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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
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
Secondary ID [1] 0 0
5U01AI046957
Secondary ID [2] 0 0
ESPRIT 001
Universal Trial Number (UTN)
Trial acronym
ESPRIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
New or Recurrent HIV Disease Progression Event Including Death
Timepoint [1] 0 0
from randomization through study end - median of 7.6 years follow-up
Secondary outcome [1] 0 0
New or Recurrent Serious HIV Disease Progression Event Including Death
Timepoint [1] 0 0
from randomization through study end - median of 7.6 years follow-up
Secondary outcome [2] 0 0
Number of Participants Who Died From Any Cause
Timepoint [2] 0 0
from randomization through study end - median of 7.6 years follow-up
Secondary outcome [3] 0 0
Participants With a New Disease Progression Event or Death
Timepoint [3] 0 0
from randomization through 15 November 2008 - median of 7.6 years follow-up
Secondary outcome [4] 0 0
Absolute CD4 Cell Counts Averaged Throughout Followup
Timepoint [4] 0 0
from randomization through study end - median of 7.6 years follow-up
Secondary outcome [5] 0 0
Plasma HIV RNA Levels
Timepoint [5] 0 0
From randomization through study end - median of 7.6 years follow-up
Secondary outcome [6] 0 0
Number of Participants With Changes in Anti-retroviral Treatment (ART)
Timepoint [6] 0 0
From randomization through study end - median of 7.6 years follow-up
Secondary outcome [7] 0 0
Grade 4 Signs and Symptoms
Timepoint [7] 0 0
From randomization through study end - median of 7.6 years follow-up
Secondary outcome [8] 0 0
Pattern of Use of Prophylaxis for Opportunistic Infections
Timepoint [8] 0 0
last followup visit - median of 7.6 years follow-up
Secondary outcome [9] 0 0
Hepatic, Metabolic, and Cardiac Conditions
Timepoint [9] 0 0
From randomization through study end - median of 7.6 years follow-up

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2008
Sample size
Target
Accrual to date
Final
4150
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Interchange General Practice CRS - Canberra
Recruitment hospital [2] 0 0
Canberra Hosp., Canberra Sexual Health Clinic CRS - Woden
Recruitment hospital [3] 0 0
Burwood Road Gen. Practice CRS - Burwood
Recruitment hospital [4] 0 0
St. Vincent's Hospital CRS - Darlinghurst
Recruitment hospital [5] 0 0
Taylor Square Private Clinic CRS - Darlinghurst
Recruitment hospital [6] 0 0
Holdsworth House Gen. Practice CRS - Darlinghurst
Recruitment hospital [7] 0 0
John Hunter Hosp., Immunology & Infectious Diseases Unit CRS - Newcastle
Recruitment hospital [8] 0 0
407 Doctors CRS - Surry Hills
Recruitment hospital [9] 0 0
Albion Street Ctr. CRS - Surry Hills
Recruitment hospital [10] 0 0
Queensland Health - AIDS Med. Unit CRS - Brisbane
Recruitment hospital [11] 0 0
Cairns Base Hosp., Sexual Health Services CRS - Cairns
Recruitment hospital [12] 0 0
Gladstone Road Medical Ctr. CRS - Highgate Hill
Recruitment hospital [13] 0 0
Nambour Gen. Hosp. CRS - Nambour
Recruitment hospital [14] 0 0
Royal Adelaide Hosp. CRS - Adelaide
Recruitment hospital [15] 0 0
The Care & Prevention Programme CRS - Adelaide
Recruitment hospital [16] 0 0
Carlton Clinic CRS - Carlton
Recruitment hospital [17] 0 0
The Alfred Hosp., Clinical Research - Infectious Diseases Unit CRS - Melbourne
Recruitment hospital [18] 0 0
Prahran Market Clinic CRS - Melbourne
Recruitment hospital [19] 0 0
Northcote Clinic CRS - Northcote
Recruitment hospital [20] 0 0
Royal Melbourne Hosp., Victorian Infectious Diseases Service CRS - Parkville
Recruitment hospital [21] 0 0
The Ctr. Clinic INSIGHT CRS - St. Kilda
Recruitment hospital [22] 0 0
Royal Perth Hospital CRS - Perth
Recruitment hospital [23] 0 0
Gold Coast Sexual Health Clinic CRS - Miami, Queensland
Recruitment postcode(s) [1] 0 0
2601 - Canberra
Recruitment postcode(s) [2] 0 0
2606 - Woden
Recruitment postcode(s) [3] 0 0
2134 - Burwood
Recruitment postcode(s) [4] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [5] 0 0
- Darlinghurst
Recruitment postcode(s) [6] 0 0
2305 - Newcastle
Recruitment postcode(s) [7] 0 0
2010 - Surry Hills
Recruitment postcode(s) [8] 0 0
- Surry Hills
Recruitment postcode(s) [9] 0 0
- Brisbane
Recruitment postcode(s) [10] 0 0
4870 - Cairns
Recruitment postcode(s) [11] 0 0
4101 - Highgate Hill
Recruitment postcode(s) [12] 0 0
4560 - Nambour
Recruitment postcode(s) [13] 0 0
5000 - Adelaide
Recruitment postcode(s) [14] 0 0
- Carlton
Recruitment postcode(s) [15] 0 0
3004 - Melbourne
Recruitment postcode(s) [16] 0 0
- Melbourne
Recruitment postcode(s) [17] 0 0
3070 - Northcote
Recruitment postcode(s) [18] 0 0
3052 - Parkville
Recruitment postcode(s) [19] 0 0
- St. Kilda
Recruitment postcode(s) [20] 0 0
- Perth
Recruitment postcode(s) [21] 0 0
- Miami, Queensland
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
Argentina
State/province [17] 0 0
Buenos Aires
Country [18] 0 0
Argentina
State/province [18] 0 0
Provincia De Santa Fe
Country [19] 0 0
Argentina
State/province [19] 0 0
Cordoba
Country [20] 0 0
Argentina
State/province [20] 0 0
La Plata
Country [21] 0 0
Argentina
State/province [21] 0 0
Mendoza
Country [22] 0 0
Austria
State/province [22] 0 0
Vienna
Country [23] 0 0
Austria
State/province [23] 0 0
Wien
Country [24] 0 0
Belgium
State/province [24] 0 0
Bruxelles
Country [25] 0 0
Brazil
State/province [25] 0 0
Sao Paulo
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Canada
State/province [26] 0 0
Alberta
Country [27] 0 0
Canada
State/province [27] 0 0
British Columbia
Country [28] 0 0
Canada
State/province [28] 0 0
Nova Scotia
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
Canada
State/province [31] 0 0
Saskatchewan
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Denmark
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Aalborg
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Denmark
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Aarhus
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Denmark
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Copenhagen
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Denmark
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Hvidovre
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Denmark
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Odense
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France
State/province [37] 0 0
Pringy
