Back to resultsSafety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy
Primary Purpose
HIV Infections
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aldesleukin
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Recombinant Proteins, Injections, Subcutaneous, Interleukin-2, Dose-Response Relationship, Drug, CD4 Lymphocyte Count, Anti-HIV Agents, Viral Load, Pharmacokinetics
Eligibility Criteria
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.
Sites / Locations
- Sorra Research Ctr / Med Forum
- Pacific Oaks Research
- Orange County Ctr for Special Immunology
- St Lukes Medical Group
- Kaiser Foundation Hospital
- Denver Inf Disease Consultants
- Dupont Circle Physicians Group
- Community AIDS Resource Inc
- Steinhart Medical Associates
- Specialty Med Care Ctrs of South Florida Inc
- AIDS Research Alliance - Chicago
- Northstar Med Clinic
- Fenway Community Health Ctr
- North Jersey Community Research Initiative
- Albany Med College
- Anderson Clinical Research Inc
- Associates in Med and Mental Health
- Research and Education Group
- Anderson Clinical Research
- Central Texas Clinical Research
- N Texas Ctr for AIDS & Clin Rsch
- Gathe, Joseph, M.D.
- Virginia Mason Med Ctr
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002449
Brief Title
Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2001
Overall Recruitment Status
Unknown status
Study Start Date
August 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Chiron Corporation
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Recombinant Proteins, Injections, Subcutaneous, Interleukin-2, Dose-Response Relationship, Drug, CD4 Lymphocyte Count, Anti-HIV Agents, Viral Load, Pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
212 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aldesleukin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Sorra Research Ctr / Med Forum
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35203
Country
United States
Facility Name
Pacific Oaks Research
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Orange County Ctr for Special Immunology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
St Lukes Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
Kaiser Foundation Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Denver Inf Disease Consultants
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Dupont Circle Physicians Group
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
200091104
Country
United States
Facility Name
Community AIDS Resource Inc
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Steinhart Medical Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Specialty Med Care Ctrs of South Florida Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
AIDS Research Alliance - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Northstar Med Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Fenway Community Health Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
North Jersey Community Research Initiative
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071032842
Country
United States
Facility Name
Albany Med College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Anderson Clinical Research Inc
City
Rego Park
State/Province
New York
ZIP/Postal Code
11374
Country
United States
Facility Name
Associates in Med and Mental Health
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74114
Country
United States
Facility Name
Research and Education Group
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Anderson Clinical Research
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15221
Country
United States
Facility Name
Central Texas Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
N Texas Ctr for AIDS & Clin Rsch
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Gathe, Joseph, M.D.
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Virginia Mason Med Ctr
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy
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