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

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: IL-2 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Jorge Tavel, MD, Study Chair, Affiliation: National Institute for Allergy and Infectious Diseases, National Institutes of Health


The purpose of this study is to determine the effect of short cycles of recombinant interleukin-2 (also known as rIL-2 or aldesleukin) given with or without anti-HIV drugs in HIV infected patients. The effects will be compared with a study group that receives no IL-2 or antiretroviral therapy. Study hypothesis: Intermittent aldesleukin, when given without antiretroviral therapy to patients with early HIV infection, will produce no change in HIV viral load and increases in CD4+ T lymphocyte counts comparable to aldesleukin administered with antiretrovirals.

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Mean Change in CD4+ T Lymphocyte Count

Secondary outcome:

Discontinuation of IL-2

Plasma HIV RNA

Change in CD4 T Lymphocyte Count

HIV-1 Genotype Changes

Fasting Lipid Profile

Disease Progression or Death

Initiation of Continuous ART

Change in HIV-RNA Copies/ml (log10) From Baseline to Month 12

Thyroid Stimulating Hormone


Detailed description: Highly active antiretroviral therapy (HAART) has dramatically improved prognosis and lowered morbidity and mortality rates for HIV infected patients. However, significant drug toxicities, difficulties with patient compliance to HAART regimens, and development of drug resistance highlight the need for less toxic, immune-based strategies. Aldesleukin is a synthetic protein that can increase CD4 counts; it is currently approved by the Food and Drug Administration (FDA) for use in patients with metastatic melanoma and renal cell carcinoma. Previous studies of aldesleukin in HIV infected patients indicated that increased CD4 counts can persist for years after aldesleukin administration, and aldesleukin given with HAART may also lead to significant lowering of viral load. This study will examine the immunologic effects of intermittent cycles of aldesleukin administered with and without HAART as compared to no therapy in HIV infected patients. This study will last approximately 31 months. Participants will be randomly assigned to one of three groups at study entry. Group A will receive no aldesleukin or HAART. Group B 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 C 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 C 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). HAART will not be provided by the study. Some Group B and C participants may take part in additional cycles of aldesleukin if they meet certain study criteria. All participants in this study will have at least 8 study visits; these visits will occur at study entry and Weeks 4, 8, 12, 16, 20, 24, and 32. Blood collection will occur at all visits and will include tests for CD4 count and viral load. Groups B and C will have additional blood collection within 4 days prior to the start of each aldesleukin cycle. On the last day of each aldesleukin cycle, Groups B and C will be assessed for toxicities, adverse events, and adherence to the aldesleukin daily injections; they will also have another blood collection. Group C participants will have an additional blood collection for HIV genotyping after they have completed their third aldesleukin cycle. Extended follow-up visits will occur approximately every 4 months for an additional two years. Blood collection will occur at these visits and will include tests for CD4 count, viral load, and other laboratory tests.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Fundacion Arriaran CRS, Santiago, Chile

Ospedale San Raffaele S.r.l. CRS, Milano 20127, Italy

Univ. of Milan, Ospedale Luigi Sacco, Institute of Infectious and Tropical Diseases CRS, Milano 20157, Italy

Univ. Hosp. Ctr. of the Med. School of Casablanca, Infectious Diseases Unit CRS, Casablanca, Morocco

Wojewodzki Szpital Zakazny CRS, Warsaw, Poland

Hospital de Cascais, HDDI, Departamento Medicina Interna CRS, Cascais, Portugal

Hosp. de Egas Moniz, Servicio de Infecciologia e Medicina Tropical CRS, Lisboa, Portugal

Hosp. de Santa Maria, Servico de Doencas Infecciosas CRS, Lisboa, Portugal

Hosp. Clinico de Barcelona CRS, Barcelona, Spain

Chiang Rai Regional Hosp. INSIGHT CRS, Chiangrai, Thailand

Khon Kaen Univ., Srinagarind Hosp., Div. of Infectious Diseases & Tropical Medicine, Dept. of Medici, Khon Kaen, Thailand

Leicester Royal Infirmary, Dept. of Infection & Tropical Medicine CRS, Leicester, United Kingdom