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France
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Angers
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France
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Besancon
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France
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Bobigny
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France
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Clamart
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France
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Colombes
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France
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Creteil
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France
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Garches
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France
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Le Kremlin-Bicetre
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France
State/province [46] 0 0
Marseille
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France
State/province [47] 0 0
Montpellier
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France
State/province [48] 0 0
Nice
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France
State/province [49] 0 0
Paris
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France
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Strasbourg
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France
State/province [51] 0 0
Suresenes
Country [52] 0 0
Germany
State/province [52] 0 0
Berlin
Country [53] 0 0
Germany
State/province [53] 0 0
Bochum
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Germany
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Bonn
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Germany
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Duesseldorf
Country [56] 0 0
Germany
State/province [56] 0 0
Frankfurt
Country [57] 0 0
Germany
State/province [57] 0 0
Hamburg
Country [58] 0 0
Germany
State/province [58] 0 0
Heidelberg
Country [59] 0 0
Germany
State/province [59] 0 0
Koln
Country [60] 0 0
Germany
State/province [60] 0 0
Munchen
Country [61] 0 0
Germany
State/province [61] 0 0
Wuerzburg
Country [62] 0 0
Ireland
State/province [62] 0 0
Dublin
Country [63] 0 0
Israel
State/province [63] 0 0
Haifa
Country [64] 0 0
Israel
State/province [64] 0 0
Rehovot
Country [65] 0 0
Israel
State/province [65] 0 0
Tel Aviv
Country [66] 0 0
Italy
State/province [66] 0 0
Brescia
Country [67] 0 0
Italy
State/province [67] 0 0
Firenze
Country [68] 0 0
Italy
State/province [68] 0 0
Milano
Country [69] 0 0
Italy
State/province [69] 0 0
Modena
Country [70] 0 0
Italy
State/province [70] 0 0
Pavia
Country [71] 0 0
Italy
State/province [71] 0 0
Roma
Country [72] 0 0
Japan
State/province [72] 0 0
Osaka
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Japan
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Tokyo
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Morocco
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Casablanca
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Netherlands
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Amsterdam
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Netherlands
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Groningen
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Haarlem
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Netherlands
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Tilburg
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Norway
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Oslo
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Poland
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Chorzow
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Szczecin
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Warsaw
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Wroclaw
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Portugal
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Cascais
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Portugal
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Lisboa
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Singapore
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Singapore
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Spain
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Guipuzcoa
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Spain
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A Coruna
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Spain
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Barcelona
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Spain
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Madrid
Country [91] 0 0
Spain
State/province [91] 0 0
Murcia
Country [92] 0 0
Spain
State/province [92] 0 0
Sevilla
Country [93] 0 0
Sweden
State/province [93] 0 0
Stockholm
Country [94] 0 0
Switzerland
State/province [94] 0 0
Ticino
Country [95] 0 0
Thailand
State/province [95] 0 0
Ratchathewi
Country [96] 0 0
Thailand
State/province [96] 0 0
Chiangrai
Country [97] 0 0
Thailand
State/province [97] 0 0
Chonburi
Country [98] 0 0
Thailand
State/province [98] 0 0
Khon Kaen
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Brighton
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Northern Ireland
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Oxford
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Scotland
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Birmingham
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Exeter
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Leicester
Country [106] 0 0
United Kingdom
State/province [106] 0 0
London
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Newcastle Upon Tyne
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Peterborough
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Government body
Name
National Institute of Allergy and Infectious Diseases (NIAID)
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Chiron Corporation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Donald Abrams, MD
Address 0 0
University of California, San Francisco
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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


Results are available at https://clinicaltrials.gov/study/NCT00004978