NCT00006066

Brief Summary

The purpose of this study is to determine the safety of a drug called interleukin-2 (IL-2) given with anti-HIV therapy in children with HIV infection. This study will also determine the best dose of IL-2 to give children. IL-2 is an important substance produced by the body's white blood cells that helps the body fight infection. People with HIV infection do not produce enough IL-2. It is hoped that IL-2 treatment will help boost the immune system in people with HIV infection. It has not been studied very much in children and doctors need to know what doses are safe to give.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P75+ for phase_1 hiv-infections

Geographic Reach
2 countries

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

July 14, 2000

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

First QC Date

July 14, 2000

Last Update Submit

October 28, 2021

Conditions

HIV Infections

Keywords

Injections, SubcutaneousInterleukin-2Dose-Response Relationship, DrugDrug Therapy, CombinationImmunocompromised HostCD4 Lymphocyte CountAnti-HIV Agents

Interventions

Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine AdsorbedBIOLOGICAL
Diphtheria and Tetanus Toxoids AdsorbedBIOLOGICAL
Tetanus and Diphtheria Toxoids AdsorbedBIOLOGICAL
Bacteriophage phi X 174DRUG
AldesleukinDRUG

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • A child may be eligible for this trial if he/she:
  • Is HIV-positive.
  • Is 2 to 18 years old (consent of parent or guardian required if under 18).
  • Has received 12 or more weeks of anti-HIV drug therapy, consisting of at least 3 drugs. This combination may include a nucleoside reverse transcriptase inhibitor (NRTI), a nonnucleoside reverse transcriptase inhibitor, or a protease inhibitor, or 3 NRTIs. Combinations of NRTIs may not include abacavir (ABC). Patients may have taken ABC if it was not in combination with 2 other NRTIs. (This reflects a change in the requirement for anti-HIV therapy.)
  • Has a plasma HIV RNA level of less than 10,000 copies/ml.
  • Has evidence of a weakened immune system (based on CD4 cell counts and absolute CD4 percentage less than 25 percent). (This reflects a change in how a weakened immune system is defined.)
  • Has a parent or guardian who is willing to comply with study requirements.
  • Has symptoms of HIV infection.

You may not qualify if:

  • A child will not be eligible for this study if he/she:
  • Has an active opportunistic (AIDS-related) infection.
  • Is pregnant.
  • Is taking certain medications, such as steroids or other drugs that affect the immune system, within 6 weeks prior to study entry.
  • Is taking ABC.
  • Is taking certain antibodies.

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

Usc La Nichd Crs

Los Angeles, California, 90033, United States

Location

UCSD Maternal, Child, and Adolescent HIV CRS

San Diego, California, United States

Location

UCSF Pediatric AIDS CRS

San Francisco, California, 941430105, United States

Location

Children's National Med. Ctr. Washington DC NICHD CRS

Washington D.C., District of Columbia, 20010-2970, United States

Location

Children's National Med. Ctr., ACTU

Washington D.C., District of Columbia, 20060, United States

Location

Univ. of Miami Ped. Perinatal HIV/AIDS CRS

Miami, Florida, 33161, United States

Location

USF - Tampa NICHD CRS

Tampa, Florida, 33701, 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 Ny Nichd Crs

New York, New York, 10016, United States

Location

Columbia IMPAACT CRS

New York, New York, 10032, United States

Location

SUNY Upstate Med. Univ., Dept. of Peds.

Syracuse, New York, 13210, United States

Location

Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

San Juan, 009365067, Puerto Rico

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Tetanus ToxoidJ protein, Bacteriophage phi X 174aldesleukin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ToxoidsVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Savita Pahwa

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

July 14, 2000

First Posted

August 31, 2001

Study Completion

June 1, 2006

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

US(13)PR(1)