An International Study to Evaluate Recombinant Interleukin-2 in HIV Positive Patients Taking Anti-retroviral Therapy
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.
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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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to see if it is effective to give HIV positive patients recombinant interleukin-2 (rIL-2) in addition to anti-HIV therapy. Patients will be followed over a minimum of 4 years to study the long-term effects of rIL-2 on their HIV disease progression. Anti-HIV therapy has been very successful in treating HIV positive patients and in keeping viral load (level of HIV in the blood) low. However, anti-HIV drugs cannot completely rid the body of the virus, and the immune system is never completely restored in HIV positive patients. Doctors hope that giving patients recombinant interleukin-2 (rIL-2) in addition to their anti-HIV therapy will help improve their immune systems and keep them healthier over a longer period of time. rIL-2 is a hormone naturally produced by the body during an immune response to a microbial infection.
Study identification
- NCT ID
- NCT00004978
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 4,150 participants
Conditions and interventions
Conditions
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
- Mar 2000 (Type not available)
- Primary completion
- Nov 2008 (Actual)
- Completion
- Nov 2008 (Actual)
- Last update posted
- Nov 5, 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 5, 2021 · Synced Nov 4, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00004978 live on ClinicalTrials.gov.