A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients With CD4 Counts Greater Than 300 Cells/mm3
NCT ID: NCT00000949
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
460 participants
INTERVENTIONAL
2000-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Aldesleukin
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Donald I. Abrams
Role: STUDY_CHAIR
Norman Markowitz
Role: STUDY_CHAIR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Community Consortium / UCSF
San Francisco, California, United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States
Washington Reg AIDS Prog / Dept of Infect Dis
Washington D.C., District of Columbia, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, United States
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
Detroit, Michigan, United States
Henry Ford Hosp
Detroit, Michigan, United States
Southern New Jersey AIDS Clinical Trials
Camden, New Jersey, United States
North Jersey Community Research Initiative
Newark, New Jersey, United States
Partners in Research / New Mexico
Albuquerque, New Mexico, United States
Harlem AIDS Treatment Grp / Harlem Hosp Ctr
New York, New York, United States
The Research and Education Group
Portland, Oregon, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States
Richmond AIDS Consortium / Div of Infect Diseases
Richmond, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Abrams DI, Bebchuk JD, Denning ET, Davey RT, Fox L, Lane HC, Sampson J, Verheggen R, Zeh D, Markowitz NP; Terry Beirn Community Programs for Clinical Research on AIDS. Randomized, open-label study of the impact of two doses of subcutaneous recombinant interleukin-2 on viral burden in patients with HIV-1 infection and CD4+ cell counts of > or = 300/mm3: CPCRA 059. J Acquir Immune Defic Syndr. 2002 Mar 1;29(3):221-31. doi: 10.1097/00126334-200203010-00002.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
11615
Identifier Type: REGISTRY
Identifier Source: secondary_id
CPCRA 059
Identifier Type: -
Identifier Source: org_study_id