Effectiveness of Interleukin-2 (IL-2) Plus Anti-HIV Therapy in HIV-Positive Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00001131
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : May 15, 2015
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

January 17, 2000
August 31, 2001
May 15, 2015
May 2004
June 2007   (Final data collection date for primary outcome measure)
  • Augmentation and extention of HTL response [ Time Frame: Throughout study ]
  • Reduction in extent of damage and acceleration of immune system recovery [ Time Frame: Throughout study ]
  • Delay of and reduction in recurrent viremia compared to historical controls [ Time Frame: Throughout study ]
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Complete list of historical versions of study NCT00001131 on Archive Site
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Effectiveness of Interleukin-2 (IL-2) Plus Anti-HIV Therapy in HIV-Positive Patients
Procedure for Initiation, Administration, and Discontinuation of Interleukin-2 (IL-2) Therapy in Conjunction With Highly Active Antiretroviral Therapy

The purpose of this study is to find out if the immune systems of HIV-positive patients can be improved by treatment with anti-HIV medications plus interleukin-2 (IL-2) in the early stages of HIV infection.

IL-2 is a protein found naturally in the blood that can help boost the immune system. HIV spreads throughout the body by invading CD4 cells, which are cells of the immune system that fight infection. Doctors hope that adding IL-2 to a current anti-HIV drug combination can help restore the CD4 cell count and the immune functions. This study will look at how the HIV virus acts during the early stages of HIV infection, how the immune system responds to HIV, and what impact early treatment with anti-HIV medications has on the course of HIV infection.

At the time of initial HIV infection, CD4 cells are susceptible to infection, and the virus infects many T cells during the first 4 to 6 weeks. Many of these infected cells subsequently maintain the virus in a latent state. Immune reconstitution with daily low-dose IL-2 therapy is intended to correct or improve the deficiency in CD4 cells, while maintaining a high frequency of CD8+ HIV-specific CTL and increasing natural killer (NK) cells. After a year of HAART plus IL-2, it may be possible to discontinue HAART while maintaining IL-2 stimulatory therapy, and the immune reactivity repaired and stimulated by IL-2 should be able to contain the virus and maintain latency.

Patients are randomized to add IL-2 to their current HAART regimen or simply to remain on their current HAART regimen. IL-2 therapy is initiated at Month 3 of HAART. IL-2 is injected subcutaneously daily for 9 months, in addition to HAART. After completion of this 1-year treatment period, patients are evaluated for discontinuation of HAART. Patients with a viral load below 50 copies/ml throughout HAART plus IL-2, a CD4 count of at least 500 cells/mm3, and no onset of opportunistic infections may have HAART discontinued and IL-2 continued as monotherapy for an additional 6 months. After completing 6 months of IL-2 monotherapy, eligible patients may have IL-2 therapy discontinued.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infections
  • Drug: Aldesleukin
    Subcutaneous injection of IL-2 in the amount of 2.0 X 10^6 mIU per day for the entire duration of therapy
    Other Name: Chiron IL-2
  • Drug: HAART
    Current HAART regimen to be continued for duration of therapy or until certain criteria specified by the study is met
  • Experimental: A
    Patients will recieve a daily, self-administered subcutaneous injection of IL-2 while continuing treatment with their current oral anti-HIV medications
    • Drug: Aldesleukin
    • Drug: HAART
  • Active Comparator: B
    Patients will only follow their current oral anti-HIV medication regimen. No additional IL-2 injection will be given.
    Intervention: Drug: HAART
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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June 2007
June 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria

Patients may be eligible for this study if they:

  • HIV-infected.
  • Viral load of 5,000 copies/ml or less within 3 months.
  • Completed at least 3 months of anti-HIV medications.
  • Have a refrigerator to store the needles for IL-2 shots.

Exclusion Criteria

  • Glucocorticoids or other drugs that affect the immune system such as INF-alpha, G-CSF, or GM-CSF.
Sexes Eligible for Study: All
Child, Adult, Older Adult
Contact information is only displayed when the study is recruiting subjects
United States
AIEDRP AI-06-001
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National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Joseph B Margolick
National Institute of Allergy and Infectious Diseases (NIAID)
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP