Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy

June 23, 2005 updated by: Chiron Corporation

A Bridging Dose-Escalation Study of the Safety, Pharmacokinetic Properties, and Immunologic Effect of Subcutaneous L2-7001 (Recombinant Human Interleukin-2) in Patients Infected With HIV With CD4+ T-Cell Counts of 300 to 500 Cells/mm3 and Viral Burden Under 10,000 Copies/Ml on Active Antiretroviral Therapy (ART)

The purpose of this study is to see if it is safe and effective to give HIV-positive patients L2-7001 (a type of interleukin-2) plus anti-HIV therapy. Interleukin-2 (IL-2) is a substance naturally produced by the body's white blood cells that plays an important role in helping the body fight infection. IL-2 may be able to boost the immune systems of people with HIV infection.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study takes place in two phases. Phase A consists of an open-label dose-escalation of L2-7001 through four dose levels. Ascending dose cohorts of five patients are studied. The safety and tolerability of L2-7001 is assessed in preparation for the second phase of the study and to estimate an MTD. Phase B involves randomization of 190 patients to (a) one of three dose levels of L2-7001 plus ART, (b) one of two dosing levels of Proleukin plus ART, or (c) ART alone. L2-7001 and Proleukin are given SC every 12 hours for the first 5 days of an 8-week cycle for three cycles. Serum IL-2 levels, soluble IL-2 receptor levels, and levels of pro-inflammatory cytokines are evaluated in 8 patients randomized to each treatment cohort of Phase B. All patients completing this phase of the protocol are eligible to be screened for enrollment in a maintenance use protocol which will allow for access to L2-7001.

Study Type

Interventional

Enrollment

212

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35203
        • Sorra Research Ctr / Med Forum
    • California
      • Beverly Hills, California, United States, 90211
        • Pacific Oaks Research
      • Fountain Valley, California, United States, 92708
        • Orange County Ctr for Special Immunology
      • San Diego, California, United States, 92101
        • St Lukes Medical Group
      • San Francisco, California, United States, 94118
        • Kaiser Foundation Hospital
    • Colorado
      • Denver, Colorado, United States, 80220
        • Denver Inf Disease Consultants
    • District of Columbia
      • Washington, District of Columbia, United States, 200091104
        • Dupont Circle Physicians Group
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Community AIDS Resource Inc
      • Miami, Florida, United States, 33142
        • Specialty Med Care Ctrs of South Florida Inc
      • Miami, Florida, United States, 33133
        • Steinhart Medical Associates
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Northstar Med Clinic
      • Chicago, Illinois, United States, 60657
        • AIDS Research Alliance - Chicago
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Fenway Community Health Ctr
    • New Jersey
      • Newark, New Jersey, United States, 071032842
        • North Jersey Community Research Initiative
    • New York
      • Albany, New York, United States, 12208
        • Albany Med College
      • Rego Park, New York, United States, 11374
        • Anderson Clinical Research Inc
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74114
        • Associates in Med and Mental Health
    • Oregon
      • Portland, Oregon, United States, 97210
        • Research and Education Group
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15221
        • Anderson Clinical Research
    • Texas
      • Austin, Texas, United States, 78705
        • Central Texas Clinical Research
      • Dallas, Texas, United States, 75219
        • N Texas Ctr for AIDS & Clin Rsch
      • Houston, Texas, United States, 77004
        • Gathe, Joseph, M.D.
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Med Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Have a viral load below 10,000 copies/ml.
  • Have a CD4 count between 300 and 500 cells/mm3.
  • Have been on stable anti-HIV therapy for 4 months. Patients must be taking at least 2 drugs, 1 of which must be a protease inhibitor or a nonnucleoside drug (NNRTI).
  • Are at least 18 years old.
  • Agree to use an effective barrier method of birth control, such as condoms, during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have an AIDS-defining illness. (Patients who have had an AIDS-defining illness that was cured may still be eligible.)
  • Have an alcohol or drug abuse problem that the doctors feel would affect their ability to participate.
  • Have cancer requiring chemotherapy.
  • Have a history of autoimmune disease.
  • Have uncontrolled diabetes or certain thyroid problems.
  • Have mental illness or other serious medical condition that the doctors feel would affect their ability to participate.
  • Have received IL-2 in the past.
  • Have taken corticosteroids or certain medications that affect the immune system in the past 4 weeks.
  • Have taken hydroxyurea in the past 4 months.
  • Are pregnant or breast-feeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiron Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1999

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

July 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B007
  • CS-MM-9901

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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