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

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ClinicalTrials.gov Identifier: NCT00001131
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : May 15, 2015
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
HIV Infections Drug: Aldesleukin Drug: HAART Not Applicable

Detailed Description:

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Procedure for Initiation, Administration, and Discontinuation of Interleukin-2 (IL-2) Therapy in Conjunction With Highly Active Antiretroviral Therapy
Study Start Date : May 2004
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Aldesleukin

Arms and Interventions
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Arm Intervention/treatment
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
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
Active Comparator: B
Patients will only follow their current oral anti-HIV medication regimen. No additional IL-2 injection will be given.
 Drug: HAART
Current HAART regimen to be continued for duration of therapy or until certain criteria specified by the study is met


Outcome Measures
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Primary Outcome Measures :
  1. Augmentation and extention of HTL response [ Time Frame: Throughout study ]
  2. Reduction in extent of damage and acceleration of immune system recovery [ Time Frame: Throughout study ]
  3. Delay of and reduction in recurrent viremia compared to historical controls [ Time Frame: Throughout study ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001131


Locations
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Joseph B Margolick
More Information
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001131     History of Changes
Other Study ID Numbers: AI-06-001
AIEDRP AI-06-001
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: May 15, 2015
Last Verified: September 2013

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Interleukin-2
Drug Therapy, Combination
Drug Administration Schedule
Viremia
 T-Lymphocytes, Cytotoxic
Anti-HIV Agents
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Aldesleukin
Interleukin-2
 Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents