NCT00000949

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P50-P75 for phase_3 hiv-infections

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2000

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 27, 2021

Conditions

HIV Infections

Keywords

AIDS-Related Opportunistic InfectionsInterleukin-2Dose-Response Relationship, DrugAdolescent BehaviorCD4 Lymphocyte CountRNA, ViralQuality of LifeAnti-HIV AgentsViral Load

Interventions

AldesleukinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Community Consortium / UCSF

San Francisco, California, 94110, United States

Location

Denver CPCRA / Denver Public Hlth

Denver, Colorado, 80204, United States

Location

Washington Reg AIDS Prog / Dept of Infect Dis

Washington D.C., District of Columbia, 20422, United States

Location

AIDS Research Consortium of Atlanta

Atlanta, Georgia, 30308, United States

Location

AIDS Research Alliance - Chicago

Chicago, Illinois, 60657, United States

Location

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med

New Orleans, Louisiana, 70112, United States

Location

Wayne State Univ - WSU/DMC / Univ Hlth Ctr

Detroit, Michigan, 48201, United States

Location

Henry Ford Hosp

Detroit, Michigan, 48202, United States

Location

Southern New Jersey AIDS Clinical Trials

Camden, New Jersey, 08103, United States

Location

North Jersey Community Research Initiative

Newark, New Jersey, 07103, United States

Location

Partners in Research / New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Harlem AIDS Treatment Grp / Harlem Hosp Ctr

New York, New York, 10037, United States

Location

The Research and Education Group

Portland, Oregon, 97210, United States

Location

Philadelphia FIGHT

Philadelphia, Pennsylvania, 19107, United States

Location

Richmond AIDS Consortium / Div of Infect Diseases

Richmond, Virginia, 23298, United States

Location

Related 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. doi: 10.1097/00126334-200203010-00002.

    PMID: 11873071BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAIDS-Related Opportunistic InfectionsAdolescent Behavior

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesOpportunistic InfectionsBehavior

Study Officials

  • Donald I. Abrams

    STUDY CHAIR

  • Norman Markowitz

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

July 1, 2000

Last Updated

October 29, 2021

Record last verified: 2021-10

Locations

US(15)