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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000949
• Other study ID #: CPCRA 059
• Secondary ID: 11615
• Status: Completed
• Phase: Phase 3
• Est. completion date: July 2000

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: July 2000
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Infections

Intervention

Drug:
• Aldesleukin

Locations

Country	Name	City	State
United States	Partners in Research / New Mexico	Albuquerque	New Mexico
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Southern New Jersey AIDS Clinical Trials	Camden	New Jersey
United States	AIDS Research Alliance - Chicago	Chicago	Illinois
United States	Denver CPCRA / Denver Public Hlth	Denver	Colorado
United States	Henry Ford Hosp	Detroit	Michigan
United States	Wayne State Univ - WSU/DMC / Univ Hlth Ctr	Detroit	Michigan
United States	Louisiana Comm AIDS Rsch Prog / Tulane Univ Med	New Orleans	Louisiana
United States	Harlem AIDS Treatment Grp / Harlem Hosp Ctr	New York	New York
United States	North Jersey Community Research Initiative	Newark	New Jersey
United States	Philadelphia FIGHT	Philadelphia	Pennsylvania
United States	The Research and Education Group	Portland	Oregon
United States	Richmond AIDS Consortium / Div of Infect Diseases	Richmond	Virginia
United States	Community Consortium / UCSF	San Francisco	California
United States	Washington Reg AIDS Prog / Dept of Infect Dis	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation