ClinicalTrials.gov record
Completed Phase 3 Interventional Results available

An International Study to Evaluate Recombinant Interleukin-2 in HIV Positive Patients Taking Anti-retroviral Therapy

ClinicalTrials.gov ID: NCT00004978

Public ClinicalTrials.gov record NCT00004978. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 20, 2026, 7:17 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Open-Label, Phase III, International Study of Subcutaneous Recombinant IL-2 in Patients With HIV-1 Infection and CD4+ Cell Counts 300/mm^3 or Greater: Evaluation of Subcutaneous Proleukin in a Randomized International Trial

Study identification

NCT ID
NCT00004978
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Enrollment
4,150 participants

Conditions and interventions

Conditions

Interventions

  • Recombinant interleukin-2 (rIL-2) Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 29, 2000
Primary completion
Oct 31, 2008
Completion
Oct 31, 2008
Last update posted
Nov 4, 2021

2000 – 2008

United States locations

U.S. sites
78
U.S. states
16
U.S. cities
36
Facility City State ZIP Site status
VA Greater Los Angeles Healthcare System, Infectious Diseases Section CRS Los Angeles California 90073
Dr. M. Estes Med. Practice CRS Mill Valley California 94941-3013
Dr. Robert Scott Med. Practice CRS Oakland California 94609
East Bay AIDS Ctr. CRS Oakland California 94705
Dr. Shawn Hassler Med. Practice CRS San Francisco California 94102
Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS San Francisco California 94110-0242
Positive Health Practice West/ Dr. Steve Deeks CRS San Francisco California 94110
Dr. William Owen Med. Practice CRS San Francisco California 94114-1010
Dr. Martin Mass Med. Practice CRS San Francisco California 94114
San Francisco VAMC, Infectious Diseases Clinic CRS San Francisco California 94121
UCSF PHP, Gen. Internal Medicine Practice CRS San Francisco California 94143
Castro-Mission Health Ctr. CRS San Francisco California 94144
Dr. Virginia Cafaro Med. Practice CRS San Francisco California
Denver Infectious Diseases Consultants CRS Denver Colorado 80204-4507
Denver Public Health CRS Denver Colorado
Univ. of Colorado Health Science Ctr. CRS Denver Colorado
Whitman-Walker Clinic CRS Washington D.C. District of Columbia 20009
George Washington Univ. Med. Ctr. Infectious Diseases - Clinical Trials Unit CRS Washington D.C. District of Columbia 20037
Walter Reed Army Med. Ctr., Infectious Disease Clinic CRS Washington D.C. District of Columbia 20307
Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS Washington D.C. District of Columbia 20422
Dr. Timothy A. Price Med. Practice CRS Washington D.C. District of Columbia
Miami VAMC CRS Miami Florida 33125
Univ. of Miami, Infectious Diseases Clinical Research Unit CRS Miami Florida 33136
ARCA, Central Clinc CRS Atlanta Georgia 30308
Emory Univ. Crawford Long Hosp. CRS Atlanta Georgia 30308
Atlanta VAMC CRS Decatur Georgia 30033
Klein & Slotten Medical Associates CRS Chicago Illinois 60610
Jesse Brown VAMC CRS Chicago Illinois 60612
Univ. of Illinois Family Ctr. for Infectious Disease CRS Chicago Illinois 60612
Lakeshore Infectious Disease Associates CRS Chicago Illinois 60657
North Side Family Medicine CRS Chicago Illinois 60657
Northwestern Memorial Physicians Group CRS Chicago Illinois 60657
Med. Ctr. of Louisiana at New Orleans, HIV Outpatient Clinics CRS New Orleans Louisiana 70112
Tulane University Health Sciences Center, Louisiana Community AIDS Research Program(LaCARP) CRS New Orleans Louisiana 70112
New Orleans VAMC CRS New Orleans Louisiana 70146
NIH Clinical Ctr., NIAID HIV Clinic CRS Bethesda Maryland 20814-9692
National Naval Med. Ctr., Infectious Diseases Special Immunology Clinic CRS Bethesda Maryland 208995000
Henry Ford Hosp. CRS Detroit Michigan
Wayne State Univ. CRS Detroit Michigan
St. John Hosp. & Med. Ctr., Infectious Diseases Dept. CRS Grosse Pointe Woods Michigan 48236
William Beaumont Hosp., Infectious Disease Research CRS Royal Oak Michigan 48073
Abbott Northwestern Hosp., Clinic 42 CRS Minneapolis Minnesota 55404
Mayo Clinic INSIGHT CRS Rochester Minnesota 55905
Cooper Univ. Hosp. CRS Camden New Jersey 07754
ID Care Inc. - Hillsborough CRS Hillsborough New Jersey 08844
Jersey Shore Univ. Med. Ctr. CRS Neptune City New Jersey 07754
New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS Newark New Jersey 07103
Cathedral Healthcare System, St. Michael's Med. Ctr. CRS Newark New Jersey
St. Joseph's Hosp. & Med. Ctr. of New Jersey CRS Paterson New Jersey
Raritan Bay Med. Ctr., Perth Amboy Division CRS Perth Amboy New Jersey 08861
ID Care - Randolph CRS Randolph Township New Jersey 07869
Infectious Disease Specialists of N.J., North Jersey Community Research Initiative CRS Union New Jersey 07083
The Early Intervention Program at Kennedy Hosp. CRS Voorhees Township New Jersey 08043
St. Vincent Hosp. & Med. Ctr. CRS New York New York 10011
Harlem Hospital Ctr./Columbia University CRS (Gordin CTU) New York New York 10037
Jacobi Med. Ctr., Ambulatory Care Pavillion CRS The Bronx New York 10461
Bronx VAMC CRS The Bronx New York 10468
Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS Portland Oregon 97201
Multnomah County Health Dept., HIV Health Services Ctr. CRS Portland Oregon 97204
The Research & Education Group-Portland CRS Portland Oregon 97209
Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS Portland Oregon 97213
Kaiser Immune Deficiency Clinic of Portland CRS Portland Oregon 97227
Legacy Clinic Emanuel CRS Portland Oregon 97301
Salem Hosp. CRS Salem Oregon 97301
Kaiser Permanente Lancaster Clinic CRS Salem Oregon 97305
Temple Univ. School of Medicine CRS Philadelphia Pennsylvania 19140
Michael E. DeBakey VAMC CRS Houston Texas 77030
Northwest Clinic CRS Houston Texas 77030
Thomas Street Clinic CRS Houston Texas 77030
Univ. Clinical Research Ctr., Memorial Hermann Hosp. CRS Houston Texas 77030
Legacy Community Health Services, Inc., Montrose Clinic, Inc. Houston Texas
South Texas Veterans Health Care System, Immunosuppression Clinic CRS San Antonio Texas 78284
Hanover Med. Park (Mechanicsville, VA) CRS Mechanicsville Virginia 23116
Naval Med. Ctr. Portsmouth CRS Portsmouth Virginia 23708
CrossOver Health Ctr. CRS Richmond Virginia 23224
South Richmond Health Care Ctr. CRS Richmond Virginia 23224
Hunter Holmes McGuire VAMC CRS Richmond Virginia 23249
Virginia Commonwealth Univ. Medical Ctr. CRS Richmond Virginia

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 170 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00004978, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 4, 2021 · Synced May 20, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00004978 live on ClinicalTrials.gov.

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