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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001131
First received: January 17, 2000
Last updated: September 4, 2013
Last verified: September 2013

January 17, 2000
September 4, 2013
May 2004
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  • Augmentation and extention of HTL response [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Reduction in extent of damage and acceleration of immune system recovery [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Delay of and reduction in recurrent viremia compared to historical controls [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00001131 on ClinicalTrials.gov 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.

Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
    Interventions:
    • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
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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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001131
AI-06-001, AIEDRP AI-06-001
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
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