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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00004978
Registration number
NCT00004978
Ethics application status
Date submitted
10/03/2000
Date registered
31/08/2001
Date last updated
5/11/2021
Titles & IDs
Public title
An International Study to Evaluate Recombinant Interleukin-2 in HIV Positive Patients Taking Anti-retroviral Therapy
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Scientific title
A Randomized, Open-Label, Phase III, International Study of Subcutaneous Recombinant IL-2 in Patients With HIV-1 Infection and CD4+ Cell Counts 300/mm^3 or Greater: Evaluation of Subcutaneous Proleukin in a Randomized International Trial
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Secondary ID [1]
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0
5U01AI046957
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Secondary ID [2]
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ESPRIT 001
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Universal Trial Number (UTN)
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Trial acronym
ESPRIT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV Infections
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0
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Condition category
Condition code
Infection
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0
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Studies of infection and infectious agents
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Infection
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0
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Recombinant interleukin-2 (rIL-2)
Experimental: rIL-2 - Recombinant interleukin-2 (rIL-2) therapy used with combination anti-HIV medication of choice.
No intervention: No rIL-2 - Control arm uses anti-HIV medication of choice without rIL-2.
Treatment: Drugs: Recombinant interleukin-2 (rIL-2)
Recombinant interleukin-2 at a dose of 7.5 MIU given twice daily subcutaneously for 5 consecutive days every 8 weeks for at least 3 cycles.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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New or Recurrent HIV Disease Progression Event Including Death
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Assessment method [1]
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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
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Timepoint [1]
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from randomization through study end - median of 7.6 years follow-up
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Secondary outcome [1]
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New or Recurrent Serious HIV Disease Progression Event Including Death
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Assessment method [1]
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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.
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Timepoint [1]
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0
from randomization through study end - median of 7.6 years follow-up
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Secondary outcome [2]
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Number of Participants Who Died From Any Cause
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Assessment method [2]
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0
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Timepoint [2]
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from randomization through study end - median of 7.6 years follow-up
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Secondary outcome [3]
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Participants With a New Disease Progression Event or Death
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Assessment method [3]
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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
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Timepoint [3]
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from randomization through 15 November 2008 - median of 7.6 years follow-up
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Secondary outcome [4]
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Absolute CD4 Cell Counts Averaged Throughout Followup
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Assessment method [4]
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Average of all available CD4+ cell counts measured at follow-up visits
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Timepoint [4]
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0
from randomization through study end - median of 7.6 years follow-up
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Secondary outcome [5]
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Plasma HIV RNA Levels
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Assessment method [5]
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log10 HIV-RNA averaged throughout follow-up
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Timepoint [5]
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From randomization through study end - median of 7.6 years follow-up
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Secondary outcome [6]
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Number of Participants With Changes in Anti-retroviral Treatment (ART)
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Assessment method [6]
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Number of participants who changed ART at least once during the study period.
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Timepoint [6]
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From randomization through study end - median of 7.6 years follow-up
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Secondary outcome [7]
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Grade 4 Signs and Symptoms
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Assessment method [7]
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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.
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Timepoint [7]
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From randomization through study end - median of 7.6 years follow-up
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Secondary outcome [8]
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Pattern of Use of Prophylaxis for Opportunistic Infections
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Assessment method [8]
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Number of participants using pneumocystis pneumonia (PCP) prophylaxis at the last attended followup visit.
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Timepoint [8]
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last followup visit - median of 7.6 years follow-up
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Secondary outcome [9]
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Hepatic, Metabolic, and Cardiac Conditions
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Assessment method [9]
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Number of participants experiencing a "serious non-AIDS" event defined as first serious cardiovascular, renal, or hepatic event, or non-AIDS malignancy.
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Timepoint [9]
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From randomization through study end - median of 7.6 years follow-up
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Eligibility
Key inclusion criteria
* HIV positive
* Have a CD4 cell count of 300 cells/mm3 or more within 45 days of study entry
* Are on combination anti-HIV therapy or are beginning anti-HIV therapy at the time of study entry
* Are at least 18 years old
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Have received IL-2 before
* Have cancer requiring chemotherapy
* Have evidence of active clinical disease within the past year for any AIDS-defining illness or certain other conditions such as herpes zoster or Chagas disease. (This study has been changed. Previously, patients were ineligible if they had a history of any AIDS-defining illness or certain other conditions.)
* Have used certain medications, such as corticosteroids or drugs affecting the immune system, in the 45 days before study entry
* Have a nervous system disorder requiring antiseizure medication
* Have an autoimmune or inflammatory disease such as inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), psoriasis, optic neuritis, or any autoimmune/inflammatory diseases with potentially life-threatening complications
* Are pregnant or breastfeeding
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2000
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2008
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Sample size
Target
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Accrual to date
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Final
4150
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Interchange General Practice CRS - Canberra
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Recruitment hospital [2]
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Canberra Hosp., Canberra Sexual Health Clinic CRS - Woden
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Recruitment hospital [3]
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Burwood Road Gen. Practice CRS - Burwood
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Recruitment hospital [4]
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St. Vincent's Hospital CRS - Darlinghurst
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Recruitment hospital [5]
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Taylor Square Private Clinic CRS - Darlinghurst
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Recruitment hospital [6]
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Holdsworth House Gen. Practice CRS - Darlinghurst
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Recruitment hospital [7]
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John Hunter Hosp., Immunology & Infectious Diseases Unit CRS - Newcastle
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Recruitment hospital [8]
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407 Doctors CRS - Surry Hills
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Albion Street Ctr. CRS - Surry Hills
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Recruitment hospital [10]
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Queensland Health - AIDS Med. Unit CRS - Brisbane
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Recruitment hospital [11]
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Cairns Base Hosp., Sexual Health Services CRS - Cairns
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Gladstone Road Medical Ctr. CRS - Highgate Hill
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Nambour Gen. Hosp. CRS - Nambour
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Royal Adelaide Hosp. CRS - Adelaide
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The Care & Prevention Programme CRS - Adelaide
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Recruitment hospital [16]
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Carlton Clinic CRS - Carlton
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The Alfred Hosp., Clinical Research - Infectious Diseases Unit CRS - Melbourne
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Recruitment hospital [18]
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Prahran Market Clinic CRS - Melbourne
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Recruitment hospital [19]
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Northcote Clinic CRS - Northcote
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Recruitment hospital [20]
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Royal Melbourne Hosp., Victorian Infectious Diseases Service CRS - Parkville
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Recruitment hospital [21]
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The Ctr. Clinic INSIGHT CRS - St. Kilda
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Recruitment hospital [22]
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Royal Perth Hospital CRS - Perth
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Recruitment hospital [23]
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Gold Coast Sexual Health Clinic CRS - Miami, Queensland
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Recruitment postcode(s) [1]
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2601 - Canberra
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Recruitment postcode(s) [2]
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2606 - Woden
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Recruitment postcode(s) [3]
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2134 - Burwood
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Recruitment postcode(s) [4]
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2010 - Darlinghurst
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Recruitment postcode(s) [5]
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- Darlinghurst
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Recruitment postcode(s) [6]
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2305 - Newcastle
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Recruitment postcode(s) [7]
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2010 - Surry Hills
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Recruitment postcode(s) [8]
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- Surry Hills
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Recruitment postcode(s) [9]
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- Brisbane
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Recruitment postcode(s) [10]
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4870 - Cairns
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Recruitment postcode(s) [11]
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4101 - Highgate Hill
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Recruitment postcode(s) [12]
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4560 - Nambour
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Recruitment postcode(s) [13]
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5000 - Adelaide
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Recruitment postcode(s) [14]
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- Carlton
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Recruitment postcode(s) [15]
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3004 - Melbourne
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Recruitment postcode(s) [16]
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- Melbourne
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Recruitment postcode(s) [17]
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3070 - Northcote
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Recruitment postcode(s) [18]
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3052 - Parkville
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Recruitment postcode(s) [19]
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- St. Kilda
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Recruitment postcode(s) [20]
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- Perth
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Recruitment postcode(s) [21]
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- Miami, Queensland
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Recruitment outside Australia
Country [1]
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United States of America
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California
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United States of America
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Colorado
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District of Columbia
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Florida
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Georgia
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Illinois
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Louisiana
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Maryland
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Michigan
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Minnesota
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New Jersey
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New York
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Oregon
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Pennsylvania
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Texas
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Virginia
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Argentina
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La Plata
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Argentina
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Mendoza
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Ontario
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Aalborg
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Aarhus
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Odense
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Pringy
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Angers
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France
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Besancon
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Clamart
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Colombes
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Garches
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Montpellier
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Nice
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Koln
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Israel
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Haifa
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Israel
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Rehovot
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Israel
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Italy
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Brescia
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Italy
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Firenze
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Italy
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Italy
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Modena
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Italy
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Pavia
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Italy
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Roma
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Japan
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Osaka
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Tokyo
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Cascais
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Lisboa
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Singapore
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Guipuzcoa
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A Coruna
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Murcia
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Ticino
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Thailand
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Ratchathewi
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Thailand
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Chiangrai
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Thailand
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Chonburi
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Khon Kaen
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Brighton
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Northern Ireland
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Oxford
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Scotland
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Birmingham
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Exeter
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Leicester
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London
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Newcastle Upon Tyne
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Peterborough
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Sheffield
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Funding & Sponsors
Primary sponsor type
Government body
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Name
National Institute of Allergy and Infectious Diseases (NIAID)
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Chiron Corporation
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Summary
Brief summary
The purpose of this study is to see if it is effective to give HIV positive patients recombinant interleukin-2 (rIL-2) in addition to anti-HIV therapy. Patients will be followed over a minimum of 4 years to study the long-term effects of rIL-2 on their HIV disease progression. Anti-HIV therapy has been very successful in treating HIV positive patients and in keeping viral load (level of HIV in the blood) low. However, anti-HIV drugs cannot completely rid the body of the virus, and the immune system is never completely restored in HIV positive patients. Doctors hope that giving patients recombinant interleukin-2 (rIL-2) in addition to their anti-HIV therapy will help improve their immune systems and keep them healthier over a longer period of time. rIL-2 is a hormone naturally produced by the body during an immune response to a microbial infection.
