Clinical Trials


A Study to Evaluate the Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients With CD4 Cell Counts of at Least 350 Cells/mm3

This study has been completed
National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID) Identifier

First received: November 2, 1999
Last updated: November 7, 2016
Last Verified: April 2014
History of Changes


To demonstrate the safety and tolerability of subcutaneously administered interleukin-2 (IL-2) plus antiretrovirals in patients with HIV infection and CD4 counts of 350 cells/mm3 or more. To demonstrate the immunological efficacy of subcutaneous IL-2 therapy plus antiretroviral therapy relative to antiretroviral therapy alone.

IL-2, given through injection under the skin, in combination with anti-HIV therapy can increase CD4 cell counts. This study examines 3 doses of IL-2 in order to determine the safest and most effective dose to use.

Condition Intervention Phase
HIV Infections

Drug : Aldesleukin
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Phase II Study of Subcutaneous Interleukin-2 (Proleukin) Plus Antiretroviral Therapy vs. Antiretroviral Therapy Alone in Patients With HIV Infection and at Least 350 CD4+ Cells/mm3

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Enrollment: 72
Study Start Date: October 1997
Study Completion Date: December 1999
Primary Completion Date: December 1999 (Final data collection date for primary outcome measure)

Detailed Description:

Interleukin-2 administered subcutaneously, in combination with antiretrovirals, results in increases in CD4+ cell count that might impact upon HIV disease progression. A Phase III trial involving large numbers of HIV-positive patients is the next step in the development process. To develop appropriate clinical experience with the combination, this Phase II trial will allow administration of IL-2 plus antiretroviral therapy to a small number of patients in sites being considered for the Phase III trial.
Patients are randomized to control therapy with antiretrovirals alone (36 patients) or antiretrovirals plus IL-2 given subcutaneously every 12 hours for 5 days every 8 weeks. Three doses of IL-2 are studied, with 12 patients evaluated at each dose.
If at least 9 of the first 12 patients complete the 5-day dosing period without dose-limiting toxicities, the next 12 patients randomized are treated with the next higher dose; if this dose is tolerated, the last 12 patients randomized receive the highest study dose. Patients enrolled at the first two doses of IL-2 who complete three courses have their dose escalated to a maximum of the highest dose.



Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  


Inclusion Criteria
You may be eligible for this study if you:

  • Are HIV-positive.
  • Have a CD4 cell count greater than or equal to 300 cells/mm3.
  • Are at least 18.
  • Have been on antiretroviral therapy for at least 7 days prior to study entry.

  • Exclusion Criteria
    You will not be eligible for this study if you:
  • Abuse alcohol or drugs, or have any serious psychiatric or medical illnesses that would affect your safety or ability to complete the study.
  • Have a history of cancer (other than Kaposi's sarcoma), an AIDS-defining illness, a central nervous system (CNS) abnormality, or an autoimmune/inflammatory disease.
  • Are pregnant or breast-feeding.
  • Have ever received IL-2.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00000889


Hospital de Clinicas 'Jose de San Martin' C601-040 CRS
Ciudad de Buenos Aires, Buenos Aires, Argentina
Hospital F.J. Muniz C601-050 CRS
Ciudad de Buenos Aires, Buenos Aires, Argentina
Hospital General de Agudos J.M. Ramos Mejia CPCRA CRS
Ciudad de Buenos Aires, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires C601-020 CRS
Ciudad de Buenos Aires, Buenos Aires, Argentina

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)


Study Chair: M Losso
More Information

More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00000889   History of Changes  
Other Study ID Numbers: IRP 021A  
  SQ 1 ARG  
  SQIL-2 Argentina  
Study First Received: November 2, 1999  
Last Updated: November 7, 2016  

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

CD4 Lymphocyte Count
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Aldesleukin processed this data on May 24, 2020
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