolar mood disorders and disturbances  2/849 (0.24%)  2 0/846 (0.00%)  0
Personality disorders and disturbances in behaviour  0/849 (0.00%)  0 1/846 (0.12%)  2
Psychiatric disorders NEC  4/849 (0.47%)  5 0/846 (0.00%)  0
Schizophrenia and other psychotic disorders  2/849 (0.24%)  2 0/846 (0.00%)  0
Suicidal and self-injurious behaviours NEC  10/849 (1.18%)  11 4/846 (0.47%)  4
Renal and urinary disorders     
Nephropathies  1/849 (0.12%)  1 4/846 (0.47%)  4
Renal disorders (excl nephropathies)  5/849 (0.59%)  6 12/846 (1.42%)  13
Urinary tract signs and symptoms  2/849 (0.24%)  3 2/846 (0.24%)  2
Urolithiases  4/849 (0.47%)  6 3/846 (0.35%)  3
Reproductive system and breast disorders     
Breast disorders  0/849 (0.00%)  0 1/846 (0.12%)  1
Cervix disorders (excl infections and inflammations)  0/849 (0.00%)  0 2/846 (0.24%)  2
Male reproductive tract infections and inflammations  1/849 (0.12%)  1 0/846 (0.00%)  0
Prostatic disorders (excl infections and inflammations)  0/849 (0.00%)  0 1/846 (0.12%)  1
Uterine, pelvic and broad ligament disorders  0/849 (0.00%)  0 3/846 (0.35%)  3
Vulvovaginal disorders (excl infections and inflammations)  0/849 (0.00%)  0 1/846 (0.12%)  1
Respiratory, thoracic and mediastinal disorders     
Bronchial disorders (excl neoplasms)  2/849 (0.24%)  2 4/846 (0.47%)  6
Thoracic disorders (excl lung and pleura)  1/849 (0.12%)  1 0/846 (0.00%)  0
Lower respiratory tract disorders (excl obstruction and infection)  3/849 (0.35%)  3 3/846 (0.35%)  3
Pleural disorders  2/849 (0.24%)  3 1/846 (0.12%)  1
Pulmonary vascular disorders  3/849 (0.35%)  3 2/846 (0.24%)  2
Respiratory disorders NEC  4/849 (0.47%)  4 11/846 (1.30%)  12
Upper respiratory tract disorders (excl infections)  0/849 (0.00%)  0 1/846 (0.12%)  1
Skin and subcutaneous tissue disorders     
Epidermal and dermal conditions  3/849 (0.35%)  3 0/846 (0.00%)  0
Skin and subcutaenous tissue disorders NEC  0/849 (0.00%)  0 2/846 (0.24%)  2
Surgical and medical procedures     
Vascular therapeutic procedures  1/849 (0.12%)  1 0/846 (0.00%)  0
Nervous system, skull and spine therapeutic procedures  1/849 (0.12%)  1 0/846 (0.00%)  0
Hepatobiliary therapeutic procedures  1/849 (0.12%)  1 1/846 (0.12%)  1
Vascular disorders     
Aneurysms and artery dissections  2/849 (0.24%)  3 0/846 (0.00%)  0
Arteriosclerosis, stenosis, vascular insufficiency and necrosis  1/849 (0.12%)  1 2/846 (0.24%)  2
Decreased and nonspecific blood pressure disorders and shock  3/849 (0.35%)  3 3/846 (0.35%)  4
Embolism and thrombosis  4/849 (0.47%)  4 0/846 (0.00%)  0
Vascular disorders NEC  1/849 (0.12%)  1 0/846 (0.00%)  0
Vascular haemorrhagic disorders  1/849 (0.12%)  1 0/846 (0.00%)  0
Vascular hypertensive disorders  0/849 (0.00%)  0 2/846 (0.24%)  2
1
Term from vocabulary, MedDRA (12.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Proleukin Plus Antiretroviral Therapy Antiretroviral Therapy Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gary Collins, M.S.
Organization: University of Minnesota
Phone: 612-626-9006
EMail: gary-c@ccbr.umn.edu
Layout table for additonal information
Responsible Party: DAIDS, NIAID
ClinicalTrials.gov Identifier: NCT00013611    
Obsolete Identifiers: NCT00002421
Other Study ID Numbers: 0303M44961
01-I-0126 ( Other Identifier: NIAID )
First Submitted: March 24, 2001
First Posted: March 26, 2001
Results First Submitted: November 8, 2010
Results First Posted: December 13, 2010
Last Update Posted: August 8, 2011