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NCT00004978

An International Study to Evaluate Recombinant Interleukin-2 in HIV Positive Patients Taking Anti-retroviral Therapy

Last Updated: 2021-11-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-03-31

Study Completion Date

2008-11-30

Brief Summary

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The purpose of this study is to see if it is effective to give HIV positive patients recombinant interleukin-2 (rIL-2) in addition to anti-HIV therapy. Patients will be followed over a minimum of 4 years to study the long-term effects of rIL-2 on their HIV disease progression.

Anti-HIV therapy has been very successful in treating HIV positive patients and in keeping viral load (level of HIV in the blood) low. However, anti-HIV drugs cannot completely rid the body of the virus, and the immune system is never completely restored in HIV positive patients. Doctors hope that giving patients recombinant interleukin-2 (rIL-2) in addition to their anti-HIV therapy will help improve their immune systems and keep them healthier over a longer period of time. rIL-2 is a hormone naturally produced by the body during an immune response to a microbial infection.

Detailed Description

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Much progress has been made in implementing potent antiretroviral therapy that is able to maximally suppress viral replication. However, these drug combinations do not result in viral eradication and, for many patients, virologic and immunologic control cannot be maintained. Even among patients with apparent virologic control, a "ceiling effect" seems to exist with failure of CD4 cell counts to rise on average more than 100 to 150 cells/mm\^3, at least during the first 2 years of therapy. The incomplete recovery of immune function after initiation of therapy remains an obstacle in the management of HIV. Preservation of immune function by direct expansion of CD4 lymphocytes with rIL-2 could represent a significant additional treatment strategy. It also has been speculated recently that rIL-2 in combination with potent antiretroviral therapy may be a useful approach for purging HIV from the latently infected CD4 cells. It is hoped that intervention with rIL-2 therapy in combination with antiretroviral therapy at an early stage of HIV infection can prevent CD4 T-cell depletion and result in fewer AIDS-defining illnesses than with antiretroviral therapy alone.

Patients are randomized to receive subcutaneous (SC) rIL-2 therapy or no rIL-2 therapy. All patients must be taking a regimen of combination antiretroviral treatment, with the choice of therapy at the discretion of the treating clinician. Antiretroviral medications are not provided by this study. Recombinant IL-2 is given SC for 5 consecutive days every 8 weeks for at least 3 cycles unless toxicities or other contraindications develop. After the first three cycles, additional cycles are given at the discretion of each patient's physician, with a general goal of maintaining the patient's CD4 cell count at twice the baseline level or at 1,000 cells/mm\^3 or above for as long as possible. Patients in the no rIL-2 group receive no injections. Patients in both treatment groups are seen every 4 months for follow-up data collection to monitor viral load and CD4 cell counts. All patients are followed for a minimum of 4 years. During the trial, patients in the no SC rIL-2 group are not given rIL-2 at any point. However, at the end of the study, if rIL-2 is found to be effective in reducing the rate of disease progression \[AS PER AMENDMENT 12/15/00: (new and recurrent events)\], including death, all patients are offered rIL-2.

Conditions

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HIV Infections

Keywords

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Recombinant Proteins Injections, Subcutaneous HIV-1 Interleukin-2 Drug Therapy, Combination CD4 Lymphocyte Count Disease Progression Follow-Up Studies Anti-HIV Agents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rIL-2

Recombinant interleukin-2 (rIL-2) therapy used with combination anti-HIV medication of choice.

Group Type EXPERIMENTAL

Recombinant interleukin-2 (rIL-2)

Intervention Type DRUG

Recombinant interleukin-2 at a dose of 7.5 MIU given twice daily subcutaneously for 5 consecutive days every 8 weeks for at least 3 cycles.

No rIL-2

Control arm uses anti-HIV medication of choice without rIL-2.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Recombinant interleukin-2 (rIL-2)

Recombinant interleukin-2 at a dose of 7.5 MIU given twice daily subcutaneously for 5 consecutive days every 8 weeks for at least 3 cycles.

Intervention Type DRUG

Other Intervention Names

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Proleukin IL-2 Aldesleukin

Eligibility Criteria

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Inclusion Criteria

* HIV positive
* Have a CD4 cell count of 300 cells/mm3 or more within 45 days of study entry
* Are on combination anti-HIV therapy or are beginning anti-HIV therapy at the time of study entry
* Are at least 18 years old

Exclusion Criteria

* Have received IL-2 before
* Have cancer requiring chemotherapy
* Have evidence of active clinical disease within the past year for any AIDS-defining illness or certain other conditions such as herpes zoster or Chagas disease. (This study has been changed. Previously, patients were ineligible if they had a history of any AIDS-defining illness or certain other conditions.)
* Have used certain medications, such as corticosteroids or drugs affecting the immune system, in the 45 days before study entry
* Have a nervous system disorder requiring antiseizure medication
* Have an autoimmune or inflammatory disease such as inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), psoriasis, optic neuritis, or any autoimmune/inflammatory diseases with potentially life-threatening complications
* Are pregnant or breastfeeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donald Abrams, MD

Role: STUDY_CHAIR

University of California, San Francisco

Marcelo Losso, MD

Role: STUDY_CHAIR

Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina

Locations

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VA Greater Los Angeles Healthcare System, Infectious Diseases Section CRS

Los Angeles, California, United States

Site Status

Dr. M. Estes Med. Practice CRS

Mill Valley, California, United States

Site Status

Dr. Robert Scott Med. Practice CRS

Oakland, California, United States

Site Status