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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00110812




Registration number
NCT00110812
Ethics application status
Date submitted
13/05/2005
Date registered
16/05/2005
Date last updated
4/11/2021

Titles & IDs
Public title
Effect of Intermittent Aldesleukin Treatment With or Without Anti-HIV Drugs in HIV Infected People
Scientific title
STALWART: A Randomized, Open-Label, International Study of Subcutaneous Recombinant Interleukin-2 With and Without Concomitant Antiretroviral Therapy in Patients With HIV-1 Infection and CD4+ Cell Counts of 300 Cells/mm3 or More
Secondary ID [1] 0 0
10053
Secondary ID [2] 0 0
ESPRIT 002
Universal Trial Number (UTN)
Trial acronym
STALWART
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 - IL-2

No intervention: No IL-2 - Participants will receive no aldesleukin or HAART

Experimental: IL-2 without ART - Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level. Some Group 2 participants may take part in additional cycles of aldesleukin if they meet certain study criteria.

Experimental: IL-2 with pericycle HAART - Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; Group 3 participants will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle). Some Group 3 participants may take part in additional cycles of aldesleukin if they meet certain study criteria. HAART is not supplied by the study, and choice of drugs is left to the participant and physician. The HAART regimen should include at least one protease inhibitor and at least 2 nucleoside/nucleotide reverse transcriptase inhibitors.


Treatment: Drugs: IL-2
7.5 MIU injected intramuscularly; one arm uses Proleukin together with HAART of choice (protease inhibitor and at least 2 nucleoside/nucleotide reverse transcriptase inhibitors)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change in CD4+ T Lymphocyte Count
Timepoint [1] 0 0
Week 32
Secondary outcome [1] 0 0
Discontinuation of IL-2
Timepoint [1] 0 0
week 32
Secondary outcome [2] 0 0
Plasma HIV RNA
Timepoint [2] 0 0
At Week 32
Secondary outcome [3] 0 0
Change in CD4 T Lymphocyte Count
Timepoint [3] 0 0
At Month 12
Secondary outcome [4] 0 0
HIV-1 Genotype Changes
Timepoint [4] 0 0
after 3rd cycle of IL-2
Secondary outcome [5] 0 0
Fasting Lipid Profile
Timepoint [5] 0 0
week 32
Secondary outcome [6] 0 0
Disease Progression or Death
Timepoint [6] 0 0
throughout study, through Feb 28 2009 (median followup of 19 months)
Secondary outcome [7] 0 0
Initiation of Continuous ART
Timepoint [7] 0 0
from randomization through February 28, 2009
Secondary outcome [8] 0 0
Change in HIV-RNA Copies/ml (log10) From Baseline to Month 12
Timepoint [8] 0 0
month 12
Secondary outcome [9] 0 0
Thyroid Stimulating Hormone
Timepoint [9] 0 0
week 32
Secondary outcome [10] 0 0
SGOT
Timepoint [10] 0 0
week 32

Eligibility
Key inclusion criteria
* HIV infected
* CD4 count of 300 cells/mm3 or more
* Access to a HAART regimen consisting of 1 or more protease inhibitors (PIs) and 2 or more nucleoside or nucleotide reverse transcriptase inhibitors
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior use of aldesleukin
* Approved or experimental antiretroviral drug (including hydroxyurea) within 1 year prior to study entry
* Evidence of virologic failure on a PI- or nonnucleoside-based HAART regimen
* Any current indication for continuous HAART, in the opinion of the investigator
* Any contraindication to HAART, in the opinion of the investigator
* Systemic corticosteroids, chemotherapy, or experimental cytotoxic drugs within 45 days of randomization
* Approved or experimental agents with clinically significant immunomodulatory effects within 8 weeks prior to randomization
* History of any AIDS-defining illness or certain other diseases. More information on this criterion can be found in the protocol.
* Concurrent cancer requiring cytotoxic therapy
* Any central nervous system (CNS) abnormality requiring ongoing treatment with antiseizure medication
* Current or prior autoimmune or inflammatory diseases, including inflammatory bowel disease, psoriasis, optic neuritis, or any other autoimmune or inflammatory diseases with potentially life-threatening complications
* Significant heart, lung, kidney, liver, gastrointestinal, CNS, or psychiatric disease OR illicit substance use or abuse that, in the opinion of the investigator, would interfere with the study
* Pregnancy 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 2
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
1/09/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2011
Sample size
Target
Accrual to date
Final
267
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital CRS - Darlinghurst
Recruitment hospital [2] 0 0
Queensland Health - AIDS Med. Unit CRS - Brisbane
Recruitment hospital [3] 0 0
Gladstone Road Medical Ctr. CRS - Highgate Hill
Recruitment hospital [4] 0 0
Gold Coast Sexual Health Clinic CRS - Miami
Recruitment hospital [5] 0 0
Carlton Clinic CRS - Carlton
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4000 - Brisbane
Recruitment postcode(s) [3] 0 0
4101 - Highgate Hill
Recruitment postcode(s) [4] 0 0
4220 - Miami
Recruitment postcode(s) [5] 0 0
3053 - Carlton
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
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
Argentina
State/province [9] 0 0
Buenos Aires
Country [10] 0 0
Argentina
State/province [10] 0 0
Provincia De Sante Fe
Country [11] 0 0
Chile
State/province [11] 0 0
Santiago
Country [12] 0 0
Italy
State/province [12] 0 0
Milano
Country [13] 0 0
Morocco
State/province [13] 0 0
Casablanca
Country [14] 0 0
Poland
State/province [14] 0 0
Warsaw
Country [15] 0 0
Portugal
State/province [15] 0 0
Cascais
Country [16] 0 0
Portugal
State/province [16] 0 0
Lisboa
Country [17] 0 0
Spain
State/province [17] 0 0
Barcelona
Country [18] 0 0
Thailand
State/province [18] 0 0
Ratchathewi
Country [19] 0 0
Thailand
State/province [19] 0 0
Chiangrai
Country [20] 0 0
Thailand
State/province [20] 0 0
Khon Kaen
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Brighton
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Leicester
Country [23] 0 0
United Kingdom
State/province [23] 0 0
London

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
Jorge Tavel, MD
Address 0 0
National Institute for Allergy and Infectious Diseases, National Institutes of Health
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

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00110812