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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 (ESPRIT)
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.
Details
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 4150 |
| Start date | 2000-03 |
| Completion | 2008-11 |
Conditions
- HIV Infections
Interventions
- Recombinant interleukin-2 (rIL-2)
Primary outcomes
- New or Recurrent HIV Disease Progression Event Including Death — from randomization through study end - median of 7.6 years follow-up
Participants who die or experience at least one: any CDC Category C 1993 AIDS-defining events or one of the following: invasive aspergillosis, bartonellosis, Chagas disease, Herpes zoster, visceral Leishmaniasis, Hodgkin's lymphoma, non-Hodgkin's lymphoma (all cell types), microsporidiosis, nocardiosis, disseminated Penicillium marneffii, extrapulmonary Pneumocystis carinii, and Rhodococcus equi disease
Countries
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, France, Germany, Ireland, Israel, Italy, Japan, Morocco, Netherlands, Norway, Poland, Portugal, Singapore, Spain, Sweden, Switzerland, Thailand, United Kingdom