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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Interleukin-2
Dose-Response Relationship, Drug
Adolescent Behavior
CD4 Lymphocyte Count
RNA, Viral
Quality of Life
Anti-HIV Agents
Viral Load
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Community Consortium / UCSF
state: California
city: Denver
country: United States
facility: Denver CPCRA / Denver Public Hlth
state: Colorado
city: Washington
country: United States
facility: Washington Reg AIDS Prog / Dept of Infect Dis
state: District of Columbia
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Chicago
country: United States
facility: AIDS Research Alliance - Chicago
state: Illinois
city: New Orleans
country: United States
facility: Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
state: Louisiana
city: Detroit
country: United States
facility: Wayne State Univ - WSU/DMC / Univ Hlth Ctr
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hosp
state: Michigan
city: Camden
country: United States
facility: Southern New Jersey AIDS Clinical Trials
state: New Jersey
city: Newark
country: United States
facility: North Jersey Community Research Initiative
state: New Jersey
city: Albuquerque
country: United States
facility: Partners in Research / New Mexico
state: New Mexico
city: New York
country: United States
facility: Harlem AIDS Treatment Grp / Harlem Hosp Ctr
state: New York
city: Portland
country: United States
facility: The Research and Education Group
state: Oregon
city: Philadelphia
country: United States
facility: Philadelphia FIGHT
state: Pennsylvania
city: Richmond
country: United States
facility: Richmond AIDS Consortium / Div of Infect Diseases
state: Virginia
Study officials:
name: Donald I. Abrams
role: STUDY_CHAIR
name: Norman Markowitz
role: STUDY_CHAIR
References:
citation: 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.