Effect of Intermittent Aldesleukin Treatment With or Without Anti-HIV Drugs in HIV Infected People

• Register: ClinicalTrials.gov
• Last refreshed on: 15 November 2021
• Main ID: NCT00110812
• Date of registration: 13/05/2005
• Prospective Registration: Yes
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Effect of Intermittent Aldesleukin Treatment With or Without Anti-HIV Drugs in HIV Infected People STALWART
• 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
• Date of first enrolment: September 2005
• Target sample size: 267
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00110812
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Argentina, Australia, Chile, Gambia, Germany, Ireland, Italy, Morocco, Poland, Portugal, Seychelles, Spain, Thailand, United Kingdom, United States

Contacts

• Name: Jorge Tavel, MD
• Affiliation: National Institute for Allergy and Infectious Diseases, National Institutes of Health

Key inclusion & exclusion criteria

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

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: IL-2

Primary Outcome(s)

Mean Change in CD4+ T Lymphocyte Count [Time Frame: Week 32]

Secondary Outcome(s)

Discontinuation of IL-2 [Time Frame: week 32]

Change in CD4 T Lymphocyte Count [Time Frame: At Month 12]

HIV-1 Genotype Changes [Time Frame: after 3rd cycle of IL-2]

Disease Progression or Death [Time Frame: throughout study, through Feb 28 2009 (median followup of 19 months)]

Plasma HIV RNA [Time Frame: At Week 32]

Change in HIV-RNA Copies/ml (log10) From Baseline to Month 12 [Time Frame: month 12]

Initiation of Continuous ART [Time Frame: from randomization through February 28, 2009]

SGOT [Time Frame: week 32]

Fasting Lipid Profile [Time Frame: week 32]

Thyroid Stimulating Hormone [Time Frame: week 32]

Secondary ID(s)

10053

ESPRIT 002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Chiron Corporation

Results

• Results available: Yes
• Date Posted: 12/05/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00110812