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

HIV Infections Clinical Trial

Official title:

Procedure for Initiation, Administration, and Discontinuation of Interleukin-2 (IL-2) Therapy in Conjunction With Highly Active Antiretroviral Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001131
• Other study ID #: AI-06-001
• Secondary ID: AIEDRP AI-06-001
• Status: Completed
• Phase: N/A
• First received: January 17, 2000
• Last updated: May 14, 2015
• Start date: May 2004
• Est. completion date: June 2007

Study information

• Verified date: September 2013
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

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
• HAART
Current HAART regimen to be continued for duration of therapy or until certain criteria specified by the study is met

Locations

Country	Name	City	State
United States	Johns Hopkins Hosp	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Augmentation and extention of HTL response		Throughout study	No
Primary	Reduction in extent of damage and acceleration of immune system recovery		Throughout study	No
Primary	Delay of and reduction in recurrent viremia compared to historical controls		Throughout study	No

External Links

•   Click here for more information about Aldesleukin
•   Haga clic aquí para ver información sobre este ensayo clínico en español.