Effectiveness of Interleukin-2 (IL-2) Plus Anti-HIV Therapy in HIV-Positive Patients
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Purpose
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 | Intervention |
|---|---|
|
HIV Infections |
Drug: Aldesleukin Drug: HAART |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
- 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 ]
| Estimated Enrollment: | 42 |
| Study Start Date: | May 2004 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00001131
| United States, Maryland | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 21205 | |
| Principal Investigator: | Joseph B Margolick |
More Information
| 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 |
| Study First Received: | January 17, 2000 |
| Last Updated: | May 14, 2015 |
| Health Authority: | United States: Federal Government |
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 |
ClinicalTrials.gov processed this record on September 28, 2016