NCT00000849

Brief Summary

The purpose of this study is to determine the safety and maximum tolerated dose (the highest dose that can be given safely) of recombinant Interleukin-2 (rIL-2) in HIV-infected children. This study also evaluates the effect of rIL-2 on the immune system of these patients. IL-2 is a substance naturally produced by the body's white blood cells that plays an important role in helping the body fight infection. HIV-infected patients do not produce enough IL-2, and it is hoped that the use of rIL-2 may improve immune system function in these patients. First, it is necessary to determine the safety and effectiveness of this drug in HIV-infected children.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Geographic Reach
1 country

14 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
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2001

Completed
6 months 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

Interleukin-2Immunity, CellularDose-Response Relationship, DrugAcquired Immunodeficiency SyndromeAIDS-Related ComplexViral Load

Interventions

AldesleukinDRUG

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children may be eligible for this study if they:
  • Are HIV-positive.
  • Have decreased immune system functioning (CD4 count 500-1000 for 3- to 5-year-olds or CD4 count 200-500 for 6- to 12-year-olds).
  • Have symptomatic HIV infection.
  • Have a viral level less than 400 copies/ml.
  • Are between the ages of 3 and 12 (consent of parent or guardian required).

You may not qualify if:

  • Children will not be eligible for this study if they:
  • Have an active opportunistic infection.
  • Are pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Long Beach Memorial Med. Ctr., Miller Children's Hosp.

Long Beach, California, 90801, United States

Location

UCSF Pediatric AIDS CRS

San Francisco, California, 941430105, United States

Location

Univ. of Colorado Denver NICHD CRS

Aurora, Colorado, 802181088, United States

Location

Univ. of Florida Jacksonville NICHD CRS

Jacksonville, Florida, 32209, United States

Location

Chicago Children's CRS

Chicago, Illinois, 606143394, United States

Location

Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease

Chicago, Illinois, 606371470, United States

Location

Tulane/LSU Maternal/Child CRS

New Orleans, Louisiana, 701122699, United States

Location

HMS - Children's Hosp. Boston, Div. of Infectious Diseases

Boston, Massachusetts, 021155724, United States

Location

NYU Med. Ctr., Dept. of Medicine

New York, New York, 10016, United States

Location

Columbia IMPAACT CRS

New York, New York, 10032, United States

Location

Incarnation Children's Ctr.

New York, New York, 10032, United States

Location

The Children's Hosp. of Philadelphia IMPAACT CRS

Philadelphia, Pennsylvania, 191044318, United States

Location

Texas Children's Hosp. CRS

Houston, Texas, 77030, United States

Location

VCU Health Systems, Dept. of Peds

Richmond, Virginia, 23219, United States

Location

Related Publications (1)

  • Zeng C, Mawhinney S, Baron AE, McFarland EJ. Evaluating ELISPOT summary measures with criteria for obtaining reliable estimates. J Immunol Methods. 2005 Feb;297(1-2):97-108. doi: 10.1016/j.jim.2004.12.006.

    PMID: 15777934BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

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

Study Officials

  • Stuart Starr

    STUDY CHAIR

  • Steven Douglas

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

March 1, 2001

Last Updated

October 29, 2021

Record last verified: 2021-10

Locations

US(14)