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Trial website
https://clinicaltrials.gov/study/NCT00004978
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Trial related presentations / publications
Chun TW, Engel D, Mizell SB, Hallahan CW, Fischette M, Park S, Davey RT Jr, Dybul M, Kovacs JA, Metcalf JA, Mican JM, Berrey MM, Corey L, Lane HC, Fauci AS. Effect of interleukin-2 on the pool of latently infected, resting CD4+ T cells in HIV-1-infected patients receiving highly active anti-retroviral therapy. Nat Med. 1999 Jun;5(6):651-5. doi: 10.1038/9498. Connors M, Kovacs JA, Krevat S, Gea-Banacloche JC, Sneller MC, Flanigan M, Metcalf JA, Walker RE, Falloon J, Baseler M, Feuerstein I, Masur H, Lane HC. HIV infection induces changes in CD4+ T-cell phenotype and depletions within the CD4+ T-cell repertoire that are not immediately restored by antiviral or immune-based therapies. Nat Med. 1997 May;3(5):533-40. doi: 10.1038/nm0597-533. Emery S, Abrams DI, Cooper DA, Darbyshire JH, Lane HC, Lundgren JD, Neaton JD; ESPRIT Study Group. The evaluation of subcutaneous proleukin (interleukin-2) in a randomized international trial: rationale, design, and methods of ESPRIT. Control Clin Trials. 2002 Apr;23(2):198-220. doi: 10.1016/s0197-2456(01)00179-9. Arduino RC, Nannini EC, Rodriguez-Barradas M, Schrader S, Losso M, Ruxrungtham K, Allende MC, Emery S, Fosdick L, Neaton J, Tavel JA, Davey RT, Lane HC; Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT) Vanguard Group; ESPRIT Executive Committee. CD4 cell response to 3 doses of subcutaneous interleukin 2: meta-analysis of 3 Vanguard studies. Clin Infect Dis. 2004 Jul 1;39(1):115-22. doi: 10.1086/421775. Epub 2004 Jun 14. INSIGHT-ESPRIT Study Group; SILCAAT Scientific Committee; Abrams D, Levy Y, Losso MH, Babiker A, Collins G, Cooper DA, Darbyshire J, Emery S, Fox L, Gordin F, Lane HC, Lundgren JD, Mitsuyasu R, Neaton JD, Phillips A, Routy JP, Tambussi G, Wentworth D. Interleukin-2 therapy in patients with HIV infection. N Engl J Med. 2009 Oct 15;361(16):1548-59. doi: 10.1056/NEJMoa0903175. Larson GS, Carey C, Grarup J, Hudson F, Sachi K, Vjecha MJ, Gordin F; INSIGHT Group. Lessons learned: Infrastructure development and financial management for large, publicly funded, international trials. Clin Trials. 2016 Apr;13(2):127-36. doi: 10.1177/1740774515625974. Epub 2016 Feb 8. Nordell AD, McKenna M, Borges AH, Duprez D, Neuhaus J, Neaton JD; INSIGHT SMART, ESPRIT Study Groups; SILCAAT Scientific Committee. Severity of cardiovascular disease outcomes among patients with HIV is related to markers of inflammation and coagulation. J Am Heart Assoc. 2014 May 28;3(3):e000844. doi: 10.1161/JAHA.114.000844. Mocroft A, Neuhaus J, Peters L, Ryom L, Bickel M, Grint D, Koirala J, Szymczak A, Lundgren J, Ross MJ, Wyatt CM; INSIGHT SMART Study Group; ESPRIT Study Group. Hepatitis B and C co-infection are independent predictors of progressive kidney disease in HIV-positive, antiretroviral-treated adults. PLoS One. 2012;7(7):e40245. doi: 10.1371/journal.pone.0040245. Epub 2012 Jul 20. Pett SL, Carey C, Lin E, Wentworth D, Lazovski J, Miro JM, Gordin F, Angus B, Rodriguez-Barradas M, Rubio R, Tambussi G, Cooper DA, Emery S; INSIGHT-ESPRIT Study Group. Predictors of bacterial pneumonia in Evaluation of Subcutaneous Interleukin-2 in a Randomized International Trial (ESPRIT). HIV Med. 2011 Apr;12(4):219-27. doi: 10.1111/j.1468-1293.2010.00875.x. Epub 2010 Aug 31.
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Public notes
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Contacts
Principal investigator
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Donald Abrams, MD
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University of California, San Francisco
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Arduino RC, Nannini EC, Rodriguez-Barradas M, Schr...
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Journal
INSIGHT-ESPRIT Study Group; SILCAAT Scientific Com...
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Results are available at
https://clinicaltrials.gov/study/NCT00004978
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