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STALWART: A Randomized, Open-Label, International Study of Subcutaneous Recombinant Interleukin-2 With and Without Concomitant Antiretroviral Therapy in Patients With HIV-1 Infection and CD4+ Cell Counts of 300 Cells/mm3 or More
The purpose of this study is to determine the effect of short cycles of recombinant interleukin-2 (also known as rIL-2 or aldesleukin) given with or without anti-HIV drugs in HIV infected patients. The effects will be compared with a study group that receives no IL-2 or antiretroviral therapy. Study hypothesis: Intermittent aldesleukin, when given without antiretroviral therapy to patients with early HIV infection, will produce no change in HIV viral load and increases in CD4+ T lymphocyte counts comparable to aldesleukin administered with antiretrovirals.
Details
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 267 |
| Start date | 2005-09 |
| Completion | 2011-02 |
Conditions
- HIV Infections
Interventions
- IL-2
Primary outcomes
- Mean Change in CD4+ T Lymphocyte Count — Week 32
Change in CD4 count from baseline to week 32.
Countries
United States, Argentina, Australia, Chile, Italy, Morocco, Poland, Portugal, Spain, Thailand, United Kingdom