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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00004978

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

4150

Starts

2000-03-01

Expected to finish

2008-11-01

Last updated by the study team

2021-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV positive
• Have a CD4 cell count of 300 cells/mm3 or more within 45 days of study entry
• Are on combination anti-HIV therapy or are beginning anti-HIV therapy at the time of study entry
• Are at least 18 years old

You may not qualify if…

• Have received IL-2 before
• Have cancer requiring chemotherapy
• Have evidence of active clinical disease within the past year for any AIDS-defining illness or certain other conditions such as herpes zoster or Chagas disease. (This study has been changed. Previously, patients were ineligible if they had a history of any AIDS-defining illness or certain other conditions.)
• Have used certain medications, such as corticosteroids or drugs affecting the immune system, in the 45 days before study entry
• Have a nervous system disorder requiring antiseizure medication
• Have an autoimmune or inflammatory disease such as inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), psoriasis, optic neuritis, or any autoimmune/inflammatory diseases with potentially life-threatening complications
• Are pregnant or breastfeeding

Where it is running

• Dr. M. Estes Med. Practice CRS — Mill Valley, California, United States
• Dr. Robert Scott Med. Practice CRS — Oakland, California, United States
• East Bay AIDS Ctr. CRS — Oakland, California, United States
• Dr. Shawn Hassler Med. Practice CRS — San Francisco, California, United States
• Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS — San Francisco, California, United States
• Positive Health Practice West/ Dr. Steve Deeks CRS — San Francisco, California, United States
• Dr. William Owen Med. Practice CRS — San Francisco, California, United States
• Dr. Martin Mass Med. Practice CRS — San Francisco, California, United States
• San Francisco VAMC, Infectious Diseases Clinic CRS — San Francisco, California, United States
• UCSF PHP, Gen. Internal Medicine Practice CRS — San Francisco, California, United States
• Castro-Mission Health Ctr. CRS — San Francisco, California, United States
• Dr. Virginia Cafaro Med. Practice CRS — San Francisco, California, United States
• Denver Infectious Diseases Consultants CRS — Denver, Colorado, United States
• Denver Public Health CRS — Denver, Colorado, United States
• Univ. of Colorado Health Science Ctr. CRS — Denver, Colorado, United States
• Whitman-Walker Clinic CRS — Washington D.C., District of Columbia, United States
• George Washington Univ. Med. Ctr. Infectious Diseases - Clinical Trials Unit CRS — Washington D.C., District of Columbia, United States
• Walter Reed Army Med. Ctr., Infectious Disease Clinic CRS — Washington D.C., District of Columbia, United States
• Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS — Washington D.C., District of Columbia, United States
• Dr. Timothy A. Price Med. Practice CRS — Washington D.C., District of Columbia, United States
• Miami VAMC CRS — Miami, Florida, United States
• Univ. of Miami, Infectious Diseases Clinical Research Unit CRS — Miami, Florida, United States
• ARCA, Central Clinc CRS — Atlanta, Georgia, United States
• Emory Univ. Crawford Long Hosp. CRS — Atlanta, Georgia, United States
• VA Greater Los Angeles Healthcare System, Infectious Diseases Section CRS — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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