- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000949
A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients With CD4 Counts Greater Than 300 Cells/mm3
A Randomized, Open-Label, Study of the Impact of Two Doses of Subcutaneous Recombinant IL-2 (Proleukin) on Viral Burden and CD4+ Cell Count in Patients With HIV-1 Infection and CD4+ Cell Counts Greater Than or Equal to 300/mm3
The purpose of this study is to examine how rIL-2 affects HIV-positive patients with CD4 counts over 300 cells/mm3 who are on anti-HIV drug therapy. The drug rIL-2 has been shown to increase CD4 cell counts, which help the body fight off HIV.
There is strong evidence that rIL-2 increases CD4 cell counts (cells of the immune system that fight infection). This study examines the effect of 2 different amounts of rIL-2 on CD4 cell count and the amount of HIV in the blood (viral burden).
Study Overview
Detailed Description
There is substantial evidence that rIL-2 increases CD4+ cell count. Whether or not rIL-2 delays progression to AIDS and extends survival is currently unknown, such clinical benefits of rIL-2 can only be established in a large, long-term, randomized trial. This study examines the effect of two different rIL-2 doses on HIV viral burden and CD4+ cell count and provides additional information on optimal dosing, safety, and antiviral activity of rIL-2.
Patients are randomized to receive one of two subcutaneous (sc) doses of recombinant rIL-2 or no rIL-2. Those patients who take rIL-2 initially receive three courses of treatment. For this study, a course is defined as eight calendar weeks, including the five-day period of sc rIL-2 administration. Additional courses are given (no more frequently than every 6 weeks) in order to maintain a CD4+ count of at least twice its baseline level or at least 1,000 cells/mm3. Follow-up will continue for all patients until a common closing date of 12 months following enrollment of the last patient.
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94110
- Community Consortium / UCSF
-
-
Colorado
-
Denver, Colorado, United States, 80204
- Denver CPCRA / Denver Public Hlth
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20422
- Washington Reg AIDS Prog / Dept of Infect Dis
-
-
Georgia
-
Atlanta, Georgia, United States, 30308
- AIDS Research Consortium of Atlanta
-
-
Illinois
-
Chicago, Illinois, United States, 60657
- AIDS Research Alliance - Chicago
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112
- Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Henry Ford Hosp
-
Detroit, Michigan, United States, 48201
- Wayne State Univ - WSU/DMC / Univ Hlth Ctr
-
-
New Jersey
-
Camden, New Jersey, United States, 08103
- Southern New Jersey AIDS Clinical Trials
-
Newark, New Jersey, United States, 07103
- North Jersey Community Research Initiative
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87131
- Partners in Research / New Mexico
-
-
New York
-
New York, New York, United States, 10037
- Harlem AIDS Treatment Grp / Harlem Hosp Ctr
-
-
Oregon
-
Portland, Oregon, United States, 97210
- The Research and Education Group
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Philadelphia FIGHT
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Richmond AIDS Consortium / Div of Infect Diseases
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
You may be eligible for this study if you:
- Are HIV-positive.
- Agree to practice abstinence or use effective birth control methods during the study.
- Are on anti-HIV therapy and have a CD4 count of at least 300 cells/mm3.
- Are at least 18 years old.
Exclusion Criteria
You will not be eligible for this study if you:
- Have a history of progressive diseases.
- Have a history of severe autoimmune/inflammatory disease.
- Have Crohn's disease.
- Are taking antiseizure medications or certain other medications.
- Are receiving chemotherapy.
- Are pregnant or breast-feeding.
- Have ever received rIL-2.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Investigators
- Study Chair: Donald I. Abrams
- Study Chair: Norman Markowitz
Publications and helpful links
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPCRA 059
- 11615 (Registry Identifier: DAIDS ES Registry ID)
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.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on Aldesleukin
-
National Cancer Institute (NCI)CompletedMetastatic Melanoma | Renal Cell CancerUnited States
-
Cancer Biotherapy Research GroupUnknownKidney CancerUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI); Chiron CorporationCompleted
-
Blumenthal Cancer Center at Carolinas Medical CenterUnknown
-
Cancer Biotherapy Research GroupUnknownLung CancerUnited States
-
St. Anna KinderkrebsforschungUnknown
-
National Cancer Institute (NCI)Completed
-
European Organisation for Research and Treatment...CompletedLeukemiaFrance, Belgium, Netherlands, Italy, Austria, Croatia
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Blumenthal Cancer Center at Carolinas Medical CenterUnknown