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A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients With CD4 Counts Greater Than 300 Cells/mm3

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Aldesleukin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Donald I. Abrams, Study Chair
Norman Markowitz, Study Chair


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).

Clinical Details

Official title: 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

Study design: Masking: Open Label, Primary Purpose: Treatment

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Community Consortium / UCSF, San Francisco, California 94110, United States

Denver CPCRA / Denver Public Hlth, Denver, Colorado 80204, United States

Washington Reg AIDS Prog / Dept of Infect Dis, Washington, District of Columbia 20422, United States

AIDS Research Consortium of Atlanta, Atlanta, Georgia 30308, United States

AIDS Research Alliance - Chicago, Chicago, Illinois 60657, United States

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med, New Orleans, Louisiana 70112, United States

Henry Ford Hosp, Detroit, Michigan 48202, United States

Wayne State Univ - WSU/DMC / Univ Hlth Ctr, Detroit, Michigan 48201, United States

Southern New Jersey AIDS Clinical Trials, Camden, New Jersey 08103, United States

North Jersey Community Research Initiative, Newark, New Jersey 07103, United States

Partners in Research / New Mexico, Albuquerque, New Mexico 87131, United States

Harlem AIDS Treatment Grp / Harlem Hosp Ctr, New York, New York 10037, United States

The Research and Education Group, Portland, Oregon 97210, United States

Philadelphia FIGHT, Philadelphia, Pennsylvania 19107, United States

Richmond AIDS Consortium / Div of Infect Diseases, Richmond, Virginia 23298, United States

Additional Information

Click here for more information about aldesleukin

Related publications:

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.

Last updated: September 28, 2013

Page last updated: August 23, 2015

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