St. Bartholomew's Hosp., Infection & Immunity Clinical Group CRS, London EC1A 7BE, United Kingdom

St. Mary's Hosp. of London, Imperial College School of Medicine CRS, London W2 1NY, United Kingdom

Brighton & Sussex Univ. Hosp. NHS Trust, HIV Research Office CRS, Elm Grove, Brighton, United Kingdom

Funcei Crs, Ciudad de Buenos Aires, Buenos Aires C1425-AWK, Argentina

Hosp. Gen. de Agudos JM Ramos Mejia, Servicio de Inmunocomprometidos CRS, Ciudad de Buenos Aires, Buenos Aires 1221, Argentina

Hosp. Italiano de Buenos Aires, Infectious Diseases Section CRS, Ciudad de Buenos Aires, Buenos Aires 1199, Argentina

VA Greater Los Angeles Healthcare System, Infectious Diseases Section CRS, Los Angeles, California 90073, United States

Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS, Washington, District of Columbia 20422, United States

NIH Clinical Ctr., NIAID HIV Clinic CRS, Bethesda, Maryland 20814-9692, United States

Henry Ford Hosp. CRS, Detroit, Michigan 48202, United States

St. Vincent's Hospital CRS, Darlinghurst, New South Wales 2010, Australia

Lincoln Hosp. & Med. Ctr. CRS, Bronx, New York 10451, United States

Harlem Hospital Ctr./Columbia University CRS (Gordin CTU), New York, New York 10037, United States

Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS, Portland, Oregon 97213, United States

Caici Crs, Rosario, Provincia de Sante Fe, Argentina

Queensland Health - AIDS Med. Unit CRS, Brisbane, Queensland 4000, Australia

Gladstone Road Medical Ctr. CRS, Highgate Hill, Queensland 4101, Australia

Gold Coast Sexual Health Clinic CRS, Miami, Queensland 4220, Australia

Chulalongkorn University Hospital CRS, Bangkok, Ratchathewi, Thailand

Michael E. DeBakey VAMC CRS, Houston, Texas 77030, United States

Thomas Street Clinic CRS, Houston, Texas 77030, United States

South Texas Veterans Health Care System, Immunosuppression Clinic CRS, San Antonio, Texas 78229, United States

Carlton Clinic CRS, Carlton, Victoria 3053, Australia

Virginia Commonwealth Univ. Medical Ctr. CRS, Richmond, Virginia 23298, United States

Additional Information

Click here for more information on aldesleukin

Haga clic aquí para ver información sobre este ensayo clínico en español.

Related publications:

Anaya JP, Sias JJ. The use of interleukin-2 in human immunodeficiency virus infection. Pharmacotherapy. 2005 Jan;25(1):86-95. Review.

de Boer AW, Markowitz N, Lane HC, Saravolatz LD, Koletar SL, Donabedian H, Yoshizawa C, Duliege AM, Fyfe G, Mitsuyasu RT. A randomized controlled trial evaluating the efficacy and safety of intermittent 3-, 4-, and 5-day cycles of intravenous recombinant human interleukin-2 combined with antiretroviral therapy (ART) versus ART alone in HIV-seropositive patients with 100-300 CD4+ T cells. Clin Immunol. 2003 Mar;106(3):188-96.

Davey RT Jr, Murphy RL, Graziano FM, Boswell SL, Pavia AT, Cancio M, Nadler JP, Chaitt DG, Dewar RL, Sahner DK, Duliege AM, Capra WB, Leong WP, Giedlin MA, Lane HC, Kahn JO. Immunologic and virologic effects of subcutaneous interleukin 2 in combination with antiretroviral therapy: A randomized controlled trial. JAMA. 2000 Jul 12;284(2):183-9.

Marchetti G, Franzetti F, Gori A. Partial immune reconstitution following highly active antiretroviral therapy: can adjuvant interleukin-2 fill the gap? J Antimicrob Chemother. 2005 Apr;55(4):401-9. Epub 2005 Feb 24. Review.

Pett SL, Kelleher AD. Cytokine therapies in HIV-1 infection: present and future. Expert Rev Anti Infect Ther. 2003 Jun;1(1):83-96. Review.

Starting date: September 2005
Last updated: April 7, 2014

Page last updated: August 23, 2015

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