Overview

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

Status:
Completed
Trial end date:
2008-11-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:
Chiron Corporation
Treatments:
Aldesleukin
Interleukin-2
